History of Breast Implants
The 1990’s
In the early 1990s, breast implants became the subject of heated controversy as reports of women claiming their implants had seriously damaged their health became widely publicized in the media. In 1991, implant manufacturer Dow Corning lost a multi-million dollar lawsuit based on claims that its implants were the cause of a plaintiff's autoimmune disease.
In January 1992, the FDA issued a voluntary breast implant moratorium and, in April, the agency issued a ban on the use of silicone-gel filled implants for cosmetic augmentation. Women seeking breast reconstruction were still permitted access to gel implants, and some other exceptions applied.
Plastic surgeons found themselves in the middle of this controversy. Nearly 30 years of clinical experience led them to believe that implants were safe, and they sought to reassure anxious patients. Nevertheless, they recognized that manufacturers did not have adequate data to fully address some of the complex issues that had been raised. While the controversy heated up, saline-filled breast implants continued to be generally available for both breast reconstruction and augmentation.
In 1994, so-called "anatomical implants" aimed at creating a more naturally sloped breast contour, were introduced on the market. Whether such implants actually produce a more natural breast shape is still controversial.
The November 17, 2006 FDA decision follows a lengthy process in which the agency sent "approvable with conditions" letters to the two silicone breast implant manufacturers in the second half of 2005. The approvable letter stipulated a number of conditions that the manufacturers (Allergan and Mentor Corporation) needed to satisfy in order to receive FDA final approval to market and sell silicone breast implants in the United States. These letters came after an FDA advisory panel hearing in April 2005, in which the panel heard more than 20 hours of data presentations from the manufacturers and public comment.
