The FDA recently requested that breast implant maker Allergan voluntarily recall certain products, including the Allergan Biocell implants and tissue expanders.
The purpose of the recall is to protect individuals from an increased risk of large cell lymphoma (BIA-ALCL) which has been associated with the controversial textured breast products.
BIA-ALCL is a type of non-Hodgkin’s lymphoma (cancer of the immune system). It is not a form of breast cancer. In most cases, it is located in the scar tissue and fluid near the implant. In some circumstances, it can spread throughout the body.
This type of lymphoma is a serious condition and can lead to death if not diagnosed at an early stage. With early diagnosis, it is often successfully treated with surgery to remove the implant and surrounding scar tissue. Some patients may also need traditional forms of treatment, including chemotherapy or radiation. Some may require both treatments.
What is the Reason for the Allergan Biocell Recall?
The FDA issued the request for a voluntary recall after analyzing data related to almost 600 unique cases of BIA-ALCA. Of those cases, there have been 33 documented patient deaths. A total of 12 of the 13 deaths occurred in patients with Allergan breast implants. The statistics show that the risk of the patients with the Allergan Biocell implants has a six times higher risk from other manufacturers in the United States.
Based upon the FDA request, Allergan did in fact issue a worldwide voluntary recall on July 25, 2019. The company agreed that it will no longer sell or distribute the product. It also notified healthcare providers that they should no longer implant Allergan Biocell implants and tissue expanders.
Which Allergan Biocell Products Have Been Recalled?
The following products have been recalled by the medical product manufacturer Allergan:
- Allergan Natrelle Saline-Filled Breast Implants (previously sold as the McGhan RTV Saline-Filled Mammary Implant) in styles 163, 168, 363 and 468.
- Allergan Natrelle Silicone-Filled Textured Breast Implants (previously known as Inamed Silicone-Filled Breast Implants) in styles 110, 115, 120, TRL, TRLP, TRM, TRF, TRX, TCL, TCLP, TCM, TCF, TCX, TSL, TSLP, TSM, TSF, and TSX.
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants in styles 410FM, 410FF, 410MM, 410 MF, 410 ML, 410 LL, 410 LM, 410 LF, 410 FX, 410 MX, and 410 LX.
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
Lawsuits for Defective Allergan Biocell Breast Implants
If you or a loved one were diagnosed with BIA-ALCA (lymphoma) and have a recalled implant or tissue expander, you can file a defective product lawsuit against the manufacturer.
Your medical records and lab studies will establish that you were implanted with the recalled product. They will also prove that your medical condition was caused by the Allergan implant. The records will also document the type of treatment required due to the condition and your treating doctor can provide testimony regarding your overall prognosis and likely outcome.
How Much are Allergan Implant Lawsuit Settlements?
The settlement payout amounts have not been determined. Cases are just being investigated as this is a new recall. As a result, the lawsuit process is still in the investigation stage.
Many patients have or will have to undergo surgeries to remove the implants as well as cancer type treatment for the condition. This takes a huge physical and emotional toll on the patient and family.
Under the product liability laws, victims are generally entitled to compensation for the following:
- Physical pain and suffering, including past, present, and future
- Psychological and emotional damages, including past, present, and future
- Medical bills and expenses, past, present, and future
- Lost earnings and income
- Other economic losses
In cases involving a patient death, the family members can file a defective product wrongful death lawsuit.
Contact Our Allergan Breast Implant Lawsuit Lawyers
If you or someone you care about has been diagnosed with lymphoma and has an Allergan implant, contact our lawyers today to start your case.
There are strict time deadlines for filing claims. We charge no legal fees until you receive a settlement and we pay all of the case costs.
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