FDA Update on BIA-ALCL Finds More Cases, More Deaths

Silver Spring, MD On August 20, the U.S. Food and Drug Administration provided an update on adverse events relating to breast implants, including breast implant-associated anaplastic large cell lymphoma. The new FDA update on BIA-ALCL reports a total of 733 cases and 36 patient deaths globally, an increase of 160 new cases and 3 deaths since July 2019. Of those 733 cases, 84.6 percent involved Allergan implants.

The FDA estimates hundreds of thousands of American women have Allergan Biocell breast implants. The exploding number of Allergen breast implant lawsuits has now been consolidated in the multidistrict Allergan Biocell Textured Breast Implant Products Liability Litigation in the federal District Court for the District of New Jersey.

Breast Implant Side Effects

BIA-ALCL is not breast cancer, but a form of non-Hodgkin's lymphoma. In most cases, what is now sometimes referred to as “breast implant illness” or “BII” is found in the scar tissue and fluid near the implant; it can, however, spread throughout the body. A BIA-ALCL diagnosis is serious and can lead to death if not diagnosed early and promptly treated. Even when the disease is successfully managed with surgery, chemotherapy and radiation therapy, the treatment is physically invasive and emotionally traumatic. This is especially true for women who have had reconstructive surgery following breast cancer.

The top ten breast implant side effects reported to the FDA include:

• chronic fatigue;
• brain fog;
• joint pain;
•  anxiety;
•  hair loss;
• depression;
• rash;
• autoimmune diseases;
• inflammation; and
• weight problems. 

The FDA has also released a video on seven things patients should know about breast implants, including risks, complications and information about BIA-ALCL and systemic symptoms. The agency cautions, among other things, that:

• breast implants are not lifetime devices; the longer you have your implants, the more likely it will be for you to have them removed because of complications and adverse outcomes;
• you should assume that you will need to have additional surgeries because of the risk of these complications;
• the cost of implant removal or implant replacement may not be covered by insurance; and
• breast reconstruction often involves the implantation of not only a breast implant device but also a surgical mesh device. The benefit of implanting a surgical mesh as part of the breast reconstruction operation has not been reviewed by the FDA.

Growing signs of danger

In July 2019, Allergan recalled its Biocell textured breast implants and tissue expanders. The recalled products include:

• Natrelle Saline-Filled Breast Implants;
• Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants;
• BIOCELL Textured Round Gel-Filled Implants;
• Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants;
• Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants;
• Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants;
• Natrelle 133 Tissue Expanders with Suture Tabs; and
• Natrelle 133 Plus Tissue Expanders.

It was not until nearly a year later, however that the company launched a campaign to contact patients who may not have been aware of the recall. In the meantime, a great deal of damage may have already been done.

Allergan was granted premarket approval by the FDA in 2000 to market the first line of Biocell implants. Additional designs were later approved in 2006 and 2013. By January 2011, however, the FDA had identified a link between breast implants and BIA- ALCL.

In 2015, the French National Cancer Institute claimed “[t]here is a clearly established link between the occurrence of this disease [BIA-ALCL] and the presence of a breast implant.” In March 2017, the FDA warned that “[t]he risk of BIA-ALCL is higher for textured surface implants versus smooth surface implants.” In December 2018, Allergan’s Biocell textured implants lost their European certification and were suspended from the European and Brazilian markets. Within months, Allergan textured implants were also banned in France and Canada. The U.S. recall followed a year later.

Injured patients have begun to question whether Biocell textured implants are inherently dangerous or whether their injuries are a consequence of manufacturing or design defects. Troubling questions also persist about whether Allergan hid the evidence of the dangers by misreporting implant ruptures and other injuries as “routine events.” Routine events do not require public disclosures through the Manufacturer and User Facility Device Experience (“MAUDE”) database, which doctors routinely use to monitor the safety of medical devices.

Allergan Biocell Textured Breast Implant Products Liability Litigation

In August, several dozen Allergan BIA-ALCL lawsuits had been consolidated in the multidistrict litigation. But the litigation is still in its early stages and many now expect that more than a hundred cases may be joined. The first trials of bellwether cases will not occur for months.