FDA advisers say saline breast implants should stay on market despite problems

As long as women know of risk, sales should be permitted, panel concludes


WASHINGTON -- Although saline-filled breast implants fail at an "alarmingly high" rate and often cause medical complications, some brands should remain on the market, advisers to the Food and Drug Administration concluded in hearings that ended yesterday.

The panel recommended after three days of hearings that the two leading makers of the devices -- McGhan Medical Corp. and Mentor Corp., both of Santa Barbara, Calif. -- be permitted to continue sales, so long as women are adequately informed of the risk.

Panelists recommended that saline-filled implants sold by a third applicant for FDA approval, PIP America of Miami, Fla., be removed from the market because of a lack of data on their product. PIP America is the U.S. distributor for a French maker.

The FDA will consider the panel's recommendations and is expected to issue final rulings by May. Thereafter, unapproved saline implants will have to be removed from the market.

Saline breast implants have been the only breast-enhancement option since the FDA removed silicone implants from the market in the early 1990s, and an increasingly popular one. An estimated 130,000 women received saline implants last year, many for cosmetic breast-size enhancement.

Questions about their safety prompted this week's hearings. From 1985 to late 1998, the FDA received 49,661 reports of adverse reactions from the saline-filled implants, including ruptures and deflations, scarring and infections.

Among the FDA panel witnesses were women who claimed the implants had ruined their health and asked that the products be taken off the market. And there were breast cancer survivors who claimed the implants had helped them rebuild their lives and asked that they remain available for women who choose them.

Research by manufacturers did little to dispel the confusion and worry. Partial figures presented by McGhan Medical suggested there were at least minor problems among 60 percent of cosmetic patients within four years of implantation, and among 84 percent of breast reconstruction patients.

Mentor Corp. statistics based on 1,680 saline implant recipients revealed that up to 27 percent of the implants were removed within three years, most because of infections, painful scarring or leakage.

Women who receive the implants after breast cancer surgery are consistently at higher risk for complications because of their poorer health and the altered structure of their bodies. Among the complications were breast pain, asymmetry, infections, loss of sensation and scarring.

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