Allergan Breast Implant Lawsuits

As of November 2024, there were 1,215 pending lawsuits in multidistrict litigation (MDL) 2921 before U.S. District Judge Brian R. Martinotti in New Jersey.

On July 24, 2019, the Food and Drug Administration announced that it had found evidence that Allergan textured breast implants had a higher risk of Breast Implant Associated Lymphoma than other textured implants.

The manufacturer issued a worldwide recall for several brands of its Biocell textured breast implants after the FDA requested the company pull the devices from the United States market. Allergan’s subsidiaries Inamed and McGhan manufactured some of the recalled devices.

The main injury claimed in Allergan breast implant lawsuits is a rare type of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. So far, the majority of reported cases worldwide involved Allergan’s textured implants, according to the FDA.

BIA-ALCL is not breast cancer. It is a type of non-Hodgkin lymphoma. These cancerous cells develop in scar tissue and fluid near the implant, and in some cases it can spread and lead to death. However, in September 2022, the FDA issued a safety communication warning the public that types of cancer other than BIA-ALCL have been found in the scar tissue that surrounds smooth and textured implants.

Treatment requires surgery to remove the implant and affected tissue. In some cases, patients require radiation and chemotherapy. Although the disease is treatable, it can still cause trauma in patients.

“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. “Capsulectomies, positron emission tomography and computed tomography, the cost of medications (brentuximab is very expensive), and the emotional and financial impact of BIA-ALCL take a heavy toll on affected women, even if the disease is seldom fatal.”

Swanson wrote that some plastic surgeons feel it is time to abandon textured implants. He cited data from non-industry funded studies showing Allergan’s Biocell textured implants have more complications.

In addition to the BIA-ALCL risk, these implants also had greater incidences of seromas, or fluid pockets, compared to other implants. They also carried a greater risk of performance failure, pain, rupture and scar tissue around the implant known as a capsule.

Symptoms of BIA-ALCL

Symptoms of BIA-ALCL mainly include persistent swelling or pain around the breast implant. These symptoms can occur several years after receiving the implant.

A doctor may find evidence of fluid collection around the implant or capsular contracture, which occurs when scar tissue squeezes the implant. Some women have reported lumps in their breasts.

When Did the FDA First Know About the Risk?

The FDA first identified a possible association 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. In 2017, the FDA announced BIA-ALCL was primarily associated with textured implants.

The FDA held a public advisory committee meeting in March 2019 to discuss risks. Initially, the agency declined to recommend a recall. Then new data in July 2019 showed a spike in BIA-ALCL cases.

This data led to the July 2019 Allergan textured implant recall.

In August 2022, FDA reported that it had received 1,130 reports of BIA-ALCL as of April 2022. Of the 1,130 cases of BIA-ALCL reported worldwide, 953 — or 84 % — were reported for Allergan implants.

As of the most recent update in June 2023, reports climbed to 1,264. Of those reports, 1,079 involved an Allergan implant — or 85%.

The FDA received 63 reports in which a patient had died, as of June 2023. Thirty-seven of those patients had an Allergan breast implant at the time of their BIA-ALCL diagnosis.

If you are unsure if you have a Biocell textured implant, check with your plastic surgeon.

Plaintiffs in Allergan’s textured breast implant lawsuits allege the devices caused women to develop BIA-ALCL. They further allege that the defendants failed to adequately warn against this risk and failed to promptly and properly report the results of the post-marketing studies relating to these products, according to Allergan’s 2018 annual report.

Two of the women who have filed lawsuits are Vivian Skelton and Sandra Rush.

Several Allergan breast implant class action cases have been filed and are among the actions that have been consolidated in a multidistrict litigation in New Jersey. These cases are not the same as the personal injury cancer cases.

In addition, the International Consortium of Investigative Journalists reported that investors have filed a class action lawsuit claiming Allergan plc headquartered in Dublin, Ireland, concealed the link between its textured implants and the rare type of lymphoma. The suit also claims Allergan failed to inform investors that the safety findings threatened regulatory approvals in Europe.

Shareholders Accuse Allergan of Fraud

Thomas F. Cook filed the class action in New York on Dec. 21, 2018. Cook’s fraud lawsuit claimed Allergan “employed devices, schemes, and artifices to defraud” shareholders and mislead them about its textured breast implants.

“Allergan misled investors by boasting about various ‘pharma and device approvals,’” Cook’s lawsuit claimed. “The truth was revealed on December 19, 2018, when the Company announced that it had suspended the sale of [textured breast implants and tissue expanders] and that it was withdrawing all remaining supplies from European markets.”

The lawsuit came after Allergan announced it had lost its textured implant CE Mark, a European safety certificate needed to sell its devices in 33 European countries.

The French accredited certification firm LNE G-MED did not renew the company’s CE Mark because it wanted to see further data from Allergan before re-issuing the safety certificate, the International Consortium of Investigative Journalists reported.

French Recalls

Meanwhile, French regulator Agence Nationale de Sécurité du Médicament asked Allergan to recall batches of affected products from all French hospitals.

“Allergan stands behind the benefit/risk profile of our breast implant products. The ANSM request, and this action, is not based on any new scientific evidence regarding these products,” Allergan said in a Dec. 19, 2018, press release regarding its decision to suspend sales and withdraw textured breast implants in Europe.