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

Abstract

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.

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

“…Only 92 patients (5.9%) in their analysis requested implant explantation or removal with replacement. 11 When comparing studies from the United States to other countries, it is important to distinguish the vast differences in market penetration of textured implants between the United States and international markets. In Canada, textured implants at one point accounted for roughly 80% of the market share.…”

“…Although numerous studies have emerged discussing the management of textured implants and several provide data on their explantation/exchange rate, there are currently no data detailing the patient's perspective or reasoning for choosing removal of the textured devices versus monitored surveillance. [8][9][10][11][12] Given the paucity of literature examining the patient's decisions, the objective of this study was to identify patient actions in response to the FDA recall of the Style 410 anatomical textured implant.…”

The Spectrum of Non-neoplastic Changes Associated With Breast Implants

“…The United States FDA found that patients with textured Biocell implants (Allergan) were associated with an increasing number of BIA-ALCL, including an increase in mortality, prompting Allergan to a worldwide recall of their Biocell textured implants and tissue expanders in July of 2019. 5,22,110,111 The current recommendation is to remove this type of implant if a patient has BIA-ALCL, but not for asymptomatic patients.…”

“…United States. 5,116 In patients with a history of breast reconstruction due to breast cancer, textured implants conferred an overall risk of developing BIA-ALCL as high as 1 in 355 women. 117…”

“…Subsequently, many reported cases have confirmed a strong association between textured breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). [3][4][5][6][7] The heightened awareness of BIA-ALCL has resulted in a greater need for the processing and histologic examination of periprosthetic capsules. We recently developed a strategy for handling and processing periprosthetic capsules from patients with suspected BIA-ALCL.…”