Since Allergan recalled its Biocell textured breast implants in July 2019 for causing a rare form of cancer, hundreds of women who underwent breast implant surgery are finding their cancer were caused by defective Allergan breast implants.
Five months later the Judicial Panel on Multidistrict Litigation consolidated four pending class actions involving Allergan to Federal Court in New Jersey. Since December 2019, some 66 cases are pending before US District Judge Brian R. Martinotti in MDL 2921, IN RE: Allergan Biocell Textured Breast Implant Products Liability Litigation.
Allergan’s textured implants are linked to women developing anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is not breast cancer. The cancerous cells develop in scar tissue and fluid near the implant, and in some cases, it can spread and lead to death. Some symptoms of ALCL include persistent swelling or pain near the breast implant, and development seromas, or fluid pockets.
“We cannot allow women to be unnecessarily harmed while we collect data,” Dr. Eric Swanson wrote in a February 2019 article in the Annals of Plastic Surgery. “The cost of medications and the emotional and financial impact of BIA-ALCL take a heavy toll on affected women, even if the disease is seldom fatal.”
Implants and Cancer
Plaintiffs seek to force Allergan to pay for the costs of surgery, diagnostic testing, and medical monitoring in people who have Biocell implants. For those who choose not to replace their Biocell implants, Allergan has refused to cover the costs of invasive diagnostic testing and medical monitoring.
The FDA has not linked smooth Allergan breast implants to cancer, and these are not involved in the recall.
At the time of the recall, the FDA also indicated that the breast implant cancer problems have resulted in:
- 573 Breast Implant BIA-ALCL cases reported worldwide.
- 84% (481) of the cancer cases involved Allergan Breast Implants.
- 33 deaths from BIA-ALCL have been identified.
- More than 90% of breast implant cancer deaths where the model is known to involve Allergan devices.
According to the FDA, the following products have been removed from the market:
- Natrelle Saline-Filled breast implants (Styles 168, 163, 363 & 468)
- Natrelle Silicone-Filled breast implants (Styles 110, 115 & 120)
- Natrelle Inspira Silicone-Filled breast implants (multiple “T” Styles)
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
- McGhan Bidimensional Silicone-Filled breast implants (Style 153)
- McGhan Croissant Shaped Tissue Expander (Style 134)
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
The textured implants carried a greater risk of performance failure, pain, rupture, and scar tissue around implant.
The FDA first identified a connection 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.
By 2017, the FDA announced BIA-ALCL was primarily associated with textured implants, which led to the recall.
In an early case, plaintiff Misty Riportella of Santa Clarita, California filed suit against Allergan on November 1, 2019, Case 8:19-cv-02103, in federal court.
Unbeknownst to Ms. Riportella, the FDA released a report on January 26, 2011 finding “[b]ased on the published case studies and epidemiological research, the FDA believes that there is a possible association between breast implants and ALCL.”
Back in March 2000 Riportella was implanted with a Textured Saline Filled 270 cc McGhan® Style 168 breast implant on the left (No. 27-168271 Lot MR7826) and Textured Saline-Filled 270 cc McGhan®Style 168 breast implant on the right (No. 27-168271 Lot MA4827).
At the time the implants were placed into Riportella’s body, she was not advised, nor did she have any independent knowledge, that they were anything other than safe, life-long products. Nor was she advised that the product was associated and/or known to cause BIA-ALCL.
Throughout the years, different physicians discussed diagnoses such as congestive heart failure, COPD, blood flow issues, and numerous other “causes” for how Riportella was feeling. She had multiple imaging studies, x-rays, ultrasounds, CTs, blood work-ups, heart monitoring to name a few of the battery of tests she underwent.
In February 2019, Riportella’s daughter noticed a significant swelling in one of her breasts. She went to the ER and several other doctors until she was diagnosed with BIA-ALCL in June 2019. The implants and one lymph node were removed on July 17, 2019.
“Had the medical community been made aware of the existence of the true frequency, severity and significance of BIA-ALCL caused by the products, medical professionals and providers, including those who advised and served Plaintiff, would not have advised patients, including Plaintiff, to proceed with implantation of the products,” the complaint says.