Patient Decision-Making for Management of Style 410 Anatomical Implants in Breast Reconstruction

Abstract

Background: In July of 2019, the U.S. Food and Drug Administration (FDA) recalled the Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Textured Breast Implants because of a heightened risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The objective of this study was to describe patient decision-making in management of preexisting 410 textured implants. Methods: A single-institution retrospective chart review was conducted to determine all patients who received 410 anatomical implants from two surgeons. Patients who received these implants were contacted in July to September of 2019 regarding the FDA recall and asked to schedule a consultation to discuss explant/exchange versus surveillance. Outcomes analyzed included decision of surveillance versus explantation and subsequent reconstructive operations. Results: Eighty-nine patients had received 410 implants from 2013 to 2017. Of the 147 breasts that were reconstructed, 58.5% were oncologic mastectomies and 41.5% were prophylactic. The majority of patients (71.9%) cited BIA-ALCL as the predominant influencing factor in their decision for management. Other factors included appearance, implant concerns unrelated to BIA-ALCL, and other medical conditions. Twenty patients (22.5%) underwent explantation of the Style 410 implants. The remaining 77.5% of patients elected for monitored surveillance. There was a significant association between a history of breast cancer and explantation of the Style 410 implants (P = 0.0335). Conclusions: The majority of patients with Style 410 textured implants elected to undergo surveillance for BIA-ALCL. When deciding to explant or exchange the Style 410 implants, plastic surgeons should work in conjunction with their patients to carefully outline management options.