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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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