The history of breast implants actually starts much longer ago than people realize. The first recorded attempts to artificially increase the size of breasts by inserting material under the skin were carried out prior to the 1900s. The procedure involved injecting paraffin (wax) directly into the breast to increase its volume. Infections and the formation of lumps were common side effects of this primitive technique. Poor results and serious side effects were also seen with the various other foreign materials doctors used through the first part of the 1900s. These included “natural” substances like glass, ivory, and wool as well as synthetics like polymer sponges.
Fat Transfer Makes an Early Appearance
Fat transfer was actually one of the less harmful techniques used in the early days of breast augmentation surgery. Physicians would harvest fat from another area of the patient’s body and inject it into the breast. The patient’s didn’t have an adverse reaction to the material; but their bodies did break down and absorb the fat, making the technique ineffective. Today, surgeons are using newer methods and technology for autologous fat grafting to increase breast size. However, they are still facing this same problem with re-absorption. Until this challenge is overcome, artificial implants will remain the long term solution for breast augmentation.
Silicone Enters the Scene
In the mid 1950s, silicone was used for breast augmentation injections. Tens of thousands of patients ended up with hardened and deformed breasts. Many had to undergo mastectomy as a result of serious complications. A few patients died. This disastrous role of silicone early in the history of breast implants proved to be a portent of things to come for this useful but controversial medical material.
Modern Breast Implants Emerge
Today’s breast implants consist of a flexible shell and a liquid or gel filling material. Both silicone and saline breast implants were first developed in this recognizably modern form in the 1960s. Early generations of implants had high rates of rupture and leakage due to inadequate shell thickness and other design flaws. Adverse reactions such as capsular contracture were common, leading to very poor results for many patients. Some consumer advocacy groups also claimed that silicone implants were the underlying factor in various autoimmune disorders due to leakage of the silicone into surrounding tissues.
From Silicone to Saline and Back Again
In 1992, the FDA decided to ban the use of silicone breast implants for general cosmetic use. Some silicone implants were still used for breast reconstruction in mastectomy patients. On the cosmetic surgery front, only patients enrolled in safety studies had access to these breast implant devices.
In 2000, the FDA issued its first formal approval for saline breast implants. This decision ensured that women who wanted cosmetic breast augmentation surgery had an option that was viewed as reasonably safe. Saline implants had actually been in use for several decades prior to this time for reconstruction and cosmetic purposes. However, the FDA only began closely reviewing the safety of breast implants in 1992 when the agency made the decision to limit the use of silicone implants. Saline passed muster with the caveat that physicians were required to discuss the likelihood of device failure with their patients.
In the 1990s, soybean oil filled implants were briefly available in Europe. They were discontinued by the manufacturer after a number of patients had an adverse reaction to leaked filler material. Hydrogel polymer filled implants met a similar fate in the UK after too many serious side effects were reported.
In 2006, the FDA re-approved some models of silicone gel implants. The silicone devices available from major manufacturers like Allergan and Mentor in general use today are fourth generation cohesive gel implants with a multi-layered elastomer shell. These are believed to be less prone to rupture and leakage than previous implant designs. Some patients still have original third generation silicone implants in their bodies. If these require replacement, they are switched out for a newer model.
Throughout the history of breast implants, manufacturers have focused on:
1. Creating implants that look and feel more natural
2. Reducing the rates of rupture/leakage
3. Extending the longevity of the implant
4. Limiting the risk of capsular contracture
5. Keeping anatomically shaped teardrop implants from rotating out of alignment
One of the more exciting recent advances in achieving the five goals listed above is the development of cohesive gel or “gummy bear” breast implants. These are form-stable (almost solid) silicone implants that feel squishy to the touch and retain their shape even if broken or cut. This fifth generation of implants is currently approved for use in the U.S.