Arlington Heights, Ill. — The American Society of Plastic Surgeons has issued a statement that it fully supports a proposed federal rule to include vascularized composite allografts (VCA), such as faces and hands, in the national organ donation registry.

The Health Resources and Services Administration is considering having face and hand transplants fall under protocols that offer the same oversight to the processes surrounding VCA procurement that is currently provided for kidney, liver, heart and other organ donations.

The proposed federal rule would bring oversight of VCA procurement and assignation under the umbrella of the HRSA-sanctioned Organ Procurement and Transplantation Network (OPTN) and the United Network for Organ Sharing (UNOS).

The ASPS statement quotes member surgeon W.P. Andrew Lee, M.D., chairman of the department of plastic and reconstructive surgery at Johns Hopkins University School of Medicine, Baltimore, as saying, “Those of us who perform this surgery firmly believe that when you transplant a hand or face, the considerations and logistics in relation to the donor families are very much like those of the organ transplant — and quite different from the skin and bone donation because the latter are basically preserved to be put on a shelf and be used any time. A hand or a face, obviously, just like a heart, kidney or liver, cannot be without a blood supply for more than a few hours. They need to be transplanted right away.”

Unlike organ donations, tissue and bone donations are regulated by the Food and Drug Administration, leaving classification of VCAs unclear.

The ASPS sent its endorsement of the proposed rule to HRSA officials last month. The Department of Health and Human Services has set no timetable for a determination on the proposal.

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San Francisco — Results of a multicenter clinical trial show that treatment of severed peripheral nerve with processed nerve allograft compares favorably to traditional autograft nerve repair.

Led by plastic surgeon Darrell Brooks, M.D., of the Buncke Clinic in San Francisco, the observational study is based on data collected from 12 collaborative institutions with 25 surgeons, each using their own standard of care, preferred surgical techniques, rehabilitation plan and follow-up. A total of 132 individual nerve injuries were treated using the processed nerve allograft.

According to a Buncke Clinic statement, the study’s findings show that nerve allograft is effective.

Across all types of nerves, patients achieved meaningful recovery in 89 percent of surgeries involving sensory nerves, 86 percent involving motor nerves and 77 percent involving mixed nerves, traditionally more difficult to treat.

In both short and long nerve gaps, patients achieved meaningful recovery in 100 percent of gaps less than 15 mm, 76 percent of gaps 15 mm to 29 mm and 91 percent of gaps 30 mm to 50 mm.

For adults of any age, meaningful recovery was achieved in patients ages 18 to 29 (70 percent), 30 to 49 (88 percent) and 50 and older (93 percent).

No graft-related adverse effects, implant complications or tissue rejections were reported.

“It is commonly accepted among surgeons who do peripheral nerve repair that success of surgery depends on the type of injury, length of nerve discontinuity, the patient’s age and the type of nerve,” Dr. Brooks says in the statement. “Our study findings show that with processed nerve allograft, patients can have meaningful recovery regardless of these factors.”

The findings were published in the January issue of Microsurgery.

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Grand Rapids, Mich. — A recent study suggests that portable, surgeon-performed, high-resolution ultrasound may have advantages over magnetic resonance imaging (MRI) when screening for implant failure.

Preliminary results of the study, led by Grand Rapids plastic surgeon Bradley Bengtson, M.D., show that high-resolution ultrasound provides excellent visualization of current fourth- and fifth-generation silicone gel implants in scanning models. In addition, in vivo surgeon-performed ultrasound accurately identified implant status and correlated with radiologist-performed ultrasound, MRI and surgical findings.

The Food and Drug Administration currently recommends MRI for device surveillance.

