FDA identifies more cases of lymphoma linked to breast implants
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The number of lymphoma cases linked to breast implants increased nearly 28% in the second half of last year, according to the FDA.
The agency identified 733 unique cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) worldwide as of Jan. 5, up from the 573 cases that had been confirmed as of July 2019.
The number of confirmed deaths globally due to BIA-ALCL reached 36 as of Jan. 5, up from 33 in July 2019.
BIA-ALCL is a form of non-Hodgkin lymphoma known to be a risk of breast implants. Most cases are treated successfully through surgery to remove the implant and surrounding scar tissue; however, some patients need chemotherapy or radiation.
In 2011, the FDA became the first public health agency in the world to communicate about the risks for BIA-ALCL. The agency has provided regular updates since then about confirmed cases, deaths and risks.
The majority (84.5%; n = 620) of confirmed BIA-ALCL cases reported to the FDA involved implants made by Allergan.
The manufacturer of the implant in place at the time of BIA-ALCL diagnosis has been identified for 16 of the 36 patients who have died. In 15 of those 16 cases, patients were confirmed to have had Allergan breast implants, according to FDA.
Last summer, in response to a request from FDA, Allergan recalled specific models of its textured implants due to a potential risk for BIA-ALCL.
As Healio reported last fall, the FDA issued draft guidance recommending inclusion of a boxed warning on breast implant labeling to ensure women receive and understand complete information about their benefits and potential risks.
“The FDA has been diligently monitoring adverse events associated with breast implants for decades and has been working to better understand the quality of life and satisfaction a breast reconstruction patient may experience in order to refine our evaluation of breast implant benefits and risks,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “In addition, we continue to increase our scientific knowledge regarding BIA-ALCL and systemic symptoms ... and remain committed to keeping the public informed.”
The FDA tracks medical device reports related to systemic signs and symptoms referred to as breast implant illness. These symptoms include fatigue, brain fog, joint pain, anxiety, hair loss, depression, rash, autoimmune diseases, inflammation and weight problems.
The FDA received 1,080 reports of symptoms consistent with breast implant illness from January 2008 through October 2018. The number of reports of such symptoms approached 2,500 from November 2018 through October 2019, a spike agency officials attribute to increased awareness.
The FDA also is qualifying the BREAST-Q Reconstruction Module as a medical device development tool to help with the assessment of breast implants and other medical devices. Medical device development tools are scientifically validated and can be used as part of device evaluation to support regulatory decision-making.
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