Since 2011, the U.S. Food and Drug Administration (FDA) has been keeping a close watch on reported cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This form of non-Hodgkin’s lymphoma (NHL) has been most consistently linked to textured implants made by Allergan.
Number of Adverse Events Is Climbing
On August 20, 2020, the FDA published “for immediate release” its update on BIA-ALCL cases for adverse breast-implant-related events reported through January 5, 2020. Since that last public report on this matter, the agency indicates a spike in new cases—160 in all—since the July 2019 update, bringing the total of unique cases of BIA-ALCL to 733. Three deaths from the disease were also reported in this timeframe.
Numbers and Implant Types
Nearly 85 percent of BIA-ALCL cases reported to the FDA were connected with Allergan implants. Patients who reported the remaining cases did not know the manufacturer of their implants. Over 67 percent reported their cases involved textured implants. The actual number could be more, given the fact that the other 33 percent of patients did not specify how their implants were surfaced. Sixteen of the 36 BIA-ALCL deaths to date connect to textured-surface breast implants.
BIA-ALCL forms in scar tissue and fluid around breast implants; however, the disease is not considered breast cancer. Rather, it represents a cancer of the immune system, known as NHL. Once the cancer forms, it can spread to anywhere in the body. The FDA stresses that, although rare, BIA-ALCL poses a serious danger to the patient. If not promptly diagnosed and treated, the disease can cause death. Treatment generally involves surgery for implant removal. In some instances, chemotherapy and/or radiation therapy follow surgical treatment.
Growing Reports of Breast Implant Illness Also Reported
The agency also included in its update new numbers that show an increase in the number of “breast implant illness” (BII) cases. Although not a cancer, BII is a term that medical providers and their patients use when they report breast-implant-related adverse events. From November 2018 to October 2019, the number of new BII reports also increased—by nearly 2,500 new cases, according to the new information the FDA released in August.
The agency attributes the increase in BII reports to heightened media coverage of breast implants and the adverse events they can cause.
To continue the effectiveness of this reporting, the FDA encourages patients who experience problems with their breast implants to report their experiences using the agency’s Adverse Event Reporting Program.
Lawsuits Are Underway
Legal action is well underway for many women who have developed ALCL from their Allergan breast implants. A multi-district litigation (MDL) was established in December 2019 in a New Jersey federal court. To learn more about your legal options against Allergan after your adverse breast-implant-related event, consider reaching out to Levin Papantonio, co-lead counsel for the MDL.