Global adverse event reports of breast implant-associated ALCL

an international review of 40 government authority databases

Dhivya R. Srinivasa, Roberto N. Miranda, Arminder Kaura, Ashleigh M. Francis, Antonella Campanale, Rosaria Boldrini, Janette Alexander, Anand K. Deva, Paula R. Gravina, L. Jeffrey Medeiros, Karen Nast, Charles E. Butler, Mark W. Clemens

Research output: Contribution to journalArticle

52 Citations (Scopus)

Abstract

Background: Tracking world cases of breast implant-associated anaplastic large cell lymphoma (ALCL) is currently limited to patient registries at a few academic centers, dependent upon patient referral and case reports in the literature. The purpose of this study was to review and compare federal database adverse event reports of breast implant-associated ALCL encompassing the major breast implant markets worldwide. Methods: Federal implantable device regulatory bodies were contacted and database queries were performed for 40 countries. Demographics, device characteristics, pathology, treatment modalities, and outcomes were assessed when available. Results: For the countries queried, 363 unique cases were reported for breast implant-associated ALCL. Search terms "anaplastic" and "ALCL" were queried of the U.S. Manufacturer and User Facility Device Experience (MAUDE) database and yielded 258 unique cases as of September 2015, of which only 130 had pathologic markers performed. Implant surface was textured significantly more than smooth (50 percent versus 4.2 percent; p = 0.0001). Treatment, when reported (n = 136), included explantation [n = 125 (91.9 percent)], chemotherapy [n = 42 (30.8 percent)], radiation therapy [n = 25 (18.4 percent)], and/or stem cell transplant [n = 9 (6.6 percent)], and five deaths were reported. Conclusions: Federal reporting of breast implant-associated ALCL has limitations in providing clinical history, treatment, and oncologic follow-up. Worldwide and country-specific total and textured implant sales data are needed to determine critical incidence and prevalence analysis. International multi-institutional collaborations and centralized tissue consortiums working in concert with federal authorities are necessary to acquire accurate complete data on breast implant-associated ALCL.

Original languageEnglish
Pages (from-to)1029-1039
Number of pages11
JournalPlastic and Reconstructive Surgery
Volume139
Issue number5
DOIs
Publication statusPublished - May 2017

    Fingerprint

Cite this

Srinivasa, D. R., Miranda, R. N., Kaura, A., Francis, A. M., Campanale, A., Boldrini, R., ... Clemens, M. W. (2017). Global adverse event reports of breast implant-associated ALCL: an international review of 40 government authority databases. Plastic and Reconstructive Surgery, 139(5), 1029-1039. https://doi.org/10.1097/PRS.0000000000003233