FDA's General and Plastic Surgery Devices Advisory Panel recommended that the FDA not approve Inamed's silicone-filled breast implants for use in cosmetic surgery.

The FDA's panelists found that the Inamed’s data are insufficient to answer their safety concerns.

The FDA concluded that it is extremely difficult to determine the probability of rupture within ten years based on the short-term data provided by the manufacturer.

However, based on FDA calculations, three-quarters of implanted women could have at least one ruptured implant within a decade of receiving the devices, and specifically, that it is possible that 93% of breast cancer reconstruction patients should expect at least one broken implant within ten years.

.Since 1992, the FDA has restricted silicone-filled breast implants to a few use, such as breast reconstruction after a mastectomy, replacement of a ruptured silicone implant, or to women born with a deformity.

Source: National Research Center for Women & Families


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