Implant Files - the murky world of medical devices03 Dec 2018
In the second issue of DisFact, I wrote about the scandalous case of Johnson & Johnson faulty hip implants:
In August 2010, Johnson & Johnson’s (J&J) faulty hip implants were recalled globally as “it left large quantities of metal debris in the body and it had a very high failure rate”. 4,500 patients in India were implanted with the faulty hip joint. But neither the company nor the regulators systematically reached out to patients to inform them of the faulty implant. The victims continued to suffer.
This week, a ten-month long investigation by the Indian Express—carried out with more than 250 reporters and data specialists from 36 countries under the International Consortium of Investigative Journalists—revealed that J&J’s was not a one-off case: it’s a systemic problem that plagues the global health care industry, thanks to the dubious nexus between companies, doctors and hospitals, highlighting significant flaws in our health regulatory system. It’s frightening.
What we learnt from #ImplantFiles: “Almost every medical device, from coronary stents and pacemakers to breast and knee implants, is advertised, sold, and surgically implanted with barely any oversight. The medical device industry is booming but transparency is lacking.”
The global cost of dodgy devices:
Medical devices that broke, misfired, corroded, ruptured or otherwise malfunctioned after implantation or use — despite assurances by regulators, the industry and doctors that they were safe — were linked to 1.7 million injuries and nearly 83,000 deaths over the last decade. Nearly 5,00,000 reports mentioned an explant — a surgery to remove a device — in connection with an adverse event.
In India, almost 70% of medical devices are imported—but without any checks. The medical device industry is currently valued at $5.2 billion and contributes 4-5% to the $96.7 billion Indian health care industry.
1. Rise in the number of reported incidents: The number of “medical device adverse events”, such as deaths after the installation of a stent, has gone up from 40 in 2014 to 556 so far this year. This is an underestimate. (Read more)
2. Low reporting of device failure: “Though the reporting of device failure began in 2014, the results are still not being made public. Complaints of a very serious nature are fed into a lone computer in an obscure office in Ghaziabad.”
Basically, the Central Drugs Standard Control Organisation (CDSCO), the regulator, does not maintain a public list of devices that have been recalled from the global or Indian markets.
Why this information needs to be public: so that patients can make informed decisions.
3. Around half of the devices recalled in other countries were being sold in India: As many as 117 devices have been recalled over the past two years by the United States Food and Drug Administration after it concluded that the devices led to serious health issues, including death. However, at the time of recall, at least 57 of these devices were still being marketed in India to patients. (Read more)
The Indian Express tracked eight of these devices that are the most commonly used, and found that in each case, it was left to the manufacturer to take action. In some cases, the manufacturers claimed that the recall was due to technical defects while in others, they said the software was to blame. All eight devices are back in the market.
More specifics here: In US, ortho major forced to admit it was corrupting doctors and hospitals in India
4. What should medical device manufacturers do when problems are found: It is their responsibility to track down the recipients of withdrawn medical devices, tell them about the problems, and pay compensation. But companies are not doing so.
This example shows the state of regulation in India: the regulator didn’t even know about a case where devices were recalled.
Many users of Medtronic’s insulin pump were notified in September 2017 about the device being recalled internationally. The users of the insulin pumps - small electronic devices that infuse insulin into a body through the day - said company representatives met with them and replaced their devices. However, regulator Central Drugs Standard Control Organisation (CDSCO), has no record of this recall ever having taken place. The CDSCO is meant to regulate recalls by displaying “medical advice alerts” so that patients can know when devices are being recalled.
Medtronic recalled the devices in 2017 saying they could trigger an excessive amount of insulin in a user’s body, resulting in possible hypoglycaemia (better known as low blood sugar). Around 10,000 devices were recalled. However, senior diabetologists in Delhi say Medtronic wasn’t proactive in recalling the devices. They said they were the ones who noticed the news of the recall by the US Food and Drug Administration and informed Medtronic in India about it.
5. How companies pull it off: Medtronic, the world’s largest cardiac devices company, may have indulged in a range of irregularities to push their products in India. “Doctors were given freebies, unsuspecting patients were given these products, loans were granted to fund surgeries, and crores were spent on seminars to push products.” (Read more)
6. What are the redress mechanisms if devices found faulty?
Currently, there are no specific rules or a law that allows the government to direct a medical device company to give compensation to a victim after the device has been found faulty. Following the emergence of faulty hip implants from Johnson & Johnson, the Ministry of Health and Family Welfare is working on a formula for compensation. There are proposals that the government might include a special clause under the Medical Device Rules to include compensation for patients. But the patient can always approach a consumer court to seek damages from the device company.
The deeper question, however, is whether such misuse is an inevitable consequence of a tertiary health care system that relies excessively on the private sector. A large and vibrant public sector in tertiary health care is the only way to counteract the hurtful consequences of information asymmetries and poor regulation, especially in sectors such as medical devices, pathological tests, and so on. The government should re-examine its plan for universal health care that chooses to give too much space to a health care sector that has shown itself to be insufficiently trustworthy.