ROCKVILLE, MarylandThe FDA has approved the marketing of two silicone gel-filled breast implants, Inamed (Allergan) and MemoryGel (Mentor), for use in breast reconstruction in women of all ages and for breast augmentation in women ages 22 and older. The decision supporting the safety and efficacy of the devices came 14 years after FDA placed a moratorium on the use of silicone gel implants except in clinical trials because of concerns they might cause pain, deformity, connective tissue disease, and cancer if they ruptured. Saltwater-filled breast implants remained available.
"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to 4 years, as well as a wealth of other information to determine the benefit and risks of these products," said Daniel Schultz, MD, director of FDA's Center for Devices and Radiological Health. "The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices." Moreover, he said, "we now have a good understanding of what complications can occur and at what rates."
Nonetheless, as part of granting approval to the implants, FDA required the companies to make several postmarketing commitments. Each, for example, must support a separate study that enrolls about 40,000 women and follows them for 10 years after they receive their breast implants. Both companies must also continue their core studies, from which they submitted data to support the implants' safety and efficacy, until all patients have completed a 10-year evaluation.
Although several independent studies and a report by the Institute of Medicine have found no conclusive evidence linking breast implants to connective tissue disease or cancer, the two diseases will be a major focus of the postmarketing trials.
"The postapproval studies will continue to gather information about the safety and effectiveness of the implants," FDA said in announcing the approvals. "Information will be collected about the rates of local complications, rates of connective tissue disease and its signs and symptoms, rates of neurological disease and its signs and symptoms, potential effects on offspring of women with breast implants, potential effects on reproduction and lactation, rates of cancer, rates of suicide, potential interference of breast implants with mammography, and MRI compliance and rupture rates."
Each company must also conduct a focus group to assess laymen's understanding of its product. They are also required to continue laboratory studies to further characterize the types of device failures and to track each implant so that health professionals can be notified of updated product information.
No Lifetime Guarantee
FDA cautioned that women considering a silicone-gel implant should know that breast implants do not last a lifetime, and they will likely need at least one additional surgery in their lifetime.