Saline-filled Implants

Approved By FDA

“Women should understand that breast implants do not last a lifetime,” warned FDA medical devices chief Dr. David Feigal.

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.

CRITICS WEIGH IN Women’s health advocates condemned the decision. “The standard of safety is at a new low at FDA,” said Diana 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.

Ann's NOTE: The Institute of Medicine used existing studies to decide that implants are safe. That means the majority of what they looked at were done by the manufacturers. Not all the evidence is in yet.

Thanks to the Associated Press

Review of Implants

July 9, 2002

Saline Support

Forum:Anyone with saline breast implants time and problems related to implants or surgical procedure. LINK

Synthetic Science

Article from, 2/04

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