Aesthetic Dermatology

SEOUL, SOUTH KOREA – New evidence indicates that an important cause of extrinsic skin aging is chronic exposure to soot and other airborne particulates generated by motor vehicle exhaust.

A strong epidemiologic association has been established between residing near a busy highway and increased skin wrinkling and pigmented spots, and a plausible biologic mechanism for causality has been established. Thus, exposure to traffic-related airborne particulate matter joins solar ultraviolet radiation and tobacco smoke as the third potentially modifiable major factor identified in extrinsic skin aging, Dr. Jean Krutmann said at the World Congress of Dermatology.

Photo credit: Sergiy Serdyuk/ISTOCKPHOTO.COM

"My first major message is that nanoparticles are present in ambient air and represent a novel threat to human skin," said Dr. Krutmann, professor of dermatology and environmental health medicine at Heinrich Heine University in Düsseldorf, Germany.

He and his coinvestigators have shown that the threat is more than skin deep.

They have previously linked chronic exposure to traffic-related fine particulate polyaromatic hydrocarbons with a diverse group of other major adverse health effects in addition to skin aging.

They have shown that at one end of the life span, such exposure impairs cognitive function in the elderly (Environ. Res. 2009;109:1,004-11); ongoing prospective studies will determine whether this exposure is also involved in the pathogenesis of Alzheimer's disease.

The same landmark German epidemiologic study that linked airborne particle exposure to mild cognitive impairment – the Study on the Influence of Air Pollution on Lung Function, Inflammation, and Aging (SALIA) – has implicated exposure to traffic-related particulate matter with increased risk of type 2 diabetes (Environ. Health Perspect. 2010;118:1,273-9).

SALIA involved close to 5,000 German women who were enrolled in the mid-1980s, when they were on average 55 years old, and who have been followed for 20 years. Participants were drawn from a heavily industrialized area of Germany as well as from low-pollution rural districts.

At the other end of the life span, Dr. Krutmann and his coinvestigators have demonstrated in prospective studies of 3,390 small-town German newborns followed to age 6 years that exposure to traffic-related airborne particulates was related in dose-response fashion to longer duration of eczema (J. Dermatol. Sci. 2009;56:99-105).

How could sooty air pollution due to incomplete combustion be involved in the pathogenesis of neurodegenerative diseases and type 2 diabetes? Animal studies demonstrate that once these fine airborne particles get into the upper respiratory tract, they can move on to the systemic circulation and exert direct inflammatory effects in other organs – including the brain and pancreas, the dermatologist explained.

The skin aging study was conducted in 400 German women aged 70-80 years who were randomly drawn from the SALIA cohort. The extent of their skin aging was assessed by means of the well-validated Score of Intrinsic and Extrinsic Skin Aging (SCINEXA). Air pollution exposure was determined by the distance between a participant’s home and the nearest major roadway with a traffic volume in excess of 10,000 vehicles per day, as well as by measurement of ambient particulate matter less than 10 mcm in diameter at fixed monitoring sites.

Air pollution exposure proved to be related in dose-response fashion to an increase in pigmented spots on the cheeks and forehead, as well as to facial wrinkles (J. Invest. Dermatol. 2010;130:2,719-26).

Dr. Krutmann said that as a nonepidemiologist, he needs to understand the potential biologic mechanism underlying an epidemiologic observation before he can accept it. He and his colleagues have recently developed such persuasive evidence through animal and in vitro human skin studies.

They have shown that the polyaromatic hydrocarbons in traffic soot activate the aryl hydrocarbon receptor (AhR) expressed on keratinocytes and melanocytes. This results in increased matrix metalloproteinase-1 activity, which in turn leads to degradation of collagen in the dermal matrix and thereby to formation of wrinkles. Activation of the AhR also stimulates melanocyte proliferation, which would explain the increased formation of pigmented spots (J. Invest. Dermatol. 2011;131:203-10).

The clinical implication of these findings is that inhibition of the AhR in skin may be a novel strategy for prevention of extrinsic skin aging. Dr. Krutmann disclosed that he is working with Symrise, a German chemical company, to develop AhR antagonists suitable for topical application in cosmetics. One such product, SymHelios 1031, is already in commercial use.

SALIA and the pediatric eczema studies were funded by the German government.

