The lack of controls on the products used in medical implants has allowed thousands of materials without guarantees to end up placed inside the patients' body. In Europe there is no single agency that supervises these products, but in addition, there is no database that collects the incidents they produce to warn of negative effects. No studies are required with patients to prove their proper functioning, according to an investigation by the International Consortium of Investigative Journalists that has offered this Sunday La Sexta and El Confidencial.
These are implants such as hip prostheses, pacemakers, intraocular lenses or contraceptive devices. In Spain there are 13 daily problems with one of these implants, according to the research. The information reveals internal emails from the certification bodies in which they admit that 96% of all types of implants are approved worldwide with the only proof of a technical report: no tests are required on human subjects to certify their effectiveness and absence of problems
In Europe, for example, any element destined to be implanted must have a CE certificate that guarantees its quality. The problem, says the newspaper report, is that there is no common control. Each state has its own agency and they do not share quality criteria, so it is a crack for which a product can go to look for that CE label to a country with more lax filters. This CE does not indicate in which state the approval has been obtained. The doctors are there, so they are implanting materials with the CE certificate of guarantees with very different origins.
The pathologies in which implants and materials are applied are very extensive. The research of La Sexta shows how the lack of control and the lack of common regulation reaches faulty pacemakers, patients operated with refractive surgery, joint prostheses … The information explains that there are up to 52 organisms that issue certification without sharing criteria or information.
These cracks in the system cause a device to be banned in one state due to the secondary effects it causes and, at the same time, continue to be implemented without restriction (and legally) in another country: alert systems have not been enabled to notify the authorities sanitary facilities where this material is also authorized. It will continue to be placed until it reaches, by some channel, that notice