Allergan’s Defective Textured Breast Implants: A Brief Update on the BIA-ALCL Litigation
At this point, there is enough evidence to suggest a strong link between Allergan’s defective textured breast implants and breast implant-associated large cell lymphoma, a rare and aggressive form of non-Hodgkin’s lymphoma, as evidenced by the continued multi-district litigation with over 1,000 plaintiffs.
Usually, a combination of textured implants and a compromised immune system causes this form of lymphoma. Early symptoms include unexplained breast enlargement, asymmetry, unexplained skin rash, fluid buildup, or a lump in the armpit or breast.
Textured implants are the implants of choice for both reconstructive and cosmetic breast implant recipients. They are much more realistic than smooth implants. Furthermore, Allergan, the leading textured implant maker, insisted that its products are safer than smooth implants. In a way, that is true. Textured implants are less likely to leak or rupture than smooth implants. However, as outlined in this post, in another way, that is obviously untrue.
As of May 2023, over a thousand survivors have filed legal actions that are now pending in a New Jersey federal court. Allergan has not yet tendered a settlement offer, but most observers think it is just a matter of time until that happens. Survivors who partner with a personal injury attorney and show initiative go to the front of the line during the settlement disbursement process. So, to get the compensation they need and deserve, BIA-ALCL survivors should partner with attorneys sooner rather than later.
The Connection Between Allergan Textured Breast Implants and Cancer
One reason textured implants have less leakage is that these implants have deeper and larger divots than saline implants. This design more firmly secures the implant to the chest. However, the more invasive procedure often causes a scar tissue capsule to form around the implant. This soft capsule usually causes little or no discomfort. Therefore, survivors have no idea they’re at risk for BIA-ALCL.
Lymphoma is not the only potential health concern. According to the Food and Drug Administration, the cancer cells that develop in the scar tissue could spread throughout the body and also cause other forms of cancer.
Treatment usually means a combination of surgery to remove the implant and affected tissue, as well as radiation and chemotherapy. If doctors aggressively treat this aggressive disease, it is usually manageable. However, not all BIA-ALCL survivors can tolerate such treatments.
As mentioned, these implants are common in reconstructive surgery. If the survivor has already survived breast cancer or another serious illness, aggressive cancer treatments are impossible.
Furthermore, these treatments are quite expensive, usually more than $10,000 per month. A group health insurance company might pay part of the cost. Only a personal injury attorney can obtain compensation for all these costs.
Incidentally, lymphoma is not the only risk. In addition to BIA-ALCL, these implant recipients also had greater incidences of seromas, or fluid pockets, compared to other implants. They also carried a greater risk of performance failure and pain.
Affected Products
In August 2022, the FDA said it had received over 1,000 textured breast implant health complaints. Over 80% of these reports involved an Allergan product, like:
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants,
- Natrelle Inspira Silicone-Filled Breast Implants,
- Natrelle Saline Breast Implants,
- Natrelle Silicone-Filled Breast Implants,
- McGhan BioDimensional Silicone-Filled Biocell Textured Breast Implants,
- McGhan Magna-Site Tissue Expander,
- McGhan Style 134 Croissant Shaped Tissue Expander,
- Natrelle 133 Plus Issue Expanders,
- Natrelle 133 Tissue Expanders with and without suture tabs, and
- Style 133 Biospan Tissue Expander.
This 2022 report is just a culmination of over a decade of official health warnings. The FDA first identified a possible association between breast implants and anaplastic large-cell lymphoma in 2011. But the agency said there were too few cases at the time to properly gauge the risk.
In 2016, the World Health Organization classified the disease as a type of T-cell lymphoma that developed after receiving breast implants. The next year, as a precursor to a recall, the FDA announced BIA-ALCL was primarily associated with textured implants.
The FDA held a public advisory committee meeting in March 2019 to discuss risks. Initially, the agency declined to recommend a recall. FDA bureaucrats only issue product recalls as a last resort. Then, new data in July 2019 showed a spike in BIA-ALCL cases. This data, which was too strong to ignore, finally led to the July 2019 Allergan textured implant recall.
Legal Issues
Allergan had plenty of chances to do the right thing and warn customers about the risk of BIA-ALCL and other health problems. When a company insists on selling a dangerous product and putting profits before people, a personal injury attorney must step in and file a failure to warn or other negligence action. These actions have four basic elements:
- Duty: Manufacturers have a duty to promptly and properly warn customers about known product defects. A prompt warning would have been in 2011, not 2019. Furthermore, the warning must be proportional to the risk. Potential cancer is not a warning that can be buried in the fine print.
- Breach: Usually, a personal injury attorney works with an industry insider to establish the standard of care, such as when the company should have added a warning and what that warning must look like. A shortfall in either area is a breach of duty.
- Cause: This issue is probably holding up an Allergan settlement. As mentioned, non-Hodgkin’s lymphoma is related to a genetic abnormality. Company lawyers insist that this abnormality causes BIA-ALCL, and the Allergan implant is just a coincidence.
- Damage: Compensation in a failure to warn claim usually includes money for economic losses, such as medical bills, and noneconomic losses, such as pain and suffering. Additional punitive damages are available as well if the company intentionally disregarded a known risk.
Multidistrict litigation consolidation in New Jersey, which was mentioned above, adds another layer to an already complicated claim. MDL adds some additional procedural hurdles that most negligence claims do not have. So, unless a survivor has a very experienced personal injury attorney, the survivor must most likely settle for less.
Preparing for Your Free Consultation
Below are some questions that a personal injury attorney might ask during a defective textured breast implant consultation. If survivors have ready answers, the litigation process starts sooner.
Have you been diagnosed with breast implant-associated anaplastic large-cell lymphoma?
A current diagnosis is essential in a negligence claim. Note that BIA-ALCL is not the same as breast cancer. Instead, it is a type of non-Hodgkin lymphoma.
When did you have your breast implant surgery?
People filing lawsuits had their surgeries between 1998 and 2019. Contact your plastic surgeon who performed this procedure if you don’t remember the exact date of your surgery.
What brand of Allergan implants do you have?
Most women do not pay much attention to the make and model. Not all Allergan breast implants have been known to cause BIA-ALCL.
Has your specific model been recalled?
In July 2019, Allergan recalled its textured breast implants and tissue expanders. To find out if your breast implant or tissue expander was part of this recall, visit the FDA’s website or contact your surgeon.
Have you had your implants removed?
The FDA has not advised patients to remove their implants if they do not have symptoms of BIA-ALCL or another problem, but let your Allergan breast implant lawyer know if you have already had yours taken out.
Work With a Dedicated Personal Injury Lawyer
Injury victims are entitled to significant compensation. For a free consultation with an experienced personal injury lawyer, contact the Yost Legal Group. We do not charge upfront legal fees in these matters.