The last four times it has been a benchmark investigation, including the Panama Papers and the Swiss Leaks, into how the global rich park and move their money in offshore tax havens. This time, the International Consortium of Investigative Journalists (ICIJ) with news organisations in 36 countries, including The Indian Express in India, has put under scrutiny effectively every medical device that goes into the human body.
The result is Implant Files – and the findings are startling.
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.
Breast implants are done in basement Operating Theatres in DDA flats; at AIIMS, there is an ever-swelling crowd of patients with botched-up device surgeries. Clearly, the faulty Johnson & Johnson hip implants, which affected over 4,000 people in India and are now the subject of a case in Supreme Court, is just one symptom of a much larger malaise.
The Indian Express reporters attended medical device trade expositions in Mumbai, Chennai and New Delhi to get a measure of the booming scale and the key influencers of the industry.
Beginning today, over the next few days, The Indian Express investigation will report:
* Global majors Medtronic and Stryker, Abbott and Bayer, all operating in a regulatory regime where there is no oversight for medical devices — either for their quality, clinical testing, pricing or performance.
* As the Johnson & Johnson case showed, manufacturers too have a delayed response in telling you what matters most — that the device you are using or is inside your body has been withdrawn for use globally.
* The first Bill for medical devices was drafted 12 years ago and still not enacted. The NDA government, too, intended to bring in the legislation but last year chose the easy way out and brought in medical device rules instead. Minutes of meetings accessed by The Indian Express reveal the lackadaisical manner in which policy is debated.
* More than half of the medical and diagnostic medical equipment used in private clinics and hospitals are imported as “pre-owned” or “second hand” with no assessments done on their levels of accuracy or safety.
* A detailed review of exhaustive data on FDA shows that, curiously, Indian regulator did not make public details of recalled devices distributed in India.
* There is a steady increase in the number of patients undergoing “revision surgeries” due to faulty device design and surgical errors. The Indian Express tracked the country’s premier institute, All India Institute of Medical Sciences (AIIMS) in Delhi, which runs dedicated facilities to treat patients with botched-up orthopaedic implantation surgeries.
* The Indian Express traced cases of negligence. And met several members of the transgender community who said with so many breast implant surgeries going wrong, they were travelling to Thailand to get their silicone packs put.
A NEW GLOBAL INVESTIGATION: Health authorities have failed to protect millions worldwide from poorly tested implants that can sicken, maim and kill, the very people they were designed to help. https://t.co/I5DL5CI152 #ImplantFiles pic.twitter.com/CHvkYaq1ON
— ICIJ (@ICIJorg) November 25, 2018
The stakes couldn’t be higher.
For a country of India’s size and booming health sector, this is a very small beginning. The $5.2 billion (over Rs 35,000 crore) market is swamped with imported medical devices, accounting for almost 70% of all medical devices sold but the Government and domestic medical device manufacturers are clearly at loggerheads on who will regulate the booming sector, and how.
The Indian Express joined around 100 other reporters from 36 countries for an ICIJ meeting in Washington DC to plan the most exhaustive health investigation ever mounted. This is ICIJ’s largest ever collaboration in terms of the strength of its team, which includes the Associated Press (AP) in the US, British Broadcasting Corporation (BBC) and The Guardian in the UK, Le Monde in France, NDR and Suddeutsche Zeitung in Germany and Asahi Shimbun in Japan, among others.
But the collaborative formula was reversed — instead of media partners getting data on secure platforms, reporters who worked on the Implant Files have each helped in creating the first ever database of medical devices and adverse event reports.