Aesthetic Dermatology

PHOENIX — Investigators found significant decreases in thigh circumference following multiple treatments with a dual-wavelength laser system with mechanical manipulation, compared with untreated thighs, in a multicenter study.

Dr. Michael H. Gold and his colleagues assessed 83 women 1 month after treatment with the SmoothShapes dual-energy laser and mechanical manipulation system (Elemé Medical Inc.). Each participant had one thigh selected randomly for treatment twice a week for 4 weeks, while their other thigh served as a control.

Significant reductions in circumference were noted at the upper, mid, and lower thigh, compared with baseline and the untreated thigh, at each assessment. “The SmoothShapes two-wavelength system was highly effective in producing thigh circumference reduction at each location and at each time point,” said Dr. Gold, who is in private practice in Nashville, Tenn., and is also with Vanderbilt University in Nashville. He is a consultant for Elemé Medical, which funded the study.

A total of 59 patients were considered responders (71%), and this group achieved a 3.5-cm average thigh circumference reduction at 1 month, Dr. Gold said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Mean circumference reductions on the treated thighs were “consistently, statistically significantly greater at all time points,” Dr. Gold said. “Three months' follow-up was also statistically significant.”

Investigators enrolled participants at one of five sites in the United States and one in France. The laser system features a 915-nm wavelength that liquefies fat. The device also has a 650-nm wavelength to increase fat cell membrane permeability. Contoured rollers then move liquefied lipids from the interstitial space to the lymphatic system for drainage, according to the manufacturer. The Food and Drug Administration cleared marketing of the device for the temporary reduction in the appearance of cellulite.

With laser and manipulation system treatment, reductions in thigh circumference were noted in patients at 1 month.

Source Photos courtesy Dr. Robert A. Weiss

PHOENIX — Investigators found significant decreases in thigh circumference following multiple treatments with a dual-wavelength laser system with mechanical manipulation, compared with untreated thighs, in a multicenter study.

Dr. Michael H. Gold and his colleagues assessed 83 women 1 month after treatment with the SmoothShapes dual-energy laser and mechanical manipulation system (Elemé Medical Inc.). Each participant had one thigh selected randomly for treatment twice a week for 4 weeks, while their other thigh served as a control.

Significant reductions in circumference were noted at the upper, mid, and lower thigh, compared with baseline and the untreated thigh, at each assessment. “The SmoothShapes two-wavelength system was highly effective in producing thigh circumference reduction at each location and at each time point,” said Dr. Gold, who is in private practice in Nashville, Tenn., and is also with Vanderbilt University in Nashville. He is a consultant for Elemé Medical, which funded the study.

A total of 59 patients were considered responders (71%), and this group achieved a 3.5-cm average thigh circumference reduction at 1 month, Dr. Gold said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Mean circumference reductions on the treated thighs were “consistently, statistically significantly greater at all time points,” Dr. Gold said. “Three months' follow-up was also statistically significant.”

Investigators enrolled participants at one of five sites in the United States and one in France. The laser system features a 915-nm wavelength that liquefies fat. The device also has a 650-nm wavelength to increase fat cell membrane permeability. Contoured rollers then move liquefied lipids from the interstitial space to the lymphatic system for drainage, according to the manufacturer. The Food and Drug Administration cleared marketing of the device for the temporary reduction in the appearance of cellulite.

With laser and manipulation system treatment, reductions in thigh circumference were noted in patients at 1 month.

Source Photos courtesy Dr. Robert A. Weiss

PHOENIX — Investigators found significant decreases in thigh circumference following multiple treatments with a dual-wavelength laser system with mechanical manipulation, compared with untreated thighs, in a multicenter study.

Dr. Michael H. Gold and his colleagues assessed 83 women 1 month after treatment with the SmoothShapes dual-energy laser and mechanical manipulation system (Elemé Medical Inc.). Each participant had one thigh selected randomly for treatment twice a week for 4 weeks, while their other thigh served as a control.

Significant reductions in circumference were noted at the upper, mid, and lower thigh, compared with baseline and the untreated thigh, at each assessment. “The SmoothShapes two-wavelength system was highly effective in producing thigh circumference reduction at each location and at each time point,” said Dr. Gold, who is in private practice in Nashville, Tenn., and is also with Vanderbilt University in Nashville. He is a consultant for Elemé Medical, which funded the study.

A total of 59 patients were considered responders (71%), and this group achieved a 3.5-cm average thigh circumference reduction at 1 month, Dr. Gold said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Mean circumference reductions on the treated thighs were “consistently, statistically significantly greater at all time points,” Dr. Gold said. “Three months' follow-up was also statistically significant.”

Investigators enrolled participants at one of five sites in the United States and one in France. The laser system features a 915-nm wavelength that liquefies fat. The device also has a 650-nm wavelength to increase fat cell membrane permeability. Contoured rollers then move liquefied lipids from the interstitial space to the lymphatic system for drainage, according to the manufacturer. The Food and Drug Administration cleared marketing of the device for the temporary reduction in the appearance of cellulite.

With laser and manipulation system treatment, reductions in thigh circumference were noted in patients at 1 month.

Source Photos courtesy Dr. Robert A. Weiss

By Richard G. Glogau, M.D.

Lip enhancement can produce aesthetically pleasing results, but, increasingly, the procedure is being undertaken by ill-informed or untrained physicians and, more often, nonphysicians, who are using inappropriate fillers. The lack of experience and knowledge is threatening patient safety.

The Food and Drug Administration has never approved any therapy for lip augmentation—be it an injectable, such as botulinum toxin, or any of the collagen products on the market. Yet lip augmentation can be done safely, using the appropriate product.

However, the lack of a formal approval, the relative absence of regulatory oversight, and the profitability of administering injectables is making it possible for subpar and illegal practices to thrive.

Injectables are already the most popular cosmetic procedure—surgical or nonsurgical. Out of a total of 11.7 million cosmetic procedures in 2007, there were 2.7 million Botox Cosmetic (onabotulinumtoxinA) injections, and 1.4 million injections of hyaluronic acid products, according to the American Society for Aesthetic Plastic Surgery.

When it comes to lip augmentation, it is best to stay away from any product that lasts too long. Given the nature of the lip anatomy, the filler will sometimes not stay exactly where it was placed. That migration is much easier to address when a temporary filler, such as any of the hyaluronic acid–based products, Restylane (Medicis Aesthetics Inc.), Hylaform (Inamed Aesthetics), Juvéderm Ultra or Ultra Plus (Allergan Inc.), and Prevelle Silk (Mentor Corp.), are used.

Collagen injectables, such as Allergan's CosmoPlast and Zyderm, are easier to use superficially, and thus, in some ways, make it more feasible to sculpt the lip. But the hyaluronic acid injectables last at least 6 months, giving the patient a little bit more value.

The longest-lasting fillers are the synthetic products, which include Artefill (Suneva Medical Inc.), Radiesse (BioForm Medical Inc.), or Sculptra (Sanofi-Aventis). They are often presented to patients as a way to save money—because of the duration of the results, the patient can receive one treatment and be satisfied for at least a year, if not for a lifetime.

When the filler starts to migrate—which is always a danger with the lip—it can create unsightly lumps or bumps, sometimes leading to permanent disfigurement. Some patients may experience decreased sensitivity or granuloma reactions.

Clearly, with the use of the more permanent fillers, the risk-benefit ratio is exceeded. But there are plenty of patients being injected with these materials, often overseas, where hundreds of fillers are offered. Many patients are tempted to get injected when they're abroad, but they can return with problems and without any idea of what type of material was injected.

The filler manufacturers and the FDA have not stepped in to restrict inappropriate use of these products. The FDA does not regulate the practice of medicine, and the manufacturers must, by law, sell their products to anyone who has a medical license.

The problem is only likely to get worse, as the financial incentives that come with injectables are just too powerful for many to resist.

For now, cosmetic dermatologists should err on the side of safety and stick with the most appropriate lip augmentation products. Your patients will thank you in the long run.

