Breast Implants Labeling Recommendations By The FDA

Breast Implants Labeling Recommendations By The FDA

Introduction

On September 28, the Food and Drug Administration (FDA) issued a press release, providing final guidance on breast implant labeling recommendations and information regarding health complications, often referred to as “breast implant illness.” The Federal regulators had issued draft guidance of this document in 2019.

The final guidance recommends breast implant manufacturers to add a boxed warning informing the patients about the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) associated with breast implants. Additionally, the guidance also provides a standardized checklist as part of the informed consent process, revised MRI screening recommendations for silent ruptures of silicone gel-filled breast implants, and calls for the implementation of greater transparency regarding materials present in breast implants.

In August, the agency released a report indicating that the number of BIA-ALCL cases increased by nearly 28% in the second half of last year, and most of the identified cases were specifically linked to the textured design of certain Allergan Breast Implants.

FDA's data indicated a total of 733 BIA-ALCL diagnoses, along with 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.

A rise in the number of breast implants lawsuits filed against Allergan has been noted since the manufacturer issued a recall for its textured Biocell implants last year after the FDA concluded the textured design as the reason for all cases of BIA-ALCL. Currently, the manufacturer is facing at least 150 product liability lawsuits and class action lawsuits over breast implant cancer problems.