The Exploitation of Autoimmune Disease: Breast Implant Litigation and Its Dire Implications for Women's Health

Abstract

Men, women, and children are subject to a number of disease conditions that have been documented over many centuries. Among the most recently described and the least understood of these conditions are autoimmune diseases. As we unfortunately have seen in recent years, the obscure nature of autoimmune disorders has allowed scientific distortion by individuals who stand to profit by claiming a cause-and-effect relationship among some types of autoimmune conditions and a number of medical products, resulting in a rapidly expanding use of "junk science" in our courtrooms. Attempts have been made recently to implicate a number of environmental factors in the development of autoimmune disorders, most notably silicone gel-filled breast implants. The controversies surrounding these alleged relationships have proved to be among the most contentious, costly, and dangerous events ever to occur in women's health care.

Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants

“…However, autoimmune disease is not the only important safety issue for these devices. Epidemiology and immunology studies and editorial articles that have been cited in support of SGBI safety (i.e., Gabriel et al 57 , Hennekens et al 62 , Angell 63 , Connell 64 ) have devoted almost no attention to the health consequences of the local complications of pain, capsular contracture, disfigurement, chronic inflammation, rupture, silicone migration, and frequent surgical revisions. Gabriel et al acknowledged the gravity of these complications in their most recent article.…”

“…A further example is a 1998 article on SGBIs by Connell in the Journal of Women's Health. 64 Fully 10 pages were devoted to the "dire implications for women's health" caused by litigation and junk science. The "well known complications such as capsular contracture, rupture, and bleed," also termed by Connell as "well-known local side effects of breast implants," were virtually ignored with no consideration of the rate of failure, the frequency of related local complications, their consequences, or the need for frequent additional surgeries.…”

The dangers of junk science in obstetrics and gynecology

“…After several individuals with autoimmune diseases pointed a finger at the implants as an etiologic agent, the United States Food and Drug Administration (FDA) reviewed the available research and case reports and found no convincing evidence of any particular disorder related to the device. They also declared that there was evidence for implants serving a public health need [2]. Unfortunately, the publicity surrounding the issue resulted in a plethora of poor quality retrospective studies and case reports, adverse 'expert' clinical opinion, and subsequent lawsuits by the bushel.…”