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. (C) 2018 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.