- Canadian health regulators have ordered Allergan's Biocell breast implants off the market, thereby ending the sale of any macrotextured implants in the country.
- The announcement Tuesday rounded out a 2017 safety review on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) that found 85% of Canadian cases of the cancer were tied to Allergan implants with the macrotextured Biocell surface.
- Health Canada notified Allergan April 4 of its intent to suspend marketing licenses for the affected implants. The agency found safety information contained in the manufacturer's response "insufficient" to support continued marketing of five implant models, with potential risks outweighing potential benefits.
Between the time Health Canada moved to suspend Biocell implants and when regulators made it official Tuesday, FDA announced its approach to breast implant regulation would not include any bans.
"The type of macro-textured implants targeted by some of our international counterparts represents less than 5% of breast implants sold here," FDA wrote May 2. "At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act."
FDA's approach instead involves plans to make adverse event reporting previously hidden from public view more accessible and to work with stakeholders on a possible patient checklist and boxed warning for breast implants. Similarly, Health Canada said it would work with manufacturers to better communicate BIA-ALCL risk in instructions for use and engage with stakeholders to improve informed decision-making tools resources for patients.
In Canada, 22 out of 26 confirmed BIA-ALCL cases involved Allergan Biocell implants. Regulators said they have not received any definitive reports of BIA-ALCL linked to smooth implants. Health Canada estimates the risk of developing BIA-ALCL to be one in 3,565 with Biocell implants, compared to one in 16,703 for Mentor's Siltex micro-textured devices.
U.S. regulators were aware of 457 unique cases of BIA-ALCL as of Sept. 30, 2018, they said ahead of a March FDA advisory committee panel on breast implants. Representatives from Health Canada participated in the meeting.
"Most confirmed cases of BIA-ALCL have occurred in patients with textured surface implants, although there are known cases in patients with only smooth-surface breast implants," FDA said on its BIA-ALCL web page.
Advocates of the textured surface option say it can help implants hold in place better, and can reduce risk for capsular contracture. But macrotextured implants are also more likely to harbor bacteria than implants with smooth or microtextured surfaces, which may increase risk for BIA-ALCL.
Health Canada's action affects five Allergan licenses. The regulatory body said Allergan agreed to voluntarily recall unused affected devices from the Canadian market. The company will continue to sell other breast implant models in Canada.
Allergan's international breast implant sales amounted to $11.2 million in the most recent quarter, compared to $61.2 million in the U.S. market alone.