The reality of the lack of implant regulation in Europe is finally starting to bite.
A leaked internal FDA report “Unsafe and ineffective devices approved in the EU that were not approved in the US,” has lambasted the European system and highlighted failures in the processes.
According to the Star Tribune, the report says that the EU demands less evidence and allows private, for-profit companies to approve products for sale throughout Europe’s 27 member countries. Approvals and the evidence on which they are based are not disclosed publicly—and neither are side effects or recalls, says the newspaper.
However, it looks as though some members of the European Parliament are starting to agree. At a meeting on Wednesday, the Environment, Public Health and Food Safety Committee met to discuss the recent high profile failures of PIP breast implants and some hip prostheses.
The handling of these sagas has led to “serious negative impact on public health,” the committee said.
BMJ investigations and research have highlighted the shortcomings in device regulation: http://www.bmj.com/content/342/bmj.d2748, http://www.bmj.com/content/342/bmj.d2822, http://www.bmj.com/content/342/bmj.d2973.
Premarket studies for any implants are not mandatory in Europe, but the committee thought that this should change. Other measures include a single European data base to bring together information about medical devices on the market. This would include post-market surveillance, clinical investigations carried out, and CE certificates issued.
Deborah Cohen is the BMJ investigations editor. Follow her on twitter @deb_cohen