Dive Brief:
- Health Canada said it will update its safety review of breast implants after a spike in confirmed and suspected cases of a form of cancer known as breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.
- The Canadian health regulator said it has received reports of 22 confirmed and 22 suspected cases of BIA-ALCL since Jan. 1. The figures compare with five confirmed cases over a 10-year period reported in the agency’s initial safety review in 2017.
- Health Canada attributed the increase in cases primarily to greater awareness of BIA-ALCL by the public and healthcare professionals.
Dive Insight:
The increased scrutiny of breast implant safety in Canada follows the agency’s announcement in December that it plans to strengthen regulation of all medical devices and take steps to improve reporting of safety incidents.
Health Canada’s move comes in the wake of a series of articles by the International Consortium of Investigative Journalists, dubbed the Implant Files, that faulted both regulators and manufacturers for poor testing of medical devices and underreporting of injuries and deaths related to implants.
An ambitious action plan, unveiled by the Canadian regulator in December, called for the release of more information about decisions made on medical devices, hiring of additional inspectors and analysts, establishment of an adverse event reporting network, and creation of an expert advisory panel specifically to address women’s health issues, among other goals.
Health Canada said it will work closely with its international counterparts, including FDA, the European Commission's Scientific Committee on Health, Environmental and Emerging Risks and France's health regulator, Agence Nationale de Sécurité du Médicament et des Produits de Santé, to exchange data on breast implant safety and “ensure alignment when appropriate.”
Last week, FDA said that it had become aware of at least nine patients dying from BIA-ALCL, and that as of September 2018, it had received 660 medical device reports related to the implants indicating 457 unique cases since 2010. FDA plans to hold an advisory committee meeting in March to examine breast implant risks.
In September, MD Anderson Cancer Center shined a spotlight on risks associated with breast implants in a study that linked the devices with rheumatoid arthritis and scleroderma.
In December, manufacturer Allergan lost its CE mark in Europe for textured breast implants after France issued a mandatory recall of the devices.
BIA-ALCL is a form of non-Hodgkin lymphoma in which fluid builds up between the breast implant and surrounding tissue. It can develop months or years after an implant procedure, and occurs with both saline- and silicone gel-filled implants.
FDA first warned of a possible association between breast implants and BIA-ALCL in 2011, but lacked strong evidence linking the two. By 2016, the World Health Organization officially tied the cancer to the devices.
Health Canada said it expects to complete its breast implant safety review by this spring. At that time, it plans to inform Canadians and healthcare providers of actions required. The agency is consulting with the Canadian Society of Plastic Surgeons and Canadian Society for Aesthetic Plastic Surgery on its updated review, as it did in its initial review.
