An Allergan breast implant lawsuit is a claim against the pharmaceutical company Allergan for causing Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Plaintiffs allege that Allergan created defective breast implants and then failed to warn physicians and patients about the potential cancer risks.
The Allergan BIA-ALCL lawsuits are being joined into a multi-district litigation to speed up litigation and negotiations. Plaintiffs’ attorneys are seeking large monetary damages to cover victims’ medical bills, lost earnings, and pain and suffering.
In this article, our Allergan BIA-ALCL lawyers discuss:
- 1. Can Allergan breast implants cause cancer?
- 2. Have they been recalled?
- 3. Is the litigation a class action or individual lawsuits?
- 4. What financial compensation can I win?
- 5. Should I get my implants removed?
1. Can Allergan breast implants cause cancer?
Likely, yes. The U.S. Food and Drug Administration said that Allergan‘s textured breast implants “appeared to be directly linked to significant patient harm.” By January 5, 2020, FDA has logged 620 cases of BIA-ALCL in people with Allergan implants. The FDA reported:
[T]he risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences, including death, from BIA-ALCL.1
According to the available data, the median period of time between implantation of Allergan textured implants and a BIA-ALCL diagnosis is eight years.2
BIA-ALCL is not breast cancer. It is a kind of non-Hodgkin’s lymphoma, which is an immune system cancer. Certain genes mutate, causing T-cells to overproduce the protein ALK1 (anaplastic lymphoma kinase). This T-cell lymphoma may result from inflammation as the scar tissue forms following the breast implant surgery or from any bacterial contamination at the surgical site.
Symptoms of BIA-ALCL may include:
- Swelling of the lymph nodes
- Enlarged breasts
- Breast or underarm lumps / masses
- Changes in breast appearance, including asymmetry
- Breast hardening
- Less appetite
- Losing weight
- Night sweats
BIA-ALCL typically grows in the fluid and scar tissue by the implant. This rare cancer is curable if the plastic surgeon can remove the cancer and implants. But if the cancer spreads (“metastasizes”), BIA-ALCL can be fatal.3
2. Have they been recalled?
Yes. On July 24, 2019, the FDA requested that Allergan recall certain models of its textured breast implants. Shortly afterwards, Allergan initiated a worldwide voluntary breast implant recall of its Natrelle BIOCELL textured products. These recalled implants include:
- Natrelle Saline breast implant styles 168, 363, 468
- Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle 510 Dual-Gel styles LX, MX, FX
- Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
- Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
- Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
- Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
- Natrelle 150 Full Height and Short Height double lumen implants
- Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
- Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T4
And on September 29, 2020, the FDA recommended that all patients considering breast augmentation be warned that they have been associated with BIA-ALCL, and that this cancer develops more frequently in patients with textured – rather than smooth – implants.5
Sales of Allergan’s textured breast implants had already been suspended back in December 2018, throughout the European Union, Australia, Israel, and Brazil.6 And Canada suspended the company’s BIOCELL breast implant license in May 2019.7
3. Is the litigation a class action or individual lawsuits?
Individual lawsuits. But since December 2019, they all are being temporarily joined in a federal court MDL – short for multi-district litigation. Like class action lawsuits, MDLs expedite the litigation process involving large numbers of plaintiffs. But unlike class actions, MDLs keep the lawsuits separate.
At some point the MDL judge will order that a few representative cases go to trial. And how these bellwether trials turn out will serve as a starting point for settlement talks with all the remaining plaintiffs.
The Allergan MDL is out of the federal district of New Jersey. The MDL number is 2921. The case name is Allergan BIOCELL Textured Breast Implant Products Liability Litigation. And the presiding judges are the Honorable Brian R. Martinotti and Joseph A. Dickson.
Common claims in Allergan breast implant lawsuits are:
- Defective design
- Failure to warn; and
4. What financial compensation can I win?
Plaintiffs’ attorneys in Allergan breast implant cancer lawsuits are fighting for reimbursements for:
- All medical expenses, including surgery, radiation, and chemo as well as reconstructive surgery;
- Lost past and future earnings from being unable to work due to illness or treatment;
- Pain and suffering, which is often the largest expense;
- If the victim died, loss of support and funeral expenses; and/or
- Punitive damages for making a defective medical device, if applicable
5. Should I get my implants removed?
The FDA recommended that symptom-free people with Allergan textured implants not get them removed due to the low cancer risk. But they should consult with a women’s health care provider if they have any questions about the pros and cons of an implant removal.8
- The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication, FDA.gov. (Content current as of June 1, 2020). See also Anne K Groth & Ruth Graf, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and the Textured Breast Implant Crisis, Aesthetic Plastic Surgery (October 17, 2019).
- FDA Executive Summary Breast Implant Special Topics, Prepared for the Meeting of the General and Plastic Surgery Devices Advisory Panel, FDA.gov (March 25 and 26, 2019).
- Breast Implant-Associated Anaplastic Large Cell Lymphoma, Cleveland Clinic (February 21, 2019); Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), FDA.gov. (Content current as of October 23, 2019).
- Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders, FDA.gov. (July 25, 2019).
- Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Guidance for Industry and Food and Drug Administration Staff, FDA.gov. (September 20, 2020).
- See note 2.
- Health Canada suspends Allergan’s licences for its Biocell breast implants after safety review concludes an increased risk of cancer, Government of Canada (May 28, 2019).
- FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market, FDA.gov (July 24, 2019).