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DOW CORNING TO RELEASE ALL DOCUMENTS SPECIFIED BY FDA

 DOW CORNING TO RELEASE ALL DOCUMENTS SPECIFIED BY FDA
 WASHINGTON, Jan. 22 /PRNewswire/ -- In a press conference today, Dow


Corning today announced that the company is committed to releasing all documents requested of it by the FDA. The company said this includes a total of 90 documents comprising 10 scientific reports or studies and 80 memos and company documents.
 "The FDA already has all of these documents, including those that the FDA has labeled as new information," said Robert T. Rylee, vice president of Dow Corning and chairman of Health Care Businesses for Dow Corning Wright. "Our files have been open to the FDA since 1988 and today's announcement is consistent with the full disclosure policy we have always maintained with the agency."
 Rylee went on to say that "Naturally, we believe that by releasing this old internal company correspondence we will be doing nothing to address the real science and safety issues surrounding breast implants. In fact, by releasing these non-scientific memos, we are doing nothing more than fanning the flames created by contingency fee lawyers who base their cases against manufacturers not on what the scientific evidence shows, but on 15-year-old memos that state one person's opinion about what research should have been done."
 Rylee said he didn't believe the memos provide answers to questions women have today about the safety of silicone breast implants. However, according to Rylee, much has been said about these memos and Dow Corning wants to put to rest, once and for all, allegations made by others that the company is in any way failing to make a full disclosure of all documents requested by the FDA.
 "Once all of these documents are in the public domain we hope that the entire review process can return to a scientific basis and re-focus the discussion on much more pressing issues of importance to women today. These include questions like what new research needs to be conducted; or why health insurance coverage is being denied to women with implants; or under what conditions should women consider having implants, or consider having them removed," Rylee said.
 Rylee went on to say that despite the fact that the vast majority of women with implants are satisfied with them, much has been written and said about having implants removed. The company has always encouraged women to stay in close contact with their doctors concerning their implants as well as their overall health. In the rare instance where explaining the device is called for, that decision can best be made by doctors and patients.
 However, Rylee said, we need a consensus among experts to determine under what circumstances should implants be removed. Other questions need to be answered such as who would pay for the procedure, or how do you assess the potential benefit of explant vs. the inherent risk of any additional surgery?
 "In addition, we are reaffirming our call to form a new panel of qualified experts to examine the scientific evidence contained in all Dow Corning safety studies," Rylee said.
 "We believe that a panel should be made up of qualified experts from medical specialties such as immunology, rheumatology, toxicology and plastic surgery where the true science can be examined."
 Allegations have been made that there is a connection between implants and connective tissue disease. Our scientific studies and the world literature have not shown a connection, although clearly questions have been raised. More research is necessary and is already underway on this issue.
 Meanwhile, we think it is imperative that those who specialize in these disorders be called upon to render their judgment on all of the research to date on breast implants and immune system disorders.
 Currently, the FDA Advisory Panel does not comprise worldwide experts in immunology, rheumatology, or inflammation research. Those specialties should be well represented on any panel reviewing existing science -- or recommending future science -- and should play a major role in making a determination concerning the safety and future availability of the device, Rylee said.
 Dow Corning said that it met with the FDA this morning. The purpose of the meeting was to discuss the issue of company documents and to establish a future direction in which the device can be fairly evaluated. Also, the concerns of women -- which need to remain the very top priority -- must be alleviated by a more rational process.
 To achieve this process, all who have a stake in this debate need to have a voice. Science must be the guiding light through the entire process, but other voices need to be heard.
 "Therefore, I am today calling for the formation of a consortium to resolve the issues. That consortium should include women who are most directly affected by the debate that has gone on over the past several months. It is the women we should be thinking about first and foremost, yet they have not been heard from sufficiently.
 "Others we suggest be represented include the National Institutes of Health, the FDA, all of the manufacturers who have submitted Pre-Market Approval Applications to FDA, doctors -- both plastic surgeons who know more about the device than anyone and all of the related specialties such as surgeons, oncologists, immunologists, rheumatologists, and inflammation research specialists.
 "We would like to play a leadership role in helping to form this group and to facilitate the discussion as well as provide the full resources of Dow Corning to assist this body in the efficient completion of its tasks.
 "We will be announcing in about a week the mechanism by which members of the general public may receive copies of these studies and documents we are committing to release today," Rylee said.
 -0- 1/22/92
 /CONTACT: Scott Seeburger, 517-496-4076, Robert Grupp, 202-637-7453, or Ed Hutchison, 517-496-4578, all of Dow Corning/ CO: Dow Corning ST: District of Columbia IN: HEA SU:


PS -- NY106 -- 2566 01/22/92 20:36 EST
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Date:Jan 22, 1992
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