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A class action lawsuit filed in Canada calls for Allergan to cover the costs of having its Biocell implants removed from women suffering from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has been linked to the large-surface area, textured implant.
The complaint was filed last month in the Supreme Court of British Columbia and the Court of Queen’s Bench of Alberta, indicating Allergan failed to provide adequate warning about the textured breast implant risks when Biocell was sold in the country.
The lawsuit notes that while most cases of BIA-ALCL are resolved by having the implants removed, in many cases Canadian health care plans do not cover the removal cost, which can be as much as $10,000. The class action over the breast implant still needs to be approved by a judge.
Late last month, Canadian regulators issued an Allergan Biocell breast implant recall, banning sale of the device throughout that country. Health Canada, the country’s medical regulatory agency, indicated that Biocell implants were linked to 85% of the cases of BIA-ALCL recorded in that country.
In April, French regulators also announced a macrotextured breast implant recall in that country, saying that the implants have been overwhelmingly associated with development of ALCL that develops in the surrounding tissue.
Despite growing evidence linking textured breast implants and lymphoma, similar recalls have note been announced in the U.S., where the textured surfaces make up only a small portion of sales. The FDA recently decided against a complete ban, indicating cases of BIA-ALCL have also been linked to smooth textured implants, leading the agency to instead opt to place stronger warning labels on the implants.
Breast Implant Cancer Risks
The FDA first warned about case studies and epidemiological research that suggested there was a link between breast implants and ALCL in January 2011. Several years later, in 2017, the agency issued an updated statement about emerging information on breast implant lymphoma problems, and a number of subsequent studies have confirmed the risk of breast implant-associated ALCL.
In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants. Another study, published in October 2017, warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.
In March 2018, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer. A year later, in March 2019, the FDA held a two-day hearing on breast implant safety and benefits, revealing that it has received tens of thousands of reports of breast implant complications.
Despite growing concerns, the panel of FDA advisers decided against recommending any breast implant recalls, indicating that it was too early to determine whether the risks were limited to specific breast implant designs.