FDA approves silicone breast implants with caveats

Silicone gel filled breast implants have been approved by the US Food and Drug Administration for use in women aged 22 years or older for cosmetic purposes and for reconstruction after breast cancer surgery or in women with traumatic or congenital breast defects.

Silicone implants are said to be softer and feel more natural than implants filled with saline, which has been the only kind available for 14 years in the United States, since silicone implants were taken off the market.

However, the FDA cautioned, “Breast implants are not lifetime devices and a woman will likely need additional surgeries on her breast at least once over her lifetime; many of the changes to a woman's breast following implantation are irreversible; rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured; and a woman will need regular screening MRI (magnetic resonance imaging) examinations over her lifetime to determine if silent rupture has occurred”.

The FDA recommends magnetic resonance scanning three years after the first implant surgery and then every two years. It says that the cost of screening may exceed the cost of the initial surgery and may not be covered by health insurance.

The implants were taken off the US market 14 years ago because of thousands of lawsuits claiming they leaked and caused connective tissue disorders and cancer. The lawsuits led Dow Corning, then the leading manufacturer, to file for bankruptcy in 1995.

The Institute of Medicine published a study in 1999 that said there was no evidence that the implants caused these problems (www.iom.edu/CMS/3793/5638.aspx).

In approving the implants, Daniel Schultz, the director of the FDA's Center for Devices and Radiological Health, said, “The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labelling and will enable women and their physicians to make informed decisions”.

Before approving the implants, the FDA reviewed each manufacturer's preclinical and clinical studies. The FDA said that these studies reported complications, which included hardening of the area around the implant, breast pain, change in nipple sensation, rupture of the implant, and the need for additional surgery.

“However, the majority of women in these studies reported being satisfied with their implants,” the FDA said.

In an editorial the New York Times said, “These devices are prone to rupture, contract or cause pain and inflammation in the breast as time goes on. The FDA recommends that women have regular MRI screenings...

“Unfortunately [the agency] has a poor track record in forcing companies to complete post-marketing studies. It will need to be vigilant in keeping the implant makers honest” (www.nytimes.com, 21 Nov 2006).

The FDA will require the two companies that make the implants to do postapproval studies.

The FDA's review is at www.fda.gov/cdrh/breastimplants.

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