Center Valley, Pa. — Young Medical Spa, based here, has been cited by the Food and Drug Administration for several violations, including some related to the use of adult stem cells for breast augmentation.

The FDA’s Center for Biologics Evaluation and Research sent a warning letter to Thomas E. Young, M.D., owner and medical director of the spa, saying the facility had radically altered adult stem cells when converting them from adipose tissue, MedCity News reports.

Companies may derive adult stem cells from certain tissues as long as harvesting these cells doesn’t significantly change the structure of the cells. Stem cells may be injected back into the tissue of the person from whom the cells were derived. If regulators conclude that the process significantly changed the adipose tissue, then the tissue is considered a biological product, and must meet a more demanding set of criteria.

“Specifically, your processing alters the relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair or replacement. Therefore, the processing would not meet the definition of minimal manipulation for structural tissue such as adipose tissue,” the letter stated.

During a two-month factory inspection of the practice’s offices in Lansdale and South Center Valley, Pa., ending in January, regulators allegedly found numerous violations of good manufacturing and good tissue practices and failure to keep a record of investigations into cases in which patients suffered adverse reactions. The letter also noted a lack of appropriate laboratory testing of each batch of drug product.

According to MedCity News, there were at least six cases in which the company failed to investigate adverse reactions following surgical procedures.

If the practice does not adequately respond to the FDA’s letter, regulatory action, including seizure or injunction, may be taken without further notice.

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Nashville, Tenn. — Newly published research points to a shortage of hand specialists available to provide emergency coverage across Tennessee.

Researchers from Vanderbilt University Medical Center surveyed 119 hospitals across the state, all of which had both an operating room and an emergency room. The study evaluated the availability of both elective and emergency hand surgery services, HealthDay News reports.

Of the 93 percent of hospitals that completed the survey, 77 percent offered elective hand surgery and 58 percent offered basic emergency coverage for hand injuries. Only 18 percent offered occasional hand specialist call coverage. Only 7 percent of hospitals surveyed offered full-time hand specialist call coverage.

Hospitals with hand specialists available billed significantly more through commercial insurance than those lacking specialist coverage.

"Potential solutions include altering the structure and length of hand training itself by developing an integrated residency, arguing for increased compensation, increasing direct pay from hospitals for call coverage, creating multihospital coordinated call schedules, and encouraging more surgeons to pursue hand surgery training," the study authors concluded.

The report was published in the May issue of Annals of Plastic Surgery.

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Brussels — Cosmetic manufacturer L’Oréal’s attempt to trademark products with a similar name to Botox (onabotulinumtoxinA, Allergan), was rejected by the top European Union court.

Bloomberg News reports that the EU Court of Justice upheld earlier rulings by the EU trademark office refusing L’Oréal, the world’s largest cosmetics maker, the right to trademark the words “botolist” and “botocyl” for cosmetic products.

“The use of the marks at issue would take unfair advantage of the reputation of the Botox trademarks,” according to a court statement.

According to Allergan, L’Oréal was attempting to cash in on Botox’s reputation by using similar names for cosmetics.

“This court ruling reinforces Allergan’s position that the Botox name should only be used in relation to Allergan’s product,” a company spokeswoman said.

Representatives for L’Oréal had no immediate comment.

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New York — Very few breast reconstructions in the United States use the most advanced microsurgical techniques, according to a report in the May issue of Plastic and Reconstructive Surgery.

Both conventional and microsurgical flap techniques use a patient's own tissues to reconstruct the breast, the American Society of Plastic Surgeons reports. The newer microsurgical techniques may avoid some of the side effects and discomfort of conventional techniques, but most breast reconstruction procedures done today aren’t using the latest advances, the study suggests.

Researchers from Memorial Sloan-Kettering Cancer Center in New York used a database to analyze data on nearly 16,000 women undergoing mastectomy in 2008, about 6,000 of whom underwent immediate breast reconstruction. The overall reconstruction rate was about 38 percent, while a study from 2003 using the same database found a 24 percent rate.

Age, income and race were among many factors studied. According to research, younger women, Caucasian and Asian women and higher income earners were more likely to have implants, where women over the age of 50 were more likely to undergo reconstruction with their own tissues.
Breast implants consisted of more than 60 percent of reconstructions, while 34 percent of reconstructions were done with conventional plastic surgery skin flaps. The remaining procedures were performed using advanced microsurgical flap techniques.

"The presence of disparities in care suggests that current decision making for breast reconstruction is not based solely on patient preference or anatomic features," the study authors wrote.

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Rome — A recent study suggests autologus fat grafting procedures — enhanced stromal vascular fraction (SVF) and platelet-rich plasma (PRP) fat grafting — maintain breast volume and three-dimensional contour better than standard procedure.

Researchers from the University of Rome Tor Vergata conducted a comparative translational study of 23 women suffering soft tissue defects of the breast to compare the effects of the procedures in promoting consistent fat volume after breast reconstruction.

Study investigators compared 10 cases of SVF-enhanced autologous fat grafting and 13 cases of PRP fat grafting with the results of a control group of 10 patients undergoing a standard centrifuged fat grafting procedure, HealthDay News reports.

According to HealthDay News, the study reports that 63 and 69 percent maintenance of contour restoring and three-dimensional volume was found in the SVF and PRP groups, respectively, and only 39 percent in the control group after one year.

