Gynecology

An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.

The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.

But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.

Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.

The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)

Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."

One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."

The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.

The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.

"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."

Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.

The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.

"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.

"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.

On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.

The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.

The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.

emechcatie@frontlinemedcom.com

An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.

The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.

But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.

Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.

The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)

Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."

One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."

The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.

The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.

"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."

Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.

The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.

"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.

"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.

On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.

The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.

The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.

emechcatie@frontlinemedcom.com

An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.

The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.

But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.

Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.

The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)

Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."

One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."

The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.

The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.

"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."

Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.

The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.

"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.

"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.

On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.

The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.

The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.

emechcatie@frontlinemedcom.com

An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.

The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.

But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.

Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.

The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)

Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."

One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."

The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.

The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.

"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."

Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.

The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.

"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.

"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.

On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.

The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.

The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.

emechcatie@frontlinemedcom.com

An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.

The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.

But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.

Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.

The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)

Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."

One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."

The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.

The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.

"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."

Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.

The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.

"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.

"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.

On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.

The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.

The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.

emechcatie@frontlinemedcom.com

An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.

The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.

But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.

Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.

The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)

Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."

One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."

The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.

The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.

"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."

Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.

The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.

"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.

"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.

On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.

The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.

The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.

emechcatie@frontlinemedcom.com

Allogeneic hematopoietic stem cell transplantation from HIV-naive individuals to HIV-1–positive individuals may achieve temporary antiretroviral-free remission of infection and loss of detectable HIV-1, a study showed.

Two men with chronic HIV-1 infection received allogeneic hematopoietic stem cell transplants (HSCTs) from susceptible donors to treat Hodgkin’s and non-Hodgkin’s lymphoma, and achieved temporary remission of HIV despite stopping antiretroviral therapy (ART), with the virus undetectable in both blood and rectal mucosa.

© Dr. A. Harrison; Dr. P. Feorino / CDC

However, both experienced viral rebound – one at 12 weeks after stopping ART and one at 32 weeks – with both developing the usual symptoms of acute retroviral syndrome, according to a paper published online July 22 in the Annals of Internal Medicine.

"In summary, our results suggest that allogeneic HSCT with CCR5 wild-type donor cells may lead to loss of detectable HIV-1 from blood and rectal mucosa, but viral rebound may nevertheless occur after ART interruption despite a significant reduction in reservoir size," wrote Dr. Timothy J. Henrich of Brigham and Women’s Hospital, Boston, and his colleagues.

The researchers had previously reported the reduction in peripheral blood HIV-1 reservoirs in these two patients (Ann. Intern. Med. 2014 July 22 [doi:10.7326/M14-1027]).

"However, extensive sampling of tissues and large numbers of peripheral blood mononuclear cells for the presence of HIV-1 is necessary to understand the full effect of allogeneic HSCT on HIV-1 persistence," they wrote, arguing that treatment interruption was also necessary to establish if the virus was in remission.

Antiretroviral-free remission had previously been achieved in a patient who received an HSCT from a donor with a homozygous 32–base pair deletion in the gene encoding CCR5, a coreceptor for HIV-1. In this patient – known as "the Berlin patient" – remission has been maintained for more than 7 years, representing the only known functional cure of HIV infection.

The authors of the study suggested that while allogeneic HSCT may lead to significant and sustained reductions in the HIV-1 reservoir, the virus appears to persist in infected tissue or bound into cells, and those small numbers of infected cells were enough to restart HIV-1 replication.

Although both patients did experience rebound infection, that occurred much slower than it would have under normal circumstances, the authors said.

"Despite frequent sampling, neither of our patients had detectable HIV-1 in [peripheral blood mononuclear cells] or plasma for several months after ART discontinuation before viral rebound," they wrote.

Both patients received treatment for graft versus host disease after the transplant.

The study was supported by the Foundation for AIDS Research and the National Institute of Allergy and Infectious Diseases. Dr. Henrich had no disclosures. Some of the study’s other authors, as well as the editorial author, Dr. Lewin, declared grant support, speakers fees, and consulting fees from agencies and pharmaceutical companies.

Allogeneic hematopoietic stem cell transplantation from HIV-naive individuals to HIV-1–positive individuals may achieve temporary antiretroviral-free remission of infection and loss of detectable HIV-1, a study showed.

Two men with chronic HIV-1 infection received allogeneic hematopoietic stem cell transplants (HSCTs) from susceptible donors to treat Hodgkin’s and non-Hodgkin’s lymphoma, and achieved temporary remission of HIV despite stopping antiretroviral therapy (ART), with the virus undetectable in both blood and rectal mucosa.

© Dr. A. Harrison; Dr. P. Feorino / CDC

However, both experienced viral rebound – one at 12 weeks after stopping ART and one at 32 weeks – with both developing the usual symptoms of acute retroviral syndrome, according to a paper published online July 22 in the Annals of Internal Medicine.

"In summary, our results suggest that allogeneic HSCT with CCR5 wild-type donor cells may lead to loss of detectable HIV-1 from blood and rectal mucosa, but viral rebound may nevertheless occur after ART interruption despite a significant reduction in reservoir size," wrote Dr. Timothy J. Henrich of Brigham and Women’s Hospital, Boston, and his colleagues.

The researchers had previously reported the reduction in peripheral blood HIV-1 reservoirs in these two patients (Ann. Intern. Med. 2014 July 22 [doi:10.7326/M14-1027]).

"However, extensive sampling of tissues and large numbers of peripheral blood mononuclear cells for the presence of HIV-1 is necessary to understand the full effect of allogeneic HSCT on HIV-1 persistence," they wrote, arguing that treatment interruption was also necessary to establish if the virus was in remission.

Antiretroviral-free remission had previously been achieved in a patient who received an HSCT from a donor with a homozygous 32–base pair deletion in the gene encoding CCR5, a coreceptor for HIV-1. In this patient – known as "the Berlin patient" – remission has been maintained for more than 7 years, representing the only known functional cure of HIV infection.

The authors of the study suggested that while allogeneic HSCT may lead to significant and sustained reductions in the HIV-1 reservoir, the virus appears to persist in infected tissue or bound into cells, and those small numbers of infected cells were enough to restart HIV-1 replication.

Although both patients did experience rebound infection, that occurred much slower than it would have under normal circumstances, the authors said.

"Despite frequent sampling, neither of our patients had detectable HIV-1 in [peripheral blood mononuclear cells] or plasma for several months after ART discontinuation before viral rebound," they wrote.

Both patients received treatment for graft versus host disease after the transplant.

The study was supported by the Foundation for AIDS Research and the National Institute of Allergy and Infectious Diseases. Dr. Henrich had no disclosures. Some of the study’s other authors, as well as the editorial author, Dr. Lewin, declared grant support, speakers fees, and consulting fees from agencies and pharmaceutical companies.

Allogeneic hematopoietic stem cell transplantation from HIV-naive individuals to HIV-1–positive individuals may achieve temporary antiretroviral-free remission of infection and loss of detectable HIV-1, a study showed.

Two men with chronic HIV-1 infection received allogeneic hematopoietic stem cell transplants (HSCTs) from susceptible donors to treat Hodgkin’s and non-Hodgkin’s lymphoma, and achieved temporary remission of HIV despite stopping antiretroviral therapy (ART), with the virus undetectable in both blood and rectal mucosa.

© Dr. A. Harrison; Dr. P. Feorino / CDC

However, both experienced viral rebound – one at 12 weeks after stopping ART and one at 32 weeks – with both developing the usual symptoms of acute retroviral syndrome, according to a paper published online July 22 in the Annals of Internal Medicine.

"In summary, our results suggest that allogeneic HSCT with CCR5 wild-type donor cells may lead to loss of detectable HIV-1 from blood and rectal mucosa, but viral rebound may nevertheless occur after ART interruption despite a significant reduction in reservoir size," wrote Dr. Timothy J. Henrich of Brigham and Women’s Hospital, Boston, and his colleagues.

