The first documented attempt to augment (enlarge) the breast happened 119 years ago. For the first 68 years, breast augmentation was attempted by direct injection with materials, including paraffin, fat, and free silicone. These attempts led to disastrous consequences including infection, hard breast lumps, deformity, fat absorption, fat necrosis, and chronic inflammatory reactions. Removal was difficult, sometimes leading to measures as drastic as mastectomy. After the invention of the mammogram, these injections were found to create artifacts that made cancer screening more difficult. For these reasons, direct injections of the breast were abandoned by most plastic surgeons in the US. Free silicone injections into the breast for augmentation still continued in many other countries into the latter part of the 20th century, however.
Commercially-made breast implants were first available in the US in 1958, and over 200 different implant types and designs have been made since then. Experts estimate that 60% of these were silicone gel filled implants with the exception of 1992-2006, when the FDA moratorium was in place. During this time, saline-filled implants dominated the market. Dow Corning dominated the implant market for the first 30 years, but over 15 other companies made breast implants during the 1980s.
Although Congress gave the FDA authority to regulate medical devices in 1976, breast implants had been “grandfathered in,” and few of the products underwent rigorous testing in clinical trials prior to sale on the open market. Regulation of breast implants did not occur until 1991, when the FDA asked companies to submit premarket approval applications. As a result, the implant industry was caught blind sided when the FDA demanded comprehensive data with a 90-day deadline for completion of all safety studies. [...]
Breast augmentation is the most commonly performed cosmetic surgery in the U.S. and thus the most commonly performed breast plastic surgery. Today it is crucial to be fully aware of all the risks and complications that you could run into. In breast plastic surgery, breast implants are used for cosmetic reasons or to reconstruct the breast such as after a mastectomy, to fix hereditary malformations or as part of male-to-female gender reassignment surgical procedures.
