Silicone gel breast implant failure and frequency of additional surgeries: analysis of 35 studies reporting examination of more than 8,000 explants.

Abstract

Although it is well known that silicone gel breast implants (SGBIs) produce many "local" complications (i.e., pain, hard fibrous capsules, disfigurement, chronic inflammation, implant shell failure) and necessitate frequent surgical revisions, no large cohort retrospective quantitative analysis of clinical data has been reported to date, especially for the prevalence of failures and additional surgeries. Data from 35 different studies that encompass more than 8000 explanted SGBIs have now been analyzed and are reported here. Because examination of a prosthesis when explanted is the definitive method for determining shell integrity, the only studies that were used were ones that reported implant duration, the total number of SGBIs explanted, and the number of SGBIs for which shell rupture or failure ("not intact") was confirmed upon surgical removal. An exponential regression plot of data indicated a direct correlation of implant duration with percent shell failure (r2 = 0. 63 and r = 0.79 ). SGBI failure was found to be 30% at 5 years, 50% at 10 years, and 70% at 17 years. The failure rate was 6% per year during the first 5 years following primary implant surgery. ANOVA comparison of three implant age groups (mean implant durations of 3. 9, 10.2, and 18.9 years) indicated a highly significant statistical correlation of percent failure with implant duration (p < 0.001). Complications necessitating at least one additional surgery occurred for 33% of implants within 6 years following primary implant surgery. Shell failure was found to be an order of magnitude greater than the 4 to 6% rupture prevalence suggested by the AMA Council on Scientific Affairs in 1993, the 0.2 to 1.1% cited by manufacturers at that time, and the 5% rupture that was stated to be "not a safety standard that the FDA can accept."