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DOW CORNING REAFFIRMS SAFETY OF SILICONE BREAST IMPLANTS; AMASSES LARGEST SAFETY DATA BASE OF ANY IMPLANTABLE MEDICAL DEVICE

 DOW CORNING REAFFIRMS SAFETY OF SILICONE BREAST IMPLANTS;
 AMASSES LARGEST SAFETY DATA BASE OF ANY IMPLANTABLE MEDICAL DEVICE
 WASHINGTON, D.C., Jan. 13 /PRNewswire/ -- Dow Corning held a press conference today to reaffirm the safety of silicone breast implants and to refute unscientific allegations made against the product.
 At that press conference, Robert T. Rylee, chairman, Health Care Businesses, Dow Corning Wright said: "Dow Corning has studied the safety of Silicones for almost 40 years. In that time, we have conducted over 10,000 health and safety studies, amassing over 300,000 pages of scientific data. Of those studies, 329, which were conducted over the past 30 years, are devoted specifically to silicone breast implants.
 "The conclusion of all of those studies is that silicone breast implants are safe and effective. In fact, we believe that Dow Corning's accumulated safety studies on silicone implants is the most comprehensive body of knowledge ever amassed for an implantable device. Safe does not mean risk free. But the risks are known and understood so that a woman can make an informed decision," Rylee said.
 "In addition, today we are releasing an independent analysis of Dow Corning's studies conducted by Dr. Albert C. Kolbye, Jr. Dr. Kolbye was formerly the Associate Director for Toxicological Sciences at the FDA and is the founder and co-editor of the scientific journal "Regulatory Toxicology and Pharmacology."
 Dr. Kolbye confirmed that Dow Corning's studies establish that the silicone breast implant is safe and effective. Dow Corning took the additional step of releasing his executive summary and a summary of his extensive credentials.
 Rylee then discussed the internal company memoranda that have been discussed in the media recently. He said "To base any conclusion on the safety of silicone implants on internal nonscientific memos is nothing short of intellectual dishonesty. At best, a focus on memos shows naivete with the product's development process. At worst, it shows a concerted effort to divert attention from science because there are no grounds for banning the product based on science. This is a travesty to the millions of women who have a compelling need for this device.
 The memos by and large address the scientific basis by which Dow Corning Wright brought Silastic 1 to market. This device is no longer on the market and is not the subject of Dow Corning Wright's Pre-Market Approval Application which is being reviewed by the FDA. The memos record only one side of an internal dialogue debating which studies should be the next ones performed in developing our growing body of knowledge on implants.
 The memos do not record the existing body of knowledge Dow Corning had already accumulated on the safety of silicones in the human body. By 1975, we already had a foundation of safety studies on silicones in the human body dating back to the 1950's. The studies consistently showed that silicones were a safe material for implanted applications, Rylee said.
 Rylee added: "By 1975, did we believe more research was needed? Of course. Any responsible scientist is always seeking more data and more evidence. The only debate was which studies we would undertake next.
 "Did we know that silicone bled through the implants? Of course we did. That was generally understood. But neither us nor our colleagues believed this phenomenon was a safety issue nor do any of our subsequent studies show this to be a safety issue.
 "Did we want to reduce the amount of gel bleed? Of course we did, Because gel bleed was not a phenomenon that contributed to the implant's performance. It was unnecessary and therefore, we sought to reduce or eliminate it in our next generation products. What we are discussing here is the internal debate that is central to any product advancement."
 Rylee closed by urging that this debate on memos, not science, cease immediately. He said that probably the best example he could give is the much publicized "crossed fingers" memo referenced in print and broadcast media alike. Rylee said that many have claimed this reference meant that a Dow Corning employee was lying to physicians -- using "crossed fingers" -- when talking about safety studies.
 "Well, why doesn't someone ask the author of that memo just what he meant? The author is Chuck Leach a 29 year employee of Dow Corning, who is devastated and enraged to see his words of 15 years ago spread across the media," Rylee said.
 "Chuck has written letters to the editor explaining that 'crossed fingers,' did not mean he was lying, but that he was hopeful that additional studies would resolve the issue of gel bleed and its relationship to contracture.
