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This article was originally published in The Gray Sheet

Executive Summary

DOW CORNING SILICONE GEL BREAST IMPLANT GRAND JURY SUBPOENAS request a wide variety of information on silicone gel-filled breast implants, including information on "oven charts" falsified by the firm, according to Dow. On Feb. 8, Dow Corning received two subpoenas from the U.S. Attorney's office in Baltimore related to a grand jury investigation. FDA informed Dow Corning in January that it had asked the Justice Department to begin a criminal investigation of the company. In November, Dow Corning released a summary of a report that disclosed that the firm had falsified the oven charts, which document the temperature at which liquid silicone is heated before being inserted into breast implants ("The Gray Sheet" Nov. 9, p. 14). The summary of the report, which was commissioned by the firm and conducted by former Attorney General Griffin Bell, said that Dow Corning became aware of the falsification in 1987. However, the firm did not provide the information to FDA in its breast implant premarket approval applications when the agency asked for previously undisclosed safety data in late 1991. Dow Corning maintains that the oven charts had no effect on product safety. Dow Corning, which has withdrawn from the silicone gel breast implant business, says the subpoenas request a wide range of additional documents, including many files reviewed during the Bell investigation and subsequently submitted to FDA. In his report, Bell recommended that the firm provide FDA with all "non- privileged" breast implant-related documents that had not already been submitted to the agency. The documents include complaints, medical device reports, lot histories, product development, and studies and tests. The firm says it currently is identifying and gathering documents in order to comply with the subpoenas, which provide 30 days for a response. However, the firm maintains that it will not provide some of the documents related to the Bell report because they are privileged information. Judge Samuel Pointer of the U.S. District Court in Birmingham, Alabama recently ruled that Dow Corning did not have to provide a copy of the full report to FDA because it is protected under the attorney/client relationship ("The Gray Sheet" Feb. 8, In Brief). The agency has received requests for a criminal investigation of Dow Corning for over a year. In December 1991, the late Rep. Ted Weiss asked that the agency seek Justice Department review of whether the firm withheld safety data ("The Gray Sheet" Jan. 6, 1992, p. 3). More recently, the consumer organization Public Citizen's Health Research Group asked FDA in January to pursue a criminal investigation because the firm did not disclose certain toxicity and animal studies in response to a 1988 request from the agency ("The Gray Sheet" Jan. 18, I&W-4).

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