History of Breast Implants
Invention, controversy and eventual FDA approval
The history of silicone-gel-filled implants and breast augmentation in general is fraught with trials (literally) and errors (some life-threatening).
Surgeons have been trying to enlarge breasts since the 1890s. At that time, doctors injected paraffin wax into the breasts to enlarge them. To say it didn't work is an understatement. This practice resulted in infections, migration of the wax to other parts of the body and hard lumps in the breasts. Still, paraffin wax injections for breast augmentation were en vogue for almost 30 years.
The next fad in breast augmentation came later in the 20th century, when surgeons began attempting to extract fat from elsewhere in the body and inject it into the breasts. This procedure was (and is still) known as fat transfer breast augmentation. After decades of controversy and concern, this practice is now falling back into favor. Surgeons are perfecting their techniques, and fat-grafting may one day have a role in cosmetic breast augmentation. For now, the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery state that fat injections to the breast can be used to enhance breast appearance after reconstruction or to soften the appearance of implants. The groups do not yet recommend fat injections to the breast for cosmetic augmentation.
Liquid Silicone Injections
In the 1940s, women (most notably prostitutes and exotic dancers in Japan) started having liquid silicone oil injected into their breasts. This was another trial that ended in grave error. The liquid silicone migrated all over the body, causing granulomas (small areas of inflammation in tissue due to injury). Some women also developed chronic inflammation and organ damage as a result of these injections. Making matters worse, some injections were carried out using unsanitary, industrial-grade silicone. The side effects were so bad that the FDA banned all silicone liquid injections. Despite its checkered history, liquid silicone for cosmetic enhancement is still actively sought on the black market.
The Invention of Breast Implants
The first silicone-filled implants were developed in 1961, and were marketed in 1963. These breast implants consisted of a shell made of silicone elastomer or other material and were filled with silicone liquid. The shell kept the silicone in one place and helped create a breast-like shape, something the injections were not always able to do. Saline-filled breast implants soon followed.
Breast implants did not become popular overnight. The results were often unnatural looking, and many women developed capsular contracture (scar tissue around the implant), a side effect still relatively prevalent today. The next generation of implants were made with polyurethane foam shells, in an effort to reduce the risk of capsular contracture, but these were later found to break down into known carcinogens in animals.
At the time breast implants were first marketed, the FDA did not review medical devices. When the FDA was given authority over medical devices in 1976, breast implants were "grandfathered" in; i.e., breast implant manufacturers were not required to submit their products to a safety review.
Medical devices are categorized into three regulatory categories.
Class I: Simple devices with minimal risks that can be controlled by labeling or during manufacturing.
Class II devices: Devices for which additional measures — such as performance standards, post-market surveillance studies, and/or consumer education — are needed to control risks.
Class III: Devices with poorly established or questionable safety profiles. The manufacturer of a Class III device has to conduct additional studies to show it is safe and effective before it can be marketed.
Breast implants were originally categorized as Class II devices, but were recategorized as Class III in 1988 after reports about adverse reactions.
Silicone-Filled Implants on Trial
In the 1970s and 1980s, implant makers came up with silicone-filled implants that had thinner shells. These implants looked more natural but were more likely to rupture and leak. It was discovered that silicone gel was leaking out of the implant shells in the 1980s. The gel migrated into the pocket containing the implant and, occasionally, into other areas of the body. Many women with these implants seemed to develop autoimmune diseases and connective tissue diseases such as lupus and arthritis, and several class action lawsuits followed. Manufacturers had to pay out millions of dollars in damages as a result of these lawsuits.
The controversy went on for years with different groups and different studies voicing different opinions and coming down on different sides. In 1991, the FDA asked implant manufacturers to submit evidence that silicone-gel-filled breast implants were safe and effective. The manufacturers were unable to provide such information at that time, and the FDA opted not to approve the implants.
Instead, in January 1992, the FDA called for a voluntary moratorium on the sale and use of silicone breast implants. Later that year, the agency lifted the moratorium, but stated that silicone-gel-filled breast implants should be available only for women seeking breast reconstruction after breast cancer treatment or revision of an existing breast implant. Implant makers were instructed to conduct studies on complications and safety in women who received the implants under these restrictions. Access to silicone-gel-filled breast implants was restricted for 14 years.
During this time, saline-filled breast implants were marketed with no interruption. They were not widely used until the FDA cracked down on silicone implants. In 1993, the FDA told saline implant manufacturers that they must supply the agency with safety and effectiveness data. In 1999, the agency approved saline-filled implants from Mentor Corporation and McGhan Medical (a company that has since been bought by Allergan).
Also in 1999, the Institute of Medicine concluded that silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, but they do not cause systemic diseases such as lupus or rheumatoid arthritis.
All Eyes on the FDA
In November 2006, the FDA approved the sale of two brands of silicone-filled breast implants. Allergan received approval to market its Inamed® Silicone-Filled Breast Implants and Mentor Corporation received approval to market its Mentor MemoryGel™ Silicone Gel-Filled Breast Implants.
In 2011, five years after the re-approval of silicone gel-filled breast implants, the FDA released an interim safety report that said these implants remain relatively safe, but were not meant to last a lifetime. The FDA is requiring both manufacturers to continue studies of these implants and to keep track of their implants so if problems develop, the women who received them can be easily notified.
In 2012, the FDA gave its nod to Sientra's portfolio of Silimed-brand silicone gel breast implants. The company plans to offer implants in multiple shapes and sizes. As part of the approval, Sientra, like Allergan and Mentor, must follow women who have received their implants to make sure they are safe.
Several implant makers are now studying silicone-filled implants that contain a more viscous gel. These cohesive implants have been nicknamed "gummy bear" implants because their thickness comes close to that of the gel candies. The main benefit of gummy bear implants is that the gel doesn't migrate if the implant ruptures. These implants are currently available everywhere but the United States.
For more information on the history of silicone breast implants, check out our timeline.
The Fall and Rise of Silicone Breast Implants
The FDA states that breast implants are relatively safe, but removal/replacement may be needed within 10 years.
They're back. FDA re-approves silicone breast implants. They are now available outside of clinical trials after a 14-year hiatus.
The FDA deferred action and determined that the PMA for Inamed Corp.'s silicone gel-filled breast implant is "not approvable," calling for additional information.
FDA reviews Inamed Corp.'s silicone breast implant pre-market application (PMA)
Saline breast implants receive formal FDA market approval
FDA issues breast implant risk info booklet
Global Settlement talks begin with manufacturers
FDA issues moratorium on silicone gel breast implants; use of silicone implants restricted to breast reconstruction and clinical studies
Congress gives FDA authority to regulate medical devices; pre-existing devices grandfathered pending further evaluation
Breast implants introduced
Adapted with permission from the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons