Sub-Standard Stents & Orthopaedic Implants Pose Danger To Patients
As many hospitals, doctors and patients opt for cheaper and dangerous medical implants, need for government regulation becomes urgent
India is facing a growing population which is also ageing rapidly. And this means that spend on healthcare too is likely to increase quite dramatically.
“Global health care spending is projected to increase at an annual rate of 4.1% in 2017-2021, up from just 1.3% in 2012-2016. Ageing and increasing populations, developing market expansion, advances in medical treatments, and rising labour costs will drive spending growth,” observes Deloitte in its 2018 Global health care outlook report.
Non-communicable diseases are likely to take the lion’s share of the spend – lifestyle diseases such as diabetes, coronary disease and orthopaedic ailments. This in turn means that implants – like stents, joint replacements and other medical devices will be in great demand. Let us take a look at the medical devices market first.
“The Indian medical device sector valued at USD 4.9 billion, is relatively small but has seen unprecedented growth in the last few years. Growing at a CAGR of 17% over the last five years, the sector is expected to continue witnessing double-digit growth with a CAGR of 15% in the coming decade,” says a 2016 report by SKP Consulting.
FICCI estimates have shown that about 3 lakh Indians undergo a variety of heart procedures every year and around 1 lakh get knee replacement surgeries. The stents, fabricated joints and other implants used in these procedures contribute to about 6% of India’s USD 40 billion healthcare sector. The medical device segment alone is worth around Rs 35,000 crore.
Safety Of Implants
Why are implants so important? Well, simply because they are foreign objects made with synthetic materials that go into our bodies and reside there for the rest of our lifetime.
For instance, a stent goes directly into the heart, while the implants in the knees and hips will have to take the load of the person’s weight.
And this is why these medical devices are subject to a variety of rigorous tests before they even come to the market.
“Endothelialisation of stents has to happen,” explained Dr G Sengottuvelu, senior consultant and interventional cardiologist with Apollo Hospitals, Chennai. “This means that the stent, once inserted, over a period of time, has to become part of the blood vessel. If this does not happen, if the stent is of bad quality, a clot can form in the vessel. This is called ‘stent thrombosis’ – it is a dreadful complication that can arise and it can kill the patient,” he said.
Biocompatibility, toxicology, force tests – all of these are conducted on these implants to ensure that they are safe for human use. Implants, especially the joint replacements, are tested for their ability to withstand load, their resistance to wear and tear, elasticity and strength among other such factors.
Toxicology tests are conducted to ensure that the materials which are used to make these implants – usually titanium alloys – do not leach chemicals when they are implanted inside the body.
It is for this reason that medical devices need to be tested for safety from the beginning to the final process. From sourcing of materials to fabrication to storage and distribution, these implants must be calibrated to the highest possible quality standards.
A sub-standard implant that makes its way into the human body can cause a number of problems for the patient, sometimes culminating even in death.
“The main impact of substandard implants is implant breakage,” said Dr SH Jaheer Hussain, consultant orthopaedic surgeon at Trauma and Orthopaedic Speciality Hospital (TOSH). “So when you have a fracture and you have a substandard implant there is an implant failure, where the plate itself, implant itself breaks or the screw head breaks, and the fracture will go for non-union; which may not unite. And one more thing is Metallosis, the blackish discolouration of the tissues, where the metal particles goes and implants into the tissues. This gives a local reaction, the skin becomes dark, itching will occur. Infection rate is high due to substandard implants. These are some of the complications,” he said.
First World & China Floods Market
In June 2017, the Maharashtra Food and Drug Administration announced a seizure of Rs 7 crores worth of faulty implants which were ready to hit the market.
The situation is a precarious one in India. With the government attempting to bring prices of stents and implants under control, to make them more affordable to the poor millions in the country, sub-standard and cheap medical devices are inevitably making their way to hospitals all across the country.
Many of these devices are cheap Chinese imports. Often hospitals do not offer the patient a choice in the brand of implant that they use – marking up the cheap sub-standard Chinese product and offering an attractive “discount” to the patient has resulted in faulty implants being sold like hot cakes.
“Now, for implants to be placed, there is a drug control authority in India, which has to approve the implant, then only it can be sold,” said Dr Jaheer. “But in these local markets it is available freely so they have to take action to control this. Also the surgeons have a role where they should not compromise on the implants. Mainly where it happens is in B-centres or very small towns, where the patient cannot afford and doctors try to compromise. Doctors have to be very stringent, even if the patient cannot afford it.”
It is not just the Chinese who are producing faulty implants. Recall the Johnson and Johnson case of 2013 when the Indian government decided to pull out all the ASR hip implants manufactured by DePuy, a subsidiary of J&J.
Approximately 4700 patients had used the faulty ASR hip implants and suffered excruciating pain and repeat surgeries. A committee set up by the Centre to look into the matter found that the metal ball and socket implant, when rubbing against each other, caused metallic debris to be released into the bloodstream.
The committee found – “Some of the patients had reported that they had to undergo excruciating pain during all these and more particularly after the implant. Many patients reported general fatigue or local issues such pseudo tumour, pain walking, metallosis (increase in Cobalt and Chromium levels, Asthenozoospermia (reduced sperm motility), cyst in kidney, claudication pain. Some of them informed that they are still having difficulty in carrying out their routine activities and are confined to bed which has led them to mental turmoil and agony. These patients also informed that the cost of revision surgery was reimbursed either by the company or the insurance firms. The patients are still sceptical about their future with the implant in their body.”
In 2013, India finally pulled the plug on the ASR hip implant. But the damage was done. Of the 4700 who have the ASR hip implants in their bodies, 3600 could not be found.
What Needs To Be Done
The situation is worrisome. Demand for coronary stents and implants is growing rapidly. Globally, the stents market is set to grow at 7.8% between 2018 and 2025, reaching a market value of USD 13.8 billion by 2025. Some reports say the stents market in India is worth USD 220 million currently and is in line with global growth rates.
As for the orthotics segment, it is estimated that 60 million osteoarthritis cases in India will need orthopaedic implants by 2025. Today, two lakh knee replacements and 30,000-40,000 hip replacements are done in India, annually as per reports by the Indian Society of Hip and Knee Surgeons.
There is an urgent need to ensure that regulators are given teeth and the quality checks conducted by them are done with rigour.
Although late in coming, the amendments to the Medical Device Rules in 2017 have paved the way for more clarity in standards of manufacturing of implants.
“It is important to conduct many more randomised double blind studies,” said Dr Sengottuvelu. “These studies will give us the data that we need in order to ensure we use only quality stents.”
Overall doctors do agree that much more needs to be done in a concerted and organised manner in order to ensure that cheap and sub-standard implants are not used on patients despite the attractive profits that these implants can bring to hospitals, doctors and middlemen alike.