SEOUL, SOUTH KOREA – New evidence indicates that an important cause of extrinsic skin aging is chronic exposure to soot and other airborne particulates generated by motor vehicle exhaust.

A strong epidemiologic association has been established between residing near a busy highway and increased skin wrinkling and pigmented spots, and a plausible biologic mechanism for causality has been established. Thus, exposure to traffic-related airborne particulate matter joins solar ultraviolet radiation and tobacco smoke as the third potentially modifiable major factor identified in extrinsic skin aging, Dr. Jean Krutmann said at the World Congress of Dermatology.

Photo credit: Sergiy Serdyuk/ISTOCKPHOTO.COM

"My first major message is that nanoparticles are present in ambient air and represent a novel threat to human skin," said Dr. Krutmann, professor of dermatology and environmental health medicine at Heinrich Heine University in Düsseldorf, Germany.

He and his coinvestigators have shown that the threat is more than skin deep.

They have previously linked chronic exposure to traffic-related fine particulate polyaromatic hydrocarbons with a diverse group of other major adverse health effects in addition to skin aging.

They have shown that at one end of the life span, such exposure impairs cognitive function in the elderly (Environ. Res. 2009;109:1,004-11); ongoing prospective studies will determine whether this exposure is also involved in the pathogenesis of Alzheimer's disease.

The same landmark German epidemiologic study that linked airborne particle exposure to mild cognitive impairment – the Study on the Influence of Air Pollution on Lung Function, Inflammation, and Aging (SALIA) – has implicated exposure to traffic-related particulate matter with increased risk of type 2 diabetes (Environ. Health Perspect. 2010;118:1,273-9).

SALIA involved close to 5,000 German women who were enrolled in the mid-1980s, when they were on average 55 years old, and who have been followed for 20 years. Participants were drawn from a heavily industrialized area of Germany as well as from low-pollution rural districts.

At the other end of the life span, Dr. Krutmann and his coinvestigators have demonstrated in prospective studies of 3,390 small-town German newborns followed to age 6 years that exposure to traffic-related airborne particulates was related in dose-response fashion to longer duration of eczema (J. Dermatol. Sci. 2009;56:99-105).

How could sooty air pollution due to incomplete combustion be involved in the pathogenesis of neurodegenerative diseases and type 2 diabetes? Animal studies demonstrate that once these fine airborne particles get into the upper respiratory tract, they can move on to the systemic circulation and exert direct inflammatory effects in other organs – including the brain and pancreas, the dermatologist explained.

The skin aging study was conducted in 400 German women aged 70-80 years who were randomly drawn from the SALIA cohort. The extent of their skin aging was assessed by means of the well-validated Score of Intrinsic and Extrinsic Skin Aging (SCINEXA). Air pollution exposure was determined by the distance between a participant’s home and the nearest major roadway with a traffic volume in excess of 10,000 vehicles per day, as well as by measurement of ambient particulate matter less than 10 mcm in diameter at fixed monitoring sites.

Air pollution exposure proved to be related in dose-response fashion to an increase in pigmented spots on the cheeks and forehead, as well as to facial wrinkles (J. Invest. Dermatol. 2010;130:2,719-26).

Dr. Krutmann said that as a nonepidemiologist, he needs to understand the potential biologic mechanism underlying an epidemiologic observation before he can accept it. He and his colleagues have recently developed such persuasive evidence through animal and in vitro human skin studies.

They have shown that the polyaromatic hydrocarbons in traffic soot activate the aryl hydrocarbon receptor (AhR) expressed on keratinocytes and melanocytes. This results in increased matrix metalloproteinase-1 activity, which in turn leads to degradation of collagen in the dermal matrix and thereby to formation of wrinkles. Activation of the AhR also stimulates melanocyte proliferation, which would explain the increased formation of pigmented spots (J. Invest. Dermatol. 2011;131:203-10).

The clinical implication of these findings is that inhibition of the AhR in skin may be a novel strategy for prevention of extrinsic skin aging. Dr. Krutmann disclosed that he is working with Symrise, a German chemical company, to develop AhR antagonists suitable for topical application in cosmetics. One such product, SymHelios 1031, is already in commercial use.

SALIA and the pediatric eczema studies were funded by the German government.