 "At the time he wrote his memo he was not aware of the full extent of our research plans. As a result of Chuck's letter to the editor, the Associated Press issued a national retraction to the story. I suspect, however, that retraction only got published in Chuck's home town of Midland, Mich. Obviously restrictions and corrections just don't make good press. But the bottom line was that the story on 'crossed fingers' was wrong from the start.
 "This is probably one of the best examples I can give of how a single memo taken out of context can distort reality. The result is a relentless disruption to the scientific review of breast implants."
 Rylee closed by calling on those who believe that implants pose substantial health risks to bring forward their science.
 "If their only basis for concern is internal memos taken out of context, then the women of this country have been done a great disservice.
 "I want to call on the critics of breast implants to refocus their energies away from memos and 11th hour letters and facsimiles. To date these critics have not produced one shred of credible scientific evidence to support their position, and yet they go unchallenged. I would call on the FDA to ask these critics to bring forth their science. That is where this debate belongs," Rylee said.
 KOLBYE ASSOCIATES REPORT
 DEC. 19, 1991
 EXECUTIVE SUMMARY
 An extensive review and analysis was performed by Kolbye Associates of Dow Corning Wright's PMA submission on Silastic Breast Implants. Two hundred thirty-five non-clinical studies were reviewed, as were all clinical studies. In-depth analyses were made of all reports, and then the scientific data were reviewed and evaluated by categories. A multi disciplinary scientific team reviewed and evaluated all reports.
 In brief, we found the non-clinical studies to be extensive and complete, with a few studies still to be finalized. The clinical studies are still ongoing, for the most part.
 Essentially, the data support the safety and efficacy of the breast implants.
 Clinical studies investigating the use of double lumen mammary implant, e.g., Silastic II Gel Saline Mammary Implant H.P., and the silastic MSI Gel Saline Mammary Implant H.P. have been sponsored by Dow Corning Wright and carried out by several surgeons. The results of these studies are favorable.
 Additional studies involving the use of Dow Corning Wright single lumen mammary implants are either underway or in the planning stages. These studies involve the Silastic MSI/Silastic Mammary Implant H.P. and the Silastic MSI Mammary Implant H.P. These studies are prospective evaluations involving bilateral primary augmentation cases.
 A careful study of the comprehensive clinical studies of the Silastic II, gel filled breast implant leads to the conclusion that this old, well-established breast prosthesis is safe and effective for breast augmentation, reconstruction and revision.
 The less comprehensive clinical data currently available on the Silastic MSI breast implant follows the trends established in the Silastic II studies. These clinical tests on the MSI implants are not yet advanced enough to conclude that the MSI implants are as safe and effective as the Silastic II implants, but there is no indication that they are not safe and effective.
 The non-clinical studies have been comprehensive in scope. While some studies reflect older protocols many, including critical studies, would satisfy current protocols.
 There have been studies of biocompatibility, cytopathic effects, hemolysis, immunology, sensitization and thrombosis with consistent negative effects being reported. There are essentially no genotoxic effects under the conditions of testing. The animal testing by inhalation, injection, implantation and oral routes of exposure have produced little in the way of positive toxicological effects and certainly not in any consistent reproducible pattern. That is true for all teratology and reproduction studies currently available. All chronic data currently available indicate that there is also no carcinogenic risk for humans.
 Some residues of the breast implant materials are picked up by the regional lymph nodes but there is no evidence of systemic reaction.
 The outstanding question concerns whether women with a pre-existing proclivity to incur auto-immune diseases have a greater susceptibility to adverse effects from breast implants. It is not known whether reports in the clinical literature involve Dow Corning Wright's products. Nor is it certain how such adverse effects could have been predicted if Dow Corning Wright's products were involved.
 Conclusions:
 The non-clinical and clinical studies reported establish that Dow Corning Wright's breast implant products are safe and effective. All surgical procedures involve occasional risks of adverse results due to various causes; therefore, ultimate safety should be considered in relative terms, not absolute.
 -0- 1/13/92
 /CONTACT: Barbara Carmichael, 202-637-7360, or Robert Grupp, 517-496-6443, both for Dow Corning/ CO: Dow Corning ST: District of Columbia IN: HEA SU:


PS -- NY092 -- 9310 01/13/92 22:28 EST
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