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Mon, April 23, 2018

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BREAKING NEWS

FDA Issues Statement About Rare Cancer Associated With Breast Implants
March 22, 2018



Chronicle staff

(NATIONAL) -- On Wednesday the Food & Drug Administration (FDA) issued a statement for the public regarding its understanding of a disease known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

We we are working to update and enhance the information we have on this association, including updating the total number of known cases of BIA-ALCL and the lifetime risk of developing BIA-ALCL as reported in medical literature," said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. "We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-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 FDA has been closely tracking the relationship between breast implants and BIA-ALCL, a rare type of non-Hodgkin's lymphoma since it first identified a 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 Dr. Ashar.

To that end the FDA is providing an updated number of medical device reports (MDRs) (also known as adverse event reports) and medical literature estimates regarding risk reviewed by the agency since the last public update in March 2017.

The FDA says it is now aware of 414 total cases of BIA-ALCL. Additionally, studies reported in medical literature estimate that the lifetime risk of developing BIA-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 webpage for the agency’s breast implant "post-approval studies" to make current information about these important studies easier for patients to read and understand.

Today’s 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," said the agency's statement.
















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