FDA orders further study of foam breast implants.Polyurethane foam-coated breast implants Breast Implants Definition Breast implantation is a surgical procedure for enlarging the breast. Breast-shaped sacks made of a silicone outer shell and filled with silicone gel or saline (salt water), called implants, are used. release a small amount of a suspected cancer-causing chemical that goes into women's urine, according to researchers at the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). The agency has asked companies that used to make the devices to conduct additional studies. About 10 percent of women with breast implants have the polyurethane foam-coated variety, according to FDA spokeswoman Susan Cruzan. The foam coats the silicone envelopes that contain silicone gel. The FDA is not recommending that women have their implants removed if they are not experiencing any problems but cautions that they should be on the alert for possible problems. The implants were marketed under the names Meme, Replicon rep·li·con n. A genetic element that undergoes replication as an autonomous unit. , and Natural Y. They were made by Surgitek, Inc., a subsidiary of Bristol-Myers Squibb Co., which maintains the devices are "safe and effective." (Thomas Burton, Bristol-Myer's Foam Breast Implants Found to Release Suspected Carcinogen carcinogen: see cancer. carcinogen Agent that can cause cancer. Exposure to one or more carcinogens, including certain chemicals, radiation, and certain viruses, can initiate cancer under conditions not completely understood. , Wall St. J., Sept. 27, 1993, at B3.) In 1991, FDA scientists demonstrated under laboratory conditions that it was possible or polyurethane to break down to form the chemical 2,4 toluene toluene (tōl`y  ēn') or methylbenzene (mĕth'əlbĕn`zēn), C7H8 diamine di·am·ine n. Any of various chemical compounds containing two amino groups, especially hydrazine. Noun 1. diamine - any organic compound containing two amino groups (TDA TDA Texas Department of Agriculture TDA Trade and Development Agency TDA Transportation Development Act TDA Tax Deferred Annuity (commonly known as TSA) TDA Tienda (Spanish: store) ) at body temperature. That same year, Surgitek withdrew the devices from the market and agreed to conduct a study to clarify whether polyurethane actually breaks down in the body and, if so, to measure the quantities of TDA produced. Preliminary results from the ongoing study show that very small amounts (parts per trillion) of TDA are present in the urine of about 70 percent of the women who have polyurethane foam-coated implants. No TDA has been detected in their blood serum. Bruce Burlington, director of the FDA's center for devices, generally advised women with the devices not to have them removed. "We think the risk is very small," he said, "and the risks of surgery to remove them are real." Cruzan said it could take another year for the company, now known as Medical Engineering Corp., to conduct further research. |
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