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DOW CORNING GLAD THAT FDA FINALLY IDENTIFIES WHAT CONSTITUTES NEW INFORMATION CONCERNING BREAST IMPLANTS

 DOW CORNING GLAD THAT FDA FINALLY IDENTIFIES WHAT CONSTITUTES
 NEW INFORMATION CONCERNING BREAST IMPLANTS
 MIDLAND, Mich., Jan. 17 /PRNewswire/ -- Dow Corning has finally received today from the FDA a list of the specific documents, a portion of today from the FDA a list of the specific documents, a portion of which constitute the "new information" referred to by FDA Commissioner David Kessler in his Jan. 6 press conference. As previously announced, the company will release to the public all scientific evidence identified in that list. Dow Corning said that it had released this information previously to the FDA.
 Dow Corning also renewed its call for a review of the science by a panel of experts qualified in the fields of rheumatology, immunology and inflammation research, perhaps under the auspices of an independent government agency like the National Institutes of Health.
 "This panel of qualified experts must be assembled as soon as possible. Any delay will only serve to increase the alarm and confusion of millions of women if the information continues to be debated in the press rather than in a knowledgeable scientific forum," said Dan M. Hayes, Jr., president and chief executive officer of Dow Corning Wright.
 "Our files have always been open to the FDA, and our release of additional studies, none of which we believe shed any new light on the safety of breast implants is consistent with the full disclosure posture we have traditionally taken with the Agency," Hayes continued.
 The company said this release of additional data was in response to a letter it received from the FDA that finally identified for the company what the Agency believed to be new information that led the FDA to announce a voluntary moratorium on the use of silicone breast implants.
 "We are glad that the FDA has finally informed us of what they consider to be new information," Hayes said. "We believe millions of women have been unduly alarmed by the FDA's announcement of a moratorium. It is difficult for us to understand why this additional information has been labeled 'new,' particularly since anything the Agency did not already have was offered to them in 1988 when we issued them an open invitation to look at our files."
 In addition to releasing the scientific evidence today identified by the FDA, Dow Corning has already released to the general public, 10,000 pages of scientific studies submitted to the FDA in 1991 as part of its Pre-Market Approval Application.
 Hayes went on to say that he was encouraged to see additional scientific data sought by the Agency. "I hope this is a sign that the FDA's review of our product will return to the scientific arena, rather than rely on the innuendo, anecdotes and non-scientific internal correspondence that has typified the review process up to this point."
 "What's important is what we did. And that was to amass what is believed to be the single largest body of scientific evidence ever compiled on an implantable medical device."
 -0- 1/17/92
 /CONTACT: Barbara Carmichael of Dow Corning, 517-496-6470, or home, 517-631-8072/ CO: Dow Corning ST: Michigan IN: HEA SU:


PS -- NY074 -- 1227 01/17/92 22:11 EST
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Publication:PR Newswire
Date:Jan 17, 1992
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