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Breast Implant Informed Consent Should Include the Risk of Anaplastic Large Cell Lymphoma

Clemens, Mark W. M.D.; Miranda, Roberto N. M.D.; Butler, Charles E. M.D.

Plastic & Reconstructive Surgery: April 2016 - Volume 137 - Issue 4 - p 1117–1122
doi: 10.1097/01.prs.0000481103.45976.b1
Breast: Special Topics
Discussion
Press Release
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Summary: Breast implant–associated anaplastic large cell lymphoma (ALCL) is a rare T-cell lymphoma arising around breast implants. Public awareness has increased following a safety communication warning of the association of breast implant–associated ALCL by the U.S. Food and Drug Administration in 2011. Difficulty with determining an accurate assessment of risk, including diagnosis, or standardized treatment regimen has led surgeons to commonly omit preoperative discussion of this rare and frequently misunderstood cancer. Risk disclosure is a form of respect for patient autonomy, and informed consent has positive practical and moral consequences for the practice of plastic surgery. A model of breast implant–associated ALCL informed consent implementation and health care provider education are reviewed with 1-year process follow-up at a tertiary cancer center. Breast implant–associated ALCL should be included during preoperative counseling on the risks of breast implantation when obtaining informed consent. Pertinent aspects of decision-making include disease awareness, presenting symptoms, and resources for concerned patients. Education of health care professionals and provision of patient-focused materials ensures effectiveness of the informed consent process.

Houston, Texas

From the Departments of Plastic Surgery and Hematopathology, The University of Texas M. D. Anderson Cancer Center.

Received for publication September 11, 2015; accepted November 13, 2015.

Disclosure: Dr. Clemens has consulted for Allergan Corporation (Irvine, CA). None of the authors has a financial interest in any of the products or devices mentioned in this article.

A “Hot Topic Video” by Editor-in-Chief Rod J. Rohrich, M.D., accompanies this article. Go to PRSJournal.com and click on “Plastic Surgery Hot Topics” in the “Videos” tab to watch.” On the iPad, tap on the Hot Topics icon.

Mark W. Clemens, M.D., Department of Plastic Surgery, 1400 Pressler Street, Unit 1488, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030., mwclemens@mdanderson.org

©2016American Society of Plastic Surgeons