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FDA Updates Public Information About Known Risk of Lymphoma From Breast Implants

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On March 21, the U.S. Food and Drug Administration (FDA) issued updated information about its understanding of breast implant–associated anaplastic large cell lymphoma (ALCL).

The agency is providing an updated number of medical device reports (ie, adverse event reports) and medical literature estimates regarding risk reviewed by the agency since the last public update in March 2017. It reported that it was aware of 414 total cases of breast implant–associated ALCL. Additionally, studies reported in the medical literature estimate that the lifetime risk of developing breast implant–associated ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.

The agency is also updating the content and format of the Web page for the agency’s breast implant postapproval studies to make current information about these important studies easier for patients to read and understand. The update does not change the agency’s recommendations regarding breast implants. Choosing to obtain a breast implant is a very personal decision that patients and their providers should make based on individual needs and with the most complete information about risks and benefits.

Commentary

“The FDA has been closely tracking the relationship between breast implants and a rare type of non-Hodgkin lymphoma since we first identified this possible association. We’ve been working to gather additional information to better characterize and quantify the risk, so that patients and providers can have more informed discussions about breast implants,” said Binita Ashar, MD, Director of the Division of Surgical Devices in FDA’s Center for Devices and Radiological Health. “As part of that effort, we are working to update and enhance the information we have on this association, including updating the total number of known cases of [breast implant–associated] ALCL and the lifetime risk of developing [breast implant–associated] ALCL as reported in medical literature. We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of [breast implant–associated] ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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