UPDATE

Silicone Gel Breast Implants: Secret Industry Studies

Health Letter has reported the health risks associated with the silicone gel breast prosthesis, implanted in 130,000 American women each year, in previous issues. These complications include inflammation and scarring of the breast and surrounding tissues, swollen lymph glands draining the breast, and leakage and migration of the silicone gel leading to "allergic reactions" elsewhere in the body. Long-term hazards include the development of immune diseases such as scleroderma, with the development of thickened

skin and internal organ damage, or chronic arthritis, with stiff, aching joints which may eventually become deformed. Finally, silicone gel has been shown to cause a highly lethal soft tissue cancer in laboratory animals, and the Food and Drug Administration's (FDA) own staff felt that "there is considerable reason to suspect that silicone can [cause cancer in humans]."

The Dow Corning Corporation, the major manufacturer of silicone gel, has amassed 30 years' worth of research on the biosafety of implanted materials, including silicone and silicone gel. At an FDA hearing on January 26, 1989, a company representative stated that Dow Corning had submitted information to the FDA that included, among other items, "a summary list of 750 biosafety studies conducted by or on behalf of Dow Corning; pooled reports on 39 toxicology studies; and a final report on the two-year Industrial Biotest Labs study conducted from 1976 to 1978 [a highly disputed study which demonstrated that silicone gel produced malignant tumors of the lymphatic system]."

On January 27, the Public Citizen Health Research Group requested access to all of the information comprising Dow Corning's biosafety research, under the Freedom of Information Act. When the FDA did not respond within the 10 working days allowed, on February 14, the Public Citizen Health Research Group and the Public Citizen Litigation Group brought suit against the agency in the United States District Court for the District of Columbia and, subsequently, filed a motion for a temporary restraining order to prevent the FDA from returning some of these documents to Dow.

The Dow Corning Corporation has "intervened" in the case, and is co-defendant (with the FDA) and the defendants have until June 1 to file their "motion for summary judgment," that is, to demonstrate that there is no dispute on matters of fact relevant to the suit. We are prepared to argue this point, and to ask questions of both the FDA and Dow Corning about these documents.

It is tragic that we must sue our government to obtain information about the safety of a device that has been implanted in more than two million women in this country. This is information that the FDA should have required (and that should have been subject to outside review), as part of a pre-market approval process, some 25 years ago.