Monday, September 23

Silicone-gel implants may make comeback


FDA will consider advisory board's recommendation for re-release

An 11-year near-total ban on silicone-gel breast implants may
soon come to an end following the recommendation of a Food and Drug
Administration advisory board that their sale resume, although
subject to strict conditions.

In a hearing held last week, the FDA advisory panel heard a
variety of testimonies and reports from both sides of the debate
before a 9-6 vote approved the recommendation.

But the FDA must still make a decision based upon the advisory
board’s recommendations before silicone implants can be sold
again without restrictions.

The implants had initially been pulled from the U.S. domestic
market in 1992 when many feared silicone leakages could cause
diseases such as cancer.

Women with faulty implants reported severe pain, permanent
disfigurement and chronic illnesses as a result of implant
leakage.

Conditions for re-release include annual examinations of implant
patients to ensure no leakage, and detailed advice about implant
risks prior to surgery.

Inamed Corp., a manufacturer of the implants, sought to end the
ban, arguing that silicone implants have been exonerated of causing
serious disease, and that they are no riskier than current
salt-water filled implants.

Henry Kawamoto Jr., a professor in the plastic surgery division
of the UCLA surgery department, said silicone implants are
preferred over saline ones by both surgeons and patients.

“Silicone implants feel more natural and act more
natural,” he said. “Our patients are more satisfied
with them and so we prefer them too.”

In the case of a puncture, silicone implants leak at a much
slower rate than saline implants, which would deflate immediately.
Kawamoto said a silicon implant rupture may go unnoticed for
years.

Kawamoto also said any leakage of silicone gel or salt water
would accumulate in a protective capsule formed around the breast
implant by the human body as the body seeks to isolate the foreign
material.

He added that it is very rare for the silicon to then
disseminate into other parts of the body ““ although it has
happened before.

“Right now, we really do not know what the side effects
are,” he said. “Most women don’t know their
implant has ruptured, and it is a vocal minority of patients who
seem to have trouble with the implants.”

Kawamoto said the UCLA Medical Center would surely use silicone
implants if they were legal again.

Claims that silicon implants do not cause severe diseases are
supported by several studies, Kawamoto said, including one produced
by USC plastic surgery professor Garry Brody.

Brody started monitoring cancer rates in patients who received
implants in the early 1970s, after implants first appeared on the
market in 1964.

From results, he concluded that breast cancer rates in women
with implants are 30 percent less than in women without
implants.

Brody said he considers the implants to be “pretty
safe,” adding that breast implant procedures have risks just
like any other surgery.

“I tell my patients they bought a new body part,” he
said. “You could have a kidney that gives you trouble every
day but you could have one that doesn’t trouble you ““
health problems are relative.”

But some are critical of studies that deny a causal link between
implants and diseases.

Lynda Roth, founder and president of the Coalition of Silicone
Survivors, said many studies denying the dangers of breast implants
are usually funded by manufacturers or members of the American
Society of Plastic Surgeons.

“None of the studies were long enough, and they were all
done by people who are blatantly biased,” she said.

Roth said 47 percent of women with breast implants need
re-operation of some kind.

“There never has been a product placed on the market with
so many problems,” she said.

Brody said claims of bias were out of place.

“That is offensive ““ we are just as concerned about
our patients as these groups are,” he said.

With reports from Daily Bruin Wire Services.

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