FDA approves saline breast implants

Wednesday, May 10th 2000, 12:00 am

By: News On 6

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 products 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. David Feigal.

"One of the things they should consider ... is they've got about a one in six chance of facing another surgical operation" within three years of implantation, he added. Too many Americans have gotten breast implants without understanding that, he said.

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 continue selling only if manufacturers proved they are safe. On 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. Implants made by three smaller competitors, all U.S. offices of foreign companies, must quit selling in the United
States by Monday, the FDA ruled.

But the FDA issued lots of warnings -- writing an entire booklet that plastic surgeons were ordered to give potential patients before the day of surgery, so women can decide if implants are worth trying.

Demand the booklet if your doctor forgets to offer it, Feigal advised.

Among the warnings: 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 40 percent of cancer survivors need additional surgeries within three years.

And the longer women have implants, the more likely they are to suffer a side effect, FDA scientists say. Up to 73 percent of
patients in one study suffered at least one side effect.

In addition to pain, leakage and reoperations, other side effects include loss of nipple sensation, asymmetry and wrinkling
or puckering skin at the implant site.

Women's health advocates sharply criticized 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, complications aside, many women in the company's studies insisted
they were happy with the implants. The FDA's independent scientific advisers in March had recommended the products stay on the market,
despite declaring 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 except for a few cancer survivors in strictly controlled clinical trials, a ban that continues today. No other implants are sold in the United States.

Another option for cancer patients is for doctors to rebuild their breasts using fat and tissue from other parts of their body.

Further complicating the issue, a congressman last month demanded that the FDA explain how it could consider approving implants made by a manufacturer -- Mentor-- that was under criminal investigation for possible FDA regulation violations.

Feigal noted Mentor makes more than one type of implant. "The investigation did not deal with saline breast implants," he said,
saying he could not comment further on an open investigation.

The breast implants controversy 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-specific complications.
------

On the Net: http://www.fda.gov/cdrh/breastimplants/