The researchers had previously reported the reduction in peripheral blood HIV-1 reservoirs in these two patients (Ann. Intern. Med. 2014 July 22 [doi:10.7326/M14-1027]).

"However, extensive sampling of tissues and large numbers of peripheral blood mononuclear cells for the presence of HIV-1 is necessary to understand the full effect of allogeneic HSCT on HIV-1 persistence," they wrote, arguing that treatment interruption was also necessary to establish if the virus was in remission.

Antiretroviral-free remission had previously been achieved in a patient who received an HSCT from a donor with a homozygous 32–base pair deletion in the gene encoding CCR5, a coreceptor for HIV-1. In this patient – known as "the Berlin patient" – remission has been maintained for more than 7 years, representing the only known functional cure of HIV infection.

The authors of the study suggested that while allogeneic HSCT may lead to significant and sustained reductions in the HIV-1 reservoir, the virus appears to persist in infected tissue or bound into cells, and those small numbers of infected cells were enough to restart HIV-1 replication.

Although both patients did experience rebound infection, that occurred much slower than it would have under normal circumstances, the authors said.

"Despite frequent sampling, neither of our patients had detectable HIV-1 in [peripheral blood mononuclear cells] or plasma for several months after ART discontinuation before viral rebound," they wrote.

Both patients received treatment for graft versus host disease after the transplant.

The study was supported by the Foundation for AIDS Research and the National Institute of Allergy and Infectious Diseases. Dr. Henrich had no disclosures. Some of the study’s other authors, as well as the editorial author, Dr. Lewin, declared grant support, speakers fees, and consulting fees from agencies and pharmaceutical companies.

It may be months, even years before it’s clear whether access to and payment for contraception will be limited in the wake of the U.S. Supreme Court’s decision that for-profit companies can forego health insurance coverage of birth control methods that violate their religious belief.

At this point, only the two plaintiffs in the case – Hobby Lobby and Conestoga Wood Specialties – can change their health insurance coverage of contraception, based on the June 30 decision by the U.S. Supreme Court.

Courtesy Physicians for Reproductive Health

In the meantime, there is a lot of confusion among patients – and uncertainty among doctors -- about what the ruling means.

"We’re all scratching our heads and saying, ‘Now what?’ " said Dr. Anne Davis, medical director of Physicians for Reproductive Health. "All of us are very used to hurdles with coverage, but this is a new one."

Now, ob.gyns and other physicians may have to figure out if a patient works for an employer whose insurance will not cover certain types of contraception, or perhaps all birth control, said Dr. Davis of the department of clinical obstetrics and gynecology at Columbia University, New York.

The Supreme Court ruling is "a huge step backward," said Dr. Eve Espey, chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. For physicians, a key concern is whether they will be paid for inserting an IUD or providing another service; for patients, it’s whether they can get the contraception and if they can afford it, she said.

When concerns mount, "those services tend to not happen," Dr. Espey said.

Ob.gyns. also expressed concern that the ruling had opened the door to interference in the physician-patient relationship.

Clinicians need the freedom to select the birth control method that makes the most sense for the patient, said Dr. Davis. "It’s going to be really unfortunate if you and the patient agree, and it’s the right thing and you find out that her employer has decided it’s not the right kind of birth control because of their beliefs," she said.

Dr. Jeanne Conry, immediate past president of the American Congress of Obstetricians and Gynecologists (ACOG), said that if she has decided that an IUD is best for a 34-year-old diabetic patient, but her employer says it won’t pay for that method, "that’s not in her best interest."

"They’ve just interfered with my best treatment for the patient," said Dr. Conry, an ob.gyn with Kaiser Permanente in Roseville, Calif.

Courtesy ACOG

Dr. Mitchell Creinin, chair of the obstetrics and gynecology department at University of California, Davis, said that the ruling could return contraception to a means-tested environment, in which only those who have the means will get the most effective methods, like the IUD. Instead, he said, it should be a benefit for all. Preventing pregnancy "is a public health issue and we’ve got to look at it that way," Dr. Creinin said.

Just after the ruling, ACOG President John Jennings agreed, expressing dismay that the Court was overlooking what had been firmly established. "The value of family planning – including contraception – has been clearly demonstrated," he said, in a statement.

But pro-life groups, including Americans United for Life and the Association of Pro-Life Obstetricians and Gynecologists, applauded the Hobby Lobby decision, saying that it helps preserve the right to practice according to conscience.

"Respect for the constitutionally guaranteed rights of conscience – whether held by business owners or medical professionals – must and should be protected," said Dr. Monique Chireau, AUL board member, with the department of ob.gyn at Duke University, Durham, N.C.

Dr. Gene Rudd, senior vice president for the Christian Medical and Dental Associations (CMDA), said that he did not think the decision would have any direct impact on ob.gyns.’ practices. However, he said, "Had the Justices allowed the government to force business owners to act against their conscience, that could establish a legal precedent by which the government might one day force physicians to act against their consciences."

The CMDA’s membership view the ACA’s mandate that women receive contraceptives free of charge as a potential infringement on their right to practice according to their beliefs, said Dr. Rudd, an ob.gyn.

In a CMDA survey, "95% of our members said they’d leave medicine before being required to violate their conscience," he said. They want "women free to pursue getting the contraceptive of their choice," but not to force either individual physicians or religiously affiliated organizations or small private employers to do things that are against their beliefs.

Who might be affected?

For now, there is no definitive answer on how many women could potentially lose coverage of contraception as a result of the Supreme Court decision. Hobby Lobby has 500 stores and 13,000 employees. Conestoga Wood Specialties has 950 employees. There are 90-100 cases challenging the contraception requirement, with about half them from nonprofit organizations and half from for-profit companies. And there’s motivation to sue: Companies that do not comply with the ACA requirement face fines of $100 per day per enrollee.

According to the Dept. of Health & Human Services, about 48 million women are eligible for preventive services because they are in "non-grandfathered" health plans.

Millions of women receive family planning services outside of employer-sponsored insurance, and thus may not be directly affected. A Guttmacher Institute report shows that 19 million women need publicly funded services and supplies because they are low income or are assumed to have a low income because they are under age 20 years. Family planning services provided through federal and state government funding helped women avoid 2.2 million unintended pregnancies in 2010, according to Guttmacher.

Reversing the decision

A handful of Democrats in the House and Senate introduced legislation July 9 to reverse the Supreme Court’s decision. The Protect Women's Health From Corporate Interference Act, introduced by Sen. Patty Murray (D-Wash.), would eliminate the loophole given by the court to companies that are not religiously affiliated.

ACOG praised the effort and applauded the legislators "for recognizing that contraceptives and other essential health care services should not be treated differently than other forms of health care.

"We look forward to working with them and other Congressional leaders to ensure that the ability of physicians to provide care for women is no longer subject to outside interference," Dr. Jennings said in a statement.

The White House said in an official Statement of Administration Policy that it strongly supported the legislation, saying that it "would prevent owners of for-profit companies from asserting their personal religious views to deny their employees federally-required health benefits."

Senate Democrats attempted to bring the bill to the floor on July 16, but failed to secure enough votes for debate. Republican Senators in the meantime introduced their own legislation to guarantee that employers could not bar "access" to contraceptives. The Preserving Religious Freedom and a Woman’s Access to Contraception Act (S. 2605) was introduced by Sen. Kelly Ayotte (R-N.H.).

Neither of the bills are expected to gain much traction in either the Senate or the House.

ACOG has asked its members to report coverage problems to their regional chapters, Dr. Conry said.

The federal government also could pursue several methods of reinstating the coverage. It could give for-profit employers the same accommodation that it has given nonprofit religiously affiliated employers like schools or charities. If these employers self-attest that paying for birth control violates their beliefs, then the employer’s insurer pays for the contraception. For self-insured employers, the exemption is not as easily navigated, because they would have to pay for the coverage.

