A WORLDWIDE investigation into medical implants has found that millions of patients are at risk from poorly tested devices.聽It is time to face the problem.
If a drug has adverse effects or is聽ineffective, the medication is changed. But it is more difficult and dangerous to remedy an implanted device, such as a cardiac valve, pacemaker, breast implant or artificial joint. Why then is it so much easier to gain approval for medical devices?
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The European Medicines Agency evaluates evidence of efficacy and safety in controlled clinical trials before licensing drugs. Most of the evidence is publicly available. But medical devices can gain a European Conformity (CE) mark for use across the EU from any of dozens of Notified Bodies. These groups issue CE marks for all sorts of devices including light bulbs, toothbrushes and televisions. Notified Bodies are private firms paid by the device-makers, and the聽evidence considered is commercially confidential.
The maker of a medical device doesn鈥檛 usually need to prove it has any therapeutic benefit. A CE mark is often awarded because a device has slight differences from an approved existing device. That may be adequate for a toothbrush, but it has had fatal consequences when minor differences to a medical device have led to unanticipated functional changes.
Makers of drugs and devices have no ethical responsibility to get patients the best treatment. They are beholden to shareholders, and can market products even if competitors have better ones.
We know financial conflicts of聽interest can influence which drugs doctors prescribe, but conflicts of interest with medical devices are greater. Doctors often invent medical devices, and they or their institutions own the patents. The inventors often conduct the clinical trials, and EU rules allow devices to be marketed while trials are under way.
Training is then required to implant medical devices, and the procedures can attract high fees in聽private practice. Device-makers cascade the skills to doctors by paying skilled operators to be part-time trainers, separate from their hospital job. In that role, the trainers are part of the firm鈥檚 marketing arm. Highly paid opinion leaders may demonstrate a device at a medical conference before thousands of delegates.
I was the principal cardiologist in a trial of a device for closing holes in the heart. In 2007, I expressed concerns about its safety and efficacy, and the manufacturer sued me for libel.
The legal action against me only ended when the manufacturer went into liquidation after it became clear its devices weren鈥檛 effective. To protect patients, we must make it as difficult to gain approval for medical devices as it is for medicines, and we must outlaw dubious marketing practices.
This article appeared in print under the headline 鈥淟ife and limb鈥�
