Abhed Govil sat in the taxi rearranging his mother’s old reports from the three different hospitals where she had been operated upon for her arm fractures. He was meeting Vyom Mankodi, the technical director at Kyosin, the company whose implants had worked on his mother.
Just then his phone beeped an incoming message. It was from Paritosh’s father. “Paritosh’s body is rejecting the implant. Metal poisoning you think? Read Douglas Hansen’s article sent in e-mail. About metal corrosion in the human body.” Paritosh’s father, a research scientist in metallurgy, had been anxious about his son’s slow-healing fracture.
Abhed himself had been pondering on his mother’s experiences. And how uncanny, he thought now, that his mother Sunetra Govil had first fractured her right humerus and three years later, when the arm had just about been fixed, she fractured her left. And after three hospitals had ‘failed’ and the last of them shrugged its five-star shoulders and told her that her body was not likely to heal, that nothing more was possible, all along blaming the earlier hospitals, her fracture had been set right by a small town, relatively unknown, quiet surgeon. Dr Madhav Surya at a nondescript, yet tidy, wholesome hospital named Dhanwantri Hospital. Nothing ancy, nothing fancy.
Yesterday Dr Surya had made a remark about local implants and branded implants, which, at first, seemed very casually made but soon, Surya had urged Abhed to include in his pursuit of metallurgy, the research for good metal for implants. Maybe even a manner of branding them so that medical device manufacturers would not even think of choosing a lesser metal. That was how Abhed had Dr Surya introduce him to Mankodi.
Vyom heard with interest Sunetra’s case. It was unusual, but not surprising he said. “The Medical Device Regulation Act of 2006 came into effect only from 31 December 2009, essentially 5 years ago. Clearly your mother fell victim right during the period there was no regulation! The orthopedic implants then were of no known quality or grade. Only in 2006, the law was enacted that there must be a registration of products by every manufacturer/seller of stents and implants and doctors/hospitals have to buy registered products only.
But there were no brands worth their salt in the market; one or two global brands were there but these were considered very premium hence expensive. There were more unorganised sector players. You could buy these unbranded implants in Old Delhi by the kilo. These were just a little better than blacksmith fabricated.
Abhed: So, does the metal used in an implant lead to problems that you would say are clinically relevant? Can they rust inside the body?
Vyom: Definitely, definitely! If the metal is low grade, corrosion can take place. And the body responds to that by rejecting the implant. See it is a precision business — even a simple device like a tongue depressor needs to adhere to specifications both as to design and raw material. Ortho implants are very crucial — they are fixed inside the body, hence they also need to get along well with your blood and muscle tissues. What I mean by precision is also the quality of the steel, the design, the shape, the lightness… It is a foreign body for all intents and purposes, it needs to get along with your inner environment.
See, India does not have any logical source for medical device grade steel. It is a specific alloy where a certain treatment is done to steel, to neutralise some chemicals contained in it. When these metals go into the human body, they react with the chemicals in the steel either because of the blood flow around it or if a patient has any long-term medical condition, their medication react upon the chemicals in the steel.
Abhed: Dr Surya said the same thing. But my friend, who has recently suffered a wrist fracture, also has an implant. His fracture is not even begun to heal — it’s three weeks, his fingers are painful. This is today, 2014… what could be wrong? His father asks if there could be corrosion, poisoning...
Vyom: I am not a doctor so I should not even attempt to reply. But truth is how much does the registration process really impact the quality of implants being put out there?
Abhed: Tell me more about this chemical part…
Vyom: The chemical part people are likely to rubbish it as insignificant and many do. But the chemistry influences both, fracture healing and implant acceptance by the body system. So, chemistry also means the right biomechanical strength. See, these implants are not glue, but they are holding the bones together to enable reunion. So, when we create a construct (screws and plate) it is taking care of the biomechanical weight or strength required during the process of the bone reunion. In the case of load bearing bones like the tibia or femur, the biomechanical strength of the implant metal is very crucial. If not, like it happened to your mother’s intramedulary nail, it can break.
Abhed: And how is a patient to know good from bad? No doctor asks you ‘shall I fix a good implant or a bad?’ My mom went to the best hospitals and she paid Rs 4 lakh over her seven-year treatment only to find that the implants were coming off, were mismatched, were not what she needed!
Vyom: That is the other issue: Often the implant need not be bad, it could well be the wrong implant! (There is a third condition: Being trained right, I will come to that)
Abhed: OK, there’s this other thing related to mom’s fractures. I understand that she experienced a lot of neural unrest consequent to an implant used by EFG Hospital. I believe this can be due to bad metallurgy, reactions with some long-term medications she was on?
