Lack of oversight in medical implants can be fatal

Recent investigations into medical implant safety have revealed a troubling safety record. In Germany, patients have no access to information about the dangers of medical implants and this is the most scandalous part of the whole story.

Daria Sukharchuk
Daria Sukharchuk NewsMavens, Central & Eastern Europe
Lack of oversight in medical implants can be fatal - NewsMavens
Doctors in OR, PixaBay

Why this story matters:

The ICIJ investigation that presented hundreds of stories of failed medical devices shows the high price we are paying for fast progress in medical engineering. There is no doubt that the medical high-tech is improving, or sometimes even saving lives, of millions of people across the world. But it is also a lucrative business, which is only becoming more demanding as the global population ages.

And unfortunately, the market of medical devices is even less regulated than the one for drugs.

Sueddeutsche Zeitung, the German newspaper that took part in the investigation, explains how easy it is to get a new medical device on the market.

In 2016, a Dutch journalist Jet Schouten conducted an experiment: she took a piece of plastic mesh (the kind in which tangerines are sold), wrote an extensive documentation about how it can be repurposed into a new kind of vaginal mesh, and applied for approval at three regulatory bodies. All three were ready to grant her approval, without carrying out any tests.

They were able to do it, because, unlike drugs, medical devices don't have to be tested every time a new version is released -- so if someone has already started selling properly manufactured vaginal mesh, a new person can, technically, start selling tangerine mesh as the same device. This story is just another example of the power of lobbying and the importance of transparency. During this investigation, ICIJ has created an international database of medical devices, IMDD. Let us hope that it will be put to good use.

Details from the story:

  • Over the last 10 years, the rate of deaths engendered by faulty medical devices has been steadily growing, just as regulators have rushed to speed up the approval process.
  • In Germany, patients don't even have access to the information of which devices have been recalled in recent years.
  • The German health minister Jens Spahn (who's also currently striving to become the leading CDU party's leader and the potential new chancellor) has declined the requests to comment sent by Sueddeutsche over the last two months.
  • Many medical devices are only ever tested on men (and developed for them).
  • Latin American and Asian countries rely on European and US approval marks and don't require companies to carry out extra tests.
  • In Europe (unlike the US), the private industry also has control of the testing agencies. There are over 50 in the EU, and the manufacturer can apply to all of them in turn, until they get an approval from one.
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