Dow Corning Corp., which pioneered silicone gel breast implants, said Thursday it was quitting the business for good following public outcry that the implants could cause cancer and other health problems.
The company also said it will pay up to $1,200 per patient to defray the cost of having Dow Corning implants removed for women who cannot afford the operation and whose doctors say the operation is medically necessary.Dow Corning Chairman Keith McKennon said the gel implant is not profitable and, given the adverse publicity it's gotten in recent months, the company only expects things to get worse.
"I believe that the future use of this product will be curtailed to a considerable extent," McKennon said at a news conference.
The company stopped making and selling the implants on Jan. 6 after the Food and Drug Administration asked for a moratorium because of health concerns, but it didn't announce whether it would exit the market permanently.
The company has said there is no proof that fluid leaking from the implants causes such major health problems as cancer and autoimmune diseases. The FDA has said research needs to continue to sort that out.
"We agree with the need for more studies and are committed to fund additional research to provide an expanded scientific base to answer these questions," McKennon said.
"We will ensure that results of these studies be made available to all interested parties," he said.
In making the announcement, McKennon said, "We have decided that Dow Corning will not resume the production or sales of breast implants." He said the company is not seeking a buyer for the business but left open the possibility it may later sell the technology if other companies remaining in the business show an interest.
The company also said it was setting up a $10 million fund to pay for breast implant research.
Critics say leaking implants cause cancer and other immune-system diseases, but a link has not been proved.
Dow Corning, which has $250 million in liability insurance, faces hundreds of million of dollars in lawsuits filed by women who blame the implants for various health problems.
McKennon refused to comment when asked whether he thought the company's liability insurance was big enough to cover potential losses from the lawsuits.
McKennon said the company would not require women to sign a paper promising to not sue in exchange for Dow Corning's help in paying for the operation to remove the implants.
In December, the company was ordered to pay $7 million to a California woman who also accused Dow Corning of covering up studies that found adverse reactions in implant patients. Dow Corning is appealing that verdict.
The company and other breast-implant manufacturers and many plastic surgeons say the implants are safe.
Dow Corning controls about 30 percent of the national implant market. Bristol-Myers Squibb Co. quit the business last fall, and last week Bioplasty Inc. said it would also stop making gel implants.
Dow Corning's departure would leave two manufacturers in the market. The Mentor Corp. and McGhan Medical Corp., both of Santa Barbara, Calif., make saline-filled and silicone gel-filled implants.
Dow Corning said last month it might quit the business, after a panel advised the FDA to limit sharply the use of implants. The FDA is expected to issue its final decision by April 20.