FDA Finds A Rise In Lymphoma Cases Linked To Breast Implants

FDA Finds A Rise In Lymphoma Cases Linked To Breast Implants

Introduction

On August 20, the Food and Drug Administration (FDA) released a report indicating that the number of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) cases increased by nearly 28% in the second half of last year. Most of the identified cases are specifically linked to the textured design of certain Allergan breast implants.

According to the report, an additional 160 new cases, along with three new deaths have been identified since July 7, 2019. Currently, the data indicates a total of 733 BIA-ALCL diagnoses and a total of 36 patient deaths globally. Out of the known cases where the manufacturer has been identified, 620 are linked to breast implants sold by Allergan, Inc., and in 47 cases, the manufacturers were unknown. Only 16 manufacturers were identified of the 36 deaths, and 15 of those involved Allergan implants.

The report also includes an update on other health problems linked to breast implants, known as “breast implant illness," along with new diagnostic methods for assessing BIA-ALCL and other breast implant issues. A video guide has also been released about the information that patients should know about breast implants.

Earlier this month, Allergan filed a motion seeking dismissal of lawsuits involving its Biocell textured breast implants on pre-emption grounds, claiming that the company should not be held liable over the failure to warn claims.

Allergan Inc.’s breast implants include saline and silicone devices used in breast augmentation and reconstruction. The company is one of the largest breast implant manufacturers in the world and started selling breast implants in 2006. Allergan’s flagship breast implant brand is Natrelle, but it also sells implants under its subsidiaries Inamed and McGhan. The manufacturer received approval from the FDA on 11/17/2006.

Currently, Allergan faces at least 150 product liability lawsuits and class action lawsuits over breast implant cancer problems. The lawsuits have been consolidated to form multidistrict litigation (MDL) before U.S. District Judge Brian R. Martinotti in the District of New Jersey under MDL No.: 2921. Also, lawsuits filed in New Jersey are consolidated as part of multicounty litigation (MCL) in the New Jersey Superior Court for Bergen County, where the claims are presided by Judge Rachelle Harz for coordinated discovery and pretrial proceedings.