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BRISTOL-MYERS SQUIBB PLEASED WITH BREAST IMPLANT STUDY RESULTS

 NEW YORK, Sept. 25 /PRNewswire/ -- Bristol-Myers Squibb Company (NYSE: BMY) said today that it was pleased that the results to date of a controlled clinical study of women with polyurethane foam-covered breast implants continue to support a 1991 U.S. Food and Drug Administration (FDA) Advisory Panel recommendation that the implants not be removed. On Sept. 23, 1993, an FDA paper stated, "...it is important to understand that these study results do not raise new health concerns."
 The FDA has asked the company to conduct some additional research to complete the study and has indicated that conclusions about risk should await the completion of this work. The company is committed to resolving the questions that have been raised about these products and is confident in their safety. The company regrets that recent press reports may raise a concern which is inappropriate in light of the interim data from the study.
 In summary, the results show that no TDA (2,4-toluenediamine) was detected in the serum of women with the implants; in approximately one- quarter of this group, no TDA was detected in the urine; and in about three-quarters of the group, extremely small (parts-per-trillion) quantities of TDA were detected in the urine. Trace quantities of TDA were also detected in the urine of a few women in the control group, suggesting that there exist environmental sources of TDA exposure.
 The FDA has reviewed the company's interim report on the study. The company will meet with the FDA to discuss the completion of the final phase of the study and will submit a final report to the FDA when the study is concluded.
 In 1991, an FDA advisory panel said that the risk of cancer from polyurethane foam-covered breast implants, if any, appears minimal and advised women who have these implants not to have them removed. This advice continues to be appropriate in light of the information submitted by the company in its interim report.
 -0- 9/25/93 R
 /CONTACT: Francine Gingras, 212-546-4616, or Nancy Coleman, 212-546-4335, both of Bristol-Myers Squibb/
 (BMY)


CO: Bristol-Myers Squibb Company ST: New York IN: MTC SU:

CK -- NYSA004 -- 5747 09/27/93 07:15 EDT
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Publication:PR Newswire
Date:Sep 27, 1993
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