Battle shapes up over silicone breast implants

Sunday, August 24, 2003

August 25, 2003

WASHINGTON - The National Organization for Women (NOW) and Public Citizen called upon the U.S. Food and Drug Administration to suspend its consideration of lifting restrictions on the sale of silicone gel breast implants.

An FDA advisory panel will review on Oct. 14th and 15th, Santa Barbara, Calif.-based Inamed's application for pre-market approval for its silicon gel-filled breast implants. Aside from Mentor Corp., Inamed is the only U.S. company that still makes saline implants, according to the Los Angeles Times. The company is now seeking FDA approval to again sell silicone implants in the United States.

"We think there is a growing body of evidence that supports silicone implants," Peter Nicholson, Inamed's vice president of business development, told the Times. "Where both saline and silicone implants are still available, silicone has a 85 to 90 percent share of the market."

Now and Public Citizen aren’t nearly as optimistic when it comes to silicon implants.

On May 8th, NOW convened a panel of scientists and clinicians to review the latest research on the safety and efficacy of silicone gel breast implants. The panel included representatives of the National Institutes of Health, the Food and Drug Administration (FDA) and the Armed Forces Institute of Pathology. The panel concluded that long-term safety has not been adequately addressed in past research, specifically regarding the likelihood of leakage, rupture, and local and regional medical problems several years after implantation, according to a NOW release.

The FDA pulled silicon breast implants off the market amid myriad reports about health problems, as well as mounting lawsuits against manufacturers by women who said the devices gave them rheumatoid arthritis and other autoimmune diseases in which the body defenses turn on itself.

The problems prompted big names to exit the market and forced Dow Corning, the world's largest maker of implants, into bankruptcy after it paid $ 3.2 billion to settle a class-action lawsuit. Smaller players settled for less, including Inamed, which paid $ 31.5 million in 1998 to end its class-action lawsuit.