WASHINGTON DC: Washingtonian Plastic Surgery (WPS) has announced promising results of a long-term silicone implant safety study, co-written by WPS CEO and founder Dr. Navin Singh, M.D., M.B.A. (lead author) and published in the recent issue of the peer-reviewed journal “Plastic and Reconstructive Surgery,” the official journal of the American Society of Plastic Surgeons.
The study follows 55,279 female patients receiving primary augmentation, revision augmentation, primary reconstruction or revision-reconstruction using Natrelle round silicone breast implants. Over a five-year period, researchers compared these women’s results with national norms and outcomes for patients with saline implants, including any adverse effects that may have been found during postoperative follow-up care.
Although silicone implants were approved by the FDA in 2006, concerns about their safety have persisted among patients after a scare in the 1990s that proved to be scientifically unsound, according to Dr. Singh. His report marks the halfway point of a planned ten-year follow-up evaluation of the patient sample.
The FDA requires each manufacturer of breast implant products to conduct such studies. Dr. Singh is the head of the data safety monitoring board (DSMB) that contributed to the design of the study.
The longitudinal, thorough evaluation is intended to find complications, including exceedingly rare complications, making it necessary for researchers to follow a large sample of women who had breast implantation surgery for a variety of reasons.
The results at the five-year point are optimistic. “None of the targeted adverse outcomes, including cancers, connective tissue diseases, neurologic diseases or suicides and suicide attempts occurred at significantly higher rates in women with silicone implants compared with national norms and women with saline implants,” the authors state. “These findings add to the growing body of evidence confirming the positive long-term safety profile of silicone breast implants.”
Patients seeking breast augmentation surgery have more options now than ever-whether it be shape, size, feel or material.
“Patients can now feel confident of the safety record behind silicone implants when making the decision on which implant is best for them,” said Dr. Singh. “With the results of this study, I can say wholeheartedly that scientific evidence establishes that these implants we’ve always felt to be safe, are indeed very, very safe.”
Dr. Navin Singh is a double Board-Certified plastic surgeon in private practice and an Assistant Professor of Plastic Surgery in the Johns Hopkins University School of Medicine.
India Post News Service
