|ChemCases lets you learn chemistry and enjoy doing it by applying the same chemical principles that the inventors used develop the products you use. And you can join with other learners to debate the fundamental issues that confront these scientists as they make responsible decisions about what they do.|
Back to Concept Map
Back to Silicone 15. Breast Augmentation Implants
Ahead to 17. Bankruptcy of Dow-Corning
In the late 1960's, the company began careful refinement of its product. They sought a softer, more pliable implant. In this search, the company limited its research to combinations of the silicone materials, fluids and polymers, previously implanted. Dow Corning chemists modified the implant by decreasing the viscosity of the silicone fluid in the implant. And they developed a new, presterilized product that would reduce the handling of the implant in the surgery suite.
Dow Corning was responsible for safety studies on the implants. In researching the safety of their new developments, Dow Corning chemists considered if the lower viscosity fluid would migrate through the sac of the implant and head for the lymph nodes, from where the silicone, as a foreign body, would be eliminated. They found no increased migration of the silicones over the previous combination of materials. There always had been a trace of silicone fluid that could be found in the nodes.
PBS has published a chronology from here:
Only in 1976 did the Food and Drug Administration require that a manufacturer of a device prove to FDA that the device was "safe and efficacious," that it both do no harm and that it would work as intended. But with a decade of history of silicone implants, the FDA "grandfathered" silicone implants, believing that their safety and efficacy had been proved by the implant history itself.
Thousands and thousands of women elected silicone implants. In 1977, a woman who claimed her implants had ruptured, received a $170,000 settlement of a law suit from Dow Corning.
Finally, the FDA required manufacturers to provide safety and efficacy data. Dow Corning supplied the FDA with results of 329 studies, on schedule, in 1991.
Meanwhile, in Alabama, another jury awarded $5,400,000 to a woman who displayed only preliminary symptoms of autoimmune disease. The jury was influenced by evidence that the woman had a residue of silicone present in her lymphatic system. Experts claimed this material would present an increased risk of disease. Another California jury in 1991 awarded more than $7,000,000 to a woman whose ruptured implants are claimed to have led to autoimmune disease. Dow Corning documents appear in this trial that had not been given previously to the FDA.
The FDA assembled experts in 1991 and 1992 to evaluate implant safety. These experts were not convinced by the safety data presented by Dow Corning and three other manufacturers. The FDA Commissioner soon called for a voluntary cessation of silicone implant procedures except for reconstruction. The manufacturers agreed they would no longer supply implants and in 1992, Dow Corning pulled out of the implant business. At the end of that year, a jury linked autoimmune symptoms in a Texas woman to her ruptured implants. Lawyers and others admitted her symptoms were like a bad flu. But the jury awarded $25,000,000 against the manufacturer, Bristol-Meyers Squibb.
Dow Corning's 30-year participation in implants was over. There was pain and disease out there among implant users. Was the incidence greater than that observed among women without implants? Was the company responsible for the medical condition of the women that received its product? And would the company have a financial responsibility if it were found liable?