GAITHERSBURG, Md. -- Two brands of saline-filled breast implants should be allowed to stay on the market if women are properly warned that implants frequently break and leak and that many patients must undergo repeated operations, a federal advisory panel says.
Advisers to the Food and Drug Administration recommended today that saline implants made by McGhan Medical Corp. of Santa Barbara, Calif., should stay on the market. The expected vote came a day after the same panel backed sales of implants made by competitor Mentor Corp.
"The choice for a woman is difficult," bioethicist Nancy Dubler of New York's Montifiore Medical Center acknowledged Wednesday during a tense 13 hours of testimony and debate on the issue.
Calling Mentor's implant failure rates "alarmingly high," Dr. Stephen Li of New York's Hospital for Special Surgery added: "It's amazing to me it seems to be tolerated as just something you have to live with in these implants."
Despite those criticisms, there is no evidence that any saline implants cause major diseases. So Li and fellow FDA panelists balked at taking away women's option to choose Mentor saline-filled implants as long as they are fully warned of the risks and more safety tests are performed.
Today, the same panel recommended that FDA allow continued sales of McGhan's competing implants.
The FDA is not bound by its advisers' recommendations but typically follows them.
About 130,000 American women received saline-filled breast implants last year even though the FDA has never declared these implants safe: They hit the market before the FDA began regulating medical devices.
But the FDA recently decided they can only continue selling if manufacturers prove they truly are safe, and asked its scientific advisers to evaluate the issue.
About a dozen implant recipients, some tearful, told the panel Wednesday that saline implants are defective and dangerous and should be banned. Some held up implants removed from their bodies that were blackened with fungus, 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.
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.
Consequently, some breast cancer survivors pleaded with the FDA on Wednesday to keep the option open, saying implants help their emotional recovery after a mastectomy. "It has given me back my self-esteem and sexuality," said Jennifer Gardner of Washington.
Mentor studied 1,680 saline implant recipients. Up to 27 percent 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, FDA said. Up to 9 percent deflated within three years.
And up to 40 percent of breast cancer survivors who had implants needed repeat surgeries, either 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, the FDA said.
Breast cancer patients were at most risk for complications; they accounted for the 27 percent implant-removal rate. In contrast, 8 percent 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, and said most recipients are happy with their implants.
"We provide a safe and effective option for women," Mentor Vice President Bobby Purkait said.
But the FDA noted that the longer all women have implants, the more likely they are to suffer a side effect.
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