The study, which was co-authored by Dr. Navin Singh, followed 55,279 patients who received primary augmentation, revision-augmentation, primary reconstruction or revision-reconstruction using Natrelle round silicone breast implants.
Washington, DC-area based medical group Washington Plastic Surgery (WPS) announced on October 18 the half-point results of a 10-year study, Breast Implant Follow-Up Study, on the risks of silicone implants. Over the five-year follow-up, the findings confirmed the safety of the medical procedure that is widely done in the US.
“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,” according to the study’s authors in a press statement. “These findings add to the growing body of evidence confirming the positive long-term safety profile of silicone breast implants.”
The study followed 55,279 patients who received primary augmentation, revision-augmentation, primary reconstruction or revision-reconstruction using Natrelle round silicone breast implants. The researchers compared the results of the subjects with national norms and outcomes for patients with saline implants, including any adverse effects that may have been found during postoperative follow-up care. The research was published in Plastic and Reconstructive Surgery, the official journal of the American Society of Plastic Surgeons.
“Patients can now feel confident of the safety record behind silicone implants when making the decision on which implant is best for them,” said Washington, DC-based plastic surgeon and the study’s lead author Dr. Navin 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.” Singh is also the founder and CEO of Washington Plastic Surgery.
Although silicone implants were approved by Food and Drug Administration (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 Singh. 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 statement said.