SEOUL, SOUTH KOREA – New evidence indicates that an important cause of extrinsic skin aging is chronic exposure to soot and other airborne particulates generated by motor vehicle exhaust.

A strong epidemiologic association has been established between residing near a busy highway and increased skin wrinkling and pigmented spots, and a plausible biologic mechanism for causality has been established. Thus, exposure to traffic-related airborne particulate matter joins solar ultraviolet radiation and tobacco smoke as the third potentially modifiable major factor identified in extrinsic skin aging, Dr. Jean Krutmann said at the World Congress of Dermatology.

Photo credit: Sergiy Serdyuk/ISTOCKPHOTO.COM

"My first major message is that nanoparticles are present in ambient air and represent a novel threat to human skin," said Dr. Krutmann, professor of dermatology and environmental health medicine at Heinrich Heine University in Düsseldorf, Germany.

He and his coinvestigators have shown that the threat is more than skin deep.

They have previously linked chronic exposure to traffic-related fine particulate polyaromatic hydrocarbons with a diverse group of other major adverse health effects in addition to skin aging.

They have shown that at one end of the life span, such exposure impairs cognitive function in the elderly (Environ. Res. 2009;109:1,004-11); ongoing prospective studies will determine whether this exposure is also involved in the pathogenesis of Alzheimer's disease.

The same landmark German epidemiologic study that linked airborne particle exposure to mild cognitive impairment – the Study on the Influence of Air Pollution on Lung Function, Inflammation, and Aging (SALIA) – has implicated exposure to traffic-related particulate matter with increased risk of type 2 diabetes (Environ. Health Perspect. 2010;118:1,273-9).

SALIA involved close to 5,000 German women who were enrolled in the mid-1980s, when they were on average 55 years old, and who have been followed for 20 years. Participants were drawn from a heavily industrialized area of Germany as well as from low-pollution rural districts.

At the other end of the life span, Dr. Krutmann and his coinvestigators have demonstrated in prospective studies of 3,390 small-town German newborns followed to age 6 years that exposure to traffic-related airborne particulates was related in dose-response fashion to longer duration of eczema (J. Dermatol. Sci. 2009;56:99-105).

How could sooty air pollution due to incomplete combustion be involved in the pathogenesis of neurodegenerative diseases and type 2 diabetes? Animal studies demonstrate that once these fine airborne particles get into the upper respiratory tract, they can move on to the systemic circulation and exert direct inflammatory effects in other organs – including the brain and pancreas, the dermatologist explained.

The skin aging study was conducted in 400 German women aged 70-80 years who were randomly drawn from the SALIA cohort. The extent of their skin aging was assessed by means of the well-validated Score of Intrinsic and Extrinsic Skin Aging (SCINEXA). Air pollution exposure was determined by the distance between a participant’s home and the nearest major roadway with a traffic volume in excess of 10,000 vehicles per day, as well as by measurement of ambient particulate matter less than 10 mcm in diameter at fixed monitoring sites.

Air pollution exposure proved to be related in dose-response fashion to an increase in pigmented spots on the cheeks and forehead, as well as to facial wrinkles (J. Invest. Dermatol. 2010;130:2,719-26).

Dr. Krutmann said that as a nonepidemiologist, he needs to understand the potential biologic mechanism underlying an epidemiologic observation before he can accept it. He and his colleagues have recently developed such persuasive evidence through animal and in vitro human skin studies.

They have shown that the polyaromatic hydrocarbons in traffic soot activate the aryl hydrocarbon receptor (AhR) expressed on keratinocytes and melanocytes. This results in increased matrix metalloproteinase-1 activity, which in turn leads to degradation of collagen in the dermal matrix and thereby to formation of wrinkles. Activation of the AhR also stimulates melanocyte proliferation, which would explain the increased formation of pigmented spots (J. Invest. Dermatol. 2011;131:203-10).

The clinical implication of these findings is that inhibition of the AhR in skin may be a novel strategy for prevention of extrinsic skin aging. Dr. Krutmann disclosed that he is working with Symrise, a German chemical company, to develop AhR antagonists suitable for topical application in cosmetics. One such product, SymHelios 1031, is already in commercial use.

SALIA and the pediatric eczema studies were funded by the German government.

The Food and Drug Administration has approved LaVív, a product offering a novel approach to treating moderate to severe nasolabial folds in adults through autologous cell therapy.