That accommodation is being challenged by at least 45 legal cases that argue filling out the form violates plaintiffs’ religious beliefs because it means they are facilitating access to birth control.

The government could also pay directly for contraception for women whose employers receive an exemption. Supreme Court Justice Samuel Alito suggested such a possibility in his majority opinion in the Hobby Lobby case.

Dr. Davis said that, ideally, gynecologists would be able to give patients the contraception of choice on the same day of a visit and that the physician would be reimbursed for the cost of the device plus a fee for placing it. And, physicians should be able to counsel patients without thought of potential oversight from an employer or anyone else.

But, she said, "We are very far away from that right now."

aault@frontlinemedcom.com

On Twitter @aliciaault

It may be months, even years before it’s clear whether access to and payment for contraception will be limited in the wake of the U.S. Supreme Court’s decision that for-profit companies can forego health insurance coverage of birth control methods that violate their religious belief.

At this point, only the two plaintiffs in the case – Hobby Lobby and Conestoga Wood Specialties – can change their health insurance coverage of contraception, based on the June 30 decision by the U.S. Supreme Court.

Courtesy Physicians for Reproductive Health

In the meantime, there is a lot of confusion among patients – and uncertainty among doctors -- about what the ruling means.

"We’re all scratching our heads and saying, ‘Now what?’ " said Dr. Anne Davis, medical director of Physicians for Reproductive Health. "All of us are very used to hurdles with coverage, but this is a new one."

Now, ob.gyns and other physicians may have to figure out if a patient works for an employer whose insurance will not cover certain types of contraception, or perhaps all birth control, said Dr. Davis of the department of clinical obstetrics and gynecology at Columbia University, New York.

The Supreme Court ruling is "a huge step backward," said Dr. Eve Espey, chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. For physicians, a key concern is whether they will be paid for inserting an IUD or providing another service; for patients, it’s whether they can get the contraception and if they can afford it, she said.

When concerns mount, "those services tend to not happen," Dr. Espey said.

Ob.gyns. also expressed concern that the ruling had opened the door to interference in the physician-patient relationship.

Clinicians need the freedom to select the birth control method that makes the most sense for the patient, said Dr. Davis. "It’s going to be really unfortunate if you and the patient agree, and it’s the right thing and you find out that her employer has decided it’s not the right kind of birth control because of their beliefs," she said.

Dr. Jeanne Conry, immediate past president of the American Congress of Obstetricians and Gynecologists (ACOG), said that if she has decided that an IUD is best for a 34-year-old diabetic patient, but her employer says it won’t pay for that method, "that’s not in her best interest."

"They’ve just interfered with my best treatment for the patient," said Dr. Conry, an ob.gyn with Kaiser Permanente in Roseville, Calif.

Courtesy ACOG

Dr. Mitchell Creinin, chair of the obstetrics and gynecology department at University of California, Davis, said that the ruling could return contraception to a means-tested environment, in which only those who have the means will get the most effective methods, like the IUD. Instead, he said, it should be a benefit for all. Preventing pregnancy "is a public health issue and we’ve got to look at it that way," Dr. Creinin said.

Just after the ruling, ACOG President John Jennings agreed, expressing dismay that the Court was overlooking what had been firmly established. "The value of family planning – including contraception – has been clearly demonstrated," he said, in a statement.

But pro-life groups, including Americans United for Life and the Association of Pro-Life Obstetricians and Gynecologists, applauded the Hobby Lobby decision, saying that it helps preserve the right to practice according to conscience.

"Respect for the constitutionally guaranteed rights of conscience – whether held by business owners or medical professionals – must and should be protected," said Dr. Monique Chireau, AUL board member, with the department of ob.gyn at Duke University, Durham, N.C.

Dr. Gene Rudd, senior vice president for the Christian Medical and Dental Associations (CMDA), said that he did not think the decision would have any direct impact on ob.gyns.’ practices. However, he said, "Had the Justices allowed the government to force business owners to act against their conscience, that could establish a legal precedent by which the government might one day force physicians to act against their consciences."

The CMDA’s membership view the ACA’s mandate that women receive contraceptives free of charge as a potential infringement on their right to practice according to their beliefs, said Dr. Rudd, an ob.gyn.

In a CMDA survey, "95% of our members said they’d leave medicine before being required to violate their conscience," he said. They want "women free to pursue getting the contraceptive of their choice," but not to force either individual physicians or religiously affiliated organizations or small private employers to do things that are against their beliefs.

Who might be affected?

For now, there is no definitive answer on how many women could potentially lose coverage of contraception as a result of the Supreme Court decision. Hobby Lobby has 500 stores and 13,000 employees. Conestoga Wood Specialties has 950 employees. There are 90-100 cases challenging the contraception requirement, with about half them from nonprofit organizations and half from for-profit companies. And there’s motivation to sue: Companies that do not comply with the ACA requirement face fines of $100 per day per enrollee.

According to the Dept. of Health & Human Services, about 48 million women are eligible for preventive services because they are in "non-grandfathered" health plans.

Millions of women receive family planning services outside of employer-sponsored insurance, and thus may not be directly affected. A Guttmacher Institute report shows that 19 million women need publicly funded services and supplies because they are low income or are assumed to have a low income because they are under age 20 years. Family planning services provided through federal and state government funding helped women avoid 2.2 million unintended pregnancies in 2010, according to Guttmacher.

Reversing the decision

A handful of Democrats in the House and Senate introduced legislation July 9 to reverse the Supreme Court’s decision. The Protect Women's Health From Corporate Interference Act, introduced by Sen. Patty Murray (D-Wash.), would eliminate the loophole given by the court to companies that are not religiously affiliated.

ACOG praised the effort and applauded the legislators "for recognizing that contraceptives and other essential health care services should not be treated differently than other forms of health care.

"We look forward to working with them and other Congressional leaders to ensure that the ability of physicians to provide care for women is no longer subject to outside interference," Dr. Jennings said in a statement.

The White House said in an official Statement of Administration Policy that it strongly supported the legislation, saying that it "would prevent owners of for-profit companies from asserting their personal religious views to deny their employees federally-required health benefits."

Senate Democrats attempted to bring the bill to the floor on July 16, but failed to secure enough votes for debate. Republican Senators in the meantime introduced their own legislation to guarantee that employers could not bar "access" to contraceptives. The Preserving Religious Freedom and a Woman’s Access to Contraception Act (S. 2605) was introduced by Sen. Kelly Ayotte (R-N.H.).

Neither of the bills are expected to gain much traction in either the Senate or the House.

ACOG has asked its members to report coverage problems to their regional chapters, Dr. Conry said.

The federal government also could pursue several methods of reinstating the coverage. It could give for-profit employers the same accommodation that it has given nonprofit religiously affiliated employers like schools or charities. If these employers self-attest that paying for birth control violates their beliefs, then the employer’s insurer pays for the contraception. For self-insured employers, the exemption is not as easily navigated, because they would have to pay for the coverage.

That accommodation is being challenged by at least 45 legal cases that argue filling out the form violates plaintiffs’ religious beliefs because it means they are facilitating access to birth control.

The government could also pay directly for contraception for women whose employers receive an exemption. Supreme Court Justice Samuel Alito suggested such a possibility in his majority opinion in the Hobby Lobby case.

Dr. Davis said that, ideally, gynecologists would be able to give patients the contraception of choice on the same day of a visit and that the physician would be reimbursed for the cost of the device plus a fee for placing it. And, physicians should be able to counsel patients without thought of potential oversight from an employer or anyone else.

But, she said, "We are very far away from that right now."

aault@frontlinemedcom.com

On Twitter @aliciaault

It may be months, even years before it’s clear whether access to and payment for contraception will be limited in the wake of the U.S. Supreme Court’s decision that for-profit companies can forego health insurance coverage of birth control methods that violate their religious belief.

At this point, only the two plaintiffs in the case – Hobby Lobby and Conestoga Wood Specialties – can change their health insurance coverage of contraception, based on the June 30 decision by the U.S. Supreme Court.

