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DOW CORNING STRONGLY DISAGREES WITH FDA PANEL FINDING ON SILICONE BREAST IMPLANTS: PROTESTS INABILITY TO PRESENT ALL OF ITS DATA

DOW CORNING STRONGLY DISAGREES WITH FDA PANEL FINDING ON SILICONE
 BREAST IMPLANTS: PROTESTS INABILITY TO PRESENT ALL OF ITS DATA
 GAITHERSBURG, Md., Nov. 14 /PRNewswire/ -- Dow Corning, a manufacturer of silicone breast implants, strongly disagrees with yesterday's decision by an FDA Advisory Panel. The panel, convened to hear Pre-Market Approval Applications (PMAA) for silicone breast implants, found that the Dow Corning PMAA lacked sufficient data to prove the product is safe and effective.
 The company was quick to point out that this ruling by the panel did not necessarily signify that the product would be ruled unsafe by the FDA in its final decision in early January of 1992.
 "Our products are safe and I believe we proved that," said Dr. Robert R. LeVier, technical director, Health Care Business, Dow Corning. "We believe the outcome of the panel would have been materially different if they had the opportunity to review all of the data we provided to the FDA."
 LeVier went on to explain that in an effort to respond to a Sept. 13 letter from the FDA requesting more information from the company, Dow Corning had made available significant additional data. However, the agency then said the company could not submit the additional data it had requested, nor would it allow Dow Corning to present the data to the panel because of "administrative efficiency."
 "The result was that we had substantial additional data to present to the panel and neither the FDA nor the panel were able to include it in their deliberations," LeVier said. "We believe the process, up to this point, has been highly irregular for any medical device heretofore reviewed by the agency. The requests for information are coming to us late and the ground rules for evaluation are constantly changing."
 LeVier went on to say that this changing evaluation process bodes ill for the medical device industry overall. However, he said the company is hopeful it can enter into discussions with the FDA after the hearings to determine exactly what data the agency requires to make a fair evaluation of the device. LeVier stressed Dow Corning's willingness to work with the agency to identify data requirements and then to move aggressively in developing acceptable protocols and execute the required research.
 "We have a commitment to perform ongoing research on all of our products. In fact, we have two new epidemiology studies now underway at the University of Michigan and New York University addressing whether any new evidence exists to connect silicone breast implants with cancer or scleroderma," LeVier said. "It is symbolic of the type of commitment Dow Corning makes to research. We are anxious to work with the agency to keep these devices available to the hundreds of thousands of women who value them."
 -0- 11/14/91
 /CONTACT: Barbara Carmichael of Dow Corning Wright, 301-948-8900, ext. 2196/ CO: Dow Corning Wright; FDA ST: Maryland IN: MTC SU: SB -- DC003 -- 4261 11/14/91 08:53 EST
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Publication:PR Newswire
Date:Nov 14, 1991
Words:493
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