The Silicone Gel Implant Moratorium [Part 3 of 5]

In the spring of 1992, thirty years after the development of the silicone gel breast implant, Dr. David Kessler the head of the FDA placed a moratorium on the use of the silicone gel implant. This decision occurred despite the fact that FDA expert panels were unable to find any casual link to illness. Despite the ruling, silicone implants were released and allowed only for those women needing reconstruction after breast cancer. For all but two manufacturers, the decisions came too late. The firestorm of litigation and increasing awards based on vague “silicone induced” autoimmune disorders had caught hold. A jury in Texas where the silicone gel breast implant was born awarded over $55 million in damages in one single verdict. Just one year after the moratorium on the silicone gel breast implant was imposed; there were over 12,000 lawsuits against Dow Corning alone. By the spring of 1994, a group of companies tried to form a fund or global settlement to cover the multitude of suits regarding questions about the silicone gel breast implant in order to provide a settlement for individuals without question of any illness or cause. Despite all, the firestorm raged and by spring of 1995 Dow Corning filed for bankruptcy, with over 20,000 pending lawsuits. The human side to this tragedy is that many women believed that they had become ill from silicone gel implants. Vague flu like symptoms, aches, malaise, and fear complicated many women’s lives. There was no science which supported the relationship, but to very many the symptoms became real, and with the assistance of internists, rheumatologists, and others, plastic surgeons were left to guide and support their patients. Countless hours were spent discussing what was truly known, and many more removing implants for better or worse. The bonfire of litigation spread to the giant Dow Chemical, the parent company of Dow Corning, but as the legal battle raged, the medical community turned the silicone gel breast implant into the most studied medical device that the world has known.