- 1 multi-billion-dollar international corporation
- 1 dangerous product
- 400,000 customers each year in the U.S. alone
- 1 weak regulatory agency
- Many missed opportunities to disclose the dangers
Bake: For a decade or so.
Yield: Hundreds of cancer diagnoses and a big, fat product liability MDL.
The company is Allergan, and they truly are a corporate giant. According to the company’s website, they sell their products in 175 countries, their products treat 60+ conditions, they have 220+ research partnerships, and they have manufacturing or R&D facilities in 14 countries.
A pharmaceutical company based in Dublin, Ireland, Allergan “acquires, develops, manufactures, and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology.” Their medical aesthetics product line includes BOTOX®, CoolSculpting®, CoolTone™, Juvéderm®, and breast implants.
In 2019, the U.S. drug company AbbVie bought Allergan for $63 billion in one of the biggest deals in the global pharmaceutical industry.
The dangerous product we’re talking about here is breast implants.
The most common kind of cosmetic surgery is breast augmentation. In 2018, more than 310,000 women and teenagers in the United States underwent surgery to have their breasts enlarged with silicone or saline implants — a number that has more than tripled since 1997, when there were just over 101,000 of these procedures.
In addition to those who received implants for augmentation, about 100,000 breast cancer patients had reconstruction surgery after mastectomy, often with implants.
The lawsuits concern one particular type of breast implant: Allergan BIOCELL textured breast implants, including its Natrelle saline- and silicone-filled breast implants and tissue expanders. These products all have the same BIOCELL textured shell, which is a unique surface used only by Allergan.
Allergen BIOCELL implants do not cause breast cancer, they cause lymphoma (cancer of the immune system).
The type of cancer is called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma. In most cases, BIA-ALCL is found in the scar tissue and fluid around the implant, but in some cases, it can spread throughout the body. The disease is caused by the mutation of a specific gene which causes T-cells to produce excess amounts of a protein known as anaplastic lymphoma kinase (ALK1). The median time from implantation to diagnosis of ALCL is eight years.
Some traditional tests and routine breast cancer screenings, such as mammograms, may not be helpful in diagnosing BIA-ALCL. This is not because the breast implants “hide” the cancer, but because only very specific tests are able to find the microscopic evidence of BIA-ALCL. Additionally, because BIA-ALCL is a relatively rare condition and not always recognized by doctors, some women who developed it had difficulty getting the correct diagnosis and proper care.
As of January 5, 2020, a total of 733 cases of BIA-ALCL were submitted to the FDA. Of these, 620 (85%) reports involved Allergan breast implants.
FDA Approval with Conditions
The FDA approved Allergan breast implants in November 2006 on the condition that they conduct a large, 10-year study of nearly 60,000 participants with gel- and saline-filled implants to characterize the long-term performance and safety of the devices.
Conditions Not Met
Nine years later, in 2015, the FDA said the studies continued to show poor recruitment and follow-up rates, and did not collect adequate safety data at the four-year mark, including rates of local implant complications.
In response to Allergan’s utter failure to comply with the original condition, the FDA simply scaled it back, approving a redesigned trial protocol with a lowered enrollment target of 2,775.
- December 2018: Sales of textured Allergan breast implants were suspended in all 33 countries in Europe as well as Israel, Brazil, and Australia.
- March 2019: Back in the U.S., the FDA held hearings but did not move to recall the devices.
- May 2019: Health Canada suspended Allergan’s license for its BIOCELL breast implants after an internal safety review concluded that these implants conferred an increased risk of BIA-ALCL.
- July 2019: Allergan and the FDA announced a recall after an investigation confirmed that Allergan BIOCELL textured breast implants were linked to a higher cancer risk than any other type of breast implant. “The FDA’s analysis was attributed to a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.”
Dr. Elisabeth Potter, a plastic surgeon in Austin, Texas, has cared for women with cancer after receiving textured implants. She says the recall is an important step to protect women from the potential risks of textured implants.
“It was influenced by folks speaking up when the FDA didn’t act quickly enough,” Potter says. “The power is now back in a woman’s hands, and the FDA is backing her up. “
In December 2019, the JPML ordered that all cases pending in Federal Courts throughout the country be transferred to the United States District Court for the District of New Jersey under the Honorable Brian R. Martinotti, and U.S. Magistrate Judge Joseph Dickson.
The leadership structure appointed by the Court is inclusive and diverse, with three of the four Co-Leads being women, as are three of the seven-member Plaintiffs’ Executive Committee, and half of the twelve-member Plaintiffs’ Steering Committee.
Defendant Pushed to Take Action
The FDA issued two warning letters in May 2020 to breast implant manufacturers, including Allergan, for failing to complete post-market safety studies documenting the risks of two implant models the company took off the worldwide market last year.
Just one month later, Allergan launched a dedicated multi-channel campaign to contact patients who may not be aware of the July 24, 2019, recall of BIOCELL textured breast implants and tissue expanders. In a recent follow-up statement, Allergan announced the creation of the BIOCELL Replacement Warranty for all patients in the U.S. who currently have BIOCELL textured breast implants.
“For those who choose to replace their BIOCELL® textured devices with smooth devices in consultation with their plastic surgeon, the company will provide Allergan smooth device replacements for free. The program will run for 24 months, until July 24, 2021, and will apply to revision surgeries on or after the date of the recall announcement, July 24, 2019.” The warranty does not cover surgical fees, just the cost of the smooth breast implants themselves. This is because the FDA is not currently recommending that patients with BIOCELL textured breast implants undergo removal prophylactically.
By August 2020, more than 280 lawsuits were pending in the MDL. We will be keeping a close eye on this as it progresses through the court and will keep you posted as new developments occur.
- AGN Investor Alert – Bronstein, Gewirtz & Grossman, LLC Notifies Investors of Class Action Against Allergan plc and Lead Plaintiff Deadline – October 29, 2020
- Mazie Slater: Allergan Breast Implant Recall
- FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue
- American Board of Cosmetic Surgery Update on BIA-ALCL Allergan Recall of Textured Breast Implants
- Fierce Biotech: Allergan Receives FDA Warning Over Recalled Breast Implant Safety Studies
- MDL Panel Sends Allergan Breast Implant Cases to the Honorary Brian Martinotti U.S. District Court District of New Jersey
- Case 2:19-md-02921-BRM-JAD Document 31 Filed 01/17/20
- Special Report: Breast Implant Illness and BIA-ALCL
- Our Bodies, Ourselves: Facts About Breast Implants