Thursday, July 14, 2016
Fat grafting and the FDA
The cosmetic surgery industry is watching closely as the Food & Drug Administration is considering the way it regulates autologous fat tissue. At stake: Will plastic surgeons be allowed to use fat grafting broadly for purposes that include shaping and contouring of the body and face?
“Most physicians would rather see a broadened use allowed that represents an increased knowledge of how fat is used safely,” says Neal R. Reisman, M.D., JD, FACS, chief of Plastic Surgery at Baylor-St. Luke’s Hospital and past president of the Aesthetic Surgery Education and Research Foundation. “But I don’t think anyone has a full handle about whether they’ll go beyond what we envision as protecting the patient.”
Dr. Reisman spoke about legal issues regarding fat at this year’s The Aesthetic Meeting in Las Vegas, the annual meeting of the American Society for Aesthetic Plastic Surgery.
The FDA issued draft regulations about the use of adipose tissue in December 2014, and they have yet to be finalized. “They’ve been wise to let them be out there for a long time,” Dr. Reisman tells Cosmetic Surgery Times. “They sought and have received a lot of input.”
At issue is how the FDA’s final regulations will define the appropriate use of autologous fat, given that the use of fat injections has evolved. They’re now a major tool for plastic surgeons in areas like the face, hands, buttocks and breasts.
“I’ve been reluctant to put it in breast tissue until recently,” Dr. Reisman says. “But big studies have proven the safety and efficacy of fat injection throughout the body.”
The FDA draft rules say that autologous fat should be similar to the fat it replaces, and it defines adipose fat as “structural.” Under this perspective, the grafted tissue should serve a structural purpose. The uncertainty comes in with what is defined as “structural,” and therefore allowed under the FDA’s interpretation vs. what is “functional.”
Some things are clear, at least from Dr. Reisman’s perspective. On the “functional” front, “it certainly would be not following the guidelines to use fat to replicate or replace breast tissue with gland function and milk production,” he says.
But will the FDA go beyond that and impose additional limits that could affect the use of fat grafting in cosmetic surgery? “Hopefully the FDA will look at the studies showing the benefits of fat in a cosmetic patient,” Dr. Reisman says.