Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases.
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.
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Dhivya R
DR
Srinivasa
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Roberto N
RN
Miranda
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Arminder
A
Kaura
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Ashleigh M
AM
Francis
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Antonella
A
Campanale
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Rosaria
R
Boldrini
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Janette
J
Alexander
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Anand K
AK
Deva
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Paula R
PR
Gravina
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
L Jeffrey
LJ
Medeiros
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Karen
K
Nast
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Charles E
CE
Butler
Ann Arbor, Mich.; Houston, Texas; Rochester, Mich.; Silver Spring, Md.; Rome, Italy; Sydney, New South Wales, Australia; and Salvador, Brazil.|From the Department of Plastic Surgery, University of Michigan; the Departments of Hematopathology and Plastic Surgery, The University of Texas M. D. Anderson Cancer Center; the Department of General Surgery, University of Texas, Houston; the Oakland University William Beaumont School of Medicine; the Plastic and Reconstructive Surgery Branch, Office of Device Evaluation, and Product Evaluation Branch II, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; the Ministry of Health, General Directorate of Medical Device and Pharmaceutical Service, Unit V, Medical Device Vigilance System and Inspections; the Department of Plastic Surgery, Macquarie University; and the Medical School of Federal University of Bahia.
Mark W
MW
Clemens
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D018427:Breast Implants / Q000009:adverse effects*; D016208:Databases, Factual; D005260:Female; D014943:Global Health; D006801:Humans; D007391:International Cooperation; D017728:Lymphoma, Large-Cell, Anaplastic / Q000453:epidemiology / Q000209:etiology*; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology*; D011358:Product Surveillance, Postmarketing