A new global investigation, anchored by the International Consortium of Investigative Journalists (ICIJ) and reported by 59 news organisations in 36 nations, has turned the spotlight on faulty medical devices that slunk into the markets worldwide due to poor regulation, lax rules on testing, corruption and opacity.
Patients around the world have suffered immensely because of this — many have died due to botched surgeries and unsafe implants.
India is a big piece of The Implant Files exposé. The network of newspapers which have been part of this project includes London’s Guardian, Le Monde and Indian Express. The documents that the reporters have unearthed are now part of a searchable new database — the International Medical Devices Database. (https://medicaldevices.icij.org). This has information about some 70,000 recalls, safety alerts and field safety notices of medical devices and their connections with their manufacturers.
The investigations cover coronary stents, pacemakers, hip implants, knee implants, breast implants, pelvic meshes and intrauterine devices. Major global devices makers have been referenced.
What the collated investigations reveal is the familiar tale of a deeply entrenched system involving companies and their lobbyists, doctors who can be persuaded easily through the right incentives, or bribes if you will, and patients being goaded into unnecessary surgeries.
The findings only confirm what many of us have known or suspected all this while. The “R” word — regulations — practically does not exist in the country’s medical devices industry, and where it does, it is implemented poorly.
We have heard stories after stories about botched surgeries because someone desperately craved for bigger breasts, a more shapely figure, to shed wrinkles, weight, to grow hair suddenly and a greedy someone else was quick to tap into these insecurities.
In India, patients have suffered either because the devices were faulty or the person doing the surgery didn’t have the requisite qualifications for the task, or both. Either way, the poor regulatory framework in the country ensured that both have escaped scrutiny.
One telling example — earlier this year, the Telangana Medical Council suspended the registration of a doctor from the tony neighbourhood of Banjara Hills for two years, debarring him from practising hair transplant surgery, after the loss of an eye by a patient during a hair transplantation procedure. The doctor in question has an MBBS degree but no postgraduate qualification, and yet he had got away positioning himself as an expert in hair transplant surgeries.
The desire to look good is neither uniquely Indian nor new. But desperation fuelled by celebrity culture, use of unrealistic images in advertising, social media have led to an environment where many are prepared to do anything to change his/her looks. The dramatic rise in cosmetic surgeries has to be seen in this backdrop.
In India, the data on faulty and devices which have had to be recalled are not typically put out in the public domain, adding to the problem. Patients who have suffered are often reluctant to go public, and typically go in for “revision surgeries” to deal with botched operations, often conducted with dodgy devices.
Not all surgeries which have come under the scanner are cosmetic procedures. The implant scandal covers implants required for legitimate medical reasons as well. Think Johnson and Johnson Pvt Ltd. The Indian unit of the global pharma giant has been forced to initiate a new “India-specific” reimbursement programme for those Indian patients who have suffered due to its Acetabular Surface Replacement (ASR), or hip implants. Recent media reports say the new programme to be introduced by the company will support patients who have been implanted in India with its ASR hip implant from June 2004 to August 2010. Reimbursements will be provided if the revision surgery and the tests took place within 15 years from the date of the primary hip replacement surgery.
The Implant Files makes very disturbing reading but hopefully it will act as a springboard for patients to mobilise and demand a proper and effective regulatory system in the healthcare industry.
It is important not to get mesmerised by the dazzling growth of the healthcare industry, including the medical/cosmetic procedure segment, and insist on scrutiny of who is doing what and with what. India’s medical devices industry is estimated to be worth some $5.2 billion. The harsh truth is that in our excitement about the growth of this industry, we have overlooked that India trails behind many other countries in the rigour of reporting faults in medical devices.
As Amar Jesani, one of the founders of the Forum for Medical Ethics Society and its journal Indian Journal of Medical Ethics, points out, it is not just implants, but almost all medical devices that are marketed around the world often remain untested or tested with grossly inadequate scientific rigour, leading to many outright harmful devices — also implants — getting marketing approval. Add to this, the gross deficiency in regulation of their clinical usage on the patients. “The combined effect of the dual deficiencies is harm to a significantly large number of patients,” says Mr Jesani.
Many organisations within India supportive of patients have tried to pressure policymakers through a series of PILs over the past two decades. But a lot more must be done in spreading awareness about medical devices and the risks if quality of devices and those conducting the surgeries are not taken into account.
The recent Medical Device Rules, which became effective from January 1, 2018, mark a movement forward, but these rules are applicable only on a limited number of devices, only around 23.
There is another issue related to complicated surgeries in general which needs urgent attention.
At a time when there is so much talk about the Narendra Modi government’s push for the opening of new private hospitals in small towns to implement its newly-launched Pradhan Mantri Jan Aarogya Yojana (PMJAY), it becomes imperative to raise the “quality” issue.
Will it be a junior doctor or a senior doctor who will conduct the operations and is the doctor qualified to carry out the surgery he/she is conducting, as health analyst Anant Bhan asks.
There is no need to be alarmist about medical devices per se or surgeries, cosmetic or otherwise, but failing to ask tough questions and demanding an effective regulatory framework will endanger many more lives. That must not happen.
