Since our previous article, “Most American Women Are Unaware of BIA-ALCL“, the FDA has released an update on reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The update includes new BIA-ALCL case reports through January 5, 2020.
What’s New in BIA-ALCL Cases?
Currently, the FDA analysis of global medical device reports for BIA-ALCL covers reports received between July 7, 2019 and January 5, 2020. On August 20, 2020, the FDA updated their webpage to include a total of 733 unique cases of BIA-ALCL and 36 patient deaths globally.
According to a press announcement released by the FDA in August 2020:
Specifically, of the 733 total unique cases of BIA-ALCL reported to FDA, 620 cases were reported for Allergan implants, and 47 cases involved implants with an unknown manufacturer. With respect to implant surface for the 733 total unique cases of BIA-ALCL, 496 cases were reported to have textured implants, and 209 cases did not specify the implant surface. Of the 36 total patient deaths reported to FDA, 15 of the 16 patients for which the manufacturer of the implant is known, are reported to have had an Allergan breast implant at the time of their BIA-ALCL diagnosis. In terms of implant surface, of the 36 cases reported of patient deaths, 16 cases reported textured implants, and 19 cases did not contain information on the implant surface.
At this time, the overall incidence of developing BIA-ALCL is low. Most patients with BIA-ALCL are treated successfully through surgery to remove the implant and surrounding scar tissue. However, BIA-ALCL should be treated as a serious diagnosis, as it can lead to death if left untreated.
Allergan’s Role in BIA-ALCL Cases
Breast implant manufacturer Allergan is responsible for the majority of confirmed BIA-ALCL cases reported to the FDA. As a result, the company has faced backlash over specific textured implants. Subsequently, Allergan made the decision to recall its Biocell implant from the market in 2019. The decision came at the request of the FDA.
According to an August 2020 Healio article “FDA identifies more cases of lymphoma linked to breast implants“:
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Last fall, the FDA issued a draft guidance recommending the inclusions of a boxed warning on breast implant labeling. The guidance also called for a patient decision checklist in breast implant labeling.
FDA Device Tracking and Moving Forward
According to the same August 2020 Healio article mentioned previously:
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.
As always, we will continue to monitor the worldwide issues surrounding breast implants and BIA-ALCL. We will provide you with any new or relevant information.
We encourage you to visit our Breast Implants Lymphoma Cancer page on our website for more information. Please submit a free case evaluation if you or someone you know has been diagnosed with BIA-ALCL.
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Breast Implants: Lymphoma / Blood Cancer Cases Overview