The "Harvard Nurses Study": A new study published today in the New England Journal of Medicine concludes that there is little or no association between silicone gel breast implants and classical autoimmune disease. The "records review only" study was initiated In 1992 by sending questionnaires to nurses who had been followed as part of a larger study since 1976. All the participants in the study were at least 46 years old, As the authors themselves admit, the study does not prove that silicone gel breast implants are safe. Rather, it is just another study "with blinders on" which looks for a connection between silicone gel breast implants...and the wrong diseases, i.e., classical rheumatological diseases with typical presentations that no one contends are caused by silicone.

The Federal Judicial Findings are Women Harmed by Breast Implants: Last week, the Federal Judge overseeing the 4.2 billion global settlement of breast implant claims released figures which show that over 70,000 American women with silicone gel breast implants-have submitted valid disease claims to the settlement. Another 26,000 disease claims are being closely scrutinized and evaluated. For the most part, these women have a atypical disease consisting of a number of symptoms such as joint and muscle aches, rashes, fatigue, hair loss, cognitive deficits and a variety of unique, positive lab findings. They do not have the typical, classical autoimmune diseases and symptoms which the "Nurses Study" looked £or. When one is looking for a new, unique disease that is not found in the general population, many doctors question whether an epidemiological study such as the Nurses Health Study is useful at all.

While the questionnaires for the study were sent out in the Summer of 1992, the Study's authors excluded from their study all women who developed diseases after May of 1990, thereby excluding many women who developed symptoms years after receiving implants. There are women included in the study who had breast implants in place for as little as one month. Many other studies report the onset of symptoms 8-15 years after implantation.

Three of the study's authors, Dr. Jorge Sanchez-Cuerrero, Dr. Graham Colditz and Dr. Matthew Liang, were either personally receiving monies "from the breast" implant manufacturers or had agreed to act as a consultant for a breast implant manufacturer while they were conducting the study yet failed to disclose this conflict of interest at the time. Dr. Liang. later resigned from another epidemiological study due to this conflict of interest. Incredible (but true), Dow Coming was provided with the questionnaire before it was sent to the study's participants. Further, Dow Corning contributed $7 million to Brigham & Women's Hospital, the institution conducting the study, while the study was in progress.

"The study has severe flaws", said Attorney Fredric L. Ellis, a partner with the Boston law firm of Gilman, McLaughlin & Hanrahan, who serves on the national Medicine and Science Committee for the Plaintiffs' Steering Committee (representing women with implants and rupture, disfigurement and disease) . "It does not even look for the atypical disease that we are seeing in thousands of women across the country with silicone gel breast implants and the number of subjects in the study is so small that it would not have found an association between cigarettes and lung cancer." Moreover, Ellis accused the breast implant manufacturers of attempting to control science by hiring the authors of the study and obtaining the questionnaire before it was sent out to the study's participants. "This is just one more example of the breast implant manufacturers attempting to control scientific studies so that they can use them in a courtroom. It throws into serious question the alleged objectivity of 'science'."

Geoffrey White, Esq., of the Law Firm of White & Meany, representing 155 women in and out of the Global Settlement, noted: "The study was clearly biased and tainted. None of the nurses were personally examined, interviewed, or had their blood tested for the markers of silicone adjuvant disease which are available in 1995, and were available since 1992. It was a 'records review' study only. Thus, if a woman had not complained of a particular symptom to her doctor (Joint pain, rashes, muscle aches, fatigue, etc.), or if the doctor had not deemed the particular reported symptom worthy of mention in the medical record, it would not be picked up in the study. Unlike the 96,000 women nationwide in the Global Settlement who were specifically asked about symptoms and specifically tested for objective findings to back up their subjective symptoms, the Nurses' study is of little practical utility. It is misleading and an insult to women and the treating doctors who believe in and care for them.

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