Advocate groups may sue FDA over OK for silicone breast implants

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Advocate groups may sue FDA over OK for silicone

breast implants

By PATRINA A. BOSTIC

News Service

Wednesday, August 10, 2005

WASHINGTON — Advocacy groups say they plan to sue the

Food and Drug Administration if it allows a company's

silicone-gel filled breast implants to return to the

market without long-term data that proves the

product's safety.

After a 13-year ban on the implants, the FDA is close

to allowing them back on the market after telling

Mentor Corp. that its implants can be approved if it

follows certain conditions. The FDA has declined to

disclose those conditions.

Consumer and women's groups are also calling on

Congress to investigate the circumstances surrounding

the FDA's decision.

Women who prefer the silicone-gel implants say they

feel more real than the alternative saline-filled

implants, which have no restrictions.

Manufacturers have failed to provide the FDA with

long-term data on patients who have the implants,

which are prone to leakage within 10 to 15 years,

causing infection and painful scarring. Advocates say

doctors have removed about 172,000 faulty breast

implants.

Dr. Sidney Wolfe, a health research director for

Public Citizen, questioned why Mentor was able to

receive tentative approval without long-term studies.

" They have not ... even provided five years of

reliable data, " he said. " This industry failure

represents a combination of disrespect and reckless

disregard for the health of women and arrogance for

the law. ... The dangerous doctrine of approve now,

test later must be firmly rejected. "

In 2003, President Bush's first FDA commissioner, Mark

McClellan, established guidelines for companies to

meet if they wanted government approval for breast

implants.

Wolfe said the consumer advocacy organization is

considering filing suit if the approval for Mentor

goes forward.

Silicone-gel breast implants first were marketed in

1962, before the FDA required data that proved product

safety. Last year, doctors in the U.S. performed about

264,000 breast augmentation surgeries, according to

American Society of Plastic Surgeons.

Josh Levine, president of Mentor, noted the Texas

manufacturing facility has been audited by the FDA and

other international regulatory agencies annually since

1999.

" We remain confident this scientific process will not

be complicated by old accusations from parties with

agendas that go well beyond the safety and efficacy of

these products, " he said in a statement.

In April, an FDA advisory panel recommended Mentor's

breast implants for approval with conditions by a vote

of 7-2.

A group of female senators led by Sens. Dianne

Feinstein, D-Calif., and Olympia Snowe, R-Maine, have

sent a letter to Crawford asking the agency to

consider women's safety before it decides to allow the

implants to be marketed in the United States again.

" It's not just that it's breast implants, " said

Zuckerman, executive director of the National Research

Center for Women and Families. " It's the danger of

setting a precedent of approving an implant that is

known to have long-term risk without requiring it to

be proven safe for long-term use. "

Zuckerman said her organization would join in the

lawsuit.

Martha Burk, chairwoman of the National Council of

Women's Organization, said the FDA's move to allow

silicone-gel breast implants back on the market is a

serious problem.

When problems occur with the implants, she said,

doctors recommend that they be removed and

re-implanted, neither of which is covered by health

insurance.

Sybil Goldrich, one of the first women to speak

publicly about faulty breast implants about 18 years

ago, said if the FDA approves silicone once again,

consumers will never have a safe breast implant

" because the manufacturer will have no initiative to

go back to the drawing board, which is where this

product belongs. "

The National Organization for Women and the National

Women's Health Network also spoke out against the

FDA's tentative approval for the implants.

Patrina Bostic's e-mail address is

pbostic(at)coxnews.com