FIRST AND FINAL ADD TO DOW CORNING BREAST IMPLANTS.
/FIRST AND FINAL ADD -- NY040 -- DOW CORNING BREAST IMPLANTS/ QUESTIONS AND ANSWERS ON DOW CORNING'S CONTINUING COMMITMENT TO PATIENTS AND PHYSICIANS 1. What should I believe about the safety and efficacy of silicone breast implants? The FDA advisory panel in February concluded that there is insufficient evidence to show any link between silicone breast implants and systemic diseases of the immune system. In fairness, they also concluded that there was insufficient evidence to prove that no such link exists. Thus, continuing research is obviously important. Part of our commitment to patients and physicians is to continue our research on the safety of these devices. We need to answer those remaining questions women may have about their implants. Based on our available science, Dow Corning continues to believe that Dow Corning silicone breast implants serve a public health need and do not pose an unreasonable risk. 2. Will Dow Corning continue to sponsor research on breast implant safety issues? Yes. In February we announced an ambitious research plan of more than 30 studies, including major studies that are already underway at New York University and the University of Michigan. On March 19, we also announced the establishment of a research fund of $10 million, to be audited by the independent accounting firm of Price Waterhouse, which will be used for the sole purpose of funding research on the safety of breast implants. The research plan includes new studies of existing patients, as well as additional safety studies and chemical and physical properties research. We will assure that the results of this research are made available to all interested parties. 3. How can physicians and patients become involved in any clinical trials that do occur? This information should be forthcoming after the FDA makes its final decision about the availability of silicone breast implants, which it is scheduled to do on or before April 20. 4. Will the company pay to have implants removed? Yes, under certain circumstances and with specific criteria. In February the FDA panel recommended that implants performing satisfactorily need not be removed. We agreed with that recommendation. For patients who seek to have their Dow Corning breast implants removed for medical reasons, but who cannot afford this procedure, Dow Corning will provide up to $1,200 to support the medical costs of the removal procedure. For more information, patients can call Dow Corning's Implant Information Center, 1-800-442-5442. 5. What should I do if my Dow Corning implants need replacement? Pending the FDA decision in April, Dow Corning remains confident that women will be able to obtain replacement breast implants from other manufacturers. In addition, Dow Corning has in place a replacement warranty program for our Silastic II(R) and MSI(R) implants. This program provides women having those implants with a five-year warranty. This includes a replacement device and $600 in financial support. Dow Corning will continue this program, perhaps by increasing the dollar amount so that patients can purchase a device from other manufacturers. For more details call Dow Corning's Implant Information Center, 1-800-442-5442. 6. Will Dow Corning silicone breast implants be available overseas? No. Dow Corning's decision to permanently stop the production and sales of its implants applies worldwide. 7. What impact will this issue have on other silicone medical products manufactured and supplied by Dow Corning? The properties and performance of silicones as a biomaterial have been demonstrated to be extremely effective and are integral to modern medical technology. We believe their need will continue and they will be widely accepted by the medical community. As with any other application of our technology, further testing should be and will be done. We are confident this additional testing will support current usage and possibly lead to expanded uses of silicones for biomedical applications. Silicones used in medical devices and pharmaceutical products are produced in three primary forms: liquid, gel and elastomer. Our primary participation is through the sale of materials to people who manufacture medical devices and pharmaceutical products. Through our subsidiary, Dow Corning Wright, we also selectively produce, market and sell finished products, the vast majority of which are in the form of molded, cured elastomeric products used by physicians and other medical professionals. Examples include finger joints, catheters, intravenous tubing systems and the hydrocephalus shunt. 8. By withdrawing now, before the FDA has made a final decision, is Dow Corning admitting that the device is unsafe? Not at all. We continue to believe that the implant effectively serves a public health need and does not present an unreasonable risk. According to the conclusions of the February FDA panel, there is insufficient evidence to show a link between breast implants and systemic diseases of the immune system. Dow Corning's decision to permanently stop production and sales of implants is not related to issues of science or safety but to existing business conditions. 9. Why do you not discontinue the gel-filled version and replace it with an implant containing saline solution? Would this not be safer? We don't agree that the gel presents a health hazard. Our decision to permanently stop sales and production of breast implants would apply to the production of ANY breast implants. 10. Who at Dow Corning should patients call if they want more information? Patients should call the Implant Information Center, 1-800-442-5442. 11. Who at Dow Corning should physicians call if they want more information? Physicians should call 1-800-437-7056. -0- 3/19/92 AA NY040 /END FIRST AND FINAL ADD/ CO: Dow Corning ST: Michigan IN: MTC SU:
SH -- NY040A -- 9617 03/19/92 11:08 EST
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|Date:||Mar 19, 1992|
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