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FDA CALLS FOR TEMPORARY MORATORIUM ON SILICONE GEL BREAST IMPLANTS

FDA CALLS FOR TEMPORARY MORATORIUM ON SILICONE GEL BREAST IMPLANTS
 WASHINGTON, Jan. 6 /PRNewswire/ -- The Food and Drug Administration (FDA) today called for a moratorium on the use of silicone gel breast implants until new information on their safety can be thoroughly reviewed by an independent advisory panel and the agency can make a final decision in light of the panel's review.
 FDA Commissioner David A. Kessler, M.D., said, "We want surgeons to stop using these implants in patients until this new information can be thoroughly evaluated.
 "Women considering breast implants deserve to know whether these products are safe enough for use. I'm calling for a delay in the use of these products until our advisory panel can meet to consider new information which was not available when it met in November," Kessler said.
 The advisory panel -- the General and Plastic Surgery Devices Panel -- will reconvene within 45 days to evaluate the new data and make new recommendations on the use of these products. Some panel members have asked that the panel's recommendations be revisited. Kessler said the agency would make its decision on whether silicone gel implants should continue to be available after receiving the panel's advice.
 Saline-filled implants will not be affected by today's action and will remain available to patients.
 "Much of the new information provides additional evidence that implants could possibly cause autoimmune or connective tissue disorders. The panel looked at this issue in November; however, the new information seems to underscore safety concerns in this area," said Kessler.
 Breast implant manufacturers were required to submit scientific data demonstrating that the implants are safe and effective by July 9, 1991, and under its regulations, FDA had 180 days -- until today -- to evaluate the data and decide whether the implants could be approved for marketing. FDA had been prepared to make a decision but it recently learned that some relevant documents that could have a bearing may not have been submitted to the agency.
 "Because of these unanswered questions, we believe the products should not continue to be marketed until this new information is reviewed. Unless a woman is having problems with her implants, we are not recommending that she have them removed. On the other hand, if a woman is having symptoms she thinks may be related to her implants, she should see her doctor for advice about what to do," said Kessler.
 In November 1991, FDA's advisory panel met to consider the data submitted by four manufacturers of silicone gel breast implants. The panel said that despite the lack of sufficient data on safety and effectiveness to approve the implants, these devices serve a public health need and should continue to be available under certain conditions.
 Approximately 1 million women in the United States have breast implants, and they have been used on about 150,000 women each year. Approximately 80 percent of the implants are used for augmentation and 20 percent for breast reconstruction following cancer surgery.
 -0- 1/6/92
 /CONTACT: Susan Cruzan of the Food and Drug Administration, 301-443-3285, or after hours, 301-926-7081/ CO: Food and Drug Administration ST: District of Columbia IN: MTC HEA SU:


DC -- DC012 -- 6918 01/06/92 12:33 EST
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Date:Jan 6, 1992
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