Silicone breast prostheses: A cohort study of complaints, complications, and explantations between 2003 and 2015.

[BACKGROUND] Complications after silicone implantation, with silicone extravasation being the most severe, remain a safety issue in breast implantation surgery. The purpose of our study was to determine the incidence of medium- and long-term postoperative complaints and complications and indications for explantation in patients with a silicone breast implant.

[METHODS] This is a retrospective cohort study consisting of patients who received silicone breast implants of the fourth or fifth generation between 2003 and 2015. Long-term outcomes (> 3 months after initial placement) were derived from medical records. The association with indication of breast surgery, method of placement, and type of reconstruction was determined.

[RESULTS] In total, 448 patients (n = 738 silicone breast implants) met the inclusion criteria with a median follow-up of 330 days. Overall, 18% of the implants resulted in postoperative complaints, with discomfort or pain being the most common complaint (12%), significantly more frequent in reconstructive cases and significantly associated with subglandular placement in cosmetically augmented breasts. Physical examination revealed in 14% one or more postoperative complications, with capsular contracture being the most common complication. A total of 12% of the implants were eventually explanted within a median time of 568 days. Predominant reasons were cosmetic dissatisfaction, capsular contracture, and pain (in 37%, 21%, and 15%, respectively). Macroscopic leakage was demonstrated in 3% of the explanted prostheses.

[CONCLUSIONS] Explantation of breast implants occurred in 12%, within a median time of 1.6 years, wherein macroscopic leakage was rarely seen. Cosmetic dissatisfaction, capsular contracture, and pain were the most common indications.