Breast Implant Debate

Thirteen years after most use of silicone-gel breast implants was banned, the government reopened emotional debate last week on whether to lift the restrictions.

In an extraordinary day long hearing, dozens of women, many in tears, told federal health advisers of pain and crippling health problems when silicone leaked from broken implants into their breasts and beyond.

Others, angry at their difficulty in getting what they called the most natural-feeling implant to rebuild cancer-ravaged breasts or to enlarge small ones, urged the Food and Drug Administration to lift its near-ban.

Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. Complaints that they broke and caused illnesses began in the late 1980s, and in 1992 the FDA banned gel implants except for patients with breast cancer or a few other conditions, who could get them by enrolling in strictly controlled research studies.

The implants largely have been exonerated of causing such serious or chronic illnesses as cancer or lupus. But breaks and resulting silicone leakage, as well as painful scar tissue and other local complications, remain in question - and the FDA told manufacturers last year that durability questions in particular must be settled before it will lift the near-ban.

About 264,000 breast enlargements and 63,000 breast reconstructions were performed last year, according to the American Society of Plastic Surgeons.

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