Analysis of Allergan’s Biocell Implant Recall in a Major University Breast Center

Plastic and Reconstructive Surgery, Global Open

article

Michel A. Danino¹  Lan Dao²  Meir Retchkiman¹  Edwige Matetsa²  Jessica Iezzoni²  Joseph S. Bou-Merhi¹ 

[1]Plastic and Reconstructive Surgery Department, University of Montreal Hospital Center

[2]Department of Surgery

DOI  :  10.1097/GOX.0000000000002906

学科分类：社会科学、人文和艺术（综合）

来源: Wolters Kluwer

【 摘 要 】

Background:  In May 2019, Health Canada released a national recall of all macrotextured breast implants that later became international in July 2019 regarding increasing accounts of suspected breast implant–associated anaplastic large cell lymphoma. In Canada, this recall targeted Allergan’s Biocell implants. This report presents the postmortem of this comprehensive single-center recall, which had to be undertaken in a limited time. Methods:  Four months after the beginning of the recall, the authors analyzed the transcript of meetings to characterize the team assembled during the recall. Then, to reconstruct the systemic work plan as well as the crucial steps and actors of the recall process, a chronologic table of the 5 meetings held during the recall, agendas and transcripts of every meeting, electronic correspondences, and other documents created during the recall were consulted. Results:  Between 1996 and 2018, 1260 women were affected by the recall, meaning that they received Allergan’s macrotextured implants. Ninety-two patients underwent explantation of the device or will undergo implant explantation. To this day, no patient was diagnosed with breast implant–associated anaplastic large cell lymphoma. Conclusions:  Our center’s experience highlights the utmost importance of building a national breast implants registry. We recommend breast centers to develop preestablished crisis centers and train staff to better prepare for future device recalls and minimize waste of time. Finally, we believe that implants should be identified based on the characteristics rather than their brand name.

【 授权许可】

CC BY-NC-ND