FDA Panel Says Saline Breast Implant Can Be Sold

Saline-filled breast implants break open at “alarmingly high” rates and require women to undergo repeated surgeries, but at least one brand is safe enough to continue selling as long as women are properly warned of the risks, a government advisory board decided Wednesday.

About 130,000 American women received saline-filled breast implants last year even though the Food and Drug Administration has never declared these implants safe.

The implants sell because of a government loophole--but the FDA recently decided they can only continue selling if manufacturers prove they truly are safe, and asked its scientific advisors to evaluate brands sold by California-based Mentor Corp. and two competitors this week.

In a 13-hour meeting Wednesday, about a dozen implant recipients emotionally urged that saline implants be banned. Some held up implants removed from their bodies that were blackened with fungus that had infected the moist implants, and blamed them for causing infections, excruciating breast pain or repeated surgeries.

“Only fools will call these risks acceptable,” said Patricia Faussett of Henderson, Nev., who said her illnesses disappeared once her implants were removed.

Mentor studied 1,680 saline implant recipients. Up to 27% of the implants were removed within three years of implantation, most because patients suffered painful scar tissue, an infection, or the implant broke and leaked, FDA officials said.

Saline implants are highly prone to deflating as the salt water leaks into patients’ bodies, the FDA said. Up to 9% deflated within three years.

And the longer women have implants, the more likely they are to suffer a side effect, the FDA said. Up to 73% of patients in one study suffered a side effect.

Calling the failure rates “alarmingly high,” Dr. Stephen Li of New York’s Hospital for Special Surgery said, it is “amazing to me it seems to be tolerated as just something you have to live with in these implants.”

Still, there is no evidence the implants cause major diseases, so Li joined fellow FDA advisors in voting that Mentor’s saline implants could remain on the market as long as women get strong warnings about the risks and the maker does some additional safety testing.

The FDA is not bound by its advisors’ recommendations but typically follows them.

On Thursday and Friday, the FDA panel was to evaluate two competing companies’ brands of saline implants--and figure out how the FDA should warn women that almost everyone will almost certainly suffer some complication if they get a breast implant.

But many women are happy with the implants. Some breast cancer survivors pleaded with the FDA Wednesday to keep the option open, saying implants helped their emotional recovery after a mastectomy.

“It has given me back my self-esteem and sexuality,” said Jennifer Gardner of Washington.

Saline implants are most women’s only option. In 1992, the FDA banned use of silicone gel-filled breast implants except for a small number of women in strict clinical trials. No other implants are sold in this country.

Thousands of women in the 1990s claimed implants gave them serious diseases, from arthritis to cancer. But after repeated scientific studies, the prestigious Institute of Medicine last year declared that breast 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.

In Mentor’s study, breast cancer patients were at most risk for complications--they accounted for that 27% implant-removal rate. In contrast, 8% of implants used for cosmetic breast enlargement in healthy women were removed in three years.

Mentor blamed the discrepancy on cancer patients’ initial poor health and need for repeated medical tests and treatments that may stress an implant.

But all patients are likely to need repeat surgeries--13% of cosmetic-surgery patients and 40% of breast cancer patients--after getting saline implants, the FDA concluded.

Those surgeries could be to remove an implant for good, replace it with a new or larger one, or to remove painfully hardened spots of breast tissue surrounding the implant.

Mentor contended most women undergo re-operations because they want a different size or shape implant, not because they’re sick or hurting.

“We provide a safe and effective option for women,” said Mentor vice president Bobby Purkait.

But FDA researchers argued that most women needed repeat surgery because of complications.