The patented technology includes an advanced process that uses a patient's own fibroblasts to treat smile lines. The cells are cultured, and then injected into the patient.

The FDA approved the Fibrocell Sciences' Biologics License Application for its lead product, LaVív (azficel-T) this month (June 2011). In clinical trials, the product was well tolerated. The majority of adverse events were injection-site reactions that were generally mild to moderate in intensity and resolved within 1 week.

LaVív is expected to be available through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians are trained, the number of cities served will expand as well, according to a company statement.

Small fibroblast samples are taken from behind the patient's ear and sent to Fibrocell's laboratory. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment. The recommended course of LaVív administration is a series of three treatments, typically 3-6 weeks apart.

Additional information about LaVív is available at www.mylaviv.com.

The Food and Drug Administration has approved LaVív, a product offering a novel approach to treating moderate to severe nasolabial folds in adults through autologous cell therapy.

The patented technology includes an advanced process that uses a patient's own fibroblasts to treat smile lines. The cells are cultured, and then injected into the patient.

The FDA approved the Fibrocell Sciences' Biologics License Application for its lead product, LaVív (azficel-T) this month (June 2011). In clinical trials, the product was well tolerated. The majority of adverse events were injection-site reactions that were generally mild to moderate in intensity and resolved within 1 week.

LaVív is expected to be available through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians are trained, the number of cities served will expand as well, according to a company statement.

Small fibroblast samples are taken from behind the patient's ear and sent to Fibrocell's laboratory. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment. The recommended course of LaVív administration is a series of three treatments, typically 3-6 weeks apart.

Additional information about LaVív is available at www.mylaviv.com.

The Food and Drug Administration has approved LaVív, a product offering a novel approach to treating moderate to severe nasolabial folds in adults through autologous cell therapy.

The patented technology includes an advanced process that uses a patient's own fibroblasts to treat smile lines. The cells are cultured, and then injected into the patient.

The FDA approved the Fibrocell Sciences' Biologics License Application for its lead product, LaVív (azficel-T) this month (June 2011). In clinical trials, the product was well tolerated. The majority of adverse events were injection-site reactions that were generally mild to moderate in intensity and resolved within 1 week.

LaVív is expected to be available through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians are trained, the number of cities served will expand as well, according to a company statement.

Small fibroblast samples are taken from behind the patient's ear and sent to Fibrocell's laboratory. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment. The recommended course of LaVív administration is a series of three treatments, typically 3-6 weeks apart.

Additional information about LaVív is available at www.mylaviv.com.

SEOUL, SOUTH KOREA – European women are more interested in aesthetic procedures to improve their stomach or abdomen than their face, according to a large survey.

A majority of the women surveyed indicated they were most satisfied with how they looked about 10 years ago, when most were in their late 20s. Three-quarters of the women said they didn’t mind looking their age – they just didn’t want to look older. Eighty percent believed beauty is under an individual’s control and can be enhanced or shaped.

The Face Value Beauty Survey included 2,939 women from Italy, Spain, France, the United Kingdom, and Russia with an interest in minimally invasive aesthetic procedures. The survey was conducted online by Harris Interactive and released by Merz, its sponsor, at the World Congress of Dermatology.

Only one-quarter of women surveyed equated beauty with youth. Instead, the top five attributes cited as making women beautiful were healthy skin, an overall well-groomed appearance, beautiful hair, a charming personality, and confidence, according to Steven Basta, who presented the findings.

Fifty-six percent of European women indicated they would like to change their abdomen or stomach. Forty-four percent reported they would like to target their overall weight, 41% their breasts, 38% their face, and 38% their buttocks.

The most popular aesthetic procedure that the surveyed women had undergone was laser hair removal, at 18%. Rounding out the top five most popular procedures were chemical peels, cellulite treatments, facial dermal fillers, and facial botulinum toxin injections, each tried by 12%-13% of respondents, said Mr. Basta, CEO of Merz.

One in five European women described their personal style as "glamorous" or "extravagant." Fifty-seven percent said beauty arises from a natural appearance; half as many women said beauty stems from a made-up or glamorous look.

Three in five facial filler and/or botulinum toxin users said they had experienced a positive life change due to their treatments.