Dr. Glogau is clinical professor of dermatology at the University of California, San Francisco. He is a paid consultant and clinical investigator for Allergan, Revance Thearpeutics, and Medicis. He has also served as a clinical investigator for Contura. To respond to this column, contact Dr. Glogau at sknews@elsevier.com.

By Richard G. Glogau, M.D.

Lip enhancement can produce aesthetically pleasing results, but, increasingly, the procedure is being undertaken by ill-informed or untrained physicians and, more often, nonphysicians, who are using inappropriate fillers. The lack of experience and knowledge is threatening patient safety.

The Food and Drug Administration has never approved any therapy for lip augmentation—be it an injectable, such as botulinum toxin, or any of the collagen products on the market. Yet lip augmentation can be done safely, using the appropriate product.

However, the lack of a formal approval, the relative absence of regulatory oversight, and the profitability of administering injectables is making it possible for subpar and illegal practices to thrive.

Injectables are already the most popular cosmetic procedure—surgical or nonsurgical. Out of a total of 11.7 million cosmetic procedures in 2007, there were 2.7 million Botox Cosmetic (onabotulinumtoxinA) injections, and 1.4 million injections of hyaluronic acid products, according to the American Society for Aesthetic Plastic Surgery.

When it comes to lip augmentation, it is best to stay away from any product that lasts too long. Given the nature of the lip anatomy, the filler will sometimes not stay exactly where it was placed. That migration is much easier to address when a temporary filler, such as any of the hyaluronic acid–based products, Restylane (Medicis Aesthetics Inc.), Hylaform (Inamed Aesthetics), Juvéderm Ultra or Ultra Plus (Allergan Inc.), and Prevelle Silk (Mentor Corp.), are used.

Collagen injectables, such as Allergan's CosmoPlast and Zyderm, are easier to use superficially, and thus, in some ways, make it more feasible to sculpt the lip. But the hyaluronic acid injectables last at least 6 months, giving the patient a little bit more value.

The longest-lasting fillers are the synthetic products, which include Artefill (Suneva Medical Inc.), Radiesse (BioForm Medical Inc.), or Sculptra (Sanofi-Aventis). They are often presented to patients as a way to save money—because of the duration of the results, the patient can receive one treatment and be satisfied for at least a year, if not for a lifetime.

When the filler starts to migrate—which is always a danger with the lip—it can create unsightly lumps or bumps, sometimes leading to permanent disfigurement. Some patients may experience decreased sensitivity or granuloma reactions.

Clearly, with the use of the more permanent fillers, the risk-benefit ratio is exceeded. But there are plenty of patients being injected with these materials, often overseas, where hundreds of fillers are offered. Many patients are tempted to get injected when they're abroad, but they can return with problems and without any idea of what type of material was injected.

The filler manufacturers and the FDA have not stepped in to restrict inappropriate use of these products. The FDA does not regulate the practice of medicine, and the manufacturers must, by law, sell their products to anyone who has a medical license.

The problem is only likely to get worse, as the financial incentives that come with injectables are just too powerful for many to resist.

For now, cosmetic dermatologists should err on the side of safety and stick with the most appropriate lip augmentation products. Your patients will thank you in the long run.

Dr. Glogau is clinical professor of dermatology at the University of California, San Francisco. He is a paid consultant and clinical investigator for Allergan, Revance Thearpeutics, and Medicis. He has also served as a clinical investigator for Contura. To respond to this column, contact Dr. Glogau at sknews@elsevier.com.

By Richard G. Glogau, M.D.

Lip enhancement can produce aesthetically pleasing results, but, increasingly, the procedure is being undertaken by ill-informed or untrained physicians and, more often, nonphysicians, who are using inappropriate fillers. The lack of experience and knowledge is threatening patient safety.

The Food and Drug Administration has never approved any therapy for lip augmentation—be it an injectable, such as botulinum toxin, or any of the collagen products on the market. Yet lip augmentation can be done safely, using the appropriate product.

However, the lack of a formal approval, the relative absence of regulatory oversight, and the profitability of administering injectables is making it possible for subpar and illegal practices to thrive.

Injectables are already the most popular cosmetic procedure—surgical or nonsurgical. Out of a total of 11.7 million cosmetic procedures in 2007, there were 2.7 million Botox Cosmetic (onabotulinumtoxinA) injections, and 1.4 million injections of hyaluronic acid products, according to the American Society for Aesthetic Plastic Surgery.

When it comes to lip augmentation, it is best to stay away from any product that lasts too long. Given the nature of the lip anatomy, the filler will sometimes not stay exactly where it was placed. That migration is much easier to address when a temporary filler, such as any of the hyaluronic acid–based products, Restylane (Medicis Aesthetics Inc.), Hylaform (Inamed Aesthetics), Juvéderm Ultra or Ultra Plus (Allergan Inc.), and Prevelle Silk (Mentor Corp.), are used.

Collagen injectables, such as Allergan's CosmoPlast and Zyderm, are easier to use superficially, and thus, in some ways, make it more feasible to sculpt the lip. But the hyaluronic acid injectables last at least 6 months, giving the patient a little bit more value.

The longest-lasting fillers are the synthetic products, which include Artefill (Suneva Medical Inc.), Radiesse (BioForm Medical Inc.), or Sculptra (Sanofi-Aventis). They are often presented to patients as a way to save money—because of the duration of the results, the patient can receive one treatment and be satisfied for at least a year, if not for a lifetime.

When the filler starts to migrate—which is always a danger with the lip—it can create unsightly lumps or bumps, sometimes leading to permanent disfigurement. Some patients may experience decreased sensitivity or granuloma reactions.

Clearly, with the use of the more permanent fillers, the risk-benefit ratio is exceeded. But there are plenty of patients being injected with these materials, often overseas, where hundreds of fillers are offered. Many patients are tempted to get injected when they're abroad, but they can return with problems and without any idea of what type of material was injected.

The filler manufacturers and the FDA have not stepped in to restrict inappropriate use of these products. The FDA does not regulate the practice of medicine, and the manufacturers must, by law, sell their products to anyone who has a medical license.

The problem is only likely to get worse, as the financial incentives that come with injectables are just too powerful for many to resist.

For now, cosmetic dermatologists should err on the side of safety and stick with the most appropriate lip augmentation products. Your patients will thank you in the long run.

Dr. Glogau is clinical professor of dermatology at the University of California, San Francisco. He is a paid consultant and clinical investigator for Allergan, Revance Thearpeutics, and Medicis. He has also served as a clinical investigator for Contura. To respond to this column, contact Dr. Glogau at sknews@elsevier.com.

BETHESDA, MD. — A Food and Drug Administration advisory panel cast mixed votes on whether data on an injectable product derived from autologous fibroblast cells had demonstrated that it was safe and effective for treating moderate to severe nasolabial fold wrinkles in adults, the indication for which it is under review for approval.

At the meeting, the FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted 11-3 that the data submitted by the manufacturer showed the product was effective in treating moderate to severe nasolabial fold wrinkles. Dr. Michael Olding, the panel's plastic surgeon and chief of plastic surgery at George Washington University, Washington, voted yes on the efficacy question, but emphasized that the indication was narrow and the product had not been shown to be effective in treating the nasolabial fold or contour deficiencies. He and the other panelists also said that they did not believe the agent had been shown to be effective in people over age 65 years, in nonwhite populations, or in older men, who were not well represented in the two pivotal trials. The efficacy had been seen primarily in white women under age 65 years, who accounted for most of the patients.

The panel also voted 8-6 that the data on the product, azfibrocel-T, had not demonstrated that it was safe for the indication, citing gaps in the data, including uncertainty over its mechanism of action and whether it induced scar formation or collagen production.

Other safety concerns included not knowing what happens to the fibroblasts over time and the lack of biopsies to help make that determination, as well as the lack of long-term data and the likelihood that, once approved, it would be widely used off-label, and there are no data to support other uses. The panel, however, did not appear overly concerned about the potential tumorigenicity of the product, although they said longer term data were needed to address this theoretical risk. The panel was not asked specifically whether to recommend approval.