Courtesy Physicians for Reproductive Health

In the meantime, there is a lot of confusion among patients – and uncertainty among doctors -- about what the ruling means.

"We’re all scratching our heads and saying, ‘Now what?’ " said Dr. Anne Davis, medical director of Physicians for Reproductive Health. "All of us are very used to hurdles with coverage, but this is a new one."

Now, ob.gyns and other physicians may have to figure out if a patient works for an employer whose insurance will not cover certain types of contraception, or perhaps all birth control, said Dr. Davis of the department of clinical obstetrics and gynecology at Columbia University, New York.

The Supreme Court ruling is "a huge step backward," said Dr. Eve Espey, chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. For physicians, a key concern is whether they will be paid for inserting an IUD or providing another service; for patients, it’s whether they can get the contraception and if they can afford it, she said.

When concerns mount, "those services tend to not happen," Dr. Espey said.

Ob.gyns. also expressed concern that the ruling had opened the door to interference in the physician-patient relationship.

Clinicians need the freedom to select the birth control method that makes the most sense for the patient, said Dr. Davis. "It’s going to be really unfortunate if you and the patient agree, and it’s the right thing and you find out that her employer has decided it’s not the right kind of birth control because of their beliefs," she said.

Dr. Jeanne Conry, immediate past president of the American Congress of Obstetricians and Gynecologists (ACOG), said that if she has decided that an IUD is best for a 34-year-old diabetic patient, but her employer says it won’t pay for that method, "that’s not in her best interest."

"They’ve just interfered with my best treatment for the patient," said Dr. Conry, an ob.gyn with Kaiser Permanente in Roseville, Calif.

Courtesy ACOG

Dr. Mitchell Creinin, chair of the obstetrics and gynecology department at University of California, Davis, said that the ruling could return contraception to a means-tested environment, in which only those who have the means will get the most effective methods, like the IUD. Instead, he said, it should be a benefit for all. Preventing pregnancy "is a public health issue and we’ve got to look at it that way," Dr. Creinin said.

Just after the ruling, ACOG President John Jennings agreed, expressing dismay that the Court was overlooking what had been firmly established. "The value of family planning – including contraception – has been clearly demonstrated," he said, in a statement.

But pro-life groups, including Americans United for Life and the Association of Pro-Life Obstetricians and Gynecologists, applauded the Hobby Lobby decision, saying that it helps preserve the right to practice according to conscience.

"Respect for the constitutionally guaranteed rights of conscience – whether held by business owners or medical professionals – must and should be protected," said Dr. Monique Chireau, AUL board member, with the department of ob.gyn at Duke University, Durham, N.C.

Dr. Gene Rudd, senior vice president for the Christian Medical and Dental Associations (CMDA), said that he did not think the decision would have any direct impact on ob.gyns.’ practices. However, he said, "Had the Justices allowed the government to force business owners to act against their conscience, that could establish a legal precedent by which the government might one day force physicians to act against their consciences."

The CMDA’s membership view the ACA’s mandate that women receive contraceptives free of charge as a potential infringement on their right to practice according to their beliefs, said Dr. Rudd, an ob.gyn.

In a CMDA survey, "95% of our members said they’d leave medicine before being required to violate their conscience," he said. They want "women free to pursue getting the contraceptive of their choice," but not to force either individual physicians or religiously affiliated organizations or small private employers to do things that are against their beliefs.

Who might be affected?

For now, there is no definitive answer on how many women could potentially lose coverage of contraception as a result of the Supreme Court decision. Hobby Lobby has 500 stores and 13,000 employees. Conestoga Wood Specialties has 950 employees. There are 90-100 cases challenging the contraception requirement, with about half them from nonprofit organizations and half from for-profit companies. And there’s motivation to sue: Companies that do not comply with the ACA requirement face fines of $100 per day per enrollee.

According to the Dept. of Health & Human Services, about 48 million women are eligible for preventive services because they are in "non-grandfathered" health plans.

Millions of women receive family planning services outside of employer-sponsored insurance, and thus may not be directly affected. A Guttmacher Institute report shows that 19 million women need publicly funded services and supplies because they are low income or are assumed to have a low income because they are under age 20 years. Family planning services provided through federal and state government funding helped women avoid 2.2 million unintended pregnancies in 2010, according to Guttmacher.

Reversing the decision

A handful of Democrats in the House and Senate introduced legislation July 9 to reverse the Supreme Court’s decision. The Protect Women's Health From Corporate Interference Act, introduced by Sen. Patty Murray (D-Wash.), would eliminate the loophole given by the court to companies that are not religiously affiliated.

ACOG praised the effort and applauded the legislators "for recognizing that contraceptives and other essential health care services should not be treated differently than other forms of health care.

"We look forward to working with them and other Congressional leaders to ensure that the ability of physicians to provide care for women is no longer subject to outside interference," Dr. Jennings said in a statement.

The White House said in an official Statement of Administration Policy that it strongly supported the legislation, saying that it "would prevent owners of for-profit companies from asserting their personal religious views to deny their employees federally-required health benefits."

Senate Democrats attempted to bring the bill to the floor on July 16, but failed to secure enough votes for debate. Republican Senators in the meantime introduced their own legislation to guarantee that employers could not bar "access" to contraceptives. The Preserving Religious Freedom and a Woman’s Access to Contraception Act (S. 2605) was introduced by Sen. Kelly Ayotte (R-N.H.).

Neither of the bills are expected to gain much traction in either the Senate or the House.

ACOG has asked its members to report coverage problems to their regional chapters, Dr. Conry said.

The federal government also could pursue several methods of reinstating the coverage. It could give for-profit employers the same accommodation that it has given nonprofit religiously affiliated employers like schools or charities. If these employers self-attest that paying for birth control violates their beliefs, then the employer’s insurer pays for the contraception. For self-insured employers, the exemption is not as easily navigated, because they would have to pay for the coverage.

That accommodation is being challenged by at least 45 legal cases that argue filling out the form violates plaintiffs’ religious beliefs because it means they are facilitating access to birth control.

The government could also pay directly for contraception for women whose employers receive an exemption. Supreme Court Justice Samuel Alito suggested such a possibility in his majority opinion in the Hobby Lobby case.

Dr. Davis said that, ideally, gynecologists would be able to give patients the contraception of choice on the same day of a visit and that the physician would be reimbursed for the cost of the device plus a fee for placing it. And, physicians should be able to counsel patients without thought of potential oversight from an employer or anyone else.

But, she said, "We are very far away from that right now."

aault@frontlinemedcom.com

On Twitter @aliciaault

MELBOURNE – Speakers at the opening plenary of the 20th International AIDS Conference struggled with their emotions as they paid tribute to colleagues – including former International AIDS Society President Dr. Joep Lange – who were killed when Malaysian Airlines flight MH17 crashed in Ukraine.

Dr. Lange was instrumental in research and implementation of mother-to-child transmission therapy, and as president of the society, showed a rare combination of enthusiasm, commitment, and perseverance, Lambert Grijns, Dutch Ambassador for Sexual and Reproductive Health and Rights and HIV/AIDS, said July 20.

Bianca Nogrady/Frontline Medical News

Dr. Lange’s partner, Jacqueline van Tongeren, of the Amsterdam Institute for Global Health and Development, also was killed in the incident, along with Lucie van Mens, who Mr. Grijns said had advocated the cause of sex workers at a time when few other were doing so.

"She was a driving force in advocacy for the female condom, she gave the product its rightful place in the field of sexual reproductive health and rights, and her impact will continue to be felt," Mr Grijns told the packed auditorium.

Other high-profile researchers on the flight included Martine de Schutter, program manager for Bridging The Gap, who Mr. Grijns said had been a staunch defender of human rights and the right to good health; Glenn Thomas from the World Health Organization’s communications team; and Pim de Kuijer, a prominent AIDS campaigner and lobbyist for Stop AIDS Now!

