What is breast augmentation?

Breast augmentation is a means for a woman to increase the size of her breasts. Usually this is done by surgically implanting artificial breasts, but recently there is an increased interest in using a person's own fat or stem cells to create a breast made from one's own tissue. Current implants are made with a silicone rubber shell and are filled with either silicone gel or saline (salt water). Each type of implant can come in a variety of sizes and shapes, as well as surfaces such as smooth or textured. The choice of which implant to use is an individualized one and will be made in consultation with the surgeon after regarding such factors as size desired, the anatomy of the patient's chest and natural breasts and other technical factors which will influence the surgeon. The FDA currently has approved two companies to make and sell implants in the USA: Mentor and Allergan, the latter selling under the Naturelle name. This does NOT mean that the devices are FDA approved! How can that be? The FDA was created originally to create safety for food, then years later for drugs and finally in 1976 for devices. At that time, breast implants had already been on the market for several years, apparently without ill-effect. So, the FDA allowed the devices to continue on the market without the scientific studies they usually required to prove devices safe and effective, a process called grandfathering. When controversy arose over the gel implants in the early 1990's, the FDA issued a moratorium on such devices, allowing them to be implanted only under very restricted terms. This moratorium lasted until just a few years ago. There are still restrictions/conditions on the use of gel implants predominantly related to the concern that if they rupture, the gel might cause problems. Because saline implants do not contain gel, there is less concern regarding these types of implants but NONE of the implants have ever been approved by the FDA!