More on flawed studies

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http://www.maryalice.com/cases/implants.html

Thousands of Women Suffering illnesses constitute more than 'anecdotes' Dr. Kessler of FDA states that studies have shown that silicone gel is a potent stimulant to the immune system and could generate antibodies that attack collagen, a component of connective tissue. In 1992, the FDA received more than 23,000 reports of problems with implants, including complaints of "bleeding" implants, connective tissue disorders that could lead to arthritis-like pain and swelling in the joints, fibrous tissue spreading around the implants, and swelling of skin and limbs.

R. Weiner, associate professor of medicine at the University of California at Los Angeles, asserted in August 1994 that "[o]nce you see these women, that's all it takes to be convinced silicone implants can make them sick. . . . There's no one who has seen a large number of these women who disagrees."

Safety concerns prompted France in May 1995 to halt the importation, manufacture, sale or use of silicone-gel breast implants. In May, the Ministry of Health stated that implants filled with any product other than physiologic saline can rupture and "result in grave danger." France will not allow implants back on the market "until they have been definitely shown without risk to the user."

Two recent studies are fatally flawed One of the most-cited papers used to criticize the link between silicone implants and connective-tissue diseases suffers from fundamental flaws. The "Mayo Clinic" study published in June 1994 (1) failed to ask women uniform questions or employ standard laboratory testing; (2) failed to look for the "atypical" signs and symptoms suffered by women with silicone poisoning; (3) admitted that the control group (749 women with implants and 1,498 without) was insufficient and that an accurate study would require 62,000 women with implants and 124,000 without over 10 years; (4) suggested an implant failure rate in excess of 30 percent (of the 749 women with implants, 257 had surgical revisions); and (5) concluded that "No statistically valid conclusions can be drawn from this study."

Further, the study is at least subject to question since it was financed in part by the Plastic Surgery Educational Foundation, the educational arm of the American Society of Plastic and Reconstructive Surgeons. This group has been given hundreds of thousands of dollars for research by implant manufacturers.

A study published in June 1995 -- the "Harvard" study -- suffers from similar flaws. Specifically, it (1) failed to ask women uniform questions or use standard laboratory testing; (2) failed to look for signs of "atypical" connective- tissue diseases, the symptoms of which do not fall into any clear diagnostic category; (3) studied too few women with breast implants (1,183 women with implants, 876 of which were silicone gel filled); and (4) failed to account for the fact that women with silicone implants may not manifest illnesses during the first eight years after implantation.

Further, as with the Mayo Clinic study, author bias is at issue. Two authors of the Harvard study have admitted under threat of perjury that they are paid consultants to breast implant makers. Also, Dow Corning has donated $5 million to Boston's Brigham and Women's Hospital, which played a key role in this study.

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