Dangerous lack of information in the case of implants

Despite the increasing suspicion of messages, important information can be incorrect implants or prostheses, kept under lock and key. The report of the “Süddeutsche Zeitung”, as well as WDR and NDR under the keyword “Implant Files” with other media of the international research network International Consortium of Investigative Journalists (ICIJ).

In Germany, the number of incidents has increased five-fold according to the Reports, in the past ten years, tripled in the United States. If a medical product could have led to death or serious health problems, would need manufacturers, Doctors and hospitals to report this actually. The research of SZ, NDR and WDR suggest, however, that often against this mandatory reporting will breach.

According to the Reports, in 2017, have been reported in Germany alone, approximately 14,000 incidents. More than half have proven to be, according to the Federal Ministry of health, the product as the cause. Only about half of the occurrences of the respective product had not been studied at all.

One reason for the problems are the method of the research according to the lack of approval. Since 2010, around 10,000 medical products in Germany to be certified, but only about 80 certifications have been rejected. An internal memo of the Federal Ministry of health estimated that 90 percent of all High-risk products coming on the market without previously, in clinical studies, been tested.

Most of the countries do not have databases

Also, there is no reliable information system to notify patients in the event of problems with implants. Only about 20 percent of all countries in the world in public databases with security existed according to research by the ICIJ at all warnings, and recalls of medical products. On the Homepage of the Federal Institute for drugs and medical devices (BfArM) to give it an Overview of recalls and warnings raise no claim to completeness.

For the increase in suspicious transaction reports, according to the BfArM for several reasons: on the one Hand, the number of the medicine products. On the other hand, there is also a significantly improved reporting behaviour of Doctors and clinics, said the BfArM spokesman Maik Pommer. The authority would doctors and hospitals regularly to the reporting obligation.

Although a 2017 adopted EU should ensure the guideline for medical products for more safety. According to the Reports, the basic problems remain. This includes ensuring that medical products would not have to be controlled in Europe by public Agencies and certified. Rather, this success by private institutions, which are in the order of the manufacturer.

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