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Dow Corning Expected to Stop Making Gel Implants : Health: The firm may offer aid program for removal of devices. Lawmaker calls for continued safety study.

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TIMES STAFF WRITER

Dow Corning, the leading maker of silicone gel breast implants, is expected to announce today that it will no longer manufacture the controversial devices, sources said.

The company, which has waged a fierce, yearlong battle with federal regulators to keep the implants on the market, “has decided to get out of the silicone implant business,” a knowledgeable source said.

“When you have a company that does all the things it does, a diversified company, and a product with low profitability and high liability, it’s just not good business for them to continue,” the source said.

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The company also is expected to announce a financial aid program in which it would pay up to $1,000 to help women who need the implants removed but cannot afford the cost, the sources said.

The cost of the operation can vary, depending on “where you are and exactly what has to be done,” said one source in the plastic surgeon community. “In some cases, $1,000 will cover the entire procedure. In others, it will only cover 30% to 50%.”

Neither officials at the Food and Drug Administration, which has been contemplating a ban on the products, nor Dow Corning officials would comment on the reports.

Rep. Ted Weiss (D-N.Y.), chairman of a key House subcommittee that has been investigating the safety of silicone implants for more than a year, said Wednesday that “regardless of . . . business decisions, we must not allow Dow (Corning) to abandon the 1 million American women who already have breast implants. These women are entitled to as much information as possible about the potential risks of those implants.”

Weiss urged FDA Commissioner David A. Kessler to require the company to continue studies o determine the safety of the implants, “whatever Dow’s plans for the future. Hundreds of thousands of women . . . have a right to know how long those implants will last and the likelihood of long-term risks.”

The departure of Dow Corning will leave only two companies remaining in the silicone gel implant business: McGhan Medical Corp. of Carpinteria, Calif., and Mentor Corp. of Santa Barbara. A fourth company, Bioplasty Inc. of St. Paul, Minn., recently announced it would cease making silicone implants.

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Sources said Dow Corning was seeking to sell the silicone gel implant portion of its business.

Dow Corning’s decision to shut down its breast implant division is not expected to have a significant financial impact on the company, a 50-50 venture of Dow Chemical and Corning Inc. Less than 1% of its $1.8 billion in annual revenues comes from breast implants. The bulk of its business is supplying industrial silicones to the aerospace, auto and food processing industries, among others.

Dow Corning already has taken a $25-million charge against earnings in the fourth quarter of 1991 to cover costs of temporarily shutting down its implant manufacturing business. Company officials have said for several months that they were studying whether to continue the implant division, which they contend has not been profitable for about five years.

Dow Corning said it has $250 million in insurance to cover potential liability for the product, but some plaintiffs’ lawyers have estimated that the thousands of potential lawsuits--at least hundreds have been filed so far--could add up to more than $1 billion in costs to the company.

The lawsuits have been filed by women claiming that the implants caused numerous serious health problems. The company has consistently maintained that its products are safe, and it is fighting the litigation.

So serious has the overall issue of the implants’ safety become that Dow Corning announced a shift in its top officers in February. Keith R. McKennon was named chief executive officer and chairman of the board. He replaces Lawrence A. Reed as CEO and John S. Ludington as board chairman. Reed will continue as president. McKennon will concentrate on breast implant-related issues.

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For nearly a year, the implants have been the focus of a painful and emotional national debate that has pitted women against women and raised soul-searching questions about the values of a breast-conscious society.

Many women have argued that the implants have made a profound difference in their lives, especially for reconstruction after breast cancer surgery, while others have blamed the devices as the source of debilitating conditions that have caused enormous suffering.

Serious concerns have been raised over the health consequences of implant rupture--when the device breaks--and of slow leakage, or “gel bleed,” over time through the envelope surrounding the implant.

A relationship is suspected between silicone and the development of autoimmune diseases--including certain connective tissue disorders--and cancer, although the scientific evidence is considered inconclusive.

In February, a committee of outside experts convened by the FDA recommended sharp restrictions on the use of implants except for those women seeking them for reconstruction purposes. The panel also said that all women who receive implants under these guidelines would be required to participate in long-term research to evaluate the health risks of the devices.

The FDA is expected to follow the panel’s recommendation and is likely to announce a decision in late April. A voluntary moratorium on the sale and use of silicone gel implants has been in place since Jan. 6.

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The proposal reflected many panel members’ concerns about the need for more research into the possible dangers of silicone, along with their feeling that there was a compelling public health reason for the devices to remain available--especially to breast cancer patients following mastectomy.

Under the recommendation, women seeking the controversial devices for cosmetic reasons--usually breast enlargement--would have limited access within carefully controlled human studies.

The panel said that all women who need the implants for reconstruction purposes should have them, including breast cancer patients, women with congenital breast abnormalities and those who have suffered some kind of trauma that has deformed the breast.

Implants filled with saline--or salt water--remain on the market and are considered safer than silicone gel devices. However, saline implants are also expected to come under FDA scrutiny soon.

Times staff writer Susan Moffat in Los Angeles contributed to this story.

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