Affiliation:
1. From the Department of Plastic and Reconstructive Surgery, Shaare Zedek Medical Center; and Faculty of Medicine, Hebrew University of Jerusalem.
Abstract
Summary:
The use of breast implants is consistently on the rise owing to increases in aesthetic and reconstructive breast surgery. Implant rupture is a potential complication, the rate of which has increased over time. Therefore, implant removal or replacement is a common procedure, and needed for most breast implants at some point during the patient’s lifetime. Surgical removal of ruptured implants is messy, cumbersome, time-consuming, and, overall, unpleasant. The authors have developed a custom-made device that effectively removes a silicone implant, whether ruptured or intact. To determine its efficiency, the authors conducted a prospective clinical trial of 25 women (45 breasts) undergoing removal or replacement of breast implants with the device between January of 2019 and January of 2022. Device safety and efficiency were assessed, and the need for the device was evaluated through a survey among 25 board-certified plastic surgeons. The mean implant age was 12.8 years, and mean volume was 370 g. The mean time to extract the implant with the device was 10.7 seconds. Twenty-two implants (49%) were ruptured. There were no minor or major complications during the procedure or follow-up. The mean follow-up period was 6 months. Surgeons’ intention to use this device in their own practices for removal of intact and ruptured implants was very high. This novel device may prove indispensable for explantation of both intact and ruptured silicone implants.
CLINICAL QUESTION/LEVEL OF EVIDENCE:
Therapeutic, IV.
Publisher
Ovid Technologies (Wolters Kluwer Health)