"Engineered fat grafting based on the (addition) of SVF or PRP is a reliable alternative to breast implant based on some initial indications," the authors concluded.

The study was published in Stem Cells Translational Medicine.

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Boston — A recent report reveals that researchers have discovered a mechanism by which developing organisms recognize and repair head and facial abnormalities.

This is the first time that this kind of process has been analyzed through mathematical modeling, researchers say.

Scientists from Tufts University showed that cell groups can assess their shape and position in relationship to other organs, and also perform the required movements and remodeling functions in order to compensate for important abnormalities in patterns, Medical News Today reports.

"We have found that when we created defects in the face experimentally, facial structures move around in various ways and mostly end up in their correct positions,” said Michael Levin, Ph.D., director, Center for Regenerative and Developmental Biology, Tufts University School of Arts and Sciences. “This suggests that what the genome encodes ultimately is a set of dynamic, flexible behaviors by which the cells are able to make adjustments to build specific complex structures.”

Earlier research had found self-correcting mechanisms in some embryonic processes, but not the face. These had not been analyzed mathematically to study the precise dynamics of the corrective process, Medical News Today reports.

The study investigators induced craniofacial defects in frog embryos and then analyzed changes of the craniofacial structures such as eyes, jaws, otic capsules and so on in terms of their shape and position.

The study showed that the abnormalities, particularly in the jaws and branchial arches, were reduced as the tadpoles aged, and eye and nose tissue became more normal over time.

The team noticed that in tadpoles with severe abnormalities, a major shift occurred in the facial structures to repair these malformations, as if the system was able to detect and correct deviations.

"Such understanding would have huge implications not only for repairing birth defects, but also for other areas of systems biology and complexity science,” Dr. Levin said.

The study was published in the May issue of Developmental Dynamics.

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Ann Arbor, Mich. — According to researchers at the University of Michigan, the highest-risk outpatient surgery patients have a huge increase in risk of venous thromboembolism (VTE) requiring therapy.

The study, published in the Annals of Surgery, analyzed data from the American College of Surgeons National Surgical Quality Improvement Program database, looking at the period from 2005 to 2009. Adult outpatient surgery or surgery along with subsequent 23-hour observation patients were part of the study, HealthDay News reports.

Study investigators found an overall 30-day incidence of VTE of 0.15 percent. Risk factors that independently increased the possibility of VTE were current pregnancy, active cancer, age, high body mass index, two-hour or more operative time, arthroscopic surgery, saphenofemoral junction surgery and venous surgery not involving the great saphenous vein. Using a weighted risk index, the study found a 20-fold difference in 30-day VTE between lowest-risk and highest-risk patients.

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Gold Coast, Australia — The amount time a surgical team has worked together is associated with the number of miscommunications and interruptions during procedures, according to a study published in the AORN Journal.

Researchers from Australia’s Griffith University studied 160 surgical procedures in 10 specialties over six months to identify the correlation between interruptions, team familiarity and miscommunications during operations. Interruptions were classified as conversational or procedural, and miscommunications were classified as audience, purpose, occasion, content or experience, HealthDay News reports.

The researchers found a significant and inversely relationship between the amount of time a team spent working together and the number of miscommunications. The volume of miscommunications also correlated positively with the number of interruptions.

"These results may help to inform the development of evidence-based interventions designed to mitigate the effects of miscommunications in surgery," according to the report.

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Milwaukee — The main component of Botox (onabotulinumtoxinA, Allergan) may provide a modest ancillary benefit to patients who suffer from chronic migraines and chronic daily headaches when compared to placebo, according to a report in the Journal of the American Medical Association.

"Botulinum toxin A compared with placebo was associated with a small-to-modest benefit for chronic daily headaches and chronic migraines, but was not associated with fewer episodic migraine or chronic tension-type headaches per month," the authors wrote.

HealthDay News reports that researchers with the Medical College of Wisconsin, Milwaukee, conducting pooled analyses noted a reduction in headaches per month in study participants affected by either chronic daily headaches or chronic migraines. No statistically significant correlation was seen between botulinum toxin A and reduction in episodic migraine headaches or chronic tension-type headaches.

Compared to placebo, botulinum toxin A was associated with more occurrences of adverse effects, such as skin tightness, neck stiffness, neck pain, muscle weakness, paresthesias and blepharoptosis.

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Suwanee, Ga. — Drugmaker Halscion announced that its product Celotres has received European CE mark approval. Celotres is a hydrogel scaffold used to improve wound healing and scarring.

Celotres received the CE mark approval based on the successful results of European clinical trials. The trials were conducted among 100 female patients undergoing laparotomy or laparoscopy gynecologic procedures, and showed that after 12 months, the scars treated with Celotres were evaluated by both observers and subjects as appearing significantly better using both the Patient and Observer Scar Assessment Scale and the Anchored Visual Analog Scale.

There were no serious device-related adverse events reported with Celotres use and an evaluation of all adverse events showed no difference between treatment and control for any event.

“We are pleased to reach this significant milestone for Halscion and look forward to making Celotres available to European physicians this year,” said Kathleen Beauchamp, president and CEO of Halscion.

The CE mark shows that a product conforms to consumer laws for the entire European Economic Area and allows a product to be sold among all nations in the confederation.

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