The product, previously called Isolagen, was marketed commercially in the United States between 1995 and 1999 as a nonregulated product, and in the United Kingdom between 2002 and 2007. It is manufactured by Fibrocell Science Inc., which until August was Isolagen Technologies Inc. If approved, the product will be marketed as Laviv.

Azfibrocel-T is derived from fibroblasts obtained from three punch biopsies taken from behind the ear that are sent to a Fibrocell facility. Once there, they are isolated, harvested, prepared in an injectable cell suspension, frozen, and shipped to clinicians overnight, for use within 48 hours. The cells are harvested an average of 50 days after the biopsies, according to the company.

Treatment is administered in three doses at 5-week intervals and is injected with a 29-guage needle directly into the papillary dermis of the nasolabial fold wrinkles, where the fibroblasts “are believed to produce and organize extracellular matrix proteins, including collagen, by a mechanism analogous to natural wound healing,” according to the company.

In the two pivotal, identical U.S. multicenter, double-blind trials, a total of 421 patients were randomized to receive three injections of azfibrocel-T or vehicle to the nasolabial fold wrinkles. Patients' mean age was 56 years, and most were white women.

At 6 months after the first treatment, significantly more of the patients who received the active treatment evaluated themselves as having a 2-point improvement in a 5-point scale evaluating the appearance of the “lower part of their face,” when compared with those who had received the vehicle (57% and 46% of those who received azfibrocel-T in both studies, compared with 30% and 8%, respectively, among those in the vehicle groups). This was one of the two primary endpoints.

The second primary endpoint was a 2-point improvement on the Lemperle scale as assessed by a blinded evaluator's live assessment at the 6-month visit, using a photo guide of the scale. When enrolled, patients' wrinkles were at least a grade 3 (moderately deep) on the 6-point scale that ranges from 0 (no wrinkle) to 5.

The differences in evaluator assessments of the azfibrocel-T–treated patients and those who received the vehicle were not as wide as the patients' assessments, but were statistically significant. At 6 months, 33% of the patients in one study and 19% in the second study were evaluated as having a 2-point improvement, compared with 7% of those on the vehicle in both studies.

The most common adverse events associated with treatment were injection site reactions, namely erythema, swelling, bruising, and bleeding; these effects were mostly mild to moderate and did not last longer than 7–14 days. There was one case of a basal cell carcinoma near the injection site diagnosed 5 months after the third treatment. Clinical experience to date indicates the risk of scarring and keloids is minimal, according to the company, which has proposed plans for a mandatory physician training program.

Voting no on both efficacy and safety, panelist Dr. Lynn A. Drake of Harvard Medical School, Boston, said she was concerned about the lack of nonvisible evidence to support safety. She and other dermatologists on the panel said that it was important to determine whether normal or scar tissue was present after treatment, whether collagen was produced, and if so, what type, and whether elastin was affected.

Dr. Drake questioned whether the lack of efficacy in people over age 65 was indicative of the inability of the elderly to scar, and emphasized that once a new treatment for wrinkles becomes available, it is widely used immediately in all age groups and often in locations where it might not be safe.

If approved, azfibrocel-T would be the first cellular product for treating nasolabial fold wrinkles and the first fibroblast product contained in an injectable cell suspension, according to the FDA. It would be the second autologous cell product to be approved; the first is Carticel, a preparation of autologous chondrocytes used to repair knee cartilage. Clinical studies are underway in facial acne scars, gingival recession, and vocal fold scarring. A study in burn scars is being planned, the company said.

The FDA usually follows the recommendations of its advisory panels.

BETHESDA, MD. — A Food and Drug Administration advisory panel cast mixed votes on whether data on an injectable product derived from autologous fibroblast cells had demonstrated that it was safe and effective for treating moderate to severe nasolabial fold wrinkles in adults, the indication for which it is under review for approval.

At the meeting, the FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted 11-3 that the data submitted by the manufacturer showed the product was effective in treating moderate to severe nasolabial fold wrinkles. Dr. Michael Olding, the panel's plastic surgeon and chief of plastic surgery at George Washington University, Washington, voted yes on the efficacy question, but emphasized that the indication was narrow and the product had not been shown to be effective in treating the nasolabial fold or contour deficiencies. He and the other panelists also said that they did not believe the agent had been shown to be effective in people over age 65 years, in nonwhite populations, or in older men, who were not well represented in the two pivotal trials. The efficacy had been seen primarily in white women under age 65 years, who accounted for most of the patients.

The panel also voted 8-6 that the data on the product, azfibrocel-T, had not demonstrated that it was safe for the indication, citing gaps in the data, including uncertainty over its mechanism of action and whether it induced scar formation or collagen production.

Other safety concerns included not knowing what happens to the fibroblasts over time and the lack of biopsies to help make that determination, as well as the lack of long-term data and the likelihood that, once approved, it would be widely used off-label, and there are no data to support other uses. The panel, however, did not appear overly concerned about the potential tumorigenicity of the product, although they said longer term data were needed to address this theoretical risk. The panel was not asked specifically whether to recommend approval.

The product, previously called Isolagen, was marketed commercially in the United States between 1995 and 1999 as a nonregulated product, and in the United Kingdom between 2002 and 2007. It is manufactured by Fibrocell Science Inc., which until August was Isolagen Technologies Inc. If approved, the product will be marketed as Laviv.

Azfibrocel-T is derived from fibroblasts obtained from three punch biopsies taken from behind the ear that are sent to a Fibrocell facility. Once there, they are isolated, harvested, prepared in an injectable cell suspension, frozen, and shipped to clinicians overnight, for use within 48 hours. The cells are harvested an average of 50 days after the biopsies, according to the company.

Treatment is administered in three doses at 5-week intervals and is injected with a 29-guage needle directly into the papillary dermis of the nasolabial fold wrinkles, where the fibroblasts “are believed to produce and organize extracellular matrix proteins, including collagen, by a mechanism analogous to natural wound healing,” according to the company.

In the two pivotal, identical U.S. multicenter, double-blind trials, a total of 421 patients were randomized to receive three injections of azfibrocel-T or vehicle to the nasolabial fold wrinkles. Patients' mean age was 56 years, and most were white women.

At 6 months after the first treatment, significantly more of the patients who received the active treatment evaluated themselves as having a 2-point improvement in a 5-point scale evaluating the appearance of the “lower part of their face,” when compared with those who had received the vehicle (57% and 46% of those who received azfibrocel-T in both studies, compared with 30% and 8%, respectively, among those in the vehicle groups). This was one of the two primary endpoints.

The second primary endpoint was a 2-point improvement on the Lemperle scale as assessed by a blinded evaluator's live assessment at the 6-month visit, using a photo guide of the scale. When enrolled, patients' wrinkles were at least a grade 3 (moderately deep) on the 6-point scale that ranges from 0 (no wrinkle) to 5.

The differences in evaluator assessments of the azfibrocel-T–treated patients and those who received the vehicle were not as wide as the patients' assessments, but were statistically significant. At 6 months, 33% of the patients in one study and 19% in the second study were evaluated as having a 2-point improvement, compared with 7% of those on the vehicle in both studies.

The most common adverse events associated with treatment were injection site reactions, namely erythema, swelling, bruising, and bleeding; these effects were mostly mild to moderate and did not last longer than 7–14 days. There was one case of a basal cell carcinoma near the injection site diagnosed 5 months after the third treatment. Clinical experience to date indicates the risk of scarring and keloids is minimal, according to the company, which has proposed plans for a mandatory physician training program.

Voting no on both efficacy and safety, panelist Dr. Lynn A. Drake of Harvard Medical School, Boston, said she was concerned about the lack of nonvisible evidence to support safety. She and other dermatologists on the panel said that it was important to determine whether normal or scar tissue was present after treatment, whether collagen was produced, and if so, what type, and whether elastin was affected.