The majority of facial injectable users reported never admitting to their significant other, close friends, or family that they had undergone such treatments, or they did so only selectively. Instead, they typically claimed their new look was the result of facials, makeup, diet, exercise, or being in love.

SEOUL, SOUTH KOREA – European women are more interested in aesthetic procedures to improve their stomach or abdomen than their face, according to a large survey.

A majority of the women surveyed indicated they were most satisfied with how they looked about 10 years ago, when most were in their late 20s. Three-quarters of the women said they didn’t mind looking their age – they just didn’t want to look older. Eighty percent believed beauty is under an individual’s control and can be enhanced or shaped.

The Face Value Beauty Survey included 2,939 women from Italy, Spain, France, the United Kingdom, and Russia with an interest in minimally invasive aesthetic procedures. The survey was conducted online by Harris Interactive and released by Merz, its sponsor, at the World Congress of Dermatology.

Only one-quarter of women surveyed equated beauty with youth. Instead, the top five attributes cited as making women beautiful were healthy skin, an overall well-groomed appearance, beautiful hair, a charming personality, and confidence, according to Steven Basta, who presented the findings.

Fifty-six percent of European women indicated they would like to change their abdomen or stomach. Forty-four percent reported they would like to target their overall weight, 41% their breasts, 38% their face, and 38% their buttocks.

The most popular aesthetic procedure that the surveyed women had undergone was laser hair removal, at 18%. Rounding out the top five most popular procedures were chemical peels, cellulite treatments, facial dermal fillers, and facial botulinum toxin injections, each tried by 12%-13% of respondents, said Mr. Basta, CEO of Merz.

One in five European women described their personal style as "glamorous" or "extravagant." Fifty-seven percent said beauty arises from a natural appearance; half as many women said beauty stems from a made-up or glamorous look.

Three in five facial filler and/or botulinum toxin users said they had experienced a positive life change due to their treatments.

The majority of facial injectable users reported never admitting to their significant other, close friends, or family that they had undergone such treatments, or they did so only selectively. Instead, they typically claimed their new look was the result of facials, makeup, diet, exercise, or being in love.

SEOUL, SOUTH KOREA – European women are more interested in aesthetic procedures to improve their stomach or abdomen than their face, according to a large survey.

A majority of the women surveyed indicated they were most satisfied with how they looked about 10 years ago, when most were in their late 20s. Three-quarters of the women said they didn’t mind looking their age – they just didn’t want to look older. Eighty percent believed beauty is under an individual’s control and can be enhanced or shaped.

The Face Value Beauty Survey included 2,939 women from Italy, Spain, France, the United Kingdom, and Russia with an interest in minimally invasive aesthetic procedures. The survey was conducted online by Harris Interactive and released by Merz, its sponsor, at the World Congress of Dermatology.

Only one-quarter of women surveyed equated beauty with youth. Instead, the top five attributes cited as making women beautiful were healthy skin, an overall well-groomed appearance, beautiful hair, a charming personality, and confidence, according to Steven Basta, who presented the findings.

Fifty-six percent of European women indicated they would like to change their abdomen or stomach. Forty-four percent reported they would like to target their overall weight, 41% their breasts, 38% their face, and 38% their buttocks.

The most popular aesthetic procedure that the surveyed women had undergone was laser hair removal, at 18%. Rounding out the top five most popular procedures were chemical peels, cellulite treatments, facial dermal fillers, and facial botulinum toxin injections, each tried by 12%-13% of respondents, said Mr. Basta, CEO of Merz.

One in five European women described their personal style as "glamorous" or "extravagant." Fifty-seven percent said beauty arises from a natural appearance; half as many women said beauty stems from a made-up or glamorous look.

Three in five facial filler and/or botulinum toxin users said they had experienced a positive life change due to their treatments.

The majority of facial injectable users reported never admitting to their significant other, close friends, or family that they had undergone such treatments, or they did so only selectively. Instead, they typically claimed their new look was the result of facials, makeup, diet, exercise, or being in love.

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA's November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA's new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA's November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA's new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA's November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA's new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

Increases in the volume of dermatologic procedures over the past 15 years are the result of dermatology's reinvention of itself as a surgical specialty, as well as a result of what is a very real skin cancer epidemic.

But that, coupled with the disproportionate percentage of the total reimbursed relative value unit (RVU) pool going to dermatologists, has raised red flags for those charged with cutting costs, and has left the specialty particularly vulnerable to cuts in reimbursement.

