In July of 2019, the U.S. Food and Drug Administration (FDA) requested that Allergan recall all of its Biocell textured breast implants after reports of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) were explicitly linked to Allergan’s product.
You can view the recall information here.
What Is BIA-ALCL?
BIA-ALCL is a type of non-Hodgkin’s lymphoma. It is not a traditional form of breast cancer, as it is not found in the breast tissue. Instead, this rare disease grows in the scar tissue and fluid surrounding the implant.
It is unclear as to why textured breast implants – which are sometimes referred to as “gummy bear implants” – are specifically associated with this type of cancer. However, the FDA claims that Allergan’s implants are six times more likely to increase the risk of BIA-ALCL.
How Common Are Gummy Bear Implants?
Fortunately, textured implants are only used in about 10% of breast implant surgery.
Women who have these textured breast implants are not currently being advised to replace or remove them unless they are having symptoms, which may include:
- persistent swelling or pain near the implant or in the lymph nodes
- fluid buildup near the implants or breast lumps
- hardening of the breast implant area
When to Look for Symptoms
Symptoms generally occur several years after the initial surgery. If patients experience them, they should see their plastic surgeon right away. The surgeon can test the fluid near the implant and identify whether or not the fluid contains the CD30-protein associated with BIA-ALCL. If the protein is found to be present, it may be necessary to remove the implant, along with the scar tissue surrounding the device. If the disease is caught in the early stages, there is an 89% recovery rate (89% of women are cancer-free after 5 years). If the cancer is not detected in a timely manner, it can metastasize to other parts of the body.
How Long Did Allergan Know About the Risk?
The FDA first identified the risk of BIA-ALCL in 2011, however, the agency needed more data before it could issue a recall or warning. By 2019, the FDA had identified 573 cases of BIA-ALCL worldwide, including 33 deaths.
Of these cases, 481 were associated with Allergan textured breast implants. This information, combined with recalls in Europe, Israel, Brazil, Australia and Canada, led to the United States recall of Allergan Biocell textured breast implants.
After the recall, Allergan announced it would cover the costs of new implants but would not cover any surgical costs for women who wished to replace their textured implants.
In response, two women filed lawsuits claiming they developed BIA-ALCL after receiving Allergan textured breast implants and requesting damages (financial compensation) from the company.
Those Affected Should Act Now
If you or a family member has undergone breast augmentation using Biocell textured breast implants, and been diagnosed with BIA-ALCL, you may have a case against Allergan.
Brett H. Oppenheimer, PLLC can help you determine the strength and validity of your claim.
You could be eligible for compensation, which can help cover:
- medical expenses,
- lost wages,
- pain and suffering,
- and more.
Brett H. Oppenheimer is an attorney with experience holding medical device companies, such as Allergan, accountable for their defective products.
Make an appointment with Brett today to discuss your Allergan textured breast implant case.
Simply call (502) 242-8877 or fill out our quick, easy contact form.