To Report an increase in injuries and deaths from defective medical implants to provide the Federal Minister of health, Jens Spahn for more transparency in the medical products. An implant Register should be created. “We are building an industry-independent body in which all of the built-in implants to be reported,” said Spahn of the Rheinische Post. At the same time, the Minister of shortcomings acknowledged. If you have problems with a medical product, the German Federal Institute for drugs and medical devices (BfArM) “not a total overview of all similar cases” and, therefore, no Chance that patients have to warn against errors.
According to the results of an international Search, the, in Germany, the channels NDR and WDR and the Süddeutsche Zeitung were involved, injuries and deaths that could be in connection with implants, greatly increased. In Germany alone have been reported, therefore, in the past year, 14.034 suspected cases. The market leader in medical technology, the U.S. company Medtronic, could cases, with up to 9,300 deaths and 292,000 inhabitants, injuries are solely brought in the U.S., according to Reports.
A spokesman for the health Ministry said, taking the reports very seriously. “Each individual, there is described the case is tragic and one too many.”
SPD-health politician Karl Lauterbach called on the government to Act. “We need to improve patient safety,” he told the Neue Osnabrücker Zeitung. For potentially hazardous side effects of implants, studies with humans should get “” a “much greater significance”. What is needed is a seamless implant Register and its publication is also. More stringent rules would have to ensure that the implants, which showed abnormalities, “be immediately withdrawn from the market”. Lauterbach accused the Union and the FDP, to have such stricter conditions in the past prevented.
pseudo-innovation and products that are harmful
insurance Also called the statutory health improvements. “In the case of medical products, certificate innovations, and even products that are harmful to come much to easily in the supply. There are no safe rules and regulations that prevent it,” said Doris Pfeiffer, Chairman of the Board of the GKV-leading organization. Examples ranged from “self-dissolving Stents up to metal-on-metal hip replacements”. Politicians have done for years, “despite numerous reminders too little”, although the statutory health insurance have repeatedly pointed out the problems.
The EU Commission called for a better implementation of rules and controls. At the EU level was decided as a consequence of the scandal of ruptured breast implants 2017, a new set of rules, a spokeswoman said. The EU member States, manufacturers, and Doctors were asked, the more stringent quality and safety standards, and to make their work more transparent.
The German medical technology Association (BVMed) pointed out that patient safety had already become “a top priority”. The industry is regulated “already extremely strong”, said CEO Joachim Schmitt. The new EU regulation, the requirements would be further increased.