Between 1995 and 2008, skin biopsies increased by 76%, destructions by 64%, excisions by 17%, actinic keratoses (AKs) of 15 or greater by 17%, and use of pathology code 88305 by 81%. Even more striking - and potentially at the expense of cuts of up to 25%-30% in reimbursement for these procedures - Mohs surgery is up about 400%, according to the most recent data.

The powers that be aren't looking too favorably upon these increases, especially considering that from 1992 to 2002, the total reimbursed RVU pool percentage for dermatologists increased from 2.5% to 2.9%, while dermatologists accounted for only 1% of all physicians.

This increase is appropriate, given the overhead required for the surgical components of dermatology practice and the increased demand, but it has led to a view of dermatologists as greedy and overpaid.

I don't think we're the greedy dermatologists that many make us out to be; we're office-based, frontline specialists responding to an unrecognized epidemic. But those charged with cutting costs don't see it that way, because they either don't understand or refuse to acknowledge that there is a very real skin cancer epidemic in this country.

A review of multiple Medicare and Ambulatory Medical Care Service databases showed that the number of procedures for skin cancer increased 77% from nearly 1.2 million in 1992 to nearly 2.1 million in 2006. The most recent estimate is that the total number of nonmelanoma skin cancers in the U.S. population is about 4 million.

There are a number of misconceptions about dermatology that are contributing to the specialty's being under siege, and some of them are from dermatologists themselves.

Among the fundamental misconceptions by MedPAC, Congress, and the Centers for Medicare and Medicaid Services are the following:

• What dermatologists do is not important and is mostly cosmetic.

• The increase in RVUs comes from waste and abuse, and from unimportant minor-procedure codes that pay too much.

• There is no skin cancer epidemic.

• New money is not needed in the payment pool for health care.

Dermatologists themselves are also guilty of misconceptions about the specialty. For example, there is a misconception among dermatologists that training more dermatologists and physician extenders will benefit dermatology, when in actuality they will increase utilization and trigger more scrutiny and punishment in the form of cuts to reimbursement.

Similarly, promoting dermatology services to the public won't help until the utilization constraints on the payer side have been solved.

In the next 5 years, it is likely that physicians - and particularly specialists - will take the brunt of any cost-savings attempts by Congress. Dermatology, in particular, will be targeted for cuts because of increased utilization.

I also predict that in the next 5 years the skin cancer epidemic will continue as baby boomers age; that Mohs surgery will not regain its multiple surgery reduction exemption; that appropriateness criteria for Mohs, AK destruction, and perhaps even shaves, skin biopsies, and pathology will emerge; that existing ambulatory surgery centers will become more valuable because new centers will become difficult to license; that Mohs surgeons will band together in groups; and that cosmetic procedures will continue to increase as baby boomers age.

In the face of so many misconceptions and some dire predictions about the future of the specialty, it is imperative that dermatologists work together to educate Congress, MedPAC, and the CMS about the skin cancer epidemic, and prove that dermatologists are the solution, not the problem.
We have to show them that as their constituents live longer, they get more diseases per unit of time, and that we aren't making this up to make more money.

We also have to convince them that epidemics require new money to allow them to be addressed adequately.

This will require a coordinated agenda at the highest levels. Quality must be defined and measured on our terms, and utilization must be controlled or we will risk losing our specialty. We must define our peer groups within dermatology, and a list must be developed of acceptable and unacceptable nominees to the Independent Payment Advisory Board - the panel appointed by Congress to determine payment structure, which is perhaps the biggest threat to the specialty.

What else can you do? Join the American Medical Association (AMA), not because of their politics but because our representation is dependent on your membership. Also, donate to the SkinPAC. This is critical to get politicians elected who understand us. And elect strong, decisive people - not necessarily the nicest people - to your leadership and board of directors because there are some challenges and tough decisions ahead.

Dr. Coldiron is president of the American College of Mohs Surgery and a clinical assistant professor of dermatology at the University of Cincinnati. He has a private practice in Cincinnati.

Increases in the volume of dermatologic procedures over the past 15 years are the result of dermatology's reinvention of itself as a surgical specialty, as well as a result of what is a very real skin cancer epidemic.

