Rapid innovations in science and technology have led to a booming worldwide market for high-tech implantable devices. There is high demand for the devices and millions of success stories to celebrate across the globe.
There is a flip side to this. Implants come with risks. They may sometimes be so close to vital organs that they may begin to start pressing against sensitive nerves, and removal may carry risks of serious injury or death. They may be broken or defective or at an elevated risk of malfunctioning, which can result in seizures, hallucinations, and suicidal tendencies to say the least.
A recent report, Implant Files by the International Consortium of Investigative Journalists, has addressed the perils of patients living with implants. Along with a network of 250 reporters and experts from 58 news organizations in 36 countries, ICIJ conducted hundreds of interviews and examined scores of documents. It goes into detail on the lack of regulation in several countries, manipulation and lobbying by manufacturers to increase revenue, and absence of recalls of faulty devices. No large-scale human trials for devices are conducted like they are for prescription drugs.
Nearly 500,000 reports over the last decade describe explant surgeries in connection with a medical device. Beyond the numbers, ICIJ interviews with dozens of patients who had medical implants removed bring into sharp relief the often grisly toll of explant surgery, femur bones snapped during removal of recalled hip implants, massive blood loss during the retrieval of a faulty heart device, and dangerous synthetic materials abandoned inside the spine.
India is a case in point. There is complete absence of a regulatory system, no recourse to direct a manufacturer to compensate a victim of a faulty device, a handful of devices regulated by CDSCO, and a mere 23 medical devices monitored with the ceiling price fixed by The National Pharmaceutical Pricing Authority of India. Is it any surprise that in a Rs 36500 crore medical device industry, there were only 14 recalls from the beginning of 2013 through 2017?