Phase 1 of the study evaluated several base and transducer systems, using them for both in vitro and ex vivo scanning model assessments of a variety of normal and damaged implant models. In phase 2, these technologies were applied clinically to provide imaging experience in three patients previously diagnosed with unilateral implant failure. In phase 3, a preliminary prospective evaluation was performed to compare the accuracy of MRI, surgeon-performed high-resolution ultrasound, and radiologist-performed high-resolution ultrasound scans in predicting the shell integrity of 29 implants in 15 consecutive breast implant patients who subsequently underwent secondary implant surgery.

In phase 1, all hardware models easily detected both intact and intentionally damaged shells in currently marketed fourth-generation responsive gel implants and in investigational, fifth-generation highly cohesive gel devices. Although multiple transducers were able to detect shell failure, the 12-MHz head produced the best images at the normal clinical depth range. Confirmatory scans in phase 2 correctly identified the side of rupture and were consistent with MRI and surgical findings. In phase 3, high-resolution ultrasound accurately predicted implant shell integrity in all 29 imaged breasts as confirmed at the time of surgery in both symptomatic and asymptomatic patients.

In a statement issued by the American Society for Aesthetic Plastic Surgery, Dr. Bengston says, “Our preliminary findings show that portable, surgeon-performed, high-resolution ultrasound is feasible for screening silicone gel breast implants, matching the capabilities of MRI in detecting shell failure. Although we are still working to define the role of this technology in the screening and diagnosis of patients with different silicone gel breast implant styles, there are several obvious benefits over MRI, including convenience, cost, availability, and dynamic, real-time visualization of the implant.”

The study appears in the February issue of Aesthetic Surgery Journal.

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Evanston, Ill. — Health professionals need to be aware of the potential health problems caused by body piercing, a trend among an increasing number of young people today, say researchers at Northwestern University’s Feinberg School of Medicine.

The Chicago Sun-Times reports that the paper details medical consequences resulting from piercings of ears, nose, mouth, nipples, navel and genitalia — and suggests ways to minimize and even prevent these complications.

The paper notes that while body piercing is fairly safe overall, bacterial infection is the No. 1 complication, affecting about 20 percent of body piercings. Other complications include allergies, loss of blood, scarring and interference with medical procedures, such as MRI, X-ray or ultrasound.

The Sun-Times quotes lead author Jaimee Holbrook, M.D., a clinical research fellow in the department of dermatology, as saying, “As piercing becomes more popular, the healthcare community should become familiar with how to remove the jewelry, in the case of an emergency situation, as well as understand piercing complications and related health risks.”

The review article was written while the researchers, along with investigators from the Rehabilitation Institute of Chicago, were conducting a trial on technology that uses magnetic tongue studs to help quadriplegics use computers and drive their own wheelchairs. According to the Sun-Times, the Feinberg team not only reviewed the medical literature on piercings, but also visited local piercing parlors to talk with professionals and watch them work.

The paper was published in the February issue of the American Journal of Clinical Dermatology.

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Chicago — Many popular cosmetic procedures are both safe and effective when performed by qualified individuals, according to a new study from Northwestern University Feinberg School of Medicine. For some treatments, however, data is still lacking, researchers say.

Investigators analyzed 98 studies on cosmetic procedures in order to reach conclusions on some of the most common procedures currently available to consumers. Researchers found that patients wanting to smooth wrinkles should feel safe getting injectables such as Botox (onabotulinumtoxinA, Allergan), Dysport (abobotulinumtoxinA, Medicis) and other neurotoxins, which were found to be effective as well as safe.

Other procedures that deliver scientifically confirmed results include liposuction and laser procedures to treat broken blood vessels, port wine stains and rosacea and to remove brown spots and hair, according to the American Society for Aesthetic Plastic Surgery.

The study also identified a few procedures that, although effective, have less scientific evidence behind them. They include use of infrared light or ultrasound devices to shrink and tighten the skin, use of low-level laser light to remove fat, and super-cooling of fat cells to “melt” fat. Though these procedures are approved by the Food and Drug Administration and have proved safe and effective in the short term, less is known about their long-term safety and effectiveness because they are relatively new, according to surgery.org.