But that, coupled with the disproportionate percentage of the total reimbursed relative value unit (RVU) pool going to dermatologists, has raised red flags for those charged with cutting costs, and has left the specialty particularly vulnerable to cuts in reimbursement.

Between 1995 and 2008, skin biopsies increased by 76%, destructions by 64%, excisions by 17%, actinic keratoses (AKs) of 15 or greater by 17%, and use of pathology code 88305 by 81%. Even more striking - and potentially at the expense of cuts of up to 25%-30% in reimbursement for these procedures - Mohs surgery is up about 400%, according to the most recent data.

The powers that be aren't looking too favorably upon these increases, especially considering that from 1992 to 2002, the total reimbursed RVU pool percentage for dermatologists increased from 2.5% to 2.9%, while dermatologists accounted for only 1% of all physicians.

This increase is appropriate, given the overhead required for the surgical components of dermatology practice and the increased demand, but it has led to a view of dermatologists as greedy and overpaid.

I don't think we're the greedy dermatologists that many make us out to be; we're office-based, frontline specialists responding to an unrecognized epidemic. But those charged with cutting costs don't see it that way, because they either don't understand or refuse to acknowledge that there is a very real skin cancer epidemic in this country.

A review of multiple Medicare and Ambulatory Medical Care Service databases showed that the number of procedures for skin cancer increased 77% from nearly 1.2 million in 1992 to nearly 2.1 million in 2006. The most recent estimate is that the total number of nonmelanoma skin cancers in the U.S. population is about 4 million.

There are a number of misconceptions about dermatology that are contributing to the specialty's being under siege, and some of them are from dermatologists themselves.

Among the fundamental misconceptions by MedPAC, Congress, and the Centers for Medicare and Medicaid Services are the following:

• What dermatologists do is not important and is mostly cosmetic.

• The increase in RVUs comes from waste and abuse, and from unimportant minor-procedure codes that pay too much.

• There is no skin cancer epidemic.

• New money is not needed in the payment pool for health care.

Dermatologists themselves are also guilty of misconceptions about the specialty. For example, there is a misconception among dermatologists that training more dermatologists and physician extenders will benefit dermatology, when in actuality they will increase utilization and trigger more scrutiny and punishment in the form of cuts to reimbursement.

Similarly, promoting dermatology services to the public won't help until the utilization constraints on the payer side have been solved.

In the next 5 years, it is likely that physicians - and particularly specialists - will take the brunt of any cost-savings attempts by Congress. Dermatology, in particular, will be targeted for cuts because of increased utilization.

I also predict that in the next 5 years the skin cancer epidemic will continue as baby boomers age; that Mohs surgery will not regain its multiple surgery reduction exemption; that appropriateness criteria for Mohs, AK destruction, and perhaps even shaves, skin biopsies, and pathology will emerge; that existing ambulatory surgery centers will become more valuable because new centers will become difficult to license; that Mohs surgeons will band together in groups; and that cosmetic procedures will continue to increase as baby boomers age.

In the face of so many misconceptions and some dire predictions about the future of the specialty, it is imperative that dermatologists work together to educate Congress, MedPAC, and the CMS about the skin cancer epidemic, and prove that dermatologists are the solution, not the problem.
We have to show them that as their constituents live longer, they get more diseases per unit of time, and that we aren't making this up to make more money.

We also have to convince them that epidemics require new money to allow them to be addressed adequately.

This will require a coordinated agenda at the highest levels. Quality must be defined and measured on our terms, and utilization must be controlled or we will risk losing our specialty. We must define our peer groups within dermatology, and a list must be developed of acceptable and unacceptable nominees to the Independent Payment Advisory Board - the panel appointed by Congress to determine payment structure, which is perhaps the biggest threat to the specialty.

What else can you do? Join the American Medical Association (AMA), not because of their politics but because our representation is dependent on your membership. Also, donate to the SkinPAC. This is critical to get politicians elected who understand us. And elect strong, decisive people - not necessarily the nicest people - to your leadership and board of directors because there are some challenges and tough decisions ahead.

Dr. Coldiron is president of the American College of Mohs Surgery and a clinical assistant professor of dermatology at the University of Cincinnati. He has a private practice in Cincinnati.

Increases in the volume of dermatologic procedures over the past 15 years are the result of dermatology's reinvention of itself as a surgical specialty, as well as a result of what is a very real skin cancer epidemic.