Prof. Françoise Barré-Sinoussi, IAS president and the director of the regulation of retroviral infections unit at the Institut Pasteur in Paris, called for a moment’s silence in their memory, during which the audience spontaneously rose to its feet.

"Our colleagues were traveling because of their dedication to bringing an end to AIDS, and our determination to continue their work honors their commitment," she said.

MELBOURNE – Speakers at the opening plenary of the 20th International AIDS Conference struggled with their emotions as they paid tribute to colleagues – including former International AIDS Society President Dr. Joep Lange – who were killed when Malaysian Airlines flight MH17 crashed in Ukraine.

Dr. Lange was instrumental in research and implementation of mother-to-child transmission therapy, and as president of the society, showed a rare combination of enthusiasm, commitment, and perseverance, Lambert Grijns, Dutch Ambassador for Sexual and Reproductive Health and Rights and HIV/AIDS, said July 20.

Bianca Nogrady/Frontline Medical News

Dr. Lange’s partner, Jacqueline van Tongeren, of the Amsterdam Institute for Global Health and Development, also was killed in the incident, along with Lucie van Mens, who Mr. Grijns said had advocated the cause of sex workers at a time when few other were doing so.

"She was a driving force in advocacy for the female condom, she gave the product its rightful place in the field of sexual reproductive health and rights, and her impact will continue to be felt," Mr Grijns told the packed auditorium.

Other high-profile researchers on the flight included Martine de Schutter, program manager for Bridging The Gap, who Mr. Grijns said had been a staunch defender of human rights and the right to good health; Glenn Thomas from the World Health Organization’s communications team; and Pim de Kuijer, a prominent AIDS campaigner and lobbyist for Stop AIDS Now!

Prof. Françoise Barré-Sinoussi, IAS president and the director of the regulation of retroviral infections unit at the Institut Pasteur in Paris, called for a moment’s silence in their memory, during which the audience spontaneously rose to its feet.

"Our colleagues were traveling because of their dedication to bringing an end to AIDS, and our determination to continue their work honors their commitment," she said.

MELBOURNE – Speakers at the opening plenary of the 20th International AIDS Conference struggled with their emotions as they paid tribute to colleagues – including former International AIDS Society President Dr. Joep Lange – who were killed when Malaysian Airlines flight MH17 crashed in Ukraine.

Dr. Lange was instrumental in research and implementation of mother-to-child transmission therapy, and as president of the society, showed a rare combination of enthusiasm, commitment, and perseverance, Lambert Grijns, Dutch Ambassador for Sexual and Reproductive Health and Rights and HIV/AIDS, said July 20.

Bianca Nogrady/Frontline Medical News

Dr. Lange’s partner, Jacqueline van Tongeren, of the Amsterdam Institute for Global Health and Development, also was killed in the incident, along with Lucie van Mens, who Mr. Grijns said had advocated the cause of sex workers at a time when few other were doing so.

"She was a driving force in advocacy for the female condom, she gave the product its rightful place in the field of sexual reproductive health and rights, and her impact will continue to be felt," Mr Grijns told the packed auditorium.

Other high-profile researchers on the flight included Martine de Schutter, program manager for Bridging The Gap, who Mr. Grijns said had been a staunch defender of human rights and the right to good health; Glenn Thomas from the World Health Organization’s communications team; and Pim de Kuijer, a prominent AIDS campaigner and lobbyist for Stop AIDS Now!

Prof. Françoise Barré-Sinoussi, IAS president and the director of the regulation of retroviral infections unit at the Institut Pasteur in Paris, called for a moment’s silence in their memory, during which the audience spontaneously rose to its feet.

"Our colleagues were traveling because of their dedication to bringing an end to AIDS, and our determination to continue their work honors their commitment," she said.

ATLANTA – A communitywide condom distribution program is proving successful for expanding access to and awareness of free condoms, and for reducing the incidence of sexually transmitted diseases among teens in Philadelphia.

The program, which includes the Philadelphia Freedom Condom program and Take Control Philly, is a comprehensive, youth-targeted STD prevention initiative launched in April 2011 by the Philadelphia Department of Public Health (PDPH). A 2013 assessment, including interviews with 301 black/African American and/or Hispanic/Latino individuals aged 13-24 years showed that knowledge of at least one aspect of the campaign had almost doubled since 2011, when baseline data were collected from 300 individuals in that age group (97% vs. 52%), Matthew Prior of the PDPH reported in a poster at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

CDC

Furthermore, 82% of respondents in 2013 vs. 18% in 2011 reported having seen information about the Freedom Condom program, 9% in 2013 vs. 1% in 2011 said they had received a free condom from a commercial business, and 70% in 2013 vs. 58% in 2011 knew where to get free condoms.

Although there was no significant change in reported condom use at last sexual encounter between 2011 and 2013, the overall number of gonorrhea cases declined significantly from approximately 1,600 cases in the first quarter of 2011 to approximately 1,400 cases in the first quarter of 2104; the greatest decline was among adolescents, who accounted for about 8% of cases in the first quarter of 2011 vs. about 5% in the first quarter of 2014, Mr. Prior found.

This followed a 38% increase in the number of gonorrhea cases among adolescents from 2009 to 2010, he noted.

The Freedom Condom program aimed to improve access to condoms, in part through a free condom mailing program, and Take Control Philly aimed to prevent STDs among adolescents through a sexual health awareness campaign and by addressing sexual risk-taking behaviors among a target population. Baseline data showed that 61% of adolescents surveyed had ever had sexual intercourse, 15% had sexual intercourse before the age of 13 years, 40.4% did not use a condom during their last sexual intercourse, and 27.2% had sexual intercourse with four or more persons during their lifetime.

"Multiple strategies were used to promote the Take Control Philly website and the Freedom Condom [program], including social media advertisement, traditional media advertisement, expanded condom distribution, community event outreach, and promotion in Philadelphia public high schools," Mr. Prior wrote.

Between April 2011 and 2014, more than 8.2 million condoms were distributed through the program. The success in promoting the program is due in part to the Philadelphia health commissioner and other city health leaders, whose support was pivotal to the planning and launch of the initiative, he noted.

Also, promotion of the program website through traditional media avenues and Facebook advertising was effective for increasing website traffic and condom mailing requests, he said.

"Communitywide condom distribution expansion is a promising approach for addressing STDs in youth," he concluded, adding that using multiple strategies for increasing program awareness is necessary for reaching youth.

Mr. Prior reported having no relevant financial disclosures.

ATLANTA – A communitywide condom distribution program is proving successful for expanding access to and awareness of free condoms, and for reducing the incidence of sexually transmitted diseases among teens in Philadelphia.

The program, which includes the Philadelphia Freedom Condom program and Take Control Philly, is a comprehensive, youth-targeted STD prevention initiative launched in April 2011 by the Philadelphia Department of Public Health (PDPH). A 2013 assessment, including interviews with 301 black/African American and/or Hispanic/Latino individuals aged 13-24 years showed that knowledge of at least one aspect of the campaign had almost doubled since 2011, when baseline data were collected from 300 individuals in that age group (97% vs. 52%), Matthew Prior of the PDPH reported in a poster at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

CDC

Furthermore, 82% of respondents in 2013 vs. 18% in 2011 reported having seen information about the Freedom Condom program, 9% in 2013 vs. 1% in 2011 said they had received a free condom from a commercial business, and 70% in 2013 vs. 58% in 2011 knew where to get free condoms.

Although there was no significant change in reported condom use at last sexual encounter between 2011 and 2013, the overall number of gonorrhea cases declined significantly from approximately 1,600 cases in the first quarter of 2011 to approximately 1,400 cases in the first quarter of 2104; the greatest decline was among adolescents, who accounted for about 8% of cases in the first quarter of 2011 vs. about 5% in the first quarter of 2014, Mr. Prior found.

This followed a 38% increase in the number of gonorrhea cases among adolescents from 2009 to 2010, he noted.

