The U.S. Food and Drug Administration (FDA) requested that Allergan, a pharmaceutical company, recall its BIOCELL textured breast implants in July 2019. These implants are linked to an increased risk of a cancer known as breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.
A full list of the recalled implants and tissue expanders can be found here.
A recent FDA analysis found over 570 women diagnosed with this type of lymphoma, 84% of whom had the implants at the time of diagnosis. The FDA estimates that women with the BIOCELL implants are six times more likely to be diagnosed with BIA-ALCL than women with any other type of implants.
What is BIA-ALCL?
BIA-ALCL is a rare type of non-Hodgkin’s lymphoma that affects immune system cells. It’s typically found in the scar tissue around both saline and silicone breast implants. It is not a type of breast cancer. Below is an illustration of where in the breast BIA-ALCL is found, in the fluid surrounding the implant or in the fibrous capsule.
FDA.gov, modified from Thompson et al, 2010
Symptoms of BIA-ALCL include:
- Breast asymmetry, hardening, or pain
- A lump in the breast or armpit
- Fluid buildup
- Overlying skin rash
Patients who experience any of the above symptoms should consult with their doctor. BIA-ALCL is treatable if caught and treated early. Treatment usually consists of a surgery to remove the implants and scar tissue, chemotherapy, or radiation therapy.
Implants Linked to Immune System Disorders
Women with breast implants are also at a higher risk of primary immunodeficiency, or weakening of the immune system. A weakened immune system makes patients vulnerable to frequent, hard-to-treat, long-lasting infections.
Sadly, primary immunodeficiency also increases the risk of cancer.
Should You Remove Your Implants?
Removal isn’t recommended for women who aren’t experiencing any of the above systems, even if you currently have these BIOCELL implants or tissue expanders. Doing so could put you at risk for other surgical complications.
Instead, monitor your implants and overall health, and report any changes to your doctor. Cancer and immune system issues can take time to develop, so regular monitoring is important.
Read more on the FDA’s BIA-ALCL fact sheet here.
Speak to a Breast Implant Injury Lawyer Today
Our experienced Allergan breast implant lawyers are here for you to fight irresponsible Big Pharma companies like Allergan. If you have or had Allergan’s breast implants and have been diagnosed with BIA-ALCL or primary immunodeficiency, contact us for a free case evaluation. A member of our team is always on stand-by to hear your story.