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Thursday, January 27, 2022

Implant Files | 9 am, Room No. 7, AIIMS – 2 out of 10 here have had an implant gone wrong

From clinics in small towns to hospitals in big cities, victims of botched surgeries make a beeline to this OPD for a second shot.

Written by Kaunain Sheriff M | New Delhi |
Updated: November 26, 2018 10:40:28 am
Dr C S Yadav with Shashikanta Varshney, 55, in AIIMS Delhi. Her complaint: implanted with the wrong knee device. (Express Photos: Kaunain Sheriff M)

Call it the ward for the second and the third, in some cases, the fourth surgery.

At 9 am every day, over a dozen patients shuffle into Room Number 7 on the first floor of the All India Institute of Medical Sciences (AIIMS) right above one of the country’s busiest out-patient departments, the Rajkumari Amrit Kaur OPD.

Within minutes, two security guards make way for Dr C S Yadav, one of India’s top orthopaedic surgeons, and his team to enter. By the time the staff start calling out the list of patients, every inch of space inside the room is packed.

READ: #ImplantFiles – Big medical device bazaar: Faulty implants, basement surgeries, lives at risk

Every patient is here because he or she has had a surgery related to a medical device which has gone wrong — and needs a revision surgery. This is the last stop of hope for hundreds of patients, most of whom are the victims of botched hip implant surgeries, each costing lakhs of rupees and conducted across the country, from clinics in small towns to large corporate hospitals in big cities.

Arvind Kumar, 51. His complaint: 2 botched hip implant surgeries. (Express Photos: Kaunain Sheriff M)
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In India, there are an estimated 1.2 lakh knee replacement and around 70,000 hip replacement surgeries annually. And Dr Yadav’s OPD in AIIMS is among the few in the country solely for implant revision surgeries.

“AIIMS conducts over 1,500 hip and knee replacement surgeries – 20 per cent of them are revision surgeries. An implant lasts for at least 10 years. But due to surgical errors, many patients have to undergo revision surgery within months… 80 per cent of these surgeries are because of surgical errors, mostly to correct faulty hip implants,” says Yadav.

“Most of these cases come to us from Tier III cities. You will ask me, who is the villain. There is no single villain: industry and market forces, untrained doctors, poorly designed and hyped implant devices and inadequate infrastructure in operation theatres,” he says.

Yadav has been running his “independent OPD for revision surgeries” since 2008 — he consults patients every Monday, Wednesday and Friday, and conducts surgeries on Tuesdays, Thursdays and Saturdays.

The Indian Express spent a day at Dr Yadav’s OPD to meet some of the faces and voices behind his findings — from a man who suffered two botched hip implant surgeries in UP, to a woman whose hip screws were removed and fixed twice after infection in Haryana, and a patient who was implanted with a “wrong” device at a private hospital in Noida.

Also read: #ImplantFiles – Big medical device bazaar: Faulty implants, basement surgeries, lives at risk

On a stretcher, Arvind Kumar, 51, has travelled over 700 km from Ambedkar Nagar near Ayodhya for his second follow-up session after his hip replacement surgery at AIIMS on July 24, 2018. It was his third replacement surgery after two similar procedures conducted at a private hospital in Lucknow went horribly wrong.

Sunita Sharma, 38. Her complaint: hip implant infection. (Express Photos: Kaunain Sheriff M)

“It’s not just the intense pain and mental trauma. I lost my job as a sales manager at a private firm in Chandigarh, and have already spent over Rs 13 lakh for treatment. What started as simple fracture on my left hip, which I suffered in a road accident in Rohtak, has pushed my life into a corner from where I can’t escape,” says Kumar.

Records show Kumar was referred to a government hospital in Chandigarh by doctors at the Rohtak district hospital. On July 21, 2014, the fracture was repaired with a hip screw which is a common orthopaedic implant. “But after the surgery, I started experiencing a severe burning sensation in my hip. The screws were then removed and a new plate fixed. That did not help and I went to Lucknow for treatment,” says Kumar.

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Records show that on September 4, 2014, he underwent a total hip replacement at a private hospital in Lucknow, a 50-bed facility. “Within five months, my hip got dislocated. When I went back, I was taken to the operation theatre for the hip to be readjusted. In September, 2015, the hip got dislocated again. And again, the hospital asked me to undergo the same procedure, which failed,” says Kumar.

“The doctor told me that I would have to undergo a revision surgery, which was conducted in August 2016. This January, as I was trying to sit down, the screw of the implant got loose and cup got dislocated. I rushed to doctor but he advised me to undergo another surgery to implant a new device. That day, I realised that the doctor didn’t know what he was doing,” he says.

Kumar finally consulted government doctors at the King George Medical University. “They advised me that only AIIMS will be able to fix the problem,” says Kumar.
Dr Yadav, who has been tracking global trends in orthopaedic implant treatment over the last two decades, points to the role of medical device companies in many of these botched surgeries. “The industry decides the implant’s design and longevity but in many cases, hides the information on its drawbacks. It influences the choices of surgeons and patients, and scientific meets where live demonstration surgeries are conducted,” he says.

“This influence is also seen in R&D, introduction of the implant in the market, and at the level of the dealer. There have been instances in recent times, when a gold standard technique is condemned and fear created among surgeons. Then, hype is created about a new product. The surgeon has to balance safety and innovation,” says Dr Yadav.

Dr Yadav’s first patient after a quick lunch is Shashikanta Varshney, 55, who underwent a knee replacement surgery at a top hospital in Noida. After suffering pain in her left hip joint for years, she decided to replace it with a prosthesis, or an artificial joint.

“I worked in the postal department and the job was physically demanding. Later, as my weight increased, I started experiencing pain in my hip. I consulted different doctors, all of them told me to undergo a hip replacement,” she says.

Varshney’s records show that the surgery was conducted on April 24, 2016. “I paid Rs 5 lakh for the implant but within two months, I was suffering from unbearable pain on that hip. I returned to the doctor who advised a revision surgery to implant a new device without telling me why. I was shocked,” she says.

Varshney did not opt for the revision immediately. “I went to three other private ospitals. All of them said that the implant had loosened and that I had to undergo a revision surgery. No one could tell me why the implant had loosened. That’s when I decided to knock at the door of AIIMS,” she says.

As Dr Yadav completes Varshney’s examination, he pulls out a startling number. “There are 150 types of total knee replacement implants that are available. Does this make any sense? If the same standard is used in the aviation industry, how many disasters do you think will occur,” he says.

According to him, Varshney’s case is “not only one of surgical error, but also of a wrong choice of implant”. “Selection is most vital to prevent early failure. Just because you implant a particular device does not necessarily mean it’s the right one. Surgeons should not rush for change. In the last 20 years, many technologies have come and gone without a proper outcome. New techniques and prosthesis should be foolproof,” he says.

Finally, Dr Yadav wraps up his OPD with “the real question”: “What should the industry do? The answer is simple: unbiased teaching and training, development of infrastructure, honest research in the development of new prosthesis… and yes, it should not propagate wrong information.”

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