In germany last year, 14.034 cases had been reported involving injuries, deaths or other problems that could be related to medical devices. The broadcasters NDR and WDR as well as the "suddeutsche zeitung" reported that the number of suspected cases of fraud was rising sharply. The three media outlets would have investigated the matter in cooperation with the international consortium of investigative journalists (ICIJ) as well as some 60 media partners. The research would be published worldwide under the title "implant files".
The increase in the number of reports has been registered for years by the responsible authority – the federal institute for drugs and medical devices (bfarm) – and is also published. The most recent figure on the website is from 2016, when 12.000 cases have been reported.
However, according to its own account, the institute has found in its reviews in the past that in about 40 percent of cases the reported problem did not originate from the medical device. It was therefore in the legal sense no reportable "occurrence" had been. For example, the institute refers to a malfunction or improper designation of a medical device that could have led to the death or deterioration of the health of a patient.
According to the bfarm, there are several reasons for the increase in notifications: on the one hand, the number of medical devices is increasing. On the other hand, however, the number of reports of problems is also on the rise, he says. There is a significantly improved reporting behavior of doctors and clinics, said bfarm spokesman maik pommer to dpa. The bfarm regularly reminds physicians and hospitals of the obligation to notify.
However, according to NDR, WDR and "SZ", there is a lack of compliance with this reporting obligation. The example of breast implants illustrates this: according to the research association, 3170 implants were removed from german hospitals last year because the tissue around the silicone cushions was painfully scarred; however, only 141 of these cases were reported.
As further problem the research group sees that such medical devices in europe would not have to be controlled and certified by national authorities. Rather, this was done by private institutes working on behalf of the manufacturers. According to its own information, the bfarm is not responsible for the approval of medical devices; however, it registers reports of problems.