Following an international enquiry into defective medical implants—Implant Files, launched in 2014—there have been calls for a European marketing authorisation for implants after a comparative study with a benefit/risk ratio, as with medicinal products. To date, numerous incomplete records have been deemed admissible and, all over the world, many victims have been compensated. Some have died.
This involves Essure implants in particular. They were approved in Europe and the US in 2001 and 2002, respectively. Approximately 1 million women received these implants. Thousands of cases with complications were recorded such as oxidation or migration of the implant towards the abdomen, causing perforations. In France, these devices were removed in approximately 1,000 cases. Legal proceedings have been initiated.
The Essure marketing authorisation was suspended in Europe last year. Bayer stopped sales in the US, citing a decline in demand, and in Australia, justifying the decision on commercial grounds.