Risks Associated With the Allergan Breast Implant
Written by AskTheLawyers.com™ on behalf of Michael E. Trauscht with The Law Office Of Michael Trauscht.
In 2019, the U.S. Food and Drug Administration (FDA) requested that pharmaceutical company Allergan (Natrelle) recall their BIOCELL® textured breast implants and tissue expanders over significant risks to patient health, including BIA-ALCL, a rare form of cancer.
BIA-ALCL is a T-cell lymphoma that can develop following breast implants like those produced by Allergan.
Breast implant-associated anaplastic large-cell lymphoma or BIA-ALCL is not a type of breast cancer; it is actually a rare form of non-Hodgkin's lymphoma which attacks the immune system. While the cancer is generally discovered in the tissues surrounding the implants, it can spread throughout the body as well. Treatment of BIA-ALCL generally involves removal of the implant, surrounding tissue, and in some cases chemotherapy and radiation. In some cases BIA-ALCL may be fatal, especially if left untreated. As of June 2020, the FDA identified 573 cases of BIA-ALCL worldwide with 33 deaths occurring. Of those, 481 cases and 12 out of 13 deaths were attributed specifically to Allergan breast implants.
Symptoms of BIA-ALCL may include the following;
- Pain and/or swelling in the area of the implants
- Presence of a mass in the area of the implants, breast, or armpits
- Change in appearance of breasts
- Hardening of the breasts
- Enlargement of breasts
- Redness or rash on the skin
- Weight loss
- Evidence of fluid collection near the implants
It’s important to note that these symptoms may not occur until years after the surgery, and should always be reviewed by a medical professional when they do.
The FDA recommends anyone who has received an Allergan/Natrelle BIOCELL® implant consult their doctor.
The parties thought to be at risk of developing BIA-ALCL include patients who received an implant, the surgeons who conducted the implant, and even health care providers who treated patients with breast implants. However, the FDA cautions patients who have no symptoms against an immediate removal of the implants, “due to the low risk of developing BIA-ALCL”. Allergan has issued Urgent Medical Device Recall letters to their U.S. customers and is currently facing litigation from those who have experienced negative side effects or the development of BIA-ALCL since receiving a textured breast implant or tissue expander.
Allergan implants thus far addressed in the recall include:
Allergan Natrelle Saline-Filled Textured Breast Implants
Allergan Natrelle Silicone-Filled Textured Breast Implants
Allergan Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone- Filled Textured Breast Implants
Allergan Natrelle 133 Plus Tissue Expander
Allergan Natrelle 133 Tissue Expander with Suture Tabs
A full list of the affected products can be found here on the FDA’s website.
Patients injured by a defective pharmaceutical, implant, or medical device may be eligible to file a product liability claim.
Damages that may compensated in a product liability claim include but are not limited to the following:
- Past and future medical bills
- Lost wages
- Life care expenses
- Pain and suffering
- Mental anguish
- Additional damages in the event of the patient’s death
If you or a loved one have suffered adverse health effects after receiving an Allergan/Natrelle breast implant or tissue expander, reach out to a product liability attorney to discuss your options for recovery.