NEW YORK, March 12, 2019 /PRNewswire/ – A recent article published in the Aesthetic Surgery Journal, the clinical, peer-reviewed journal of the American Society for Aesthetic Plastic Surgery (ASAPS/The Aesthetic Society) is calling for the FDA to expedite its oversight of companies and clinics offering stem-cell products and therapies.
Stem-cell technology, a compelling area of medical research, is widely accepted in therapies for cancer and blood disorders (with clinical trial evidence suggesting stem cells might speed wound healing, improve heart function, and treat scleroderma). Most applications are still in the early stages of being assessed for benefits, limitations, and safety. Yet, in the last decade many new manufacturers of stem cell products have come into existence, and a huge number of clinics offering stem-cell therapies have opened their doors to eager medical consumers as well as those seeking cosmetic solutions. The most frequent complications of cosmetic stem-cell treatments appear to be contamination and infection.
"We are not in favor of overzealous regulation, but the fact is, organized medicine on its own isn't equipped to monitor and prevent abuses involving cellular-based treatments," states Dr. Robert Singer, MD, FACS, past-president of ASAPS and an author of the study. "Any procedure marketed in the cosmetic arena holds immense interest to consumers and a high risk for patient abuse," he explains.
The FDA announced a regulatory framework in 2017 giving cellular-based treatment clinics and companies 36 months to comply. To better protect public safety while allowing legitimate research to continue, the multi-specialty stem-cell task force recommends:
- Enlisting the help of national surgical-facility-accrediting agencies that already have useful systems in place for monitoring safety
- Collaborating more aggressively with state legislatures and medical boards on related issues such as medical scope of practice
- Requesting support from the Federal Trade Commission to stop false and misleading advertising regarding cellular-based therapies
Organized plastic surgeons are eager to cooperate with the FDA to work towards advancing stem-cell science while protecting the safety and welfare of our patients.
The full Editorial can be read here: https://academic.oup.com/asj/advance-article/doi/10.1093/asj/sjz033/5315584
The American Society for Aesthetic Plastic Surgery (ASAPS/The Aesthetic Society) is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of more than 2,600 members in North America and internationally; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements. ASAPS is at the forefront of innovation in aesthetic plastic surgery and cosmetic medicine globally.
American Society for Aesthetic Plastic Surgery