Breast Implants: A Brief History
The first known breast implant was in 1887, using tissue from the patient’s opposite breast. This was further expanded in 1893, but abandoned shortly thereafter because tissue loss to the recipient was significant. Paraffin injections began around 1889 with good short term results but in the long term, resulted in significant medical issues. Subsequently, in the early 1900s various substances were placed in the breast: rubber, glass, ivory, sponges and even foam. These materials proved to be failures and were abandoned.
In the 1950s and 1960s silicone injections increased in popularity especially after WWII. Free liquid silicone was injected into the breast, but over time severe complications arose, requiring mastectomy.
Breast implants as we know them today comprise a firm outer silicone shell and silicone gel interior. This new concept was derived in the 1950s from a urological implant and prompted the development of the new form of breast implants in 1963. This, largely developed by Dow Corning, was termed the first generation breast implant.
After the release of these implants, surgeons gave constant feedback which prompted the creation of thinner silicone outer shells and less firm inner compositions- resulting in a softer feel. This second-generation thin shell too often resulted in “gel bleed”, which in turn caused capsular contracture with similar rates as seen years earlier with free liquid silicone. The third generation silicone breast implants evolved in the 1980s and gave rise to a firmer outer shell which is used today. In 1987, a fourth generation came, with a textured silicone outer covering in the hopes of reducing capsular contracture. In 1993, the fifth –and most current- generation arrived, with a cohesive inner gel producing a low gel-bleed implant. Since the first implant, there have been over 240 styles and 8,300 models of silicone breast implants.
Saline breast implants first appeared in French literature in 1965. The concept of this implant was a silicone shell that could be filled with water. Over the years, their problems of valve leak, deflation, and wrinkles have been lessened, and they maintain great popularity to date.
Government regulation and class-action litigation caused the US Food and Drug Administration (FDA) to call for a general withdrawal of silicone gel-filled implants in 1992. Silicone implants were changed from a Class 2 to a Class 3 device by the FDA, describing “a potential unreasonable risk of illness or injury”. However, the FDA went on to explain that silicone breast implants are not necessarily unsafe, but rather that more data is needed before a final determination. Nevertheless, the market took this as a ban on silicone breast implants and many lawsuits erupted- including a class action settlement of $4 billion. This ruling caused many breast implant manufacturers to close shop. Much ongoing breast implant technology was lost. The Medical Devices Amendment Act made clear that subsequent silicone breast implants would undergo extensive pre-market approval, or be similar to the currently used breast implants.
In late 2009, the data from 10 years of research performed by the only two remaining silicone implant companies, and the physicians who participated in the studies, was complete. These multiple studies unanimously concluded that silicone breast implants did not cause the immune complex diseases for which they were blamed during litigation. Silicone breast implants are proven to be very safe and are again very popular. Breast augmentation is today the number one cosmetic surgery performed in the United States.