Dr. Drake questioned whether the lack of efficacy in people over age 65 was indicative of the inability of the elderly to scar, and emphasized that once a new treatment for wrinkles becomes available, it is widely used immediately in all age groups and often in locations where it might not be safe.

If approved, azfibrocel-T would be the first cellular product for treating nasolabial fold wrinkles and the first fibroblast product contained in an injectable cell suspension, according to the FDA. It would be the second autologous cell product to be approved; the first is Carticel, a preparation of autologous chondrocytes used to repair knee cartilage. Clinical studies are underway in facial acne scars, gingival recession, and vocal fold scarring. A study in burn scars is being planned, the company said.

The FDA usually follows the recommendations of its advisory panels.

BETHESDA, MD. — A Food and Drug Administration advisory panel cast mixed votes on whether data on an injectable product derived from autologous fibroblast cells had demonstrated that it was safe and effective for treating moderate to severe nasolabial fold wrinkles in adults, the indication for which it is under review for approval.

At the meeting, the FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted 11-3 that the data submitted by the manufacturer showed the product was effective in treating moderate to severe nasolabial fold wrinkles. Dr. Michael Olding, the panel's plastic surgeon and chief of plastic surgery at George Washington University, Washington, voted yes on the efficacy question, but emphasized that the indication was narrow and the product had not been shown to be effective in treating the nasolabial fold or contour deficiencies. He and the other panelists also said that they did not believe the agent had been shown to be effective in people over age 65 years, in nonwhite populations, or in older men, who were not well represented in the two pivotal trials. The efficacy had been seen primarily in white women under age 65 years, who accounted for most of the patients.

The panel also voted 8-6 that the data on the product, azfibrocel-T, had not demonstrated that it was safe for the indication, citing gaps in the data, including uncertainty over its mechanism of action and whether it induced scar formation or collagen production.

Other safety concerns included not knowing what happens to the fibroblasts over time and the lack of biopsies to help make that determination, as well as the lack of long-term data and the likelihood that, once approved, it would be widely used off-label, and there are no data to support other uses. The panel, however, did not appear overly concerned about the potential tumorigenicity of the product, although they said longer term data were needed to address this theoretical risk. The panel was not asked specifically whether to recommend approval.

The product, previously called Isolagen, was marketed commercially in the United States between 1995 and 1999 as a nonregulated product, and in the United Kingdom between 2002 and 2007. It is manufactured by Fibrocell Science Inc., which until August was Isolagen Technologies Inc. If approved, the product will be marketed as Laviv.

Azfibrocel-T is derived from fibroblasts obtained from three punch biopsies taken from behind the ear that are sent to a Fibrocell facility. Once there, they are isolated, harvested, prepared in an injectable cell suspension, frozen, and shipped to clinicians overnight, for use within 48 hours. The cells are harvested an average of 50 days after the biopsies, according to the company.

Treatment is administered in three doses at 5-week intervals and is injected with a 29-guage needle directly into the papillary dermis of the nasolabial fold wrinkles, where the fibroblasts “are believed to produce and organize extracellular matrix proteins, including collagen, by a mechanism analogous to natural wound healing,” according to the company.

In the two pivotal, identical U.S. multicenter, double-blind trials, a total of 421 patients were randomized to receive three injections of azfibrocel-T or vehicle to the nasolabial fold wrinkles. Patients' mean age was 56 years, and most were white women.

At 6 months after the first treatment, significantly more of the patients who received the active treatment evaluated themselves as having a 2-point improvement in a 5-point scale evaluating the appearance of the “lower part of their face,” when compared with those who had received the vehicle (57% and 46% of those who received azfibrocel-T in both studies, compared with 30% and 8%, respectively, among those in the vehicle groups). This was one of the two primary endpoints.

The second primary endpoint was a 2-point improvement on the Lemperle scale as assessed by a blinded evaluator's live assessment at the 6-month visit, using a photo guide of the scale. When enrolled, patients' wrinkles were at least a grade 3 (moderately deep) on the 6-point scale that ranges from 0 (no wrinkle) to 5.

The differences in evaluator assessments of the azfibrocel-T–treated patients and those who received the vehicle were not as wide as the patients' assessments, but were statistically significant. At 6 months, 33% of the patients in one study and 19% in the second study were evaluated as having a 2-point improvement, compared with 7% of those on the vehicle in both studies.

The most common adverse events associated with treatment were injection site reactions, namely erythema, swelling, bruising, and bleeding; these effects were mostly mild to moderate and did not last longer than 7–14 days. There was one case of a basal cell carcinoma near the injection site diagnosed 5 months after the third treatment. Clinical experience to date indicates the risk of scarring and keloids is minimal, according to the company, which has proposed plans for a mandatory physician training program.

Voting no on both efficacy and safety, panelist Dr. Lynn A. Drake of Harvard Medical School, Boston, said she was concerned about the lack of nonvisible evidence to support safety. She and other dermatologists on the panel said that it was important to determine whether normal or scar tissue was present after treatment, whether collagen was produced, and if so, what type, and whether elastin was affected.

Dr. Drake questioned whether the lack of efficacy in people over age 65 was indicative of the inability of the elderly to scar, and emphasized that once a new treatment for wrinkles becomes available, it is widely used immediately in all age groups and often in locations where it might not be safe.

If approved, azfibrocel-T would be the first cellular product for treating nasolabial fold wrinkles and the first fibroblast product contained in an injectable cell suspension, according to the FDA. It would be the second autologous cell product to be approved; the first is Carticel, a preparation of autologous chondrocytes used to repair knee cartilage. Clinical studies are underway in facial acne scars, gingival recession, and vocal fold scarring. A study in burn scars is being planned, the company said.

The FDA usually follows the recommendations of its advisory panels.

Elsevier Global Medical News

Elsevier Global Medical News

Elsevier Global Medical News

The proliferation of bariatric surgery procedures performed each year in the United States has led to a burgeoning demand for body contouring.

Prior to 2000, it was rare for patients who experienced massive weight loss to seek help from plastic surgeons; in fact, this patient population was almost nonexistent, according to Dr. Al Aly, a board-certified plastic surgeon who practices in Iowa City.

Today, the demand for procedures such as abdominoplasties, upper arm lifts, and thigh lifts has never been higher.

According to the American Society of Plastic Surgeons, between 1992 and 2008 the number of abdominoplasties performed grew by 593%, from 16,810 to 116,512; the number of thigh lifts grew by 731%, from 1,023 to 8,504; and the number of upper arm lifts grew an astounding 2,982%, from 434 to 13,374. Meanwhile, the number of lower body lifts—a procedure that essentially did not exist in 1992—stood at 8,647 in 2008.

Dr. J. Peter Rubin, a board-certified plastic surgeon who directs the multidisciplinary Life After Weight Loss clinical program at the University of Pittsburgh, estimates that 90% of his clinical practice involves body contouring after massive weight loss.

“These are fairly complex and technically challenging procedures that are best done by surgeons who have a strong grounding in plastic surgery principles and strong training in plastic surgery,” said Dr. Rubin, coauthor of “Aesthetic Surgery After Massive Weight Loss” (Elsevier Medical Publishing, 2006).

Dr. Aly evaluates potential body-contouring candidates a minimum of 18 months after they have undergone bariatric surgery.

“We tend to not want to operate on people who are aiming for specific weight levels,” said Dr. Aly, author of “Body Contouring After Massive Weight Loss” (Quality Medical Publishing, 2005). “We want to operate on people who are in a comfortable lifestyle and are not doing heroic things to reach a particular weight level. If you have access to the bariatric surgeon that the patient was referred from, that's one of your best sources. Ask them if they feel that the patient has stabilized their weight loss.”

Dr. Susan Downey, a board-certified plastic surgeon who practices in Los Angeles, addresses goals and expectations with body-contouring candidates up front. She asks them about their cosmetic priorities, how long they've been at their present weight, and whether they've had plateaus with their weight loss. In her practice, abdominoplasty usually tops the list of procedures requested, followed by breast lift/augmentation; arm lift; thigh lift; and lower body lift (belt lipectomy), a combination procedure that includes abdominoplasty, a thigh lift, and a buttock lift.

