Silicone Breast Implants on Trial and the Advent of ‘Junk Science’ [Part 2 of 5]

As we continue to look back at the amazing history of the silicone gel breast implant, it seemed that by the 1980’s we had the ideal solution at hand for augmentation and reconstruction of the breast. Though implant rupture might require a second surgery for removal, and implant hardening was a problem for some, there were few safely concerns. As the implants had now been on the market for nearly thirty years, it seemed an unnecessary effort to collect the scientific data that the FDA asked for in 1988. By 1990, there were several manufacturers with a wide choice of implant sizes and styles. However, companies and surgeons began to collect and submit the data and studies to the FDA by the hundreds. Over the past decades, the number of silent implant leaks and ruptures were growing and everything changed for plastic surgeons in December of 1990. Many of us have recollections of where we were the night when ‘Face to Face’ with Connie Chung aired, raising the fears about the dangers of silicone gel breast implants, exposing her own unhappy experience and those of others. The level of national awareness went to an all time high with images of leaking ‘goo’ in the media and rising health concerns. Still despite the data collected, we could find no health problems or cancer links to the silicone gel implants, though questions arose -- could the implants be proven to be safe? By the next year, the FDA assembled a panel of experts from all areas of medicine and material experts, including toxicology, immunology and oncology as well as plastic surgeons, to review all the data available. That same year what the FDA panel was not able to find, a link between silicone gel implants and any human illness, trial lawyers in Alabama did. According to plaintiffs’ experts, an individual with breast implants had developed an autoimmune condition caused by the implants. Actually this was the second such case where “experts” introduced a theory that silicone gel somehow affected the immune system causing illness. Thus “junk science” the ability to introduce scientific theory as fact in order to receive financial compensation was established in U.S. courtrooms. In short order, hundreds of lawsuits were filed against both surgeons and implant manufacturers, and by 1992 silicone gel breast implants were voluntarily withdrawn for use. Left with only saline breast implants, we held our breath and waited. And just when things looked very dark indeed, they became darker. More to come.