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A History of Breast Implants

In November 2006, the U.S. Food and Drug Administration (FDA) approved silicone gel-filled breast implants for sale in the United States. Two brands of silicone-filled implants have been approved, the Mentor MemoryGel™, made by the Mentor Corporation, and the Inamed ® Silicone-Filled Breast Implants, made by Allergan.

A Short History of Breast Augmentation

The history of silicone gel-filled implants—and breast augmentation and breast implants in general—has been bumpy. Surgical attempts at enlarging the breasts have been made since the 1890s. At that time, doctors injected paraffin (candle wax, basically) into the breasts to enlarge them. This resulted in disastrous infections, migration of the paraffin to other parts of the body, and ugly hard lumps in the breasts. Still, it took until the 1920s for people to stop using paraffin to enlarge the breasts. In the early 1900s, there were a few reports of surgeons inserting glass or ivory balls into the breasts to expand them

Then, surgeons attempted to take pieces of fat from elsewhere in the body and insert them in the breasts. That failed, since the body would reabsorb the fat, but do so in a way that created lumps. Adding insult to injury, the scars from where the fat was taken and from where it was inserted were unattractive.

In the 1940s, women (notably Japanese prostitutes and exotic dancers) started having liquid silicone oil injected into their breasts. The silicone liquid behaved sort of like natural breast tissue, but since nothing was keeping it in the breast area, it migrated all over the body, where the body would react to it by forming granulomas, which are a mass of granulation tissue that the body forms around infections and foreign bodies. Women suffered chronic inflammation and organ damage. Worse, sometimes the people performing the injections (who were not always physicians) used unsanitary industrial grade silicone. The side effects were so bad that the FDA banned all silicone liquid injections, whether they were medical grade or not.

At the same time, several companies were attempting to come up with some method or device that could enlarge the breasts. Sterile sponges were used for a time and looked good at first, but then scar tissue formed around the sponge and the breast shriveled and hardened.

Breast Implants Are Developed

The first silicone-filled implants were developed in 1961 and were marketed in 1963. These consisted of a shell of silicone elastomer or other material that was 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. Within the next years, implants filled with saline were developed.

Although implants were available, their use at that time was relatively rare because the results were often not very natural looking. Many women with early breast implants developed capsular contracture, where the body formed a hard shell of scar tissue around the implant. When this happens, the breasts become hard and possibly misshapen; sometimes, the contracture was painful. In an attempt to prevent capsular contracture, some implants were made with shells of polyurethane foam, a product that was 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 and did not need an FDA review for safety. Medical devices are categorized into three regulatory categories. Class I devices are usually simple devices with minimal risks that can be controlled by labeling or during manufacturing. Class II devices are more complicated and additional measures (called controls) are needed to control risks. Controls may include performance standards, post-market surveillance studies, user education, or other measures. If there is no information about whether a device is safe and effective, it is put into class III, and the maker has to conduct studies before it is marketed to show its safety and effectiveness. Class III devices includes devices that have poorly established or questionable records of safety and effectiveness.

Breast implants were originally categorized as Class II devices and then were recategorized as Class III devices in 1988, after there were reports about adverse reactions.

Silicone-Filled Implants

In the 1970s and 1980s, implant makers came up with silicone-filled implants that had thinner shells, which made them more natural looking when implanted, but also made them prone to rupture and leakage. In the 1980s, it was found that silicone gel was leaking out of the implant shells. The gel was found to have migrated into the pocket containing the implant, and occasionally, elsewhere in the body.

During the 1980s and 1990s, more reports surfaced of women developing autoimmune diseases and connective tissue diseases after they had breast augmentation with silicone implants. Many women brought lawsuits against implant makers because of these claims and because implants ruptured. Several class action lawsuits were won and manufacturers had to pay out millions in damages. However, the implant makers won many lawsuits as well.

Many diseases—notably autoimmune disorders and connective tissue diseases—were linked in the popular media with implants, but no epidemiology studies had been done. In 1991, an advisory panel to the FDA concluded that there was no evidence that gel-filled implants were unsafe, but that there was not enough evidence to prove that they were safe. In 1995, the American College of Rheumatology, the medical organization for physicians who treat bone and connective tissue disorders issued a statement saying that there was compelling evidence that breast implants did not cause systemic disease. That same year, a large epidemiology study was published that found no increased risk of connective tissue disease or in women with silicone implants. In 1997, the American Academy of Neurology reported that there is no link between implants and nerve disorders.

In 1991, the FDA asked implant manufacturers to submit evidence that silicone gel-filled breast implants were safe and effective. However, the manufacturers were unable to provide the FDA with this information. Because there was not enough data on safety and effectiveness, the FDA determined that silicone gel-filled breast implants could not be approved.

In January 1992, the FDA called for a voluntary moratorium on the sale and insertion of silicone breast implants. Later that year, the agency lifted the moratorium but decided that silicone gel-filled breast implants should be available only for women seeking breast reconstruction (such as after a mastectomy) 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.

In 1999, the Institute of Medicine, a part of the nongovernmental National Academy of Sciences, issued a 400-page report from an independent committee that concluded that, although silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, they do not cause systemic diseases such as lupus erythematosus or rheumatoid arthritis. Congress had asked the Institute to set up the committee, which examined findings from earlier research and conducted public hearings.

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.

However, the FDA is requiring both manufacturers continue their long-term studies of women who received the implants before 2006 and to conduct a 10-year post-approval study that will involve 40,000 women. This is a very large population for a medical study. The study will evaluate complications; rates of connective tissue disease; rates of neurological disease; potential effects on offspring of women with breast implants; potential effects on reproduction and breastfeeding; rates of cancer; rates of suicide; potential interference of breast implants with mammography; rates of rupture, and patient compliance with the recommendation for regular magnetic resonance imaging (MRI). The makers must also keep track of all the implants they make, so that if any implants or specific factory lots of implants have problems, the women who received them can be notified.

During the time of this upheaval for silicone-filled implants, saline-filled breast implants were marketed with no interruption, although they were not widely used until after the sales of silicone-filled implants were restricted. They were not subject to the moratorium or the strictures on sales that affected silicone-filled implants. In 1993, The FDA told makers of saline implants that they must supply the agency with safety and effectiveness data. In 1999, the FDA approved saline-filled implants from Mentor Corporation and McGhan Medical, a company that has since been bought by Allergan.

More recently, studies have indicated that silicone-filled breast implants do not increase a woman’s risk of breast or other types of cancers. Researchers came to this conclusion after an in-depth review of numerous large-scale, long-term studies on the safety and risks of silicone breast implants from around the world.

Current Status of Cohesive Silicone Breast Implants (“Gummy Bears”)

Several implant makers are developing silicone-filled implants that contain a thicker silicone gel. Instead of being a thick liquid, these gels are more like a soft solid, almost approaching the consistency of gelatin or custard. Cohesive implants have been nicknamed “gummy bear” implants because thickness comes close to that of the gel candies.

If you were to cut a pie slice from a cohesive silicone breast implant it would not leak. The gel would stay within the shell even if the shell were to rupture. The greater thickness of a cohesive silicone gel is due to more cross-links between the molecules of silicone, which makes a more cohesive solid.

Both Mentor Corporation and Allergan refer to the gel used in their approved implants as cohesive. However, both companies are developing even more cohesive (“highly cohesive”) implants. Investigational studies have started in the United States of cohesive implants made by Mentor, Allergan, and Silimed, a Brazilian company. A small number of surgeons are taking part in these clinical trials.

The downside to firmer implants is that they must be inserted through a larger incision.