Breast Implants

Implant Background

The history of the silicone-gel implant is convoluted and controversial. Dow Corning, based in Midland, Michigan, and a joint venture of Dow Chemical, introduced the silicone-gel implant to an unregulated market in 1963. Direct silicone injections, undergone by as many as 50,000 women, had been a popular method of breast enlargement until horror stories of blindness, gangrene, pneumonia, and even death promoted many state legislators to enact laws banning the practice. Dow Corning became involved in the practice through sales of industrial-grade silicone that was being sterilized and injected by doctors across the country. The company eventually was indicted by a federal grand jury in 1967 for shipping a non-approved drug three years earlier. Dow Corning, claiming to have no knowledge of what the silicone was being used for, pleaded no contest to the charges and paid a $5,000 fine.

The legitimate marketing of silicone breast implants by Dow Corning was launched under the trade name Silastic. The new implants contained sealed silicone-gel in a sack of silicone sheeting that was designed to prevent fluid escape, maintain shape, and mimic the feel of actual breast tissue. Orders for the product flooded the company, and by 1967 an estimated 40,000 women had silicone breast implants. Product sales represented a billiondollar business for Dow and five other corporations, particularly during the peak years for implants from 1979 to 1993. The Department of Health and Human Services estimated that by the early 1990s, one million women had silicone-gel breast implants, with the majority of cases involving elective augmentation surgery.

Implant Effects

Consumer complaints that the implants were leaking, hardening, and rupturing continued to haunt the market. As early as 1982, physicians and researchers began to claim that the implants were associated with connective tissue diseases (CTD) and health problems connected to autoimmune disorders, including lupus, scleroderma, polymyalgia, and rheumatoid arthritis.

Many of the complications resulted in permanent disabilities and disfigurement. When siliconegel implants ruptured, the surrounding tissue became infected with silicone and required extensive surgery. Between 1983 and 1991, the FDA received 5,000 implant-related complaints. Many consumers believed that manufacturers marketed the product without warnings of known risks and acted in bad faith.

Dow Corning was accused of withholding information on the long-term toxicity of silicone. Preliminary research by Dow showed that laboratory animals suffered from birth defects, nervous system disorders and even death as a result of the implants. A 1995 research study of 775 patients found that 91 percent of the polyurethane-coated silicone implants[Page 108] on average had ruptured and 31 percent of the conventional silicone devices had ruptured. Internal memos from Dow Corning addressed the “bleeding” silicone problem and directed sales representative to clean any oil from the implant before showing it to prospective buyers. Corporate communications suggest that the company had been aware of leaks and ruptures since in the early 1970s and had manipulated the quality control records of the product. Finally, in 1985, package inserts included printed warnings of possible immune system diseases.

...