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US and European patients at risk without medical device registry

Written by Diane Archer

The BBC reports on findings of the Royal College of Surgeons that the rules for approving medical devices in the United Kingdom leave a lot to be desired, much as they do in the US. Notwithstanding widespread reports of patients at risk, the European Union, like the US, succumbed to pressure from industry and won’t support a medical device registry. Before agreeing to having a medical device implanted in your body, make sure you understand everything you can about it.

To protect patients from dangerous devices being implanted in them, the Royal College of Surgeons has been advocating for a compulsory registry of all devices so that they can be tracked for efficacy and safety over the long-term. That would help physicians understand whether a particular device causes harm and help patients avoid harm.

We need such a registry in the US as well. But, industry, so far, is winning this fight. The argument is that a registry would somehow jeopardize discoveries of new devices that could save lives. Without the registry, however, no one can understand how serious the problem with a device is, and many patients can be harmed. A registry is a fairly simple after-market regulatory solution as compared to having a government body that checks all devices before they go to market–which would be the safest solution.

In the United Kingdom, investigations by 58 media organizations reveal that patients are getting unsafe implants, just as they are in the US. These unsafe implants include pacemakers, artificial hips, and contraceptives. A BBC Panorama investigation in collaboration with the International Consortium of Investigative Journalists shows that the European Union has approved implantable devices that have not worked in clinical trials or that have only been shown to work on pigs and corpses.

The United Kingdom’s government agency spokesman defended the process in place today. He argued that it has been around for 25 years and “improved and transformed countless lives.” He fears that a registry could undermine innovation.

But, it is hard to justify innovation that leads to a pacemaker failing with parts falling off inside patients, which is what happened to patients in the UK who received the Nanostim pacemaker. Only after the government learned about 90 patients seriously harmed and one dying from the Nanostim was it recalled. The Nanostim had been approved to go to market after only one 90-day trial on 33 patients.

For sure, some medical devices are life-saving. But, others cause serious injury. Investigators uncovered back implants that cracked inside patients, which had not worked in tests on baboons. In addition, they found that some birth control implants cause damage and bleeding, some defibrillators misfire, and some mesh implants used to help with incontinence lead to abdominal pain.

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