But that, coupled with the disproportionate percentage of the total reimbursed relative value unit (RVU) pool going to dermatologists, has raised red flags for those charged with cutting costs, and has left the specialty particularly vulnerable to cuts in reimbursement.

Between 1995 and 2008, skin biopsies increased by 76%, destructions by 64%, excisions by 17%, actinic keratoses (AKs) of 15 or greater by 17%, and use of pathology code 88305 by 81%. Even more striking - and potentially at the expense of cuts of up to 25%-30% in reimbursement for these procedures - Mohs surgery is up about 400%, according to the most recent data.

The powers that be aren't looking too favorably upon these increases, especially considering that from 1992 to 2002, the total reimbursed RVU pool percentage for dermatologists increased from 2.5% to 2.9%, while dermatologists accounted for only 1% of all physicians.

This increase is appropriate, given the overhead required for the surgical components of dermatology practice and the increased demand, but it has led to a view of dermatologists as greedy and overpaid.

I don't think we're the greedy dermatologists that many make us out to be; we're office-based, frontline specialists responding to an unrecognized epidemic. But those charged with cutting costs don't see it that way, because they either don't understand or refuse to acknowledge that there is a very real skin cancer epidemic in this country.

A review of multiple Medicare and Ambulatory Medical Care Service databases showed that the number of procedures for skin cancer increased 77% from nearly 1.2 million in 1992 to nearly 2.1 million in 2006. The most recent estimate is that the total number of nonmelanoma skin cancers in the U.S. population is about 4 million.

There are a number of misconceptions about dermatology that are contributing to the specialty's being under siege, and some of them are from dermatologists themselves.

Among the fundamental misconceptions by MedPAC, Congress, and the Centers for Medicare and Medicaid Services are the following:

• What dermatologists do is not important and is mostly cosmetic.

• The increase in RVUs comes from waste and abuse, and from unimportant minor-procedure codes that pay too much.

• There is no skin cancer epidemic.

• New money is not needed in the payment pool for health care.

Dermatologists themselves are also guilty of misconceptions about the specialty. For example, there is a misconception among dermatologists that training more dermatologists and physician extenders will benefit dermatology, when in actuality they will increase utilization and trigger more scrutiny and punishment in the form of cuts to reimbursement.

Similarly, promoting dermatology services to the public won't help until the utilization constraints on the payer side have been solved.

In the next 5 years, it is likely that physicians - and particularly specialists - will take the brunt of any cost-savings attempts by Congress. Dermatology, in particular, will be targeted for cuts because of increased utilization.

I also predict that in the next 5 years the skin cancer epidemic will continue as baby boomers age; that Mohs surgery will not regain its multiple surgery reduction exemption; that appropriateness criteria for Mohs, AK destruction, and perhaps even shaves, skin biopsies, and pathology will emerge; that existing ambulatory surgery centers will become more valuable because new centers will become difficult to license; that Mohs surgeons will band together in groups; and that cosmetic procedures will continue to increase as baby boomers age.

In the face of so many misconceptions and some dire predictions about the future of the specialty, it is imperative that dermatologists work together to educate Congress, MedPAC, and the CMS about the skin cancer epidemic, and prove that dermatologists are the solution, not the problem.
We have to show them that as their constituents live longer, they get more diseases per unit of time, and that we aren't making this up to make more money.

We also have to convince them that epidemics require new money to allow them to be addressed adequately.

This will require a coordinated agenda at the highest levels. Quality must be defined and measured on our terms, and utilization must be controlled or we will risk losing our specialty. We must define our peer groups within dermatology, and a list must be developed of acceptable and unacceptable nominees to the Independent Payment Advisory Board - the panel appointed by Congress to determine payment structure, which is perhaps the biggest threat to the specialty.

What else can you do? Join the American Medical Association (AMA), not because of their politics but because our representation is dependent on your membership. Also, donate to the SkinPAC. This is critical to get politicians elected who understand us. And elect strong, decisive people - not necessarily the nicest people - to your leadership and board of directors because there are some challenges and tough decisions ahead.

Dr. Coldiron is president of the American College of Mohs Surgery and a clinical assistant professor of dermatology at the University of Cincinnati. He has a private practice in Cincinnati.