“What bothers me [from a cosmetic standpoint] may not be what bothers them,” Dr. Downey noted. “I had one patient who wanted her eyes done first because the bags under her eyes got more pronounced as her face got smaller from the weight loss. You can do two or three procedures if a patient is in good medical condition. We usually limit ourselves to about 6-8 hours of surgery.”

Dr. Aly cautioned against combining too many procedures in one sitting. “I understand it would be [more convenient] for patients to combine several procedures, but there are safety reasons and there are also some physical reasons to consider if you want the best result,” he said. “If you have opposing vectors, for example, you tend to not know where things are going to end up. If you combine some of those procedures, you can end up with things looking less than ideal. You cannot shortcut things.”

According to published reports, Dr. Downey said, up to 30% of patients with massive weight loss have complications after body contouring. “I would say it's up to 10% for a major complication and up to 30% for a minor complication,” she estimated. “These patients have a higher rate of hematoma formation, a higher rate of seroma, and wound-healing issues. A lot of it has to do with the fact that the skin is so overstretched at the time that you do the surgery.”

Extensive scarring after the procedures is common, “but the improvement in body contour is quite dramatic and well worth the scars,” she added.

Recovery time varies among patients, Dr. Aly said, and tends to be longer after a belt lipectomy (4-6 weeks) than after other common procedures, including an upper body lift (2-3 weeks), an upper arm lift (2-3 weeks), and a thigh lift (2-4 weeks).

Some medical insurance companies cover the panniculectomy portion of the abdominal contour, including anesthesia, but other procedures generally are not covered. “That's one of the issues with this field: The insurance companies are bound to the criteria of medical necessity,” Dr. Rubin said. “It's sometimes hard to justify true medical necessity by the standard of the insurance company for some of these body-contouring operations, despite the overwhelmingly positive impact it will have on the person's quality of life. With these economic times, I'm not sure we're going to see that getting better quickly.”

Future advances in the field may benefit from adult stem cells. Dr. Rubin and his associates at the University of Pittsburgh's Adipocyte Biology Laboratory are studying stem cells from fat-tissue samples of body-contour patients that “have the potential to be transformed in culture into many different other cell types,” he said. “We are looking at the potential of these cells to aid in the healing process in a variety of disease states and, specifically, how we can use these cells to regenerate new tissue for reconstructive surgery.” Clinical trials are expected to launch in the next 3-5 years.

In the meantime, Dr. Rubin and other experts interviewed for this article expect body contouring to continue maturing as a subspecialty. “We close today considerably faster than we did back in 1998 and 1999, cutting our time by half,” Dr. Aly observed. “Some of that is efficiency, but some of that is also technology. These surgeries will be better from the standpoint of safety, because we will be able to get more efficient in the OR.”

These procedures produce an immeasurable impact on patient self-perception, Dr. Aly stated, recalling that a patient with massive weight loss once told him, “[Bariatric surgery] gave me back my life. It's part of a life transformation. Plastic surgery allows me to enjoy it.”

Body contouring, Dr. Aly said, “is part of a life transformation, and we as surgeons are part of that.”

Source Elsevier Global Medical News

Before and after results of an upper body lift in a male bariatric surgery patient: Experts in the field expect body contouring to mature into a subspecialty.

Source Courtesy Dr. Al Aly

The proliferation of bariatric surgery procedures performed each year in the United States has led to a burgeoning demand for body contouring.

Prior to 2000, it was rare for patients who experienced massive weight loss to seek help from plastic surgeons; in fact, this patient population was almost nonexistent, according to Dr. Al Aly, a board-certified plastic surgeon who practices in Iowa City.

Today, the demand for procedures such as abdominoplasties, upper arm lifts, and thigh lifts has never been higher.

According to the American Society of Plastic Surgeons, between 1992 and 2008 the number of abdominoplasties performed grew by 593%, from 16,810 to 116,512; the number of thigh lifts grew by 731%, from 1,023 to 8,504; and the number of upper arm lifts grew an astounding 2,982%, from 434 to 13,374. Meanwhile, the number of lower body lifts—a procedure that essentially did not exist in 1992—stood at 8,647 in 2008.

Dr. J. Peter Rubin, a board-certified plastic surgeon who directs the multidisciplinary Life After Weight Loss clinical program at the University of Pittsburgh, estimates that 90% of his clinical practice involves body contouring after massive weight loss.

“These are fairly complex and technically challenging procedures that are best done by surgeons who have a strong grounding in plastic surgery principles and strong training in plastic surgery,” said Dr. Rubin, coauthor of “Aesthetic Surgery After Massive Weight Loss” (Elsevier Medical Publishing, 2006).

Dr. Aly evaluates potential body-contouring candidates a minimum of 18 months after they have undergone bariatric surgery.

“We tend to not want to operate on people who are aiming for specific weight levels,” said Dr. Aly, author of “Body Contouring After Massive Weight Loss” (Quality Medical Publishing, 2005). “We want to operate on people who are in a comfortable lifestyle and are not doing heroic things to reach a particular weight level. If you have access to the bariatric surgeon that the patient was referred from, that's one of your best sources. Ask them if they feel that the patient has stabilized their weight loss.”

Dr. Susan Downey, a board-certified plastic surgeon who practices in Los Angeles, addresses goals and expectations with body-contouring candidates up front. She asks them about their cosmetic priorities, how long they've been at their present weight, and whether they've had plateaus with their weight loss. In her practice, abdominoplasty usually tops the list of procedures requested, followed by breast lift/augmentation; arm lift; thigh lift; and lower body lift (belt lipectomy), a combination procedure that includes abdominoplasty, a thigh lift, and a buttock lift.

“What bothers me [from a cosmetic standpoint] may not be what bothers them,” Dr. Downey noted. “I had one patient who wanted her eyes done first because the bags under her eyes got more pronounced as her face got smaller from the weight loss. You can do two or three procedures if a patient is in good medical condition. We usually limit ourselves to about 6-8 hours of surgery.”

Dr. Aly cautioned against combining too many procedures in one sitting. “I understand it would be [more convenient] for patients to combine several procedures, but there are safety reasons and there are also some physical reasons to consider if you want the best result,” he said. “If you have opposing vectors, for example, you tend to not know where things are going to end up. If you combine some of those procedures, you can end up with things looking less than ideal. You cannot shortcut things.”

According to published reports, Dr. Downey said, up to 30% of patients with massive weight loss have complications after body contouring. “I would say it's up to 10% for a major complication and up to 30% for a minor complication,” she estimated. “These patients have a higher rate of hematoma formation, a higher rate of seroma, and wound-healing issues. A lot of it has to do with the fact that the skin is so overstretched at the time that you do the surgery.”

Extensive scarring after the procedures is common, “but the improvement in body contour is quite dramatic and well worth the scars,” she added.

Recovery time varies among patients, Dr. Aly said, and tends to be longer after a belt lipectomy (4-6 weeks) than after other common procedures, including an upper body lift (2-3 weeks), an upper arm lift (2-3 weeks), and a thigh lift (2-4 weeks).

Some medical insurance companies cover the panniculectomy portion of the abdominal contour, including anesthesia, but other procedures generally are not covered. “That's one of the issues with this field: The insurance companies are bound to the criteria of medical necessity,” Dr. Rubin said. “It's sometimes hard to justify true medical necessity by the standard of the insurance company for some of these body-contouring operations, despite the overwhelmingly positive impact it will have on the person's quality of life. With these economic times, I'm not sure we're going to see that getting better quickly.”

Future advances in the field may benefit from adult stem cells. Dr. Rubin and his associates at the University of Pittsburgh's Adipocyte Biology Laboratory are studying stem cells from fat-tissue samples of body-contour patients that “have the potential to be transformed in culture into many different other cell types,” he said. “We are looking at the potential of these cells to aid in the healing process in a variety of disease states and, specifically, how we can use these cells to regenerate new tissue for reconstructive surgery.” Clinical trials are expected to launch in the next 3-5 years.

