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FDA Gets Conflicting Recommendations on Silicone Breast Implants

April 15, 2005

Breast Implants • FDA's Breast Implant Decision Shows 'Double Standard,' Critics Charge • Safety of Silicone Gel Breast Implants Questioned • FDA Gets Conflicting Recommendations on Silicone Breast Implants • FDA Opens Breast Implant Review

A Food and Drug Administration advisory committee has recommended permitting the use of one brand of silicone breast implants while continuing to keep another company's implants off the market, but there's uncertainty about whether the FDA will follow the panel's recommendations.

The FDA normally follows the advice of its expert panels but the agency has lately come under strict oversight for its alleged failure to keep dangerous pharmaceutical products off the market, so there is considerable doubt about what it will decide to do with the panel's recommendations.

The expert panel recommended lifting restrictions on cosmetic implants made by Mentor Corp. just one day after it voted against letting Inamed Corp. return to the marketplace with its implants.

Why? There was a slightly lower rate of ruptures in a trial of the Mentor devices, while Inamed had a higher rupture rate in at least one of its models.

The ban applies only to women who are having the implants for purely cosmetic reasons. It does not affect women who have undergone mastectomies, had rejection issues with saline implants or have other medical issues.

The FDA effectively banned silicone implants in 1992 because of concerns that they caused a wide range of health problems, everything from chronic fatigue to cancer. Those risks have never been confirmed but there is still concern about the possible damage caused when implants rupture or leak, allowing silicone to spread throughout the body.

Opinions are decidedly mixed about whether women motivated by cosmetics should rush into getting silicone-gel implants if they again become available.

"Despite Mentor Corporation’s approval, questions remain about the safety of implants - how long they can stay in a woman's body and what health effects there are if they rupture and the silicone gel leaks into the woman's breast or beyond," said David Kufeld of Weitz & Luxenberg, PC, a New York law firm that has represented women allegedly harmed by the implants.

"Women suffering from the harmful effects of silicone breast implants ... say the implants can cause painful scarring, disfigurement, and severe health problems if the silicone leaks into the body. The implants have been largely cleared of accusations of causing cancer and lupus, but with a 1% to 20% rupture rate, serious health concerns persist," Kufeld said.

In its recommendations, the committee recommended improved training for doctors who implant the Mentor devices and for improved patient education and informed-consent procedures.

The committee also recommended regular exams for women who get the devices and rapid removal if a puncture or leak is suspected.

Since the FDA's 1992 ban on silicone implants, women have turned to saline-filled devices which are safer but not as cosmetically suitable. It's estimated there were 264,000 saline implants in 2004.

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