FDA Links Breast Implants to Increased ALCL Risk
People with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma (ALCL), the U.S. Food and Drug Administration (FDA) announced in April 2019 (https://www.fda.gov/medical-devices/breast-implants/breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl). Typically the cancer is limited to the scar tissue and fluid near an implant, but some patients experience spread throughout the body. The risk increases with textured implants in particular.
In May 2019, FDA released a statement (https://www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-amy-abernethy-md-phd-and-jeff-shuren-md-jd-director-fdas) committing to keep the public and healthcare professionals informed about the risks associated with breast implants, including breast implant-associated ALCL, capsular contracture, and implant rupture. The agency outlined an awareness plan for gynecologists, dermatologists, internists, and pathologists to ensure that they understand the risks, communicate them to patients, and test specifically for breast implant-associated ALCL in patients with implants who are being evaluated for lymphoma.
At the time, FDA did not recall the implants or prohibit their use, but it emphasized its routine monitoring of global medical device reports and announced a change to its own medical device reporting system, requiring individual device reports that will be publicly available in the Manufacturer and User Facility Device Experience database.
Since the initial announcement, however, FDA received subsequent medical device reports of associated ALCL and issued a request for recall in July 2019 (https://voice.ons.org/news-and-views/fda-recalls-textured-breast-implants-because-of-lymphoma-risk).