Characterizing Patient Decisions and Subsequent Operations in Individuals with the Style 410 Anatomic Implants
Carter J. Boyd, Ara A. Salibian, Jonathan M. Bekisz, Nolan S. Karp, Mihye Choi
Hansjörg Wyss Department of Plastic Surgery, NYU Langone, New York, New York
Background: In July of 2019, the Food and Drug Administration (FDA) recalled the Allergan Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Textured Breast Implants (Allergan, Santa Barbara, CA, USA) for heightened risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Plastic surgeons assumed the role of educating and counseling their patients in relation to this type of implant and the risk for developing BIA-ALCL. Given the paucity of literature examining patient decisions regarding surveillance versus explanation, the objective of this study was to characterize patient behavior in relation to the recall.
Methods: An IRB approved retrospective chart review was conducted to assess for all patients receiving the 410 anatomic implants from two surgeons. Out of 90 patients identified with Style 410 implants for breast reconstruction. Office staff in July-September of 2019 notified patients of the FDA recall of the 410 implants and asked patients to schedule a consultation to discuss explant/exchange versus surveillance. Patients were followed longitudinally to assess for subsequent reconstructive operations. Descriptive statistics and Student’s t-tests were used where appropriate.
Results: Average patient age was 53 ± 11.5 years. Of patients receiving breast reconstruction with Style 410 implants, 60 (66.7%) patients underwent bilateral reconstruction, while the remaining had unilateral reconstruction (33.3%). For 72.2% of patients, consultation regarding the 410 implants predominantly surrounded the risks/benefits of BIA-ALCL. In the remaining patients, cosmesis (n=7), implant concerns unrelated to BIA-ALCL (n=5), other medical conditions (n=2), and unknown reasons (n=11) were the primary factors influencing the patient’s decision. Twenty (22.2%) patients had subsequent operations to explant the 410 implants, 5 of which had their explanation prior to the FDA recall. Seventeen (85%) of these patients had concurrent exchange of the implants to smooth round implants. Three (15%) patients did not have implants subsequently placed after explanation. Of those undergoing explantation, 10 (50%) cited concern for BIA-ALCL as the primary reason. Age was not significantly different between patients who chose to explant their 410 implants compared to women electing for surveillance (50.3 vs. 53.8 years; p=0.117). In patients undergoing implant exchange, newly placed implants were on average 33.5 cc larger.
Conclusions: The majority of patients have elected to undergo surveillance for BIA-ALCL. Plastic surgeons should work in conjunction with their patients to carefully outline the risks and benefits of all possible options and provide thorough education on BIA-ALCL.
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