In the meantime, Dr. Rubin and other experts interviewed for this article expect body contouring to continue maturing as a subspecialty. “We close today considerably faster than we did back in 1998 and 1999, cutting our time by half,” Dr. Aly observed. “Some of that is efficiency, but some of that is also technology. These surgeries will be better from the standpoint of safety, because we will be able to get more efficient in the OR.”

These procedures produce an immeasurable impact on patient self-perception, Dr. Aly stated, recalling that a patient with massive weight loss once told him, “[Bariatric surgery] gave me back my life. It's part of a life transformation. Plastic surgery allows me to enjoy it.”

Body contouring, Dr. Aly said, “is part of a life transformation, and we as surgeons are part of that.”

Source Elsevier Global Medical News

Before and after results of an upper body lift in a male bariatric surgery patient: Experts in the field expect body contouring to mature into a subspecialty.

Source Courtesy Dr. Al Aly

The proliferation of bariatric surgery procedures performed each year in the United States has led to a burgeoning demand for body contouring.

Prior to 2000, it was rare for patients who experienced massive weight loss to seek help from plastic surgeons; in fact, this patient population was almost nonexistent, according to Dr. Al Aly, a board-certified plastic surgeon who practices in Iowa City.

Today, the demand for procedures such as abdominoplasties, upper arm lifts, and thigh lifts has never been higher.

According to the American Society of Plastic Surgeons, between 1992 and 2008 the number of abdominoplasties performed grew by 593%, from 16,810 to 116,512; the number of thigh lifts grew by 731%, from 1,023 to 8,504; and the number of upper arm lifts grew an astounding 2,982%, from 434 to 13,374. Meanwhile, the number of lower body lifts—a procedure that essentially did not exist in 1992—stood at 8,647 in 2008.

Dr. J. Peter Rubin, a board-certified plastic surgeon who directs the multidisciplinary Life After Weight Loss clinical program at the University of Pittsburgh, estimates that 90% of his clinical practice involves body contouring after massive weight loss.

“These are fairly complex and technically challenging procedures that are best done by surgeons who have a strong grounding in plastic surgery principles and strong training in plastic surgery,” said Dr. Rubin, coauthor of “Aesthetic Surgery After Massive Weight Loss” (Elsevier Medical Publishing, 2006).

Dr. Aly evaluates potential body-contouring candidates a minimum of 18 months after they have undergone bariatric surgery.

“We tend to not want to operate on people who are aiming for specific weight levels,” said Dr. Aly, author of “Body Contouring After Massive Weight Loss” (Quality Medical Publishing, 2005). “We want to operate on people who are in a comfortable lifestyle and are not doing heroic things to reach a particular weight level. If you have access to the bariatric surgeon that the patient was referred from, that's one of your best sources. Ask them if they feel that the patient has stabilized their weight loss.”

Dr. Susan Downey, a board-certified plastic surgeon who practices in Los Angeles, addresses goals and expectations with body-contouring candidates up front. She asks them about their cosmetic priorities, how long they've been at their present weight, and whether they've had plateaus with their weight loss. In her practice, abdominoplasty usually tops the list of procedures requested, followed by breast lift/augmentation; arm lift; thigh lift; and lower body lift (belt lipectomy), a combination procedure that includes abdominoplasty, a thigh lift, and a buttock lift.

“What bothers me [from a cosmetic standpoint] may not be what bothers them,” Dr. Downey noted. “I had one patient who wanted her eyes done first because the bags under her eyes got more pronounced as her face got smaller from the weight loss. You can do two or three procedures if a patient is in good medical condition. We usually limit ourselves to about 6-8 hours of surgery.”

Dr. Aly cautioned against combining too many procedures in one sitting. “I understand it would be [more convenient] for patients to combine several procedures, but there are safety reasons and there are also some physical reasons to consider if you want the best result,” he said. “If you have opposing vectors, for example, you tend to not know where things are going to end up. If you combine some of those procedures, you can end up with things looking less than ideal. You cannot shortcut things.”

According to published reports, Dr. Downey said, up to 30% of patients with massive weight loss have complications after body contouring. “I would say it's up to 10% for a major complication and up to 30% for a minor complication,” she estimated. “These patients have a higher rate of hematoma formation, a higher rate of seroma, and wound-healing issues. A lot of it has to do with the fact that the skin is so overstretched at the time that you do the surgery.”

Extensive scarring after the procedures is common, “but the improvement in body contour is quite dramatic and well worth the scars,” she added.

Recovery time varies among patients, Dr. Aly said, and tends to be longer after a belt lipectomy (4-6 weeks) than after other common procedures, including an upper body lift (2-3 weeks), an upper arm lift (2-3 weeks), and a thigh lift (2-4 weeks).

Some medical insurance companies cover the panniculectomy portion of the abdominal contour, including anesthesia, but other procedures generally are not covered. “That's one of the issues with this field: The insurance companies are bound to the criteria of medical necessity,” Dr. Rubin said. “It's sometimes hard to justify true medical necessity by the standard of the insurance company for some of these body-contouring operations, despite the overwhelmingly positive impact it will have on the person's quality of life. With these economic times, I'm not sure we're going to see that getting better quickly.”

Future advances in the field may benefit from adult stem cells. Dr. Rubin and his associates at the University of Pittsburgh's Adipocyte Biology Laboratory are studying stem cells from fat-tissue samples of body-contour patients that “have the potential to be transformed in culture into many different other cell types,” he said. “We are looking at the potential of these cells to aid in the healing process in a variety of disease states and, specifically, how we can use these cells to regenerate new tissue for reconstructive surgery.” Clinical trials are expected to launch in the next 3-5 years.

In the meantime, Dr. Rubin and other experts interviewed for this article expect body contouring to continue maturing as a subspecialty. “We close today considerably faster than we did back in 1998 and 1999, cutting our time by half,” Dr. Aly observed. “Some of that is efficiency, but some of that is also technology. These surgeries will be better from the standpoint of safety, because we will be able to get more efficient in the OR.”

These procedures produce an immeasurable impact on patient self-perception, Dr. Aly stated, recalling that a patient with massive weight loss once told him, “[Bariatric surgery] gave me back my life. It's part of a life transformation. Plastic surgery allows me to enjoy it.”

Body contouring, Dr. Aly said, “is part of a life transformation, and we as surgeons are part of that.”

Source Elsevier Global Medical News

Before and after results of an upper body lift in a male bariatric surgery patient: Experts in the field expect body contouring to mature into a subspecialty.

Source Courtesy Dr. Al Aly

PORTLAND, ORE. — As the chief of dermatologic surgery at the University of Washington, Seattle, Dr. Daniel Berg likes to have a handful of nontraditional topical hemostatic agents handy.

One is bone wax, a combination of beeswax and isopropyl.

He's had to use it twice in his 15 years of practice to tamponade bleeding of a bone: once on the skull and once in the nasal region.

“You warm up the bone wax, pack it, and stuff it into [the bleeding site] like Silly Putty,” Dr. Berg said at the annual meeting of the Pacific Dermatologic Association. “Consider having a box of it on standby if you do any surgery, particularly on the scalp.”

Possible complications of the agent include a granulomatous reaction, infection, and impediment of osteogenesis. He keeps a box of bone wax packets in his office, and he replaces it every few years when it expires.

A new alternative to bone wax is Ostene, a water-soluble alkylene oxide copolymer manufactured by Ceremed Inc. that dissolves in 24 hours (Dermatol. Surg. 2008;34:431-45).

Dr. Berg also discussed Gelfoam, an absorbable gelatin sponge manufactured by Pharmacia and Upjohn, which he uses for diffuse oozing.

The product promotes clotting and granulation, liquefies in several days, and is degraded over a period of 4-6 weeks. It is applied after being moistened with saline or with a local anesthetic.

“I don't like to put it into wounds that I'm covering over, because although it liquefies and is degraded, it can serve as a nidus for infection,” he said. “A great use is to line forehead flap pedicles with Gelfoam.”

