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DOW CORNING CRIMINAL PROSECUTION FOR WITHHOLDING SILICONE SAFETY DATA

This article was originally published in The Gray Sheet

Executive Summary

DOW CORNING CRIMINAL PROSECUTION FOR WITHHOLDING SILICONE SAFETY DATA is sought by Public Citizen's Health Research Group. In a Jan. 14 letter to FDA, the consumer advocacy group requests prosecution of the company and its officials because Dow Corning "violated federal law by deliberately withholding safety data on its silicone used in medical devices, especially breast implants" in a January 1989 report to the agency. The report was submitted in response to a 1988 request from FDA to identify all animal safety studies and chronic toxicity studies of silicone materials that had been conducted by the company. HRG claims that Dow Corning failed to include in the report 29 safety studies that revealed potential health risks of silicone materials. Existence of the additional studies was disclosed in two more recent Dow documents: a premarket approval application submitted to FDA in July 1991 for its silicone gel-filled breast implants and data released by the company in February 1992 ("The Gray Sheet" Feb. 17, 1992, p. 5). In response to the HRG letter, Dow Corning says it is reviewing its records to determine why the 29 studies were omitted from the 1989 report. The company expects to issue a formal response the week of Jan. 18. HRG has singled out several medical device manufacturers as candidates for criminal prosecution over the past year. For example, Dow Corning was among 10 companies which HRG said should be prosecuted in July for violations of medical device reporting regulations ("The Gray Sheet" July 13, p. 3). In August, it urged prosecution of Siemens-Elema AB for failing to cease distribution of ventilators it allegedly knew to pose safety risks, and in November, the group called for prosecution of Pfizer for withholding safety data on its Bjork- Shiley heart valve. In its letter to FDA regarding the Dow Corning report, HRG highlights a number of health risks it claims are revealed in the withheld studies. According to the group, the studies lend support to theories that link silicone with problems such as autoimmune disease and fetal anomalies. For example, a 1974 study on "the immunological enhancing activity of silicones in guinea pigs" showed "that various silicones, used in breast implants, could act as an adjuvant which would stimulate the immune system." HRG adds: "This report is particularly significant because it supports the theory that silicone can cause autoimmune disease." In addition, a 1966 study "reported increased number of resorptions and birth- defects," HRG states. HRG also claims that Dow Corning "did not identify a significant 1978 study" of rabbits which "found that the silicone gel was not suitable for long term implantation because of the inflammatory response." According to HRG, a 1985 study noted: "the apparent disappearance of approximately 50% of the gel from the injection site is of concern." HRG argues that if FDA had been made aware of the studies in 1989, the agency would have taken action at that time to limit the use of silicone breast implants. "If the agency had received the documents that were withheld in 1989, we are confident that it would have acted much sooner to halt the use of silicone breast implants for cosmetic purposes." FDA called for a moratorium on the use of silicone breast implants in January 1992 and in April began a three-part program to allow availability for "urgent need" patients and for clinical trials ("The Gray Sheet" April 20, p. 1). Dow Corning closed down its breast implant business in March ("The Gray Sheet" Nov. 9, p. 14). A recent report of Dow's breast implant operations, conducted by former Attorney General Griffen Bell revealed, among other things, that Dow falsified breast implant manufacturing data ("The Gray Sheet" Nov. 9, p. 14). As part of FDA's ongoing investigation of the company, the agency conducted an inspection of Dow's Hemlock, Michigan facilities the week of Jan. 11 to review breast implant manufacturing records, including the silicone gel "oven charts" falsified by the company. Dow says it supplied FDA with copies of the documents in December, but that FDA wanted to review the originals. Dow Corning delivered the breast implant manufacturing information and "thousands" of other documents in December in compliance with a recommendation made by Bell, who said the company should give all "non-privileged" documents to FDA. Dow also has given FDA a list of all the people who were interviewed by Bell's firm, King & Spaulding, during the investigation, and has retained an independent consultant to review compliance with good manufacturing practices regulations at the company. Both steps also were suggested by Bell. FDA has asked Dow Corning to provide the agency with a copy of the Bell report. The company gave FDA a copy of Bell's recommendations in November, but did not provide the agency with a copy of the report. Dow maintains that the report is "central" to the company's litigation defense and that it is protected under the attorney/client relationship. Dow says that all the documents on which Bell based his report were included in the December shipment to FDA, and that the company will assist FDA in its review of the data whenever necessary.
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