Health
FDA says no to silicone gel implants
NEWS IN BRIEF — Posted Jan. 26, 2004
The Food and Drug Administration effectively barred silicone gel breast implants from re-entering the marketplace until additional data are gathered by the manufacturer. The agency took this action in a Jan. 8 draft guidance despite a recommendation last fall by one of its advisory panels that the agency approve the sale of implants for widespread use.
Since 1992, the silicone implants have only been used for breast cancer patients participating in clinical trials because of concerns that silicone leaking from implants caused serious health problems.
The FDA is recommending that testing be done to determine how long silicone implants will last before rupturing in the body and that modes and causes of rupture be addressed.
Implants filled with saline, which is considered more safe than silicone gel, continue to be available.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/01/26/hlbf0126.htm.