Topical bovine thrombin is another agent Dr. Bergs likes to have at his disposal. Supplied as a sterile powder that has been freeze dried in the final container, along with mannitol and sodium chloride, thrombin directs conversion of fibrinogen to fibrin. It is sprayed on the wound or saturated on Gelfoam.

“I've only used this once in a patient that kept bleeding on aspirin and Plavix [clopidogrel],” he said.

Rare complications include allergy to bovine products, disseminated intravascular coagulation if the product gets into large vessels, and immune-mediated coagulopathies.

Dr. Berg concluded his presentation by discussing hemostatic agents that contain microfibrillar collagen, such as Avitene, manufactured by Davol Inc. These products attract blood platelets and, according to Dr. Berg, tend to be more effective than Gelfoam.

Sticky, powderlike substances, these products are applied directly with surgical gloves and have little immunogenicity; there have been rare reports of allergic or foreign body reactions.

Dr. Berg reported having no conflicts to disclose.

Avitene, a hemostatic agent, is used to control bleeding in a cheek flap.

Use of the agent allowed the defect to be closed with no bleeding.

Source Photos courtesy Dr. Daniel Berg

PORTLAND, ORE. — As the chief of dermatologic surgery at the University of Washington, Seattle, Dr. Daniel Berg likes to have a handful of nontraditional topical hemostatic agents handy.

One is bone wax, a combination of beeswax and isopropyl.

He's had to use it twice in his 15 years of practice to tamponade bleeding of a bone: once on the skull and once in the nasal region.

“You warm up the bone wax, pack it, and stuff it into [the bleeding site] like Silly Putty,” Dr. Berg said at the annual meeting of the Pacific Dermatologic Association. “Consider having a box of it on standby if you do any surgery, particularly on the scalp.”

Possible complications of the agent include a granulomatous reaction, infection, and impediment of osteogenesis. He keeps a box of bone wax packets in his office, and he replaces it every few years when it expires.

A new alternative to bone wax is Ostene, a water-soluble alkylene oxide copolymer manufactured by Ceremed Inc. that dissolves in 24 hours (Dermatol. Surg. 2008;34:431-45).

Dr. Berg also discussed Gelfoam, an absorbable gelatin sponge manufactured by Pharmacia and Upjohn, which he uses for diffuse oozing.

The product promotes clotting and granulation, liquefies in several days, and is degraded over a period of 4-6 weeks. It is applied after being moistened with saline or with a local anesthetic.

“I don't like to put it into wounds that I'm covering over, because although it liquefies and is degraded, it can serve as a nidus for infection,” he said. “A great use is to line forehead flap pedicles with Gelfoam.”

Topical bovine thrombin is another agent Dr. Bergs likes to have at his disposal. Supplied as a sterile powder that has been freeze dried in the final container, along with mannitol and sodium chloride, thrombin directs conversion of fibrinogen to fibrin. It is sprayed on the wound or saturated on Gelfoam.

“I've only used this once in a patient that kept bleeding on aspirin and Plavix [clopidogrel],” he said.

Rare complications include allergy to bovine products, disseminated intravascular coagulation if the product gets into large vessels, and immune-mediated coagulopathies.

Dr. Berg concluded his presentation by discussing hemostatic agents that contain microfibrillar collagen, such as Avitene, manufactured by Davol Inc. These products attract blood platelets and, according to Dr. Berg, tend to be more effective than Gelfoam.

Sticky, powderlike substances, these products are applied directly with surgical gloves and have little immunogenicity; there have been rare reports of allergic or foreign body reactions.

Dr. Berg reported having no conflicts to disclose.

Avitene, a hemostatic agent, is used to control bleeding in a cheek flap.

Use of the agent allowed the defect to be closed with no bleeding.

Source Photos courtesy Dr. Daniel Berg

PORTLAND, ORE. — As the chief of dermatologic surgery at the University of Washington, Seattle, Dr. Daniel Berg likes to have a handful of nontraditional topical hemostatic agents handy.

One is bone wax, a combination of beeswax and isopropyl.

He's had to use it twice in his 15 years of practice to tamponade bleeding of a bone: once on the skull and once in the nasal region.

“You warm up the bone wax, pack it, and stuff it into [the bleeding site] like Silly Putty,” Dr. Berg said at the annual meeting of the Pacific Dermatologic Association. “Consider having a box of it on standby if you do any surgery, particularly on the scalp.”

Possible complications of the agent include a granulomatous reaction, infection, and impediment of osteogenesis. He keeps a box of bone wax packets in his office, and he replaces it every few years when it expires.

A new alternative to bone wax is Ostene, a water-soluble alkylene oxide copolymer manufactured by Ceremed Inc. that dissolves in 24 hours (Dermatol. Surg. 2008;34:431-45).

Dr. Berg also discussed Gelfoam, an absorbable gelatin sponge manufactured by Pharmacia and Upjohn, which he uses for diffuse oozing.

The product promotes clotting and granulation, liquefies in several days, and is degraded over a period of 4-6 weeks. It is applied after being moistened with saline or with a local anesthetic.

“I don't like to put it into wounds that I'm covering over, because although it liquefies and is degraded, it can serve as a nidus for infection,” he said. “A great use is to line forehead flap pedicles with Gelfoam.”

Topical bovine thrombin is another agent Dr. Bergs likes to have at his disposal. Supplied as a sterile powder that has been freeze dried in the final container, along with mannitol and sodium chloride, thrombin directs conversion of fibrinogen to fibrin. It is sprayed on the wound or saturated on Gelfoam.

“I've only used this once in a patient that kept bleeding on aspirin and Plavix [clopidogrel],” he said.

Rare complications include allergy to bovine products, disseminated intravascular coagulation if the product gets into large vessels, and immune-mediated coagulopathies.

Dr. Berg concluded his presentation by discussing hemostatic agents that contain microfibrillar collagen, such as Avitene, manufactured by Davol Inc. These products attract blood platelets and, according to Dr. Berg, tend to be more effective than Gelfoam.

Sticky, powderlike substances, these products are applied directly with surgical gloves and have little immunogenicity; there have been rare reports of allergic or foreign body reactions.

Dr. Berg reported having no conflicts to disclose.

Avitene, a hemostatic agent, is used to control bleeding in a cheek flap.

Use of the agent allowed the defect to be closed with no bleeding.

Source Photos courtesy Dr. Daniel Berg

PORTLAND, ORE. — Its ability to provide volume and spare tissue makes the island pedicle flap a valuable technique for deep facial defects.

"When you can just about close a defect primarily and have concerns that doing so might cause unnecessary contour deformity or free margin retraction, an island pedicle flap taken from the standing cutaneous cone will rescue the repair and provide excellent cosmesis with minimal tissue loss," Dr. Roberta Sengelmann said at the annual meeting of the Pacific Dermatologic Association.

Also known as the B-to-Y flap or the kite flap, the island pedicle flap "has a rich vascular supply which comes from the underlying subcutaneous and muscular pedicle," said Dr. Sengelmann, a cosmetic dermatologic surgeon who practices in Santa Barbara, Calif., and St. Louis. "It is a terrifically viable flap and has surprisingly good mobility."

She uses it for deep defects, in areas where cosmetic junction lines and relaxed skin tension lines can camouflage the flap's kite-shaped design, to advance hair-bearing skin in cases when like skin is needed where there is a limited tissue reservoir within the cosmetic subunit.

She described the technique at the meeting. First, design the flap so that the primary and secondary flap movement will not cause anatomic distortion. Designs may be pentagonal, curved, or tapered. "These designs are used to preserve adjacent anatomical structures so as to avoid tissue distortion, but you maximize gain of the soft tissues that you have available," Dr. Sengelmann explained. "You take advantage of tissue laxity and relaxed skin tension lines."

Movement of the island pedicle flap is usually linear, "but you can rotate it [30-90 degrees], flip it [90-180 degrees], or tunnel it," she said.

Incise the flap vertically to the full thickness of the skin, free the advancing edge a few millimeters to prevent tethering down of the leading edge, and free a distal third or so of the flap to prevent limitation of movement.

