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Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases.

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.

journal_name

Plast Reconstr Surg

journal_title

Plastic and reconstructive surgery

authors

Srinivasa DR,Miranda RN,Kaura A,Francis AM,Campanale A,Boldrini R,Alexander J,Deva AK,Gravina PR,Medeiros LJ,Nast K,Butler CE,Clemens MW

doi

10.1097/PRS.0000000000003233

subject

Has Abstract

pub_date

2017-05-01 00:00:00

pages

1029-1039

issue

eissn

0032-1052

issn

1529-4242

pii

00006534-201705000-00001

journal_volume

139

pub_type

杂志文章

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Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases.