City, State – January 2019 – Dallas-based world renown plastic surgeon Rod J. Rohrich, MD, together with his colleague Dinah Wan, MD, has published a special topic article in the Plastic and Reconstructive Surgery Journal that elaborates on the importance of physicians remaining both educated and cognizant of the United States Food and Drug Administration (FDA) regulations when it comes to two separate procedures, namely fat grafting and stem cell therapy. In the article, Dr. Rohrich offers a historic basis for the importance of adhering to regulations so that the two procedures can be clinically implemented in both a responsible and informed manner.
The primary aim of the publication is to educate readers about the differences between two surgical procedures that seem similar but are very different. Autologous fat grafting is a minimally invasive procedure used for the removal of unwanted fat from one area of the boy and reinjecting it into a desired area. On the other hand, stromal vascular fraction (SVF) is a mixture of regenerative cells that are extracted via fat tissue, subsequently separated from fat cells and then reinjected back into the body. While both procedures essentially transfer stem cells from one area of the body to another, SVF isolation yields a stem cell enriched graft, while autologous fat grafting does not and therefore should not be viewed as a type of stem cell therapy.
Furthermore, Dr. Rohrich writes that there has been a lot of uncertainty in regard to the differences between the aforementioned procedures and adds in his publication that “the market has capitalized on this in the past decade to sell unproven ‘stem cell’ therapies to unknowing consumers while exploiting the regulatory liberties of traditional fat grafting.”
However, “Stem cell therapy clinics in the USA are not approved,” he adds. “Furthermore, stem cell therapy should not be confused with doing fat grafting for both reconstructive and cosmetic reasons,” Dr. Rohrich comments.
This is in line with the evolution of the FDA regulations of the two procedures which were initially regulated equally strictly. However, after realizing the differences between the two, the FDA decided to treat them as two separate procedures. In other words, autologous fat grafting is considered a 361 product that is allowed to be used in the clinical setting without the need for premarket approval. SVF isolation, on the other hand, is viewed as more than just a minimal manipulation and as such is regulated as a drug or a 351 device. In other words, given the fundamental differences between the two procedures, the FDA lifted its restrictions on fat grafting but not on SVF isolation.
The authors conclude with highlighting that the two procedures are two different operations with completely different risks and ought to be regulated accordingly. They are in full support of the FDA’s decision to regulate the clinical use SVF as a 351 device or “drug” as that immediately affects institutions that have falsely marketed themselves as stem cell clinics. “By doing so, it delivers a clear message to the medical community that the regulatory landscape on stem cells in the United States has shifted to one of heightened vigilance,” the authors conclude.
About Rod J. Rohrich, MD, FACS
Rod J. Rohrich, MD, FACS runs a clinical practice at University Hospitals/UT Southwestern Medical Center and the Dallas Plastic Surgery Institute. He is a professor and founding Chairman of the Department of Plastic Surgery at the University of Texas Southwestern Medical Center at Dallas.
Known to be one of the best cosmetic surgeons in Dallas, Dr. Rohrich is President of the Association of Academic Chairmen of Plastic Surgery, and he is member of the American Association of Plastic Surgeons, the American Society of Plastic Surgeons (ASPS), where he was President as well as on the Board of Directors for some time, the Plastic Surgery Research Council, the American Society for Aesthetic Plastic Surgery (ASAPS), where he also served on the Board of Directors for a period of time, and the American Society of Maxillofacial Surgeons. He was Director of the American Board of Plastic Surgery (ABPS) and President of the Dallas Society of Plastic Surgeons and the Texas Society of Plastic Surgeons. He is also a Founding Member of the Board of Governors of the National Endowment for Plastic Surgery. Board Certified by the American Board of Plastic Surgery.
In addition to being continuously recognized as one of the best plastic surgeons in America and an internationally-renown expert in his field, Dr. Rohrich also received several prestigious national research, teaching, and distinguished service awards. He is also Editor-in-Chief of Plastic and Reconstructive Surgery and an editor for Selected Readings in Plastic Surgery. Dr. Rohrich has published hundreds of peer review articles, several chapters and textbooks in plastic surgery ranging from rhinoplasty, craniomaxillofacial trauma, secondary rhinoplasty and ultrasound-assisted liposuction.