The impact of Allergan implant-related issues on patients with breast implants for reconstruction

Abstract

In August 2019, the Ministry of Food and Drug Safety and the Korean Soci ety of Plastic and Reconstructive Surgeons confirmed the first case report of breast im plant-associated anaplastic large cell lymphoma (BIA-ALCL) in Korea and provided rec ommendations. This study was conducted to evaluate the impact of the first case re port of BIA-ALCL on patients and whether the impact could be mitigated through ex pert recommendations. Methods A retrospective chart review was performed of patients who underwent im plant-based breast reconstruction using Biocell textured breast implants at Soonchun hyang University Hospital. After the first case report of BIA-ALCL and informing the pa tients via text messages, the pattern of outpatient visits and the proportion and indica tions of outpatient office visitors who received reoperations were analyzed. Results After the first BIA-ALCL case report in Korea, 12 patients underwent reopera tions due to other complications identified incidentally, while only three patients un derwent prophylactic surgery. Among the patients who underwent reoperation after the Allergan issues, 76.7% received implant exchange. There was no significant differ ence in the proportion of reoperation types before and after the Allergan issues and the transmission of text messages (P=0.700). Conclusions Despite the major issues, outpatients were managed successfully accord ing to our recommendations. The study found a low rate of regular outpatient visits; however, our efforts increased this rate. Therefore, methods for appropriate informa tion delivery are needed for outpatient visits, as well as a system for regular monitor ing. As experts, plastic surgeons should provide responsible leadership in this situation to relieve patients’ concerns