London — Breast implants manufactured by French company Poly Implant Prothese (PIP) may have a rupture rate as high as one in three, a new study concludes.

The study, published in the Journal of Plastic, Reconstructive and Aesthetic Surgery, examined 453 patients who received PIP implants between seven and 12 years ago, and reported a rupture rate of between 15.9 and 33.8 percent.

"Previous studies have typically reported failure rates of between 2 percent and 5 percent," said study authors Miles Berry, F.R.C.S., and Jan Stanek, F.R.C.S., in a statement to Agence France-Presse (AFP). The new study used more conclusive ultrasound scans rather than relying only on physical examinations.

The new report comes as sobering news to the more than 400,000 women worldwide who received implants made by the defunct French company. PIP closed in 2010 when it was caught using industrial-grade silicone gel in its products.

"All PIP implants, due to the high rupture rate and uncertainty about the nature of the silicone gel, may need to be removed," Dr. Stanek told the AFP, adding that further research is necessary.

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Washington — The Food and Drug Administration has issued a new draft guidance encouraging cosmetics manufacturers to subject products containing nanomaterials to additional testing.

The engineered submicroscopic particles are used in skin moisturizers, mineral makeup and sunscreen, among other cosmetics. The new guidance doesn’t require additional testing for products containing such materials, but suggests that standard testing may need to be modified, or new testing methods developed to assess the safety of the particles, according to the Associated Press.

An FDA statement says the agency does not classify nanotechnology as inherently unsafe, but notes materials at such a small scale can raise different concerns than more conventional products.

“Understanding nanotechnology remains a top FDA priority. FDA is strengthening the scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products.”

While the FDA normally doesn’t require premarket approval for cosmetics, manufacturers are responsible for the safety and proper labeling of products. This includes all cosmetics, not just those containing nanomaterials.

The guidance was released along with a draft guidance about the use of nanomaterials in food packaging. Regulators may require food companies to provide additional data establishing the safety of these particles in food packaging.

Both guidances encourage manufacturers to consult with the FDA before marking their products.

The FDA will accept comments on both proposals for 90 days.

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Arlington Heights, Ill. — Chin augmentation is by far the fastest-growing plastic surgery trend among all major demographics, according to newly released statistics from the American Society of Plastic Surgeons.

The society reports that chin augmentations grew more in 2011 than breast augmentations, Botox (onabotulinumtoxinA, Allergan) injections and liposuction combined. The increase appears to be due to increased use of video chat technology, the aging baby boomer population and a desire for workplace success, the society suggests.

Chin augmentation saw an overall increase of 71 percent among all demographics. The highest increases were among people ages 40 to 54, 77 percent increase; men of all ages, 76 percent; and people age 55 and over, 70 percent. In comparison, lip augmentation procedures rose 49 percent and cheek implants increased 47 percent.

"The chin and jawline are among the first areas to show signs of aging. People are considering chin augmentation as a way to restore their youthful look just like a facelift or eyelid surgery," said ASPS President Malcolm Z. Roth, M.D. "We also know that as more people see themselves on video chat technology, they may notice that their jawline is not as sharp as they want it to be. Chin implants can make a dramatic difference."

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Tokyo — Transplanted hair follicles derived from adult stem cells have demonstrated normal hair cycles in bald mice, according to a recent study published in Nature Communications.

Researchers at Tokyo University of Science bioengineered hair follicle germ cells from adult epithelial stem cells and dermal papilla cells. They then implanted the bioengineered cells into the skin of bald mice, resulting in normal hair cycles and other signs of normal function, including piloerection, or goosebumps, Medical News Today reports. Along with normal functioning, the implanted hair follicles also developed the correct structures and made the right connections with surrounding tissue, according to the report.

“Our findings suggest that the transplantation of a bioengineered hair follicle germ can restore natural hair function and re-establish the cooperation between the follicle and the surrounding recipient muscles and nerve fibers,” the authors wrote. “Thus, the transplantation of bioengineered hair follicle germ is potentially applicable to the future surgical treatment of alopecia.”

Aside from raising hopes of a cure for baldness, the study is a significant advance toward next-generation organ replacement regenerative therapies, which will enable the replacement of damaged organs, according to the report. Notably, the study used adult stem cells, rather than embryonic, and it also marked the first time bioengineered follicles were fully functional and integrated into surrounding tissue, according to the report.

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Washington — The Food and Drug Administration has cleared the i-Lipo (Chromogenex), a low-level laser diode fat-reduction device for body contouring, for U.S. marketing.

PRNewswire reports that the FDA based its approval on results of a recent placebo-controlled, randomized study of 34 volunteers, 19 of whom were randomly selected for the treatment group and 15 for the control group. The treatment group received eight 20-minute laser treatment sessions over a three- to four-week period, followed by a period of post-treatment exercise. Members of the control group were treated for identical periods of time and undertook the same exercise program. Participants were unaware of their group allocations until the study was completed.

The success criterion for participants was to achieve a minimum reduction of 1.57 inches from the waist circumference. Fifteen of the 19 test participants reached the criterion, while one of the 15 placebo participants reached it.

According to Chromogenex, the U.K.-based developer and manufacturer, i-Lipo is the first direct contact laser device designed for fat reduction and body contouring to win FDA clearance for circumferential reduction.

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Dallas — Results of a new retrospective study suggest that using columellar struts in rhinoplasties is more helpful than had previously been thought.

An analysis of rhinoplasties performed from 1986 to 2009 by Rod Rohrich, M.D., chairman of the plastic surgery department at UT Southwestern Medical Center in Dallas, shows that columellar struts help improve nose symmetry and projection, creating a more natural appearance.