Next, use a vertical spreading technique to undermine the flap. "The goal here is to maintain the vascular and muscular pedicle and provide enough stretch to allow adequate movement," she said. Advance the flap into place and secure the leading edge with the key suture. Undermine the defect wound margins in the mid-fat, close the secondary defect, achieve hemostasis, and approximate the flap slightly below the plane of the surrounding skin while providing perfect wound edge coaptation and eversion.

"Flaps should not be oversized," she cautioned. "When the flap is oversized, it tends to buckle up during the wound-healing process and can leave a 'pincushion-like' deformity."

To achieve optimal results, "be sure that the secondary defect can be easily closed side-to-side without distortion of anatomic structures," she added.

Other clinical pearls she shared were to "slightly undersize the flap, keeping in mind the area you are moving it to and being sure that you have enough primary movement to close the defect without compromising contour at that site."

Dr. Sengelmann acknowledged certain limitations of the island pedicle flap, including "trapdooring" and the potential for poor outcomes in areas with inadequate subdermal tissue and/or poor mobility, such as radiated, burned, or scarred skin; the nasal dorsum; and helical rim.

Even so, she concluded that the tissue-sparing aspect of this flap is "unsurpassed." There is a learning curve to "getting it right," but once the execution is mastered it provides an exceptional option for reconstruction of facial cutaneous defects.

Dr. Sengelmann disclosed no relevant conflicts of interest.

There's a learning curve to 'getting it right,' but once mastered it provides an exceptional option.

Source Dr. Sengelmann

PORTLAND, ORE. — Its ability to provide volume and spare tissue makes the island pedicle flap a valuable technique for deep facial defects.

"When you can just about close a defect primarily and have concerns that doing so might cause unnecessary contour deformity or free margin retraction, an island pedicle flap taken from the standing cutaneous cone will rescue the repair and provide excellent cosmesis with minimal tissue loss," Dr. Roberta Sengelmann said at the annual meeting of the Pacific Dermatologic Association.

Also known as the B-to-Y flap or the kite flap, the island pedicle flap "has a rich vascular supply which comes from the underlying subcutaneous and muscular pedicle," said Dr. Sengelmann, a cosmetic dermatologic surgeon who practices in Santa Barbara, Calif., and St. Louis. "It is a terrifically viable flap and has surprisingly good mobility."

She uses it for deep defects, in areas where cosmetic junction lines and relaxed skin tension lines can camouflage the flap's kite-shaped design, to advance hair-bearing skin in cases when like skin is needed where there is a limited tissue reservoir within the cosmetic subunit.

She described the technique at the meeting. First, design the flap so that the primary and secondary flap movement will not cause anatomic distortion. Designs may be pentagonal, curved, or tapered. "These designs are used to preserve adjacent anatomical structures so as to avoid tissue distortion, but you maximize gain of the soft tissues that you have available," Dr. Sengelmann explained. "You take advantage of tissue laxity and relaxed skin tension lines."

Movement of the island pedicle flap is usually linear, "but you can rotate it [30-90 degrees], flip it [90-180 degrees], or tunnel it," she said.

Incise the flap vertically to the full thickness of the skin, free the advancing edge a few millimeters to prevent tethering down of the leading edge, and free a distal third or so of the flap to prevent limitation of movement.

Next, use a vertical spreading technique to undermine the flap. "The goal here is to maintain the vascular and muscular pedicle and provide enough stretch to allow adequate movement," she said. Advance the flap into place and secure the leading edge with the key suture. Undermine the defect wound margins in the mid-fat, close the secondary defect, achieve hemostasis, and approximate the flap slightly below the plane of the surrounding skin while providing perfect wound edge coaptation and eversion.

"Flaps should not be oversized," she cautioned. "When the flap is oversized, it tends to buckle up during the wound-healing process and can leave a 'pincushion-like' deformity."

To achieve optimal results, "be sure that the secondary defect can be easily closed side-to-side without distortion of anatomic structures," she added.

Other clinical pearls she shared were to "slightly undersize the flap, keeping in mind the area you are moving it to and being sure that you have enough primary movement to close the defect without compromising contour at that site."

Dr. Sengelmann acknowledged certain limitations of the island pedicle flap, including "trapdooring" and the potential for poor outcomes in areas with inadequate subdermal tissue and/or poor mobility, such as radiated, burned, or scarred skin; the nasal dorsum; and helical rim.

Even so, she concluded that the tissue-sparing aspect of this flap is "unsurpassed." There is a learning curve to "getting it right," but once the execution is mastered it provides an exceptional option for reconstruction of facial cutaneous defects.

Dr. Sengelmann disclosed no relevant conflicts of interest.

There's a learning curve to 'getting it right,' but once mastered it provides an exceptional option.

Source Dr. Sengelmann

PORTLAND, ORE. — Its ability to provide volume and spare tissue makes the island pedicle flap a valuable technique for deep facial defects.

"When you can just about close a defect primarily and have concerns that doing so might cause unnecessary contour deformity or free margin retraction, an island pedicle flap taken from the standing cutaneous cone will rescue the repair and provide excellent cosmesis with minimal tissue loss," Dr. Roberta Sengelmann said at the annual meeting of the Pacific Dermatologic Association.

Also known as the B-to-Y flap or the kite flap, the island pedicle flap "has a rich vascular supply which comes from the underlying subcutaneous and muscular pedicle," said Dr. Sengelmann, a cosmetic dermatologic surgeon who practices in Santa Barbara, Calif., and St. Louis. "It is a terrifically viable flap and has surprisingly good mobility."

She uses it for deep defects, in areas where cosmetic junction lines and relaxed skin tension lines can camouflage the flap's kite-shaped design, to advance hair-bearing skin in cases when like skin is needed where there is a limited tissue reservoir within the cosmetic subunit.

She described the technique at the meeting. First, design the flap so that the primary and secondary flap movement will not cause anatomic distortion. Designs may be pentagonal, curved, or tapered. "These designs are used to preserve adjacent anatomical structures so as to avoid tissue distortion, but you maximize gain of the soft tissues that you have available," Dr. Sengelmann explained. "You take advantage of tissue laxity and relaxed skin tension lines."

Movement of the island pedicle flap is usually linear, "but you can rotate it [30-90 degrees], flip it [90-180 degrees], or tunnel it," she said.

Incise the flap vertically to the full thickness of the skin, free the advancing edge a few millimeters to prevent tethering down of the leading edge, and free a distal third or so of the flap to prevent limitation of movement.

Next, use a vertical spreading technique to undermine the flap. "The goal here is to maintain the vascular and muscular pedicle and provide enough stretch to allow adequate movement," she said. Advance the flap into place and secure the leading edge with the key suture. Undermine the defect wound margins in the mid-fat, close the secondary defect, achieve hemostasis, and approximate the flap slightly below the plane of the surrounding skin while providing perfect wound edge coaptation and eversion.

"Flaps should not be oversized," she cautioned. "When the flap is oversized, it tends to buckle up during the wound-healing process and can leave a 'pincushion-like' deformity."

To achieve optimal results, "be sure that the secondary defect can be easily closed side-to-side without distortion of anatomic structures," she added.

Other clinical pearls she shared were to "slightly undersize the flap, keeping in mind the area you are moving it to and being sure that you have enough primary movement to close the defect without compromising contour at that site."

Dr. Sengelmann acknowledged certain limitations of the island pedicle flap, including "trapdooring" and the potential for poor outcomes in areas with inadequate subdermal tissue and/or poor mobility, such as radiated, burned, or scarred skin; the nasal dorsum; and helical rim.

Even so, she concluded that the tissue-sparing aspect of this flap is "unsurpassed." There is a learning curve to "getting it right," but once the execution is mastered it provides an exceptional option for reconstruction of facial cutaneous defects.

Dr. Sengelmann disclosed no relevant conflicts of interest.

There's a learning curve to 'getting it right,' but once mastered it provides an exceptional option.

Source Dr. Sengelmann