Allergan has been named in a class action complaint that seeks to benefit Canadian recipients of the company’s allegedly defective breast implants.
The breast implant lawsuit was filed earlier this week in the Ontario Court of Justice and names a Toronto woman as the Representative Plaintiff. According to the complaint, she has suffered a range of debilitating symptoms and ailments since receiving Allergan breast implants in January 2014. The woman plans to have the devices removed in a bid to alleviate her suffering and mitigate the risk that she might develop breast-implant associated anaplastic large cell lymphoma (BIA-ALC) in the future.
Among other things, the complaint claims that Allergan knew or should have known of the potential for “breast implant illness” and BIA-ALC, but failed to provide Canadian patients with adequate warnings about or announce a recall. The plaintiff further asserts that she would never have undergone breast implant surgery but for the lack of proper warnings.
Just last month, Health Canada announced a ban on Allergan’s Biocell textured breast implants after a review confirmed that 24 of 28 Canadian women with BIA-ALCL had received those devices.
Biocell products were also among six polyurethane or textured implants recently banned in France due to similar concerns. Allergan’s certification to market Biocell breast implants actually expired in December, and the company had already withdrawn the devices.
More than 600 women worldwide have developed BIA-ALCL, most after having received textured breast implants. At least 17 have died from the rare form of cancer.
Thousands of others have reported “breast implant illness,” a condition that purportedly causes a range of troubling symptoms, including autoimmune, musculoskeletal and neurological disorders, and cognitive issues.
Earlier this month, the U.S. Food & Drug Administration (FDA) finally acknowledged that some breast implant patients had experienced “systemic symptoms” that only alleviated once the devices were removed. While the agency ruled out a ban, it is considering several actions to ensure women and doctors are aware of the risks linked to breast implants, including a black box warning and requiring that doctors go over a checklist with their patients prior to surgery.
The FDA also said it would require breast implant manufacturers to file individual reports on adverse events that will be made publicly available in the coming weeks. Previously, the companies were only required to provide a summary of patient problems or concerns. Unfortunately, that practice allowed the FDA to miss “unusual, unique or uncommon adverse events, which, in the case of breast implants, included BIA-ALCL.”