Canada intends to suspend sales of Allergan Biocell implants as a “precautionary measure” due to the risk of an immune-system cancer known as breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
“To protect Canadian patients from the rare but serious risk of BIA-ALCL, Health Canada is advising Allergan that the department intends to suspend its licences for Biocell breast implants as a precautionary measure,” Health Canada said in a press release.
Meanwhile, Dutch regulators will temporarily suspend macro-textured and polyurethane implants, two categories of implants linked to higher risks of BIA-ALCL.
The moves came two days after French authorities imposed a sweeping ban on macro-textured and polyurethane implants.
“The scrutiny of breast implants and risk to women is now clearly in the sights of all regulators and being demanded by patients and the media,” Dr. Anand Deva, a plastic surgeon in Sydney, Australia, who has studied breast implant safety extensively, told ICIJ.
The responses by regulators come after the International Consortium of Investigative Journalists reported last November that thousands of women around the world have suffered serious health problems after getting breast implants in its global Implant Files investigation.
Health Canada said that it was giving the company 15 days to present any new evidence, after which it would suspend its license to sell Biocell implants in Canada unless it receives a “satisfactory response.”
In the Netherlands, Health Minister Bruno Bruins wrote a letter to the Dutch parliament announcing that he was temporarily suspending sales of the products banned this week by France.
Bruins wrote that Dutch regulators would conduct their own assessment of the safety of textured breast implants by May, but that he was suspending sales of the products until the assessment is completed.
“Depending on the results of the National Institute for Public Health and the Environment investigation, further appropriate measures will be taken,” Bruins wrote.
The moves reflect recent research indicating that macro-textured and polyurethane implants pose greater risks of BIA-ALCL than other types of implants, including other textured implants.
Textured breast implants have a rough surface that is sometimes compared to sandpaper. Unlike smooth-surfaced implants, their surface adheres to the tissue that surrounds them, preventing them from moving around within the implant pocket created by the surgeon.
According to one forthcoming study, Silimed polyurethane textured implants pose a 23-times higher risk of ALCL, and Allergan Biocell textured implants pose a 16-times higher risk of ALCL, than lower surface area Siltex textured implants by Johnson & Johnson. Based on data from Australia and New Zealand, the study will appear in the May issue of the journal Plastic and Reconstructive Surgery.