Warning to Dow Corning

Dec. 31, 1991 (301) 443-3285 WARNING LETTER TO DOW CORNING WRIGHT ON BREAST IMPLANT 1-800 NUMBER FDA has determined that a hotline set up by Dow Corning Wright Corp., of Arlington, Tenn., is providing misleading information about the safety of silicone gel-filled breast implants to callers who have questions about these devices. The following may be used to respond to questions. On Dec. 30, FDA sent a warning letter to Dow Corning stating that some of the information being provided to women over the company’s toll free information line was false or was used in a confusing or misleading context. FDA’s warning letter cited verbal statements made by Dow Corning’s hotline staff that overstate the safety of their implants or minimize known or suspected side effects. FDA documented these false or misleading statements, including assertions that breast implants are 100 percent safe, that the FDA advisory panel which met on November 12, 13 and 14, l991 said that breast implants were safe, that silicone cannot migrate to other organs in the body, and that breast implants have never been linked to autoimmune or connective tissue diseases. Since Sept. 26, 1991, FDA has required manufacturers to supply accurate information on the risks associated with breast implants to women who are considering breast implant surgery. FDA has provided guidance for manufacturers and physicians on the type of information required. FDA has stated that it would regard a manufacturer as misbranding its breast prosthesis unless its labeling provides adequate information on risks. FDA believes that Dow Corning’s hotline is falsely reassuring women of the safety of breast implants when studies have not fully shown the frequency of known adverse effects, nor whether potential long-term effects such as autoimmune disease can be linked to the implants. FDA warned the company that it must cease making these overstated and misleading claims, and asked for the firm’s response on corrective actions by Jan. 2, 1992. About 2 million women in the United States have breast implants, with about 150,000 receiving them each year. In April 1991, FDA asked the manufacturers to submit scientific data showing the safety and effectiveness of silicone gel-filled implants by July 9, 1991. FDA is currently evaluating these applications to determine if the data demonstrate that the implants are safe and effective. The agency’s decision is due in early 1992. FDA has received many inquiries from women on the safety of breast implants, and will provide written consumer information on request. Inquiries should be sent (preferably on a postcard) to: Breast Implants FDA, HFE-88 Rockville, MD 2085


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