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 journalArticleResearchpeer-review

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.

LanguageEnglish
Pages1029-1039
Number of pages11
JournalPlastic and reconstructive surgery
Volume139
Issue number5
DOIs
Publication statusPublished - May 2017

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Anaplastic Large-Cell Lymphoma
Breast Implants
Databases
Equipment and Supplies
Registries
Radiotherapy
Stem Cells
Referral and Consultation
Demography
Pathology
Transplants
Drug Therapy
Incidence
Therapeutics

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
Srinivasa, Dhivya R. ; Miranda, Roberto N. ; Kaura, Arminder ; Francis, Ashleigh M. ; Campanale, Antonella ; Boldrini, Rosaria ; Alexander, Janette ; Deva, Anand K. ; Gravina, Paula R. ; Medeiros, L. Jeffrey ; Nast, Karen ; Butler, Charles E. ; Clemens, Mark W. / Global adverse event reports of breast implant-associated ALCL : an international review of 40 government authority databases. In: Plastic and reconstructive surgery. 2017 ; Vol. 139, No. 5. pp. 1029-1039.
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title = "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.",
author = "Srinivasa, {Dhivya R.} and Miranda, {Roberto N.} and Arminder Kaura and Francis, {Ashleigh M.} and Antonella Campanale and Rosaria Boldrini and Janette Alexander and Deva, {Anand K.} and Gravina, {Paula R.} and Medeiros, {L. Jeffrey} and Karen Nast and Butler, {Charles E.} and Clemens, {Mark W.}",
year = "2017",
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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 2017, 'Global adverse event reports of breast implant-associated ALCL: an international review of 40 government authority databases' Plastic and reconstructive surgery, vol. 139, no. 5, pp. 1029-1039. https://doi.org/10.1097/PRS.0000000000003233

Global adverse event reports of breast implant-associated ALCL : an international review of 40 government authority databases. / Srinivasa, Dhivya R.; Miranda, Roberto N.; Kaura, Arminder; Francis, Ashleigh M.; Campanale, Antonella; Boldrini, Rosaria; Alexander, Janette; Deva, Anand K.; Gravina, Paula R.; Medeiros, L. Jeffrey; Nast, Karen; Butler, Charles E.; Clemens, Mark W.

In: Plastic and reconstructive surgery, Vol. 139, No. 5, 05.2017, p. 1029-1039.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Global adverse event reports of breast implant-associated ALCL

T2 - Plastic and reconstructive surgery

AU - Srinivasa,Dhivya R.

AU - Miranda,Roberto N.

AU - Kaura,Arminder

AU - Francis,Ashleigh M.

AU - Campanale,Antonella

AU - Boldrini,Rosaria

AU - Alexander,Janette

AU - Deva,Anand K.

AU - Gravina,Paula R.

AU - Medeiros,L. Jeffrey

AU - Nast,Karen

AU - Butler,Charles E.

AU - Clemens,Mark W.

PY - 2017/5

Y1 - 2017/5

N2 - 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.

AB - 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.

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DO - 10.1097/PRS.0000000000003233

M3 - Article

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EP - 1039

JO - Plastic and reconstructive surgery

JF - Plastic and reconstructive surgery

SN - 0032-1052

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