Silicone breast implants have been around since 1962, encompassing a complicated and interesting history of device development that now spans over five decades. Between three U.S. manufacturers, a wide array of commercially available breast implant devices exist today. Saline-filled devices have not really changed over these years but silicone-based implants have undergone a significant evolution that has been described as having gone through five generations.
First generation silicone implants spanned the time period of 1962 to 1970. They had a very dense and viscous gel that was encased in a thick two-piece silicone elastomer shell held together with a seam. They were of a teardrop shape (not round) and had a patch on its back to try and hold it into place.The main complaints with their use was that they were too stiff and unnatural feeling and had high capsular contracture rates.
Second generation silicone implants spanned the time period of 1970 to 1982. The silicone gel was less viscous to produce a more natural feel. The outer implant shell was thinner, slightly permeable and had no seam. It also was round in shape and not tear drop. The thinner shells and less viscous silicone gels, however, lead to diffusion or bleeding of the gel outside of the implant shell leading to high rupture and capsular contracture rates.
Third generation silicone implants spanned the time from 1982 to 1992. A return to a more viscous gel with thicker multilayered shells was done to reduce the problem of silicone gel bleed and the device shell rupture rates. This also was the generation where the textured implant shell was introduced to help reduce the high rate of capsular contractures.
With a moratorium on breast implants imposed by the FDA in 1992, fourth generation silicone implants spanned the time period of 1993 to 2006. During this period, rigorous clinical studies and follow-up were done to produce a more cohesive silicone gel with an improved manufacturing and quality control process. This is what was finally approved by the FDA for the return of silicone gel breast implants to all plastic surgeons and any women older then 22 years of age.
Fifth generation silicone implants spanned the time period of 2006 to present day. The implant shells are essentially the same as before but the cohesive gel has a greater cohesiveness that retains it shape better in different positions. Such implants have become known as form stable and the urban term ‘gummy bear’ breast implant. Also, new textured anatomically shaped implants have become available to be used in a wider array of breast forms and chest dimensions. (2012)
Silicone breast implants have undergone consideration evolution over fifty years of clinical use. Today’s implant options are undoubtably the best they have ever been with more options the ever before. The concerns about the induction of autoimmune diseases by breast implants has been largely quelled by numerous studies that have demonstrated their safety. Outside of the U.S., no other industrialized country even uses saline breast implants and use silicone gel implants exclusively for breast augmentation.
Are today’s breast implants the best they will ever be? Undoubtably not if history is any indicator of how progress is made. A decade from now I would anticipate a whole new generation of silicone breast implants that offer new features and improved durability.
Dr. Barry Eppley
Indianapolis, Indiana