By Richard Alexander*

The " Harvard Nurses Study," officially titled Silicone Breast Implants and Connective Tissue Disease, was conducted by researchers at Harvard Medical School, the Harvard School of Public Health, and Brigham and Women's Hospital in Boston. The study, first presented at the October 1994 meeting of the American College of Rheumatology and published June 22, 1995 in The New England Journal of Medicine, claims that there is no association between silicone breast implants and connective tissue disease.

This study is seriously flawed and raises serious ethical issues:

• Two of the authors of the study, Dr. Graham A. Colditz and Dr. Matthew H. Liang, admitted under threat of perjury that they were paid consultants of breast implant manufacturers.
• Dr. Colditz admitted under oath that he knew Dow Corning had donated $5 million to Brigham Women's Hospital. Inappropriate scientific methodology was used. The information was gathered from questionnaires and conclusions were based on follow-up medical records. The women in the study were never examined by the researchers.
• The number of women in the study was too small and the time period too short. Of the 87,501 women studied, only 1,183 women had breast implants. The study included women who had intact, as opposed to ruptured, implants, as well as women who had had implants for as little as one month. By including women with such recent implants, the study erroneously concluded that the women would not become sick. Experts have determined that the latency period for connective-tissue disease is between 8 and 15 years after implantation.
• Conclusions about silicone poisoning were based on " classic autoimmune immune diseases" and symptoms. But silicone poisoning is a new disease, which does not show " classic" autoimmune symptoms.
• The National Cancer Institute and the National Institute of Health held a symposium in March 1995 on " The Immunology of Silicone," to discuss recent evidence of high cancer rates in women with silicone breast implants. Experts at the symposium concluded that exposure to silicone mammary implants sets into motion significant and long-lasting diseases with many immunopathic findings.
• There is a demonstrated association between silicone from breast implants and connective tissue disease. The silicone stimulates the immune system, causing the body to attack itself.
• These diseases include lupus (persistent ulcerous lesions that spread over the skin); scleroderma (an autoimmune disease causing hardening of blood vessels and connective tissue); Sjogren's disease (dryness in the eyes, mouth, nose, vagina); neurological problems such as numbness or tingling in the joints; problems with vision and hearing; silicone poisoning can also cause a fibrotic condition in the lungs which can lead to suffocation.
• Even the authors of the Harvard study admitted, " ...the study cannot be considered definitively negative" regarding the link between silicone and connective-tissue diseases.

While the Harvard study claims to support the findings of a previous pro-breast implant report by the Mayo Clinic, the Harvard study's flaws are similar to the flaws in the Mayo Clinic study which examined a small group of women in a single area of Minnesota over a brief period of time, with no follow-up research performed. In addition,

• The Mayo Clinic study was partially funded by the American Society of Plastic and reconstructive surgeons and many manufacturers of breast implants.
• The authors of the Mayo Clinic study themselves admit: " ...our study has several limitations...Our results, therefore, cannot be considered definitive proof of the absence of an association between breast implants and connective-tissue disease." (New England Journal of Medicine, 6/16/94)

* San Jose attorney Richard Alexander, a graduate of the University of Chicago Law School, was first certified as a civil trial advocate by the National Board of Trial Advocacy in 1980, currently serves as Vice President of Consumer Attorneys of California and is a founding member of the National Association of Consumer Advocates. The Alexander Law Firm holds Martindale-Hubbell's highest rating for legal ability and adherence to ethical values, is recognized in the List of Preeminent Law Firms in the United States and sponsors The Consumer Law Page on the World Wide Web [http://seamless.com/talf]. Copyright 1995 by Richard Alexander.

" The Consumer Law Page" is a trademark of The Alexander Law Firm.

RICHARD ALEXANDER
THE ALEXANDER LAW FIRM
55 S. Market Street, Suite 1080
San Jose, California 95113
(408) 289-1776; Fax 287-1776; TTY 286-1776; Email
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Copyright 1995, THE ALEXANDER LAW FIRM

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