When Dr. Bunkis and I began our careers in plastic surgery, breast implants were generally considered lifetime devices. Little thought was given to replacing implants unless problems such as capsular contracture, pain, or obvious deformity developed.
By the late 1980s, however, reports began to appear demonstrating that implants left in place for long periods would eventually rupture. While many women experienced no symptoms, the reality became clear: breast implants, like all medical devices, have a finite lifespan.
During the early 1990s, concerns regarding implant safety led the FDA to place a moratorium on the general use of silicone gel-filled breast implants. Silicone implants could still be inserted as part of large, carefully monitored FDA clinical studies. Our practice participated in these studies, and we diligently collected and submitted follow-up data on hundreds of patients.
As a result, many women during that period received saline implants, while valuable information on silicone implant safety and longevity continued to accumulate. By 2006, the FDA had gathered sufficient evidence to conclude that silicone implants did not pose a greater health risk than saline implants, and their use was once again approved for all qualified plastic surgeons.
What also became apparent from those years of research was that breast implants are not lifetime devices. Patients require periodic monitoring, and most experts now recommend considering implant exchange after approximately 15 to 20 years, ideally before rupture occurs.
Fortunately, today’s implants are dramatically improved compared to those manufactured in the 1970s and 1980s. Modern implant shells are stronger, silicone gels are more cohesive, and manufacturing standards are far more rigorous. The so-called “gummy bear” implants, for example, are designed to maintain their shape even if the shell is compromised.
