Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: MONDAY, April 15, 1991 TAG: 9104150055 SECTION: NATIONAL/INTERNATIONAL PAGE: A-2 EDITION: METRO SOURCE: Associated Press DATELINE: WASHINGTON LENGTH: Short
Susan Cruzan said she had been told results of a laboratory study were expected to be available within a week or two.
The implant is made by Surgitek, a subsidiary of the Bristol-Myers Squibb Co., and is marketed under the trade names Meme and Replicon.
The New York Times, in its Sunday editions, quoted unnamed scientists familiar with the experiments as saying preliminary calculations indicated the implant might cause cancer at the rate of 200 to 400 cases a year for every million women in whom it is inserted.
Karen Garoukian Ferraro, a spokeswoman for the company in Racine, Wis., said Surgitek had done its own studies and believes that its product is safe.
The product consists of silicon coated with a polyurethane foam to avert development of painful and unsightly lumps.
Cruzan said the FDA study concerned the potential breakdown of the coating to a chemical known as 2-toluene, or TDA, which causes liver cancer in research animals.
Last Wednesday, the FDA gave makers of silicone breast implants 90 days to prove that they are safe or to stop selling them.
by CNB