Breast Augmentation Today: Saline versus Silicone—-What Are the Facts?

Abstract

Controversy breeds excitement, and the epic saga of breast prosthesis in the United States has been no exception. In 1992, U.S. plastic surgeons began what can be considered an experiment. With new U.S. Food and Drug Administration restrictions, saline breast implants became the only option available to patients seeking breast augmentation surgery. This restriction spanned the course of almost 15 years. Initially, when we treated patients desiring breast augmentation, we were hopeful that one day silicone implants would be available again to provide our patients with a variety of options and choices. In 2006, the experiment ended as the Food and Drug Administration approved silicone implants for general clinical use in breast augmentation. A vociferous buzz surrounding silicone implants ensued, resulting in new interest and questions from our patients. With the promise of “new cohesive gels” and better durability, the floodgate was opened, and many of us have again embraced the use of silicone gel implants for breast augmentation. A recent survey conducted by the American Society of Plastic Surgeons revealed that the majority of responding members felt that many primary augmentation patients would return to exchange their saline implants for silicone implants.1 Further, members anticipated that more than 60 percent of future primary augmentation candidates would request silicone implants.1 Underneath all of this enthusiasm, have we found ourselves “back to the future”? If it were not for the health concern controversies surrounding silicone implants, which have been largely unsubstantiated in the scientific literature, it is conceivable that saline implants would never have been thoroughly investigated in the United States. The controversies led to multicenter trials and Food and Drug Administration endorsement of the safety of saline implants.2 With the reintroduction of silicone implants, comparisons between silicone and saline are inevitable. Although there is an abundant amount of general data concerning silicone implants, the relative brevity of follow-up for the current silicone implants approved recently by the Food and Drug Administration makes the analysis between saline and silicone implants unbalanced. We are now told about the “new generation” of silicone gel implants, but long-term data are not yet available. Although the current data are alluring, we must remember a straightforward fact: the data from the latest generation of silicone implants are approximately 3 to 4 years old. As physician and scientists, we know that long-term, verified, scientific knowledge is needed on potential changes in the contracture and rupture rates of these implants. One advantage of the moratorium on silicone implants was the long-term collection of data on saline implants. This data collection period spanned more than 15 years in the United States, and the information gathered substantiated that saline implants are safe and effective in our patients. Despite the uncertainty of outcomes with silicone implants, a plethora of data exists. What are the data and what should we discuss with our patients in consultation? The data we currently have are less than clear. With regard to rupture rates, studies have shown an 8to 13-year average for silicone implants; corporate data also cite a 0.5 to 3 percent 3to 4-year rupture rate.3–6 In their 2006 study, Heden et al.5 found that the rupture rate was 8 percent for silicone implants; this was contrasted with a rupture rate of 4.3 percent for saline implants,7 which increased with variance in time (Table 1). At 10 years, third-generation silicone gel implants are projected to maintain integrity at a rate of 83 percent to 85 percent; this estimate,