New FDA Label Suggested for Breast Implants
On September 29, 2020, the U.S. Food and Drug Administration (FDA) released final labeling recommendations aimed at improving patients’ understanding of the risk associated with breast implant surgery. The non-binding recommendations highlight the ongoing failure by manufacturers to adequately disclose the risks associated with breast implants to patients and their doctors. The labeling requirements specifically target the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness. BIA-ALCL is closely associated with recalled Allergan Textured Breast Implants.
What Changes Does the FDA Recommend?
The FDA’s guidance recommends that manufacturers provide a boxed warning to prominently communicate the possibility of complications associated with breast implant devices. Further guidance suggests manufacturers provide a patient checklist to help guide the discussion between doctors and patients considering breast implant surgery. The FDA also suggests labeling requirements for rupture screening as well as providing a booklet listing the chemicals and materials in the implants and their potential toxicity.
The new recommendations are intended to improve the breast implant decision process and the discussion between patients and their doctors. In the FDA’s press release, Binita Ashar, Director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health stated “After working with stakeholders, including patients, today we are recommending format and content changes to breast implant labeling so the information is presented in a way that is easy to understand. It is important that patients discuss the risks and benefits of breast implants with their health care provider and we hope that these labeling recommendations will help in facilitating these discussions.”
FDA General and Plastic Surgery Devices Panel
Over the past several years, the FDA held a series of advisory committee meetings for field experts to provide advice and recommendations to the Agency. The advisory committee discussed a range of topics including the symptoms and impact of BIA-ALCL on patients and the adequacy of adverse event reporting by the medical community. The advisory committee meetings were held in an open forum where the FDA welcomed attendance by the public.
Cancer Caused by Allergan Textured Breast Implants
Prior to being recalled in 2019, Allergan manufactured the BIOCELL textured breast implant which is closely linked to BIA-ALCL. Allergan used a unique manufacturing process known as “close salt-loss texturing” in the production of its BIOCELL implants. Plaintiff’s attorneys claim the technique is flawed and creates defective implants with extreme texturing which can shred apart and leave silicone debris inside the body. When the body reacts to the silicone particles it causes chronic inflammation leading to BIA-ALCL. In addition to cancer, many women have complained of fatigue, brain fog and other problems that are collectively known as “breast implant illness.”
Many women choose textured breast implants because they provide a firmer feel than a smooth round implant. Texturing helps the implant adhere to the breast tissue which prevents rotation of the implant within the implant pocket.
Common Breast Implant Cancer Symptoms
The most common symptoms women with BIA-ALCL first experience are persistent swelling and pain around the breast. Frequently, symptoms develop long after the surgery site has healed. In addition to pain and swelling, other common symptoms include:
Redness or discoloration
Persistent swelling and breast enlargement
Lumps in the breast or armpit
Unexplained changes in appearance of the breast
Allergan BIOCELL Textured Breast Implant MDL 2921
In December 2019, the Judicial Panel on Multidistrict Litigation formed MDL 2921 to consolidate discovery and pretrial proceedings against Allergan. The Court designated the U.S. District Court of New Jersey as the appropriate forum and assigned the cases to Judge Brian R. Martinotti who has significant experience handling complex litigation.
If your firm is considering joining the Allergan MDL litigation, Case Works can help get your cases proven up and ready to file. The Breast Implant Team at Case Works is expertly trained to evaluate medical records and work with clients to maximize the value of their claim.