Patients Considering Breast Implants Need Information on Risk of Very Rare Cancer
Women considering any type of breast implant surgery should understand their risk of an "exceedingly rare" but serious type of cancer called anaplastic large cell lymphoma (ALCL), according to a special topic paper in the April issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS).
"Breast implant-associated ALCL should be included during preoperative counseling on the risks of breast implantation when obtaining informed consent," write Dr. Mark W. Clemens and colleagues of The University of Texas M.D. Anderson Cancer Center, Houston. They outline and evaluate their institution's approach to including ALCL in the informed consent process for breast implants.
Informed Consent for ALCL: Risks, Symptoms, and When to Take Action
Breast-implant-associated ALCL is a subtype of cancer called non-Hodgkin lymphoma, and can occur in the scar tissue or fluid around breast implants. In 2011, with an update in 2016, the FDA issued a statement warning of "a very small, but increased risk" of ALCL in women with breast implants.
The true rate of breast implant-associated ALCL is unknown. Less than 150 cases of breast implant-associated ALCL have been reported since the late 1990s, whereas there are an estimated 10 million women with breast implants worldwide. Yet the risk of ALCL is at least 18 times higher than in women without implants.
It is unclear how often plastic surgeons include information about this "rare and frequently misunderstood" cancer in preoperative discussions with patients. Informal surveys suggest that up to three-fourths of plastic surgeons don't discuss ALCL when obtaining informed consent for breast implant procedures.
Dr. Clemens and colleagues evaluated their experience with implementing an informed consent process for ALCL in 585 women undergoing breast reconstruction with implants over one year. After training, healthcare workers felt adequately prepared to discuss the risk of ALCL. Although some patients had questions, none decided not to proceed with breast reconstruction after learning about ALCL.
The authors emphasize the need to make patients aware of the existence of this rare cancer, and of the most common signs and symptoms. Most cases of ALCL are diagnosed when patients seek treatment for implant-related symptoms such as pain, lumps, swelling, or differences between breasts—eight to nine years after surgery, on average.
Patients are strongly advised to take action and follow up with a physician should these symptoms occur. "Evaluation of fluid collections years after implant placement is particularly important," Dr. Clemens comments.
The informed consent process began with education for healthcare providers, including a "frequently asked questions" document available from the Plastic Surgery Foundation. In collaboration with the FDA, the ASPS and Plastic Surgery Foundation have developed an online prospective registry called PROFILE, to record cases and gather information on breast implant patients affected by ALCL.
Dr. Clemens and coauthors believe their experience shows that patients can understand information about ALCL risk, and use that information to make an informed decision about receiving breast implants. They conclude, "Informed consent should be provided to any patient with breast implants for either reconstructive or aesthetic indications."
Plastic and Reconstructive Surgery® is published by Wolters Kluwer.
Article: "Breast Implant Informed Consent Should Include the Risk of Anaplastic Large Cell Lymphoma” (doi: 10.1097/FTD.0000000000000287)
About Plastic and Reconstructive Surgery
For over 75 years, Plastic and Reconstructive Surgery® has been the one consistently excellent reference for every specialist who uses plastic surgery techniques or works in conjunction with a plastic surgeon. The official journal of the American Society of Plastic Surgeons, Plastic and Reconstructive Surgery® brings subscribers up-to-the-minute reports on the latest techniques and follow-up for all areas of plastic and reconstructive surgery, including breast reconstruction, experimental studies, maxillofacial reconstruction, hand and microsurgery, burn repair and cosmetic surgery, as well as news on medico-legal issues.
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The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world. Representing more than 11,000 physician members worldwide, the society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises more than 92 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the society represents physicians certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada.
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