The Freedom Condom program aimed to improve access to condoms, in part through a free condom mailing program, and Take Control Philly aimed to prevent STDs among adolescents through a sexual health awareness campaign and by addressing sexual risk-taking behaviors among a target population. Baseline data showed that 61% of adolescents surveyed had ever had sexual intercourse, 15% had sexual intercourse before the age of 13 years, 40.4% did not use a condom during their last sexual intercourse, and 27.2% had sexual intercourse with four or more persons during their lifetime.

"Multiple strategies were used to promote the Take Control Philly website and the Freedom Condom [program], including social media advertisement, traditional media advertisement, expanded condom distribution, community event outreach, and promotion in Philadelphia public high schools," Mr. Prior wrote.

Between April 2011 and 2014, more than 8.2 million condoms were distributed through the program. The success in promoting the program is due in part to the Philadelphia health commissioner and other city health leaders, whose support was pivotal to the planning and launch of the initiative, he noted.

Also, promotion of the program website through traditional media avenues and Facebook advertising was effective for increasing website traffic and condom mailing requests, he said.

"Communitywide condom distribution expansion is a promising approach for addressing STDs in youth," he concluded, adding that using multiple strategies for increasing program awareness is necessary for reaching youth.

Mr. Prior reported having no relevant financial disclosures.

ATLANTA – A communitywide condom distribution program is proving successful for expanding access to and awareness of free condoms, and for reducing the incidence of sexually transmitted diseases among teens in Philadelphia.

The program, which includes the Philadelphia Freedom Condom program and Take Control Philly, is a comprehensive, youth-targeted STD prevention initiative launched in April 2011 by the Philadelphia Department of Public Health (PDPH). A 2013 assessment, including interviews with 301 black/African American and/or Hispanic/Latino individuals aged 13-24 years showed that knowledge of at least one aspect of the campaign had almost doubled since 2011, when baseline data were collected from 300 individuals in that age group (97% vs. 52%), Matthew Prior of the PDPH reported in a poster at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

CDC

Furthermore, 82% of respondents in 2013 vs. 18% in 2011 reported having seen information about the Freedom Condom program, 9% in 2013 vs. 1% in 2011 said they had received a free condom from a commercial business, and 70% in 2013 vs. 58% in 2011 knew where to get free condoms.

Although there was no significant change in reported condom use at last sexual encounter between 2011 and 2013, the overall number of gonorrhea cases declined significantly from approximately 1,600 cases in the first quarter of 2011 to approximately 1,400 cases in the first quarter of 2104; the greatest decline was among adolescents, who accounted for about 8% of cases in the first quarter of 2011 vs. about 5% in the first quarter of 2014, Mr. Prior found.

This followed a 38% increase in the number of gonorrhea cases among adolescents from 2009 to 2010, he noted.

The Freedom Condom program aimed to improve access to condoms, in part through a free condom mailing program, and Take Control Philly aimed to prevent STDs among adolescents through a sexual health awareness campaign and by addressing sexual risk-taking behaviors among a target population. Baseline data showed that 61% of adolescents surveyed had ever had sexual intercourse, 15% had sexual intercourse before the age of 13 years, 40.4% did not use a condom during their last sexual intercourse, and 27.2% had sexual intercourse with four or more persons during their lifetime.

"Multiple strategies were used to promote the Take Control Philly website and the Freedom Condom [program], including social media advertisement, traditional media advertisement, expanded condom distribution, community event outreach, and promotion in Philadelphia public high schools," Mr. Prior wrote.

Between April 2011 and 2014, more than 8.2 million condoms were distributed through the program. The success in promoting the program is due in part to the Philadelphia health commissioner and other city health leaders, whose support was pivotal to the planning and launch of the initiative, he noted.

Also, promotion of the program website through traditional media avenues and Facebook advertising was effective for increasing website traffic and condom mailing requests, he said.

"Communitywide condom distribution expansion is a promising approach for addressing STDs in youth," he concluded, adding that using multiple strategies for increasing program awareness is necessary for reaching youth.

Mr. Prior reported having no relevant financial disclosures.

SILVER SPRING, MD.  – A requirement for informed consent outlining the risks of morcellation of unsuspected malignancies in women treated with laparoscopic power morcellators for presumably benign fibroids was among the recommendations made by a Food and Drug Administration advisory panel.

On July 11, the second day of a two-day meeting of the FDA’s Obstetrics and Gynecology Devices Advisory Committee, panelists also supported adding a boxed warning to the labels of laparoscopic power morcellators (LPMs). Other suggestions and recommendations included identifying characteristics of patients or fibroids, physical exam findings, and other features that could help determine patients who may have a sarcoma before treatment, as well as strategies to mitigate risks during treatment.

"There should be some labeling or special controls" to ensure that women who are being considered for treatment with this device and their physicians "get the message that we do believe there is an increased risk" and that the device is contraindicated in patients with a known or suspected malignancy, said Dr. Carol Brown, a gynecologic cancer surgeon at Memorial Sloan Kettering Cancer Center, New York.

The advisory panel did not vote on any issues and was not asked whether LPMs should be taken off the market or reclassified as class III medical devices, which require clinical data for approval.

During testimony from women and relatives of those who had been diagnosed with stage 4 LMS after treatment that included morcellation for what was thought to be uterine fibroids, "a recurring theme" was that they had not been told that morcellation could be part of their treatment, and if they had known, they may not have agreed to that treatment and chosen an alternative, she pointed out.

The FDA convened the meeting to discuss the benefits, risks, and clinical role of LPMs in the treatment of women with uterine fibroids. Panelists also were told to discuss strategies that could be used to reduce the risks of morcellation disseminating cancerous tissue into the pelvis and abdomen of women with an unsuspected uterine sarcoma or leiomyosarcoma (LMS).

Concerns about this risk have received widespread attention this year. An FDA safety advisory was issued in April recommending that the use of LPMs during a hysterectomy or myomectomy in women with uterine fibroids be discouraged. The case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage 4 LMS after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids, also garnered media attention. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign highlighting these risks, calling for a ban on the use of LPMs. They -- along with women who have had similar experiences, and husbands and sisters of women who died of disseminated LMS after undergoing morcellation for what was thought to be benign fibroids -- also spoke at the meeting. These speakers emphasized that they are aware of at least 130 such cases, despite the small number of cases reported to the FDA (21 as of June 2014).

In April, the FDA recommended that physicians discuss alternative treatment options with women who have symptomatic uterine fibroids. If power morcellation is considered the best option, the agency advised, women should be informed that their fibroids may contain cancerous cells and, if so, morcellation could significantly worsen their prognosis. Among women who undergo a hysterectomy or myomectomy for a presumed fibroid, about one in 350 have a uterine sarcoma, and about one in 500 have a leiomyosarcoma (LMS), the FDA estimates.

The currently available LPMs that are "cleared" for gynecologic indications are regulated as moderate-risk class II devices, which require little or no clinical data. The agency is considering requiring that clinical data be provided for LPMs used for gynecologic indications.

Panelists said that features and tools that could help determine whether a patient could have a sarcoma include an older age, certain symptoms, and genetic susceptibility (a history of retinoblastoma), some imaging techniques, as well as a history of pelvic radiation.

Two panelists – a surgical oncologist and a bioethicist – said that LPMs should not be used for gynecologic indications until better data are available.

"I have not seen anything in isolation or together" that could help predict whether a woman with presumed uterine fibroids has a leiomyosarcoma, said Dr. Craig Shriver, professor of surgery and director of the John P. Murtha Cancer Center at Walter Reed National Navy Military Medical Center, Bethesda, Md.

Referring to the tenets of considering all masses as cancer until proven otherwise, he said, "I have been perplexed over the last two decades watching the introduction of laparoscopic power morcellation techniques that is totally anathema to these and my core principles as a cancer surgeon," he said. Two days of testimony have "only more strongly reaffirmed my commitment and belief that at present, there is no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery," he added. They should be withdrawn from the market, reclassified as class III devices and studied in clinical trials, he recommended.