Columellar struts, grafts typically taken from the septum, can significantly project the nose and support the nasal tip. A columella that is retracted or shows too much creates a displeasing aesthetic look.

PRWeb quotes Dr. Rohrich, the study’s lead author, as saying, “Past articles have referred to the use of the columellar strut in rhinoplasty, but its role seems to have been underestimated. Compared to other variables that affect tip symmetry, the columellar strut has a unifying quality that renders it unique. Essentially, the strut provides a scaffold on which any tip correction can be used.”

The analysis, published in Plastic and Reconstructive Surgery, also classifies the type of columellar strut to use, based on more than 1,700 cases.

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Regensburg, Germany — German researchers report that diode laser therapy augmented with indocyanine green (ICG) results in good to excellent clearance of telangiectatic leg veins with no persisting side effects.

Investigators from University Hospital Regensburg assessed the safety and efficacy of ICG-augmented diode laser therapy for the treatment of telangiectatic leg veins in 15 female patients. ICG was administered intravenously and diode laser pulses with different radiant exposures were applied as a single treatment immediately afterward. The patient and a blinded investigator evaluated safety and efficacy at one and three months after treatment. Reference therapy was treatment with pulsed dye laser and diode laser without ICG.

HealthDay News reports that the safety of ICG application and diode laser treatment were rated excellent for all patients, with no persisting side effects. Researchers found clearance to be dose-dependent. Diode laser treatment at radiant exposures between 100 J/cm² and 110 J/cm² resulted in good clearance, which improved to excellent when double pulses were applied. Investigators noted poor to moderate clearance with diode laser therapy without ICG and with pulsed dye laser treatment.

“ICG-augmented diode laser therapy has proved to be a safe and effective treatment option for telangiectatic leg veins,” the authors wrote.

According to HealthDay News, Asclepion provided a MeDioStar diode laser for the study, while Pulsion Medical Systems provided the ICG.

The proof-of-concept study was published online in Lasers in Surgery and Medicine.

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Arlington Heights, Ill. — The American Society of Plastic Surgeons has earned the highest level of accreditation status — Accreditation with Commendation — from the Accreditation Council for Continuing Medical Education (ACCME).

The ACCME grants accreditation to the ASPS through March 2018, and recognizes the society as a leading provider of continuing medical education (CME) for the plastic surgery community.

“This is truly a testament to the quality of educational programs that we offer to our members,” said ASPS President Malcolm Z. Roth, M.D., in an ASPS statement. “Commendation is rare — fewer than 29 percent of the 690 ACCME-accredited CME providers have received this designation. It demonstrates that the ACCME has the highest confidence in the educational programming that ASPS offers and recognizes our efforts to collaborate with others in the CME community.”

The ACCME grants commendation to providers that demonstrate compliance with all 22 of its evaluation criteria and its accreditation policies.

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New York — More than half of nearly 800 women recently surveyed say they are willing to wait for the Food and Drug Administration to approve cohesive gel — or “gummy bear” — breast implants, according to a poll taken by ImplantInfo.com.

The devices, also known as form-stable gel silicone breast implants, are already approved for use in Europe and Canada, but have yet to earn FDA approval. ImplantInfo.com — a breast implant and augmentation information site — reports that manufacturers’ clinical trials for safety and efficacy have generated promising data, according to a statement released by the American Society for Aesthetic Plastic Surgery.

An article posted on ImplantInfo.com quotes Los Angeles plastic surgeon Steven Teitelbaum, M.D., who is involved in the trials, as saying the implants “are longer-lasting and maintain a more attractive and predictable shape, (and) the gel they’re made of is less liquid-like and more solid-like than even today’s other cohesive silicone gel implants.”

Dr. Teitelbaum says other benefits of the implants include their ability to resist gravity, less frequent hardening of scar tissue due to capsular contracture, and the fact that the devices are unlikely to leak. On the other hand, “gummy bear” implants cost more, require longer incisions and may have a firmer texture than other types of implants.

Dr. Teitelbaum told ImplantInfo.com that FDA approval of the devices hinges on product safety. “When fiascos like those with PIP (French implants that were filled with industrial-grade silicone) happen, it delays the process because it worries everyone,” he says. “But the data from (gummy bear) implants are better than for any other implants to date. It seems inevitable that they will get approved.”

But, he noted, “Many people have predicted imminent approval of gummy bear implants for years.”

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Arlington Heights, Ill. — Patients who undergo cosmetic liposuction and/or abdominoplasty procedures experience significant improvements in self-esteem and quality of life, the American Society of Plastic Surgeons reports.

A study published in the April issue of the society’s journal Plastic and Reconstructive Surgery notes that outcomes are especially good with liposuction plus abdominoplasty, although patients have somewhat higher pain scores and longer recovery times.

The study, conducted by Eric Swanson, M.D., a Leawood, Kan., plastic surgeon, evaluated quality of life and other outcomes in 360 patients undergoing liposuction and/or abdominoplasty to remove excess abdominal fat. About 60 percent of patients had only liposuction, while 35 percent underwent a combination of liposuction and abdominoplasty. The rest underwent abdominoplasty only. Outcomes were assessed an average of four months after surgery.

Liposuction plus abdominoplasty produced the highest patient satisfaction rate — more than 99 percent — with no increase in pain compared to abdominoplasty alone. Patients who had undergone abdominoplasty rated their outcomes at 9 out of 10, compared with the 8 out of 10 score for patients who had had liposuction only.

Overall, 86 percent of patients reported an improved sense of self-esteem after surgery, while about 70 percent reported improved quality of life, more commonly after liposuction plus abdominoplasty.

“Liposuction and abdominoplasty, individually and in combination, produce high rates of patient satisfaction and reliably improve self-esteem,” Dr. Swanson concluded.  

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