Background: Silicone breast implants have been used for decades and are arguably the most studied implantable device. However, the vast body of scientific literature has been unable to establish a definitive rupture rate. Various studies have evaluated implant rupture, but the meaningfulness of these data was confounded by the inclusion of different generations of implants and multiple manufacturers' implants and the selection of subjects who were already suspected of having ruptured implants. The authors' study was designed to acquire long-term rupture data specific to Inamed's third-generation silicone breast implants using magnetic resonance imaging technology.
Methods: A total of 106 women with at least one Inamed silicone breast implant (styles 40, 110, and 120) were enrolled in this multicenter, cross-sectional study. The majority received implants for cosmetic augmentation (n = 77, 72.6 percent), with a smaller number having undergone breast reconstruction (n = 11, 10.4 percent) or revision of previous breast implant operations (n = 18, 17.0 percent). Most subjects were Caucasian (n = 99, 93.4 percent) with a median age at implantation of 34 years (range, 18 to 70 years). Enrolled subjects underwent a physical examination and magnetic resonance imaging screening at one of five sites to determine the prevalence of asymptomatic rupture.
Results: A total of 199 implants were evaluated, with a median implantation time of 10.9 years (range, 9.5 to 13.2 years). Overall, 183 implants (92.0 percent) showed no evidence of rupture, 12 (6.0 percent) showed evidence of rupture, and four (2.0 percent) were indeterminate. All indeterminate evaluations were considered ruptures, providing a worst-case rupture prevalence of 8.0 percent.
Conclusion: The study results establish a rupture prevalence rate of 8.0 percent at 11 years for Inamed's silicone breast implants.