But Dr. Brown said that while she agreed with those principles, since fibroids are so common, banning the use of morcellation could result in “hundreds of thousands” of hysterectomies.

Specimen collection bags were used when LPMs were first introduced for gynecologic indications, but dropped over time. Use has increased recently as a result of the increased attention to the risks, but there is no evidence that bags are effective in reducing the risk of disseminating malignant cells in the peritoneal cavity, in the case of an unsuspected malignancy.

“If you are going to morcellate, and it can be done safely in a bag, then that should be encouraged,” said panelist Dr. Keith Isaacson, medical director of the Center for Minimally Invasive Gynecologic Surgery at Newton (Mass.) Wellesley Hospital. More work is needed to evaluate bags and the techniques for their use, and to determine how easy it is train clinicians in how to use them safely, he added. “I still believe that intuitively – and that’s all we have is intuition here – that it more likely mitigates the risk of upstaging a tumor if you morcellate within a containment system, such as a bag.”

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts, although occasionally a panelist is given a waiver, but not at this meeting.

Adverse events related to LPMs or other medical devices should be reported to the FDA.

emechcatie@frontlinemedcom.com

This article has been updated 7/14/2014.

SILVER SPRING, MD.  – A requirement for informed consent outlining the risks of morcellation of unsuspected malignancies in women treated with laparoscopic power morcellators for presumably benign fibroids was among the recommendations made by a Food and Drug Administration advisory panel.

On July 11, the second day of a two-day meeting of the FDA’s Obstetrics and Gynecology Devices Advisory Committee, panelists also supported adding a boxed warning to the labels of laparoscopic power morcellators (LPMs). Other suggestions and recommendations included identifying characteristics of patients or fibroids, physical exam findings, and other features that could help determine patients who may have a sarcoma before treatment, as well as strategies to mitigate risks during treatment.

"There should be some labeling or special controls" to ensure that women who are being considered for treatment with this device and their physicians "get the message that we do believe there is an increased risk" and that the device is contraindicated in patients with a known or suspected malignancy, said Dr. Carol Brown, a gynecologic cancer surgeon at Memorial Sloan Kettering Cancer Center, New York.

The advisory panel did not vote on any issues and was not asked whether LPMs should be taken off the market or reclassified as class III medical devices, which require clinical data for approval.

During testimony from women and relatives of those who had been diagnosed with stage 4 LMS after treatment that included morcellation for what was thought to be uterine fibroids, "a recurring theme" was that they had not been told that morcellation could be part of their treatment, and if they had known, they may not have agreed to that treatment and chosen an alternative, she pointed out.

The FDA convened the meeting to discuss the benefits, risks, and clinical role of LPMs in the treatment of women with uterine fibroids. Panelists also were told to discuss strategies that could be used to reduce the risks of morcellation disseminating cancerous tissue into the pelvis and abdomen of women with an unsuspected uterine sarcoma or leiomyosarcoma (LMS).

Concerns about this risk have received widespread attention this year. An FDA safety advisory was issued in April recommending that the use of LPMs during a hysterectomy or myomectomy in women with uterine fibroids be discouraged. The case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage 4 LMS after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids, also garnered media attention. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign highlighting these risks, calling for a ban on the use of LPMs. They -- along with women who have had similar experiences, and husbands and sisters of women who died of disseminated LMS after undergoing morcellation for what was thought to be benign fibroids -- also spoke at the meeting. These speakers emphasized that they are aware of at least 130 such cases, despite the small number of cases reported to the FDA (21 as of June 2014).

In April, the FDA recommended that physicians discuss alternative treatment options with women who have symptomatic uterine fibroids. If power morcellation is considered the best option, the agency advised, women should be informed that their fibroids may contain cancerous cells and, if so, morcellation could significantly worsen their prognosis. Among women who undergo a hysterectomy or myomectomy for a presumed fibroid, about one in 350 have a uterine sarcoma, and about one in 500 have a leiomyosarcoma (LMS), the FDA estimates.

The currently available LPMs that are "cleared" for gynecologic indications are regulated as moderate-risk class II devices, which require little or no clinical data. The agency is considering requiring that clinical data be provided for LPMs used for gynecologic indications.

Panelists said that features and tools that could help determine whether a patient could have a sarcoma include an older age, certain symptoms, and genetic susceptibility (a history of retinoblastoma), some imaging techniques, as well as a history of pelvic radiation.

Two panelists – a surgical oncologist and a bioethicist – said that LPMs should not be used for gynecologic indications until better data are available.

"I have not seen anything in isolation or together" that could help predict whether a woman with presumed uterine fibroids has a leiomyosarcoma, said Dr. Craig Shriver, professor of surgery and director of the John P. Murtha Cancer Center at Walter Reed National Navy Military Medical Center, Bethesda, Md.

Referring to the tenets of considering all masses as cancer until proven otherwise, he said, "I have been perplexed over the last two decades watching the introduction of laparoscopic power morcellation techniques that is totally anathema to these and my core principles as a cancer surgeon," he said. Two days of testimony have "only more strongly reaffirmed my commitment and belief that at present, there is no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery," he added. They should be withdrawn from the market, reclassified as class III devices and studied in clinical trials, he recommended.

But Dr. Brown said that while she agreed with those principles, since fibroids are so common, banning the use of morcellation could result in “hundreds of thousands” of hysterectomies.

Specimen collection bags were used when LPMs were first introduced for gynecologic indications, but dropped over time. Use has increased recently as a result of the increased attention to the risks, but there is no evidence that bags are effective in reducing the risk of disseminating malignant cells in the peritoneal cavity, in the case of an unsuspected malignancy.

“If you are going to morcellate, and it can be done safely in a bag, then that should be encouraged,” said panelist Dr. Keith Isaacson, medical director of the Center for Minimally Invasive Gynecologic Surgery at Newton (Mass.) Wellesley Hospital. More work is needed to evaluate bags and the techniques for their use, and to determine how easy it is train clinicians in how to use them safely, he added. “I still believe that intuitively – and that’s all we have is intuition here – that it more likely mitigates the risk of upstaging a tumor if you morcellate within a containment system, such as a bag.”

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts, although occasionally a panelist is given a waiver, but not at this meeting.

Adverse events related to LPMs or other medical devices should be reported to the FDA.

emechcatie@frontlinemedcom.com

This article has been updated 7/14/2014.

SILVER SPRING, MD.  – A requirement for informed consent outlining the risks of morcellation of unsuspected malignancies in women treated with laparoscopic power morcellators for presumably benign fibroids was among the recommendations made by a Food and Drug Administration advisory panel.

On July 11, the second day of a two-day meeting of the FDA’s Obstetrics and Gynecology Devices Advisory Committee, panelists also supported adding a boxed warning to the labels of laparoscopic power morcellators (LPMs). Other suggestions and recommendations included identifying characteristics of patients or fibroids, physical exam findings, and other features that could help determine patients who may have a sarcoma before treatment, as well as strategies to mitigate risks during treatment.

"There should be some labeling or special controls" to ensure that women who are being considered for treatment with this device and their physicians "get the message that we do believe there is an increased risk" and that the device is contraindicated in patients with a known or suspected malignancy, said Dr. Carol Brown, a gynecologic cancer surgeon at Memorial Sloan Kettering Cancer Center, New York.

The advisory panel did not vote on any issues and was not asked whether LPMs should be taken off the market or reclassified as class III medical devices, which require clinical data for approval.

During testimony from women and relatives of those who had been diagnosed with stage 4 LMS after treatment that included morcellation for what was thought to be uterine fibroids, "a recurring theme" was that they had not been told that morcellation could be part of their treatment, and if they had known, they may not have agreed to that treatment and chosen an alternative, she pointed out.

