France’s national health regulator refused to renew approval Tuesday for two types of Allergan textured breast implants. That means Allergan cannot sell its Microcell and Biocell textured breast implants in Europe.
The agency advises patients with the implants to undergo regular checks with their doctors for a blood cancer called anaplastic large cell lymphoma (ALCL), which occurs more often in women with textured breast implants. Plastic surgeons have identified more than 600 cases worldwide. ALCL is treatable.
The U.S. Food and Drugs Administration permits the sale of such implants despite knowing since 2011 about the increased risk. Last week the agency agreed to hold a meeting of medical advisors in 2019 to address concerns.
In November, the International Consortium of Investigative Journalists reported on the lack of transparency and rigor in government oversight of medical devices. U.S. figures alone revealed an average of 8,000 deaths a year linked to medical devices. The breast implant cases were one of those highlighted in the reporting.
The Guardian estimates that the medical technology market in Europe is worth around $125 billion a year, so regulators are up against a lot of economic heft.
Worried about your own implant? The ICIJ has built a database noting more than 70,000 recalls, safety alerts, and other device-related medical notices.