“Overall, cosmetic dermatologic procedures are extremely safe,” the authors wrote in the study abstract. “However, detailed information about safety and effectiveness, and especially comparative effectiveness, is not available for many procedures.”

The study appears in the January issue of Dermatologic Clinics.

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Cincinnati — Use of general anesthesia, performance of liposuction under general anesthesia, and combining surgical procedures significantly increase the risk for adverse events (AEs) in office-based surgery, a new review suggests.

A review of mandatory adverse-event reporting, derived from 10-year data from Florida and six-year data from Alabama, “confirms trends that have been previously identified in earlier analyses of this data,” wrote lead author John Starling III, M.D, of the University of Cincinnati’s department of dermatology.

Medscape Today reports that according to the study, which appears in the February issue of Dermatologic Surgery, more than two-thirds of deaths and three-quarters of hospital transfers were associated with cosmetic surgery performed under general anesthesia.

The study is especially critical of liposuction performed under general anesthesia, noting that while liposuction is one of the most common cosmetic procedures, no deaths occurred with local anesthesia. “Liposuction under general anesthesia accounted for 32 percent of cosmetic procedure-related deaths and 22 percent of all cosmetic procedure-related complications,” the researchers wrote.

In the Florida statistics, a total of 309 AEs were reported during office-based surgery, including 46 deaths and 263 reportable complications or transfers to hospital. Cosmetic surgeries performed under general anesthesia accounted for the vast majority of deaths in Florida, with liposuction and abdominoplasty the most frequently reported procedures.

In the Alabama data, 52 AEs were reported, including 49 complications or hospital transfers and three deaths. General anesthesia was implicated in 89 percent of reported incidents, of which 42 percent were cosmetic surgeries. Pulmonary complications, including pulmonary emboli and pulmonary edema, were implicated in many deaths in both states.

The authors noted one limitation in their study, which was that case logs of procedures performed under general and intravenous sedation are required in Florida, but are not in the public domain and so were unavailable for analysis. Also, researchers were unable to obtain data on the total number of liposuction procedures performed in either state, which prevented them from calculating the overall fatality rate.

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Alexandria, Va. — Last year, more patients sought out social networking sites — rather than friends — for advice and information on facial plastic surgery before choosing a procedure, a new survey suggests.

A survey conducted by the Alexandria-based American Academy of Facial Plastic and Reconstructive Surgery showed that 42 percent of patients receive most of their information about plastic surgery from social media, as compared with 2010’s 29 percent, MSNBC.com reports. Meanwhile, the percentage of patients who obtained information from friends fell to 48 percent, from 63 percent the previous year.

The majority of surgeons surveyed also reported that 70 percent of their patients request procedures by describing the area of concern rather than requesting a specific product or procedure by name.

MSNBC.com reports that AAFPRS President Tom D. Wang, M.D., issued a cautionary note, saying, “We are encouraged by the possibilities that Facebook, Twitter and other social channels offer for prospective patients, but urge all patients to exercise caution in researching facial plastic procedures to ensure information is from a reliable source. There’s a great deal of misinformation out there, and the best way to circumvent that is to consult an AAFPRS physician who is qualified, experienced and trained in performing facial plastic procedures.”

The survey also revealed that for the third consecutive year, women outranked men in every category for both surgical and nonsurgical procedures — with the exception of hair transplants — and that age played a role in surgery selection. According to the survey, women under age 35 opted for less invasive procedures, but the numbers for certain procedures decreased from the previous year. The most common nonsurgical procedures for women under age 35 were Botox (onabotulinumtoxinA, Allergan) injections, hyaluronic acid injections, chemical peels and microdermabrasion.

Rhinoplasty continued to be the most common surgical procedure performed on both women and men under age 35.