The FDA convened the meeting to discuss the benefits, risks, and clinical role of LPMs in the treatment of women with uterine fibroids. Panelists also were told to discuss strategies that could be used to reduce the risks of morcellation disseminating cancerous tissue into the pelvis and abdomen of women with an unsuspected uterine sarcoma or leiomyosarcoma (LMS).

Concerns about this risk have received widespread attention this year. An FDA safety advisory was issued in April recommending that the use of LPMs during a hysterectomy or myomectomy in women with uterine fibroids be discouraged. The case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage 4 LMS after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids, also garnered media attention. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign highlighting these risks, calling for a ban on the use of LPMs. They -- along with women who have had similar experiences, and husbands and sisters of women who died of disseminated LMS after undergoing morcellation for what was thought to be benign fibroids -- also spoke at the meeting. These speakers emphasized that they are aware of at least 130 such cases, despite the small number of cases reported to the FDA (21 as of June 2014).

In April, the FDA recommended that physicians discuss alternative treatment options with women who have symptomatic uterine fibroids. If power morcellation is considered the best option, the agency advised, women should be informed that their fibroids may contain cancerous cells and, if so, morcellation could significantly worsen their prognosis. Among women who undergo a hysterectomy or myomectomy for a presumed fibroid, about one in 350 have a uterine sarcoma, and about one in 500 have a leiomyosarcoma (LMS), the FDA estimates.

The currently available LPMs that are "cleared" for gynecologic indications are regulated as moderate-risk class II devices, which require little or no clinical data. The agency is considering requiring that clinical data be provided for LPMs used for gynecologic indications.

Panelists said that features and tools that could help determine whether a patient could have a sarcoma include an older age, certain symptoms, and genetic susceptibility (a history of retinoblastoma), some imaging techniques, as well as a history of pelvic radiation.

Two panelists – a surgical oncologist and a bioethicist – said that LPMs should not be used for gynecologic indications until better data are available.

"I have not seen anything in isolation or together" that could help predict whether a woman with presumed uterine fibroids has a leiomyosarcoma, said Dr. Craig Shriver, professor of surgery and director of the John P. Murtha Cancer Center at Walter Reed National Navy Military Medical Center, Bethesda, Md.

Referring to the tenets of considering all masses as cancer until proven otherwise, he said, "I have been perplexed over the last two decades watching the introduction of laparoscopic power morcellation techniques that is totally anathema to these and my core principles as a cancer surgeon," he said. Two days of testimony have "only more strongly reaffirmed my commitment and belief that at present, there is no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery," he added. They should be withdrawn from the market, reclassified as class III devices and studied in clinical trials, he recommended.

But Dr. Brown said that while she agreed with those principles, since fibroids are so common, banning the use of morcellation could result in “hundreds of thousands” of hysterectomies.

Specimen collection bags were used when LPMs were first introduced for gynecologic indications, but dropped over time. Use has increased recently as a result of the increased attention to the risks, but there is no evidence that bags are effective in reducing the risk of disseminating malignant cells in the peritoneal cavity, in the case of an unsuspected malignancy.

“If you are going to morcellate, and it can be done safely in a bag, then that should be encouraged,” said panelist Dr. Keith Isaacson, medical director of the Center for Minimally Invasive Gynecologic Surgery at Newton (Mass.) Wellesley Hospital. More work is needed to evaluate bags and the techniques for their use, and to determine how easy it is train clinicians in how to use them safely, he added. “I still believe that intuitively – and that’s all we have is intuition here – that it more likely mitigates the risk of upstaging a tumor if you morcellate within a containment system, such as a bag.”

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts, although occasionally a panelist is given a waiver, but not at this meeting.

Adverse events related to LPMs or other medical devices should be reported to the FDA.

emechcatie@frontlinemedcom.com

This article has been updated 7/14/2014.

The quadrivalent human papillomavirus vaccine does not increase the risk of venous thromboembolism, a study showed.

Two previous studies finding an association, one based on the Vaccine Adverse Event Reporting System and the other on the Vaccine Safety Datalink, reported few vaccinated cases, many of whom had known venous thromboembolism (VTE) risk factors, Nikolai Madrid Scheller and his colleagues at Statens Serum Institut in Copenhagen reported in a research letter (JAMA 2014;312:187-8).

©Design Pics

The team used the self-controlled case series method with the main risk period for a first diagnosis of VTE set at 1-42 days after vaccination. They excluded women who were likely pregnant at the time of the VTE or had undergone major surgery in the previous 4 weeks or had a cancer diagnosis in the previous year from the VTE.

Women with VTE aged 10-44 years were followed until the end of the study or until emigration, death, or age 45 years during the study period from Oct. 1, 2006, to July 31, 2013. Among the 1.6 million women in the population cohort, 31% had received the quadrivalent HPV vaccine, and 4,375 women had VTE, 20% of whom had been vaccinated and served as the self-controlled cases.

The researchers found no association between the quadrivalent HPV vaccine and VTE (incidence ratio, 0.77). The lack of association remained in subsequent analyses adjusting for age and oral contraceptive use, and using only cases of VTE in which the women were receiving anticoagulants 4 weeks after diagnosis.

The study did not report external funding. The authors reported no disclosures.

The quadrivalent human papillomavirus vaccine does not increase the risk of venous thromboembolism, a study showed.

Two previous studies finding an association, one based on the Vaccine Adverse Event Reporting System and the other on the Vaccine Safety Datalink, reported few vaccinated cases, many of whom had known venous thromboembolism (VTE) risk factors, Nikolai Madrid Scheller and his colleagues at Statens Serum Institut in Copenhagen reported in a research letter (JAMA 2014;312:187-8).

©Design Pics

The team used the self-controlled case series method with the main risk period for a first diagnosis of VTE set at 1-42 days after vaccination. They excluded women who were likely pregnant at the time of the VTE or had undergone major surgery in the previous 4 weeks or had a cancer diagnosis in the previous year from the VTE.

Women with VTE aged 10-44 years were followed until the end of the study or until emigration, death, or age 45 years during the study period from Oct. 1, 2006, to July 31, 2013. Among the 1.6 million women in the population cohort, 31% had received the quadrivalent HPV vaccine, and 4,375 women had VTE, 20% of whom had been vaccinated and served as the self-controlled cases.

The researchers found no association between the quadrivalent HPV vaccine and VTE (incidence ratio, 0.77). The lack of association remained in subsequent analyses adjusting for age and oral contraceptive use, and using only cases of VTE in which the women were receiving anticoagulants 4 weeks after diagnosis.

The study did not report external funding. The authors reported no disclosures.

The quadrivalent human papillomavirus vaccine does not increase the risk of venous thromboembolism, a study showed.

Two previous studies finding an association, one based on the Vaccine Adverse Event Reporting System and the other on the Vaccine Safety Datalink, reported few vaccinated cases, many of whom had known venous thromboembolism (VTE) risk factors, Nikolai Madrid Scheller and his colleagues at Statens Serum Institut in Copenhagen reported in a research letter (JAMA 2014;312:187-8).

©Design Pics

The team used the self-controlled case series method with the main risk period for a first diagnosis of VTE set at 1-42 days after vaccination. They excluded women who were likely pregnant at the time of the VTE or had undergone major surgery in the previous 4 weeks or had a cancer diagnosis in the previous year from the VTE.

Women with VTE aged 10-44 years were followed until the end of the study or until emigration, death, or age 45 years during the study period from Oct. 1, 2006, to July 31, 2013. Among the 1.6 million women in the population cohort, 31% had received the quadrivalent HPV vaccine, and 4,375 women had VTE, 20% of whom had been vaccinated and served as the self-controlled cases.

The researchers found no association between the quadrivalent HPV vaccine and VTE (incidence ratio, 0.77). The lack of association remained in subsequent analyses adjusting for age and oral contraceptive use, and using only cases of VTE in which the women were receiving anticoagulants 4 weeks after diagnosis.

The study did not report external funding. The authors reported no disclosures.