In collaboration with the International Consortium of International Journalists (ICIJ) and news organisations from 36 countries, The Indian Express has examined various aspects of the medical device industry in India and its regulation as part of a global investigation called Implant Files.
From coronary stents and pacemakers to breast and knee implants, from pelvic meshes to intrauterine devices — almost every medical device is advertised, sold, surgically implanted in a regulatory system that, effectively, doesn’t exist; in a market where global pharma majors do the hardsell via a dubious nexus with hospitals and doctors, a 10-month-long investigation by The Indian Express has found.
According to industry estimates cited on the Make in India website, the industry in India is currently valued at $5.2 billion and is expected to grow to $50 billion by 2025. India is the fourth largest medical devices market in Asia after Japan, China and South Korea.
Freebies for doctors, loans for patients
An investigation into the world’s largest cardiac devices company, Medtronic, found that the US-based company allegedly indulged in unethical practices after setting up shop in India.
In 2010, the company opened offices in over a dozen Tier II towns in West Bengal with the goal of selling pacemakers and cardiac stents to people below the poverty line. Last year, the project, which had expanded to at least 25 cities, was shelved.
The Indian Express investigation revealed a range of alleged irregularities: from corruption of doctors via promos and freebies, to ensnaring unsuspecting patients who didn’t need these products; from spending crores on conferences and seminars to push products, to screening patients and prescribing devices under the same roof.
9 am, Room No. 7, AIIMS: Where corrections are made
Patients visit one of the country’s top orthopaedic surgeons at All India Institute of Medical Sciences (AIIMS) mostly for one reason — revision surgery.
Revision surgery is when a surgery related to a medical device has gone wrong and another surgery is performed in order to fix it. It is reported that AIIMS conducts over 1,500 hip and knee replacement surgeries of which 20 per cent are revision surgeries.
First official red flags
As part of the investigation, The Indian Express accessed the “medical device adverse event” (MDAE) report, which is essentially a list of cases where a medical device implant has not worked as intended. The MDAE report shows a huge increase in cases in 2015, a year after it began recording them.
Around 903 adverse events have been reported since 2014. Serious aberrations have been reported in heart valves, pacemakers, respiratory ventilators (there are two complaints of Chinese-made products), defibrillators, infusion pumps and dental implants.
Abbott coronary stents
Of the 556 adverse reports by the Indian Pharmacopoeia Commission (IPC) this year, coronary stents manufactured by US healthcare major Abbott account for more than half of them. The company is presently estimated to account for 40 per cent of the cardiac stent market in India, but did not provide precise sales figures.
Yet what can be a matter of concern, both for regulatory authorities and hospitals which have dispatched the adverse event reports, is the repetitive, if not identical, nature of the 30-odd cases that have been reaching the IPC every month from all parts of the country.
Mirena IUD by Bayer
Intrauterine devices or IUDs rank second, in the adverse event report list of medical devices for 2018 which is being compiled and analysed by the Indian Pharmacopoeia Commission (IPC).
Of the 556 adverse event reports logged this year, there are 36 for devices manufactured by German pharmaceutical major Bayer, and they are all for Mirena, the hormone-releasing IUD commonly recommended by gynaecologists across India for birth-control or for reducing heavy menstrual and uterine bleeding. Of the 468 MDAE (medical device adverse event) reports for 2018, at least 26 have been filed for Bayer’s Mirena coils.
Botched breast implant surgeries
In north-west Delhi, on the first floor of a building, K D Plastic & Cosmetic Surgery Centre has an operation theatre and a patient ward for admitting patients coming in for breast implants. The troubling aspect is that no one is checking the implants for safety, regulators do not exist, technicians often double up as surgeons, shame and stigma prevent patients from reporting the gruesome aftermath of what has gone wrong.
And here is why members of the transgender community are at risk due to the breast implant industry remaining unregulated.