Gel implant maker Dow bowing out Criticism, drain on resources cited, U.S. officials say

March 19, 1992|By Philip J. Hilts | Philip J. Hilts,New York Times News Service

WASHINGTON B — WASHINGTON -- After months of criticism, the leading maker of silicone gel breast implants, Dow Corning Corp., has decided to bow out of the implant business, government officials said yesterday.

The company had no comment but scheduled a news conference at 9 a.m. today in Washington.

The current business climate makes it impossible for the company to let such a small part of its business drain resources, the company has reportedly told U.S. officials.

Even though the company has held the largest share of the national implant market, about 30 percent, the implant business accounts for less than 1 percent of Dow Corning's annual sales of $1.84 billion.

Dow Corning faces hundreds of lawsuits from women who contend that they suffered ill effects from the implants, and it has $250 million worth of insurance to cover its possible liabilities.

Several verdicts have gone against Dow Corning, including one for $7 million in California last December.

A voluntary moratorium on the use of implants is in effect, but until recently, an estimated 100,000 to 150,000 women got breast implants each year.

Dow Corning is the third manufacturer of silicone gel implants to stop making them since problems with the implants were reported last April.

Bristol-Myers Squibb stopped making polyurethane-coated gel implants last summer, and last week Bioplasty announced that it would stop making gel implants.

There are still two manufacturers on the market, both companies that make saline-filled as well as gel-filled implants, Mentor Corp. and McGhan Medical Corp., a subsidiary of Inamed Corp.

Saline-filled implants are thought to be safer because they contain sterile salt water instead of several ounces of silicone gel, experts say.

An estimated 1 million American women have had silicone gel breast implants, and even critics concede that most of them have had no complaints.

But some doctors have argued that the implants can rupture, allowing the silicone to migrate to other parts of the body, possibly causing local tumors and immune disorders.

Many plastic surgeons, Dow Corning and the other companies have argued that the implants are safe, but an expert panel appointed by the Food and Drug Administration recommended last month that their use be sharply curtailed because the companies had failed to make a convincing case.

FDA Commissioner David A. Kessler has until April 20 to act on the recommendation.

Disagreement over the safety of the implants has been simmering since the 1960s, but the government did not require the manufacturers to demonstrate safety until 1976, and it was not until 1988 that the FDA demanded safety data from the manufacturers.

In January, the FDA asked all doctors to stop inserting silicone breast implants while the expert panel reviewed new information.

Then last month, the panel recommended to Dr. Kessler that he substantially restrict the use of silicone breast implants while clinical trials were conducted to see whether they are safe. Only women enrolled in the trials would be eligible to get the implants.

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