FDA Panel Calls for Silicone Breast Implant Registry

An advisory panel formed by the US Food and Drug Administration (FDA; Silver Spring, MD, USA) has recommended the creation of a nationwide database to follow women who have had silicone-gel breast implants for at least a decade after surgery.

The FDA General and Plastic Surgery Devices Panel made the recommendation after concluding that current data collection demands are too onerous . Currently, women who have received their implants are required to fill out a 25-plus page questionnaire every year following surgery; not surprisingly, compliance is low. As a result, the FDA cannot definitely rule out a connection between implants and rare diseases, such as anaplastic large-cell lymphoma or connective tissue diseases. A national database could help the FDA more easily collect data on how safe and effective breast implants are many years after implantation.

The panel, which took no formal votes, also recommended discussing how to encourage patient enrollment in a large registry, and what specific data should be collected. According to the FDA, women with implants should have a breast magnetic resonance imaging (MRI) exam three years after receiving the implants, and every two years thereafter to screen for ruptures; the actual rates of the screening MRIs, however, have also been low, since not all insurance companies cover MRIs if there is no physically apparent problem, and most women are not willing to pay for an MRI out-of-pocket.

“Based on the totality of information on silicone gel breast implants, the FDA continues to believe that the currently approved devices are safe and effective for their intended use,” said William Maisel, MD, chief scientist and deputy director for the FDA's Center for Devices and Radiological Health. “There are significant complication rates associated with silicone gel breast implants, but we believe that the benefits and risks are sufficiently well understood that they should remain on the market.”

The two approved manufacturers of silicone gel-filled breast implants in the United States are Allergan (Irvine, CA, USA) and Mentor (Santa Barbara, CA, USA). The FDA approved silicone gel-filled breast implants for breast augmentation in women over age 22 and for breast reconstruction in all women in November 2006.

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