Allergan Breast Implant MDL 2921 Case Management Orders (CMOs)

Why did the FDA ask Allergan to recall its Biocell breast implants?

In July 2019, the Food and Drug Administration (FDA) asked Allergan to recall its BIOCELL textured breast implants and tissue expanders worldwide. The request followed reports linking textured implants, and BIOCELL implants in particular, to a rare cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Allergan implants with a smooth surface were not part of the recall.

What is BIA-ALCL?

BIA-ALCL is a type of non-Hodgkin lymphoma that can develop in the scar tissue and fluid around a breast implant, usually years after surgery. When it is found early and has not spread beyond the scar tissue capsule, it is often treated with surgery to remove the implant and the capsule. More advanced cases may also require chemotherapy or radiation therapy.

Signs and symptoms of BIA-ALCL

Symptoms most often appear years after the implant was placed and can include:

• Persistent swelling or fluid collecting around the implant (seroma)
• A lump or mass in or near the breast
• Breast pain, hardening, or a change in the shape or size of the breast
• Swollen lymph nodes in the armpit or neck
• Less commonly, fever, night sweats, or unexplained weight loss

Anyone with these symptoms should see a doctor promptly.

How is BIA-ALCL diagnosed?

Doctors usually start with imaging, such as ultrasound or MRI, to look for fluid or a mass around the implant. If fluid is present, it is drawn out and tested for cancer cells, including a marker called CD30. If BIA-ALCL is confirmed, additional imaging such as a PET/CT scan may be used to see whether the disease has spread. The FDA does not recommend routine screening or preventive removal of textured implants in people who have no symptoms.