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Patients as guinea pigs? Multiple medical devices in Europe exposed to problems
Release time:
2025-03-12 09:43
According to BBC reports, a joint investigation by the BBC, the International Consortium of Investigative Journalists, and multiple global media outlets including The Guardian and The British Medical Journal, has revealed that the European medical device industry is exploiting loopholes in the regulatory system, resulting in numerous unsafe and inadequately tested medical devices being implanted into patients!
Products that failed tests on baboons, or were only tested on pigs or cadavers, have entered the market and been implanted into humans. These devices include pacemakers, spinal correctors, artificial knees, and artificial hips.
The investigation also found that even doctors may be unaware of the risks associated with the treatment devices they recommend to patients.
Problems with a leadless pacemaker
Due to irregular heartbeat, 82-year-old Maureen McCrea became the first person in the UK to receive a Nanostim pacemaker. A pacemaker is a life-saving implantable device that emits electrical impulses to regulate the heartbeat. Traditional pacemakers use lead wires to transmit pulses, but the wires are prone to breakage. Nanostim was the first leadless pacemaker.
When she became the first person to receive a leadless pacemaker, Maureen was thrilled, but also felt like a "guinea pig." "To be selected, I was so grateful, it sounded too good to be true."
Three years later, however, the battery in Maureen's pacemaker malfunctioned, and doctors were unable to remove it. Now, she relies on a traditional pacemaker to sustain her life, while the faulty device remains in her heart. "I don't like having a piece of metal in my heart that's not doing anything, just sitting there."
Maureen is not alone. The batteries in the leadless pacemakers of several patients have malfunctioned, or components have come loose, resulting in at least two deaths and more than 90 serious injuries. Ultimately, this pacemaker was withdrawn from the market due to safety concerns.
The Nanostim leadless pacemaker was previously rejected by German safety agencies due to insufficient evidence of its safety. However, the company relocated to the UK and obtained approval under UK standards, leading to the injuries and deaths mentioned above.
Multiple medical devices revealed to have problems
In Europe, medical devices receive a CE mark from authorized bodies, the same mark given to toasters and kettles. There are 58 such bodies across Europe, and if any one of them approves a product, it can be used throughout the European Economic Area. However, if one body rejects approval, the company has 57 others to try.
The media investigation found that problematic devices included: implants that had failed baboon tests and split open in patients' backs; intrauterine devices causing internal injuries and bleeding; implantable defibrillators that did not work; and mesh implants for urinary incontinence causing internal pain.
The BBC found that an implant used to treat severe scoliosis in children was released onto the market after testing only on pigs and cadavers. 14-year-old Anthony had this product implanted five years ago.
The implant broke inside him after only one year. After it was replaced, the new implant broke again a year later. Anthony had to have the device permanently removed. However, the manufacturer, Nuvasive, claims that there are always risks involved in treating scoliosis.
Due to the lack of data and transparency, the problems with some medical devices remain a mystery to both patients and doctors.
Device companies are required to demonstrate the safety of their products, but in fact, the "evidence" required is much less than patients believe, and even doctors who perform implant procedures may not be able to see the evidence of safety and effectiveness of a particular device.
The British Standards Institution stated that it could not discuss the safety evidence for the Nanostim pacemaker due to "confidentiality requirements." The media investigation found that Nanostim conducted only one clinical study before being approved for market entry. This study lasted only 90 days and involved 33 patients.
"We are talking about permanent pacemakers, so I think that clinical study was too superficial." said Professor Rita Redberg, a renowned cardiologist at the University of California. "These implants are intended for ten, twenty years. A 90-day observation period cannot provide any meaningful understanding of the clinical effectiveness of this pacemaker."
The Royal College of Surgeons of England calls for radical regulatory change
"Thanks to medical devices, countless people now live healthier, higher quality lives, and are less dependent on others." said MedTech Europe, an organization representing the medical device industry. "Life without those thousands of medical devices is unimaginable." The organization also stated that certification bodies are "professional, impartial, transparent and independent people."
Nanostim pacemaker manufacturer Abbott stated that many patients have benefited from its leadless pacemaker and that many more will benefit in the future. Abbott also stated that "following CE marking, Nanostim conducted further post-market clinical surveillance studies in Europe."
In response, the Royal College of Surgeons of England called for "radical regulatory change." Professor Derek Alderson, president of the College, stated that "all implantable devices should be registered and their effectiveness and safety monitored in the long term."
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