Vyom: See, the implant is a foreign body. It is not part of the original body, right? When a metal device is implanted, it is now facing the extracellular tissue fluids as well. The surface material of the implant does undergo electrochemical reaction. Now, alloy composition is one thing; what significantly impacts healing is the fabrication methodology, heat treatment, surface finishing... these are important. Now, if the metal is not the best, some metals are low on biomechanical strength and also susceptible to crevice corrosion — at the spot where the screw meets the plate; this spot tends to corrode faster in the case of some alloys and the implant then comes loose. Some also release allergens and carcinogens... So, some manufacturers coat their alloys with a substance that makes it corrosion resistant. But all this adds to cost... and hospitals resist high-cost products.
Abhed: How does it matter since the patient is going to pay for it! Shouldn’t the hospital tell patients about the pitfalls of lower grade implants?
Vyom: First, think about it, when faced with a fracture or even an artery blockage where you need a stent, will you sit and discuss the electrochemical properties of the implant? For every patient, the need for an implant arises when it is an emergency. At this stage, all he wants is relief, life to be restored. He prefers to believe that he is in the right place, with the right team. All talk on poor quality implants, corrosion, biomechanical strength, and so forth, just blur.
My point is, everything in the body system has to accept and receive the implant. This is why we spend years and years in research not just with design but with the metallurgy itself to be sure that the culture of the implant does not play with the culture of the body. So, the implant has a role, and when the bone has healed the implant becomes passive. You can remove it. Many remove it, some do not. This is a mindset thing. Some like your mother, do not want to undergo ‘one more surgery’ to remove the plate. Technically, if it is a high quality implant, you could leave it in the system. But if it is not the best implant, there will be reaction, some which can work silently and cause small disturbances in your neurology but which you are likely to think of as being part of the ageing process.... So, this does happen and many do not link it to the implant.
For example, if a person turns diabetic at 50 and he carries an implant and after the bone has healed, the implant could react subtly with the medication that he is now taking, and this could react with his blood. Truth is, metal surfaces of implants do react with the blood environment.
Sum and substance, Abhed, is this: What is the quality of the metal used in your implant? There are industry studies on implants that have shown that a significant percentage of failures of steel implants, for example, are owing to corrosion and poor biomechanical strength. That results in failure to adapt to the patient’s body. This is why Kyosin researches new metals all the time! Owing to these known risks, we insist on a certain quality of metals whose performance has been known to be beneficial, while we also continue to work with metals that improve implant performance and the lives of patients.
Abhed: This is absurd Mr Mankodi. Between you the implant manufacturer and me, the eventual user, there is a gaping chasm of communication. I am the one who needs to know what goes into me, yet the choice is left to the surgeon! When my mother went to Dr Surya after the Bharatpur mess up, she underwent bone grafting and was fitted with a titanium plate. Her bone united in two months. How come? What did Dr Surya see that he naturally chose titanium, while the three other hospitals before him did not? This bothers me. Those were popular hospitals. Why did they not see what Surya saw?
Vyom: Dr Surya’s approach may be different. Why did Surya suggest a titanium plate and the other doctors did not? Maybe Surya knows his domain and works for himself — not for a percentage or a salary. The hospital is his, and he is the brand. He cannot afford to be ignorant. It is likely that the earlier hospitals did not have enough understanding of the different implants and how each one is used in different situations. See, it is a matter of getting trained, undergoing a one-on-one with the manufacturer and hearing from him what plate he recommends. And the manufacturer, he is a solutions engineer; he knows what his plates are meant for.
Abhed: How could a large hospital not know but a small Dhanwantri in a small town...?
Vyom: Happens. Doctors are, first, people. People vary. There are passionate doctors who care about (quality) treating right. This small doctor as you call him, I checked, seems to prefer reputed branded implants and after you called, I spoke with him and learnt that he has attended every training that the implant companies have offered. By attending the workshops, he upgrades his knowledge. The implant is not just a piece of steel. There is a lot around it which is the responsibility of both the company and the doctors to ensure that knowledge and skill transfer take place for that implant to actually be effective in a treatment. Now, do you see how choosing the right implant matters?
Abhed: But you said it depends on the doctor who cares to learn...
Vyom: Ah! Right implant also means the brand owner takes the pain to transfer skills and knowledge, which usually happens in the case of branded implants. Wrong implant means it is all mass purchase, mass sale, and the only thing that gets transferred is money and ownership. Doctors become comfortable with the instrumentation, and as a result your likely outcome with that is better. Your hands have become set to work with it. See, when a doctor experiences success with a brand, he repeats usage, and thus, becomes comfortable with a brand. Success is driven by practise and practise is driven by education by the manufacturer. Because you do it on model bones first. The brand owner ensures he teaches the doctor how to use the brand. The resource provision comes from the brand but overall it is balanced by both sides. Doctors who are technologically driven will pursue training and study how the brand works.
A doctor needs to know a brand closely especially when it comes to implants and how they respond to patient’s body. Just as there is a patient discipline issue, there is a doctor dedication issue. There may be many like your mother out there whose implants maybe coming a cropper, but they probably endure the pain, the discomfort and think all this is incidental to the fracture. But I am saying it need not be so. These implants have been made to restore you to normalcy but the tragedy of our country is this assumption that there can never be perfection.
Abhed: Not when the implant is a global brand?
Vyom: Not necessarily. Sometimes it may even be well matched but the surgery may not be done artfully. Because your understanding of the implant and how to apply in a surgical situation may not be backed by observation, study with the brand and so forth. Dr A may have done 20 surgeries and there may be a Dr B who has invested in observing how good implants work and under what situations. The difference in the patient experiences between Drs A and B will be very different and that only the patients can tell you based on the comfort level he/she feels with the bone. Family can only make cosmetic observations such as ‘he does his work’, ‘hand is moving’, she combs hair herself now’... But because each one has only his experience to go by, he cannot tell if it could have been better because he does not even know if there is a better ‘better’, or if this is the optimum level of goodness.
Even those observing her will feel: look, she can move her hands, tie her hair, one should not ask for more! We are a karma-led nation, we fear perfection! A very good implant in the hands of a bad surgeon cannot deliver performance. This responsibility was quite clear to us. Surgeons know the biology, but every implant has a process that needs to be taught. Even the joints companies and the cardiac companies; they always go out and train the surgeons.
A doctor using any implant needs to study with the brand owner, how it has to be used; surgeons must take time off to work with brand owners as this impacts their application of an implant on a patient.
Abhed: Which means the smaller towns and hence smaller hospitals will never benefit...? The benefits of liberalisation continue to be the inheritance of the bigger cities?
Vyom: The guys who want to grow don’t think like this. I have many small town doctors who attend our conferences. They come from very far off to listen to our technology. It’s reaffirming. They ask questions. I have known them to gather at a table during tea time, when they share visiting cards. An orthopedic surgeon in a slightly larger towns like Meerut, Madurai, Jabalpur, will invite these smaller town doctors to watch a surgery at their hospitals. This sharing does happen. Or the other way round where a doctor from, say, Solapur may request an orthopedist from Madurai to perform a surgery at his hospital so he benefits in so many ways!
So, there are different levels of skill transfer already happening. These smaller town doctors may not be creating a buzz in big city thinking, but they are extraordinarily proactive. Like, Dr Surya. They meet to share new learnings. So, someone from Jamshedpur who attends a new implant workshop will go back and do an educative session for doctors from Ranchi, Dhanbad, Bokaro... that is how even if the brand cannot travel to the smaller towns, we enable via building feeders through bigger cities. So, for younger doctors with the fire to learn, we have fellowships to sponsor them for 6-8 weeks’ observation or study at hospitals in larger cities. Skills thus flow.
Abhed: So, the competence of the doctor needs to be established, that is your message? How strange! Your family member is broken and crying and the doctor is saying stuff, and OTs and ward boys fill conversation... in that moment of high tension, will you question the DCP the doctor is putting in, who makes it, metallurgy, etc.? It does not even occur to you. You think: He is a doctor, he knows what he is doing. How can I ask a stupid question? Can I ask, ‘Is that injection date expired?’ I will assume that the doctor is right because he is in the business of saving lives. So, you will probably not question him, and an implant is technical, about which you know nothing anyway.
Vyom: I agree. But I still do not think that the entire responsibility has to be the doctor’s. That you are not exercising your right does not mean that the doctor is wrong.
The cultural setting of our country has virtually overshadowed that right with the element that doctor is God and karma is my lot. It is more of a belief system that trusts the doctor to provide direction. The sentiment is the same, the patient attitude the same as the whole country is caught in the grips of belief based ignorance and nobody wants to figure out the truth of his belief nor does anyone tell them this is wrong! This mood prevails across all stratas. Literate or illiterate. So a CEO will use sophisticated language — ‘I am at your mercy, dear chap, I trust you.’
I am going one step further, I am saying the patient here has a duty to know about his condition and what is necessary as a part of his treatment. He cannot throw himself at the feet of the doctor and say, save me! You must ask, you must be informed.
Net, net, my friend, there is a responsibility that a patient has towards a medical procedure being conducted on him, to find out what is the treatment being offered, what it involves. Patient education is a part of the process of patient assurance which in turn is part of a patient experience.
To be continued...
(This story was published in BW | Businessworld Issue Dated 12-01-2015)
