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Canadian health officials intend to ban Allergan’s Biocell textured breast implants in that country, due to concerns that the products may cause women to develop a rare type of cancer, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Health Canada issued a press release on April 4, advising Allergan of the agency’s decision to suspend its license to sell the Biocell breast implant in that country. The agency says it is a precautionary measure, after determining that the Biocell was linked to 86% of all reported cases of BIA-ALCL in Canada.
The pending ban comes after Health Canada completed a scientific assessment of macro-textured breast implants, as part of a larger safety review which has been ongoing since November 2018, according to the agency.
“Health Canada initiated the review because of an increase in Canadian and international cases of BIA-ALCL,” the press release states. “As of today, Health Canada has been notified of 28 confirmed Canadian cases of BIA-ALCL, of which 24 (86%) involve Allergan’s Biocell breast implant.”
Allergan’s Biocell is the only macro-textured breast implant sold in Canada, and the manufacturer has 15 days to respond to the notice of intent with any new evidence. If it cannot prove to the agency in that time that the implants are not dangerous, the license to sell the Biocell in Canada will be suspended.
The agency notes that its entire safety review will be made public before the end of April, and that it “will not hesitate” to take additional actions, if necessary.
Breast Implant Cancer Concerns
On January 26, 2011, the FDA first released a report about case studies and epidemiological research that suggested there was a link between breast implants and ALCL.
The agency then issued a statement about emerging information on the breast implant lymphoma problems last year, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real.
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.
In October 2017, a study published in the medical journal JAMA Surgery 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. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.
Last month, 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 advisors 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.