Although there were many attempts at breast augmentation using everything from wax to fat to sponges to direct injections of silicone, modern breast augmentation really begins in 1961 with the invention of the silicone breast implant. Two plastic surgeons from right here in Houston, Texas developed it while working with Dow Corning Corporation. The breast implant is a silicone envelope filled with silicone gel. The first woman received an implant in 1962. Saline implants were invented a couple of years later in France. Breast implant sales, however, remained slow until the 1980s. There was a boom in popularity and nearly 1 million implants were sold between 1980 and 1990, a majority of them being silicone implants.
FDA and Safety Standards
At this time, no safety standards were in place. In fact, the Food and Drug Administration (FDA) did not require that silicone breast implant manufacturers demonstrate their implants were safe until 1991. Saline implant companies did not have to prove their implants were safe until 2000.
As a result of reports (and lawsuits) claiming women were getting sick after receiving silicone breast implants, the FDA issued a temporary moratorium on their sale for breast augmentation. Between 1992 and 2006, silicone implants were restricted to clinical trials. The goal was to allow the FDA to study the implants and determine whether there was a connection between them and breast cancer, connective tissue disorders, or autoimmune disorders.
Approval at Last
Silicone breast implants were approved by the FDA for the first time in November of 2006. The FDA found no evidence to suggest that silicone breast implants were connected to cancer or any systematic disorders. They found no evidence suggesting silicone breast implants posed any risk to breastfeeding infants.
In short, they found no reason to suggest that silicone breast implants posed any serious health risks, so they lifted the moratorium and allowed the general sale of silicone breast implants. However, they are continuing to register breast implant recipients for participation in a large study.
If you are considering a breast augmentation, please contact board-certified Houston plastic surgeon Dr. Lapuerta for more information or to schedule a consultation. We serve patients in the Houston, Texas area.