FDA approves saline implants article: MUST READ!!!

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FDA Approves Saline Breast Implants

May 11, 2000

WASHINGTON (AP) - The government ruled Wednesday that saline-filled

breast implants made by two California companies can stay on the

market despite warnings that they break open at " alarmingly high "

rates.

Giving its first formal approval of the long-sold implants, the Food

and Drug Administration allowed the implants to continue selling as

long as women are fully informed that many will have to undergo

repeated surgeries.

" Women should understand that breast implants do not last a

lifetime, " warned FDA medical devices chief Dr. al.

About 130,000 American women received saline-filled breast implants

last year even though the FDA had never declared the implants safe -

they sold because of a government loophole.

But recently the FDA decided they could only continue selling if

manufacturers proved they are safe. Wednesday, the agency ruled that

brands sold by the two largest manufacturers, Mentor Corp. and

McGhan Medical, both of Santa Barbara, Calif., can remain on the

market.

But the FDA's formal approval came with lots of warnings for women.

Over 20 percent of women who get saline-filled breast implants need

additional surgeries within three years, most because patients

suffered painful scar tissue or an infection or the implant broke

and leaked.

The risk is worse for women who get the implants after breast cancer

surgery than for women who choose cosmetic breast enlargement, the

FDA warned. Some 39 percent of cancer survivors need additional

surgeries within three years of their original breast implant.

And the longer women have implants, the more likely they are to

suffer a side effect, the FDA says. Up to 73 percent of patients in

one study suffered at least one side effect.

That means virtually every woman who gets a breast implant will

suffer some sort of complication. The FDA did, however, mandate that

all woman seeking the implants be fully informed of those risk

statistics first.

Women's health advocates condemned the decision. " The standard of

safety is at a new low at FDA, " said Zuckerman of the National

Center for Policy Research for Women and Families. " Here you have

the benefit which is cosmetic and the risks which are serious health

problems. "

But FDA officials said they approved the implants because, despite

the complications and the risks of undergoing repeated surgeries,

many women in the company's studies insisted they were happy with

the implants. The FDA's independent scientific advisers in March had

recommended that the products stay on the market, despite declaring

that they break open and leak at " alarmingly high " rates. The panel

heard hours of testimony from dozens of women claiming the implants

left them in dire pain and disfigured them - while a few cancer

survivors said the implants were important for their emotional

recovery.

Indeed, saline-filled implants are the only option for most women

wanting implants. In 1992, the FDA banned use of silicone gel-filled

breast implants, a ban that continues today. No other implants are

sold in the United States.

An option for cancer patients is for doctors to rebuild their

breasts using fat and tissue from other parts of their body.

The controversy over breast implants arose in the early 1990s, when

thousands of women claimed implants gave them serious diseases, from

arthritis to cancer. But after repeated scientific studies, the

prestigious Institute of Medicine last year declared that implants,

whether silicone gel- or saline-filled, do not cause major diseases.

So the FDA's concerns about saline implants center on breast-related

side effects - pain, infection, deflation and repeat surgeries.

Copyright 2000 The Associated Press. All rights reserved.

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