Woman planning to have a breast implant.
A long-term study of more than 55,000 women proves safety of silicone implants, writes Dr. Navin Singh.
The results of a long-term silicone implant safety study are promising. 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 the FDA approved silicone implants in 2006, concerns about their safety have persisted among patients after a scare in the 1990s that proved to be scientifically unsound. This 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. 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.
As the lead author of the study, I’m optimistic with the results at the five-year point. We found that 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. 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. 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.