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FDA Approves Silicone Gel-Filled Breast Implants

“FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products,” said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA.  “The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices.  This information is available in the product labeling and will enable women and their physicians to make informed decisions.”

Now that the products have been determined to be safe and effective, FDA will continue to monitor them by requiring each company to conduct a large postapproval study following about 40,000 women for 10 years after receiving breast implants.  FDA often requires postmarket studies to answer important questions that can only be answered once a product is in broader use, such as the incidence of rare adverse events. 

FDA’s decision to approve these implants was based on a thorough review of each company's clinical (core) and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders.  In addition, FDA conducted inspections of each company's manufacturing facilities to determine that they comply with FDA’s Good Manufacturing Practices.  Some of the complications reported in the core studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery.  However, the majority of women in these studies reported being satisfied with their implants. Read more at fda.gov

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