GLOBE & MAIL: Second firm seeks end to implant ban
Ilena Rose
at 12:23 PM EST
Associated Press
http://www.theglobeandmail.com/servlet/story/RTGAM.20050413.wimplant0413/BNStory/International/
Washington — A second manufacturer tried Wednesday to persuade
skeptical U.S. federal health advisers that it is time to lift a
13-year near-ban on silicone-gel breast implants.
Newer versions of the implants break only rarely in the first few
years after they are put into place, and they provide enough benefit
to the women who seek them to outweigh that risk, Mentor Corp. told
advisers to the Food and Drug Administration.
“Self-esteem ... is as integral to health and well-being as any
medical issue,” Mentor chief executive Josh Levine said.
Mentor's pitch came a day after the FDA's advisers narrowly rejected
rival Inamed Corp.'s bid to bring back to the U.S. market one of the
nation's most controversial medical devices.
Inamed did not study patients long enough to predict how likely
implants are to break apart, requiring additional surgery to remove or
replace – or to settle lingering questions of the consequences when
silicone leaks into the breast or beyond, FDA's advisers decided by a
5-4 vote. Inamed so far has tracked implant recipients for three or
four years.
On Wednesday, the same panel began judging Mentor's request to allow
its own silicone implants onto the market. Only 1.4 per cent of
patients in its main study had their implants break within three
years, although Mentor officials acknowledged that, like a car,
implants will fail more often as they age. They cited a British doctor
who tracked 100 of his own patients with Mentor implants, and found
that 5.4 per cent had broken by around nine years.
FDA scientists, however, called Mentor's data too limited to be of
value in settling the key durability issue.
Silicone-gel breast implants began selling in 1962, before the FDA
required proof that all medical devices be safe and effective. In
1992, complaints that the implants broke and caused illnesses prompted
the FDA to ban gel implants except for patients with breast cancer or
a few other conditions who enrolled in strict research studies.
Thirteen years later, silicone implants largely have been exonerated
of causing serious or chronic illnesses such as cancer or lupus. Aside
from the risk of breakage, they also can cause infection and painful,
rocklike scar tissue.
Last year, some 264,000 breast augmentations and 63,000 breast
reconstructions were performed in the United States, most with salt
water-filled implants that are sold without restriction.
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