FDA Panel Recommends Approval of Silicone Breast Implants
April 18, 2005 -- A U.S. government advisory panel has recommended that silicone gel breast implants by one manufacturer be allowed back on the market. The panel rejected a similar application from a second company. The Food and Drug Administration is not bound by its advisers' recommendations, however, and the final determination rests with the agency.
The expert panel, assembled by FDA, voted 7-2 to end market restrictions on the implants. The approval is contingent on several conditions: The manufacturer must register implant recipients, monitor their health, and retrain surgeons in the proper use of the devices, and patients must sign consent forms acknowledging the risks associated with implants.
In 1992, FDA asked manufacturers to withdraw silicone gel-filled implants from the market after widespread reports of serious side effects, including neurological and connective-tissue disorders. Saline-filled implants remained available under the moratorium.
A 1999 Institute of Medicine report, Safety of Silicone Breast Implants, found that women with silicone gel or saline breast implants are no more likely than the rest of the population to develop cancer, immunologic diseases, or neurological problems. However, implants commonly lead to local complications that require surgery or other medical interventions to correct. The rate of complications varies considerably depending on the type and age of the implant, but the chance a woman will experience a problem increases with time, the report says.