The risk of developing a rare form of cancer linked to breast implants may be higher than previously reported in women who received textured implants, according to a new study reported at the 2019 American Society of Clinical Oncology (ASCOO) Annual Meeting.

The study was designed to identify complications women experienced after breast reconstruction, and involved more than 3,500 women who received textured breast implants between 1993 and 2017 from the same surgeon. Almost all patients (97.6%) received the implants during reconstruction after mastectomy and nearly all (97.6%) received Biocell textured implants made by Allergan. Patients were followed for a median of 7 years.

Researchers identified eight cases of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), or about 1 case in every 433 women. The disease was diagnosed anywhere from 8.3 years to 15.8 years after initial implantation. All eight women diagnosed with BIA-ALCL received Allergan’s Biocell textured implants.

“In this cohort the risk of BIA-ALCL with textured breast implants is higher than previously reported,” wrote the study authors. Previous studies have estimated the risk to be as low as 1 case per 6,920 women with textured implants. The study authors suggested that the “incidence may increase with longer follow-up.”

BIA-ALCL is not traditional breast cancer but a type of non-Hodgkin’s lymphoma, a cancer of the immune system. In most cases, the cancer is found in the scar tissue and fluid near the implant, but in some cases the cancer can spread throughout the body.

In February, the Food and Drug Administration (FDA) informed the public that it had received reports of 246 new cases of BIA-ALCL through September 2018, including nine deaths.

Beasley Allen lawyers investigate claims of serious injury and death related to defective medical devices. For more information, contact Melissa Prickett in the firm’s Mass Torts section.

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