While more patients appear to be obtaining their plastic surgery information from social media, only 14 percent of surgeons in 2011 said they saw an increase in requests for “celebrity procedures,” such as Angelina Jolie-esque lips. Surgeons also reported that patients are split in their concerns regarding results and cost when making the decision to undergo facial plastic surgery.

The survey’s full results are posted on the AAFPRS website.

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Arlington Heights, Ill. — The American Society of Plastic Surgeons has released statistics showing the industry enjoyed significant growth for the second consecutive year.

According to the ASPS, 13.8 million cosmetic plastic surgery procedures — both surgical and minimally invasive — were performed in the United States in 2011, up 5 percent over the 2010 figure. In addition, 5.5 million reconstructive procedures were performed last year, also a 5 percent increase over 2010 statistics.

Other significant findings:
• For the first time since 2004, facelifts were among the top five cosmetic surgical procedures.
• Chin augmentations, popular with men, were up 71 percent over 2010, with 21,000 procedures performed. Lip augmentations rose 49 percent, with more than 25,000 performed.
• Cosmetic minimally invasive procedures increased 6 percent, with nearly 12.2 million procedures. These were led by botulinum toxin type A treatments, up 5 percent, at 5.7 million procedures.
• Procedures using hyaluronic acid fillers were up 9 percent; calcium hydroxylapatite procedures rose 36 percent; and fat-injection procedures were up 19 percent.
• Reconstructive plastic surgery rose 5 percent, with the number of maxillofacial surgeries increasing 125 percent.

“We are seeing notable increases in surgical procedures, such as facelifts, that reflect the demands of an aging boomer population,” ASPS President Malcolm Z. Roth, M.D., said in a prepared statement. “However, the overall growth in cosmetic procedures is being primarily driven by a substantial rise in minimally invasive procedures.”

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Rome — A new technique involving injections of fat followed by implant placement may prove a viable alternative for breast cancer patients who have undergone radiation therapy.

According to an American Society of Plastic Surgeons news release, women who have undergone radiation therapy are usually not considered for reconstruction involving implants due to the higher risk of complications. A team of surgeons led by Marzia Salgarello, M.D., of University Hospital “A. Gemelli” in Rome, investigated the use of fat grafting to achieve better results with implant-based breast reconstruction after cancer surgery and radiation therapy.

Using the new technique, the surgeon uses liposuction to transfer fat from one part of the body and injects it into the radiation-treated area to create a bed of healthy tissue in the chest wall or remaining breast to receive the implant. Investigators used the combination technique over a three-year period with 16 patients who underwent breast cancer surgery followed by radiation therapy. Eleven of the patients had a mastectomy and five a lumpectomy or other types of breast-conserving surgery. Reconstruction began at least three to six months after the completion of radiation therapy. All patients received two or three fat grafts. The final reconstruction, including implant placement, was performed only when the area was free of signs of radiation toxicity.

Results showed that the final appearance of the reconstructed breasts was rated excellent to good in 94 percent of patients. Patient satisfaction was rated high to very high. No complications were reported at an average follow-up of 15 months. All patients had good healing of the tissues surrounding the implant.

“Fat grafting seems to reduce the radiation-induced complications in implants,” the authors wrote. “However, larger studies with a longer follow-up are required to confirm our findings.”

The study appears in the February issue of Plastic and Reconstructive Surgery.

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Brisbane, Calif. — Cutera, a provider of laser and other light-based systems used by cosmetic surgeons, has finalized its $5.1 million cash purchase of the global aesthetic business of Iridex, Mountain View, Calif.

Globe Newswire quotes Kevin Connors, president and CEO of Brisbane-based Cutera, as saying, “We are pleased to announce the closing of this acquisition, as it advances Cutera’s presence among core physicians worldwide. Now, with an expanded customer base, Cutera will be able to leverage cross-selling opportunities to our expanded installed base.”

Cutera’s most recent product offering is the VariLite dual wavelength laser system for treating pigmentation and vascular and cutaneous lesions.

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