A recent voluntary breast implant recall has sparked a class action lawsuit against the manufacturer, Allergan Inc., and related companies over the potential risk of breast implant cancer.

The Food and Drug Administration (FDA) requested several styles of Allergan’s Natrelle silicone-filled and saline-filled textured breast implants and tissue expanders be recalled in June 2020.

The breast implant recall was issued to protect consumers from a statistical increase in risk associated with these products and the development of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The disease is a type of non-Hodgkin lymphoma that develops in and around the tissue surrounding a breast implant.

According to WebMD, Allergan responded to the request by recalling the breast implant and pulling all of the associated products from global availability. The FDA had connected 481 cases of BIA-ALCL to the textured surface which is unique to the defendant’s manufacturing process, according to WebMD.

WebMD reports that 573 cases of non-Hodgkin lymphoma have been diagnosed worldwide. Of these cases, 33 people have died from the disease. In 13 out of the 33 deaths, it was ascertainable which implants were involved and 12 of them were among the list of textured products made by Allergen.

Breast Implant Cancer Class Action Lawsuit

In July 2018, plaintiff Jane Doe 1 was diagnosed with an invasive breast cancer known for its tendency to spread to lymph nodes. She chose to remove both breasts two months later to treat the disease and prevent its metastases. During surgery, Jane Doe 1 was implanted with the defendant’s tissue expanders to prepare for BIOCELL implants.

Unaware of the risk of BIA-ALCL associated with Allergan’s now recalled textured breast implants, Jane Doe 1 underwent breast reconstruction surgery in June 2019, less than a year after her double mastectomy. According to the lawsuit, the implants had been banned in European markets due to these risks, but the defendant continued to sell them without warning in the U.S.

A month after her surgery, Allergan “issued a nationwide and worldwide recall of its BIOCELL implants in response to pressure from the United States FDA and regulators in Europe,” according to the lawsuit.

“Plaintiff Jane Doe 1, like Jane Doe 2 and the many thousands of other women who likewise had BIOCELL implants, was utterly shocked at this bombshell news and beside herself with fear,” the lawsuit states.

Jane Doe 2 — a New Jersey native now living in Delaware—underwent a prophylactic double mastectomy in 2006 after learning she carried a mutated BRCA2 gene. In 2015, according to the suit, Jane Doe 2 had reconstructive surgery with Allergen textured breast implants.

Both women are suing Allergen and seeking compensation for all expenses related to the removal of the recalled products, the surgical procedure to put in implants of their choice, as well as for lost income and related pain and suffering. Jane Does 1 and 2 seek to represent a class of similarly situated women nationwide and in the states of New York, New Jersey, and Delaware.

Class Action Consolidated with Other Allergan Lawsuits

In December of 2019, the Allergan class action lawsuit was consolidated with other cases over the recalled implants. The claim was transferred by the U.S. Judicial Panel on Multidistrict Litigation to a federal court in New Jersey.

“All actions arise out of Allergan’s announcement on July 24, 2019, of a voluntary worldwide recall of its BlOCELL textured breast implants and tissue expanders,” noted the transfer order. “All actions share complex factual questions arising from the allegation that Allergan’s BIOCELL textured breast implants and tissue expanders significantly increase the risk of developing BIA-ALCL, and that Allergan failed to warn the FDA, patients, and healthcare providers of this risk.”

Judge Says No ‘Jane Does’

A New Jersey federal judge recently ruled that the plaintiffs in the Allergan Multidistrict Litigation (MDL) will not be allowed to remain anonymous in court proceedings. The plaintiffs argued that they should be able to remain “Jane Does” to protect the anonymity of their medical histories.

However, the federal court judge found that the plaintiffs had not adequately established how they would be harmed if their identities were disclosed in court documents.

“The Court notes that this was a bit of an uphill battle from the outset, as Plaintiffs made their argument through generalizations and hypothetical situations, rather than focusing on any particular Plaintiff’s actual circumstances,” stated the order.

The Allergan class action lawsuit is currently pending, along with the other lawsuits, in New Jersey federal court.

The Allergan Breast Implant MDL is In Re: Allergan BIOCELL Textured Breast Implant Products Liability Litigation, Case No. 2:19-md-02921-BRM-JAD in the U.S. District Court for the District of New Jersey.

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This article is not legal advice. It is presented
for informational purposes only.