Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants Journal Article


Authors: Cordeiro, P. G.; Ghione, P.; Ni, A.; Hu, Q.; Ganesan, N.; Galasso, N.; Dogan, A.; Horwitz, S. M.
Article Title: Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants
Abstract: Background: The risk of BIA-ALCL for patients with textured breast implants has been estimated between 1/2832 and 1/30,000 women. Existing studies estimating the numbers exposed and at risk, may have under reported cases, and/or lacked comprehensive follow-up. Our objective is to determine the risk of BIA-ALCL in a defined cohort of patients reconstructed with macro-textured breast implants and consistently followed long-term. Methods: A prospective cohort study was conducted in patients who underwent breast reconstruction by a single surgeon at Memorial Sloan Kettering Cancer Center (MSKCC) from December 1992 to December 2017. Major events related to implants were prospectively recorded. We identified cases of BIA-ALCL by cross-checking clinical, pathology and external records data. Patients were followed until lymphoma occurrence or last follow-up. The primary outcomes were incidence rate per person-years and cumulative incidence. Results: From 1992 to 2017, 3546 patients underwent 6023 breast reconstructions, mainly after breast cancer removal, or contralateral prophylactic mastectomy, using macro-textured surface expanders and implants. All reconstructions were performed by a single surgeon (PGC). Median follow-up was 8.1 years (range, 3 months – 30.9 years). Ten women, 1/354, developed ALCL after a median exposure of 11.5 years (range, 7.4–15.8 years). Overall risk of BIA-ALCL in our cohort is 1/355 women or 0.311 cases per 1000 person-years (95% CI 0.118 to 0.503). Discussion: This study, the first to evaluate the risk of macro-textured breast implants from a prospective database with long term follow-up, demonstrates that the incidence rate of BIA-ALCL may be higher than previously reported. These results can help inform implant choice for women undergoing breast reconstruction. © 2020 British Association of Plastic, Reconstructive and Aesthetic Surgeons
Keywords: adult; cancer chemotherapy; aged; cancer surgery; major clinical study; cancer risk; positron emission tomography; follow up; cancer incidence; prospective study; breast cancer; cohort analysis; breast reconstruction; graft necrosis; histology; axillary lymph node; lymphoma; seroma; cellulitis; prophylactic mastectomy; clinical outcome; anaplastic large cell lymphoma; pectoral muscle; human; female; priority journal; article; internal mammary lymph node; breast implant rupture; breast radiotherapy; bia-alcl; macro-textured
Journal Title: Journal of Plastic Reconstructive and Aesthetic Surgery
Volume: 73
Issue: 5
ISSN: 1748-6815
Publisher: Elsevier Science, Inc.  
Date Published: 2020-05-01
Start Page: 841
End Page: 846
Language: English
DOI: 10.1016/j.bjps.2019.11.064
PUBMED: 32008941
PROVIDER: scopus
PMCID: PMC7247945
DOI/URL:
Notes: Article -- Export Date: 1 July 2020 -- Source: Scopus
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MSK Authors
  1. Steven M Horwitz
    645 Horwitz
  2. Peter G Cordeiro
    283 Cordeiro
  3. Qun Ying Hu
    27 Hu
  4. Ahmet Dogan
    455 Dogan
  5. Natasha   Galasso
    40 Galasso
  6. Ai   Ni
    99 Ni
  7. Nivetha Ganesan
    48 Ganesan
  8. Paola Ghione
    74 Ghione