“Your pain is psychological, the doctor would tell me every time I went to him for a follow-up,” says K. Jyoti Rani, 44, who spends most of her day bed-ridden. “He would ask me to get an X-ray, study it, and then tell me that my hip implant was absolutely fine.”
In May 2008, Rani, a Visakhapatnam-based jewellery designer, was implanted with a metal-on-metal (MoM) articular surface replacement (ASR) hip by DePuy, a subsidiary of the pharmaceutical giant Johnson & Johnson (J&J). The implant was recalled globally in August 2010 for two reasons: it left large quantities of metal debris in the body and it had a very high failure rate. The leaching of metals, mainly cobalt and chromium, caused severe pain, neuropathy, fluid accumulation, and metal poisoning, all of which Rani suffered for years.
The company claims that its first point of contact to spread awareness about the faulty implant, its risks, and the recall were doctors. But it took six years for Rani’s orthopaedic surgeon, H.J. Sangtani, to tell her that her implant could be the root cause of her problems. The revelation came only in March 2016, when she met him for a follow-up after having had a miscarriage.
“Don’t plan for a family at the moment. Get in touch with the company on this toll-free number,” the doctor had told her, handing over the number of the ASR helpline set up by the pharmaceutical company. “I never missed my follow-up. In 2013, when my parents found a match for me, I first sought the advice of my surgeon. Even then — and this is three years after the global recall — he did not mention that the implant inserted in my body could be destroying it from within,” Rani says.
She is among the 4,500 patients in India who were implanted with the faulty hip joint. Most of them never heard about the defect from the surgeons who had operated on them. The implant manufacturer, drug regulators, and the government systematically neglected these patients and their suffering. The doctors, who they had trusted blindly, failed them too.
“Had the doctor told me about the defect, I would have had the revision surgery much earlier. I wouldn’t have got married either,” says Rani. Her in-laws and husband are extremely supportive. But she feels guilty for having made them suffer for her illness. “I can’t stop thinking that the faulty implant led to my miscarriage,” she says. Some international agencies do warn about the contraindications of MoM implants in women of child-bearing age, possibly caused by the unknown effects of metal ion release on the foetus.
Poison in the body
In 2016, when Rani finally got in touch with the company, her blood had 9.40 micrograms per litre (ug/l) of cobalt and 18.18 ug/l of chromium. The typical cobalt and chromium levels in well-functioning hip implants are 1.7 and 2.3 ug/l, respectively. Rani’s MRI report confirmed “thick-walled fluid collection” and “moderate to severe muscle atrophy” at the site of the implant.
Sangtani, who runs the Ortho Relief Hospital in Nagpur, where Rani was operated, says that there was no clinical link between the faulty implant and the miscarriage. “The company told me about the recall in 2013. I did call my patients after that,” he says, refusing to elaborate.
In February 2017, Rani underwent a revision surgery funded by J&J and carried out by another surgeon in Chennai. But that didn’t make a big difference either. Rani says that the only difference is that now the implant in her body is not a faulty one. “But the damage done by the previous implant remains. The nagging pain continues as there was a lot of tissue damage around the site of the implant. I have palpitations and loss of memory,” she says.
Vijay Vojhala, 44, a resident of Dombivli, Mumbai’s extended suburb, holds a similar grudge. “It was not a cold drink bottle lying in my refrigerator that was recalled. It was an implant inside my body, poisoning me every single day. Nothing can justify why the doctor never called to inform me about such a big development,” he says, visibly angry. Vojhala feels that the medical fraternity failed in its responsibility towards patients.
In July 2008, Vojhala underwent the hip implant surgery after being diagnosed with avascular necrosis, a condition that kills the bone due to a lack of blood circulation. Months after the joint replacement, he started having severe bouts of pain. A squeaking noise from the implant made things worse. By 2011, Vojhala, who worked as a product manager in a medical equipment manufacturing company, had developed a limp. At an orthopaedic conference a surgeon observed his discomfort and told him that his implant could be faulty. Vojhala subsequently did a blood test, which revealed extremely high levels of metals: 171.8 ug/l of cobalt and 85.76 ug/l of chromium.
Mumbai, Maharashtra, 10/09/2018: When Shailesh Bachate (left) explaining his tragic story, the wife Sayali share love to their younger son at their single room home in Sinhgad chawl at Tardeo in Mumbai. Photo: Arunangsu Roy Chowdhury
In June 2012, Vojhala underwent a revision surgery by another surgeon in Mumbai. His first orthopaedic surgeon, Sangeet Gawhale, says that the implant maker got in touch with him about three to four years after the global recall. “Till then, we had no idea about the fault. When I came across a few media reports about the defect, I tried to get in touch with seven patients. But I could reach out to only two of them,” claims Gawhale, adding that the company has acted irresponsibly and has hidden a lot of crucial information.
The background
The hip joint is the largest joint in the human body. In 2006, the Drug Controller General of India (DCGI) granted permission to import and market DePuy’s ASR hip implant, which was then being aggressively promoted as a long-lasting, durable and ideal choice for younger candidates opting for hip replacement. While most orthopaedic implants wear off over a period of 10 to 15 years, necessitating a revision surgery, the ASR hip was pushed with a promised lifespan of 20 to 25 years. The logic given was simple. The implant, consisting of the femoral head and stem, and the socket (acetabular cup), promised more longevity as both are made of metal compared to the metal- on-polyethylene implants which were widely in use then. At present, most surgeons have moved on to fourth generation ceramic-on-ceramic implants, which are known for better durability.
In 2009, when distributors were busy marketing DePuy’s prosthesis to Indian doctors, Australia withdrew it from the market. The Australian Orthopaedic Association National Joint Replacement Registry had red-flagged the early revision surgery rate of the implant. While implants in general wear off over 10 to 15 years, in the case of ASR, it was observed that patients were requiring a revision surgery much before 10 years.
In 2010, a joint registry in the U.K. announced that 12%-13% of patients were in need of a revision surgery within five years of getting an ASR implant. This finally triggered a global recall by the company in August 2010. By this time, 4,700 ASR surgeries had been carried out in India on nearly 4,500 patients. Between 2006 (when it got the marketing licence) and 2010, DePuy Medical Private Ltd., Mumbai, imported a total of 15,829 ASR implants into India. While the price of a single MoM implant could be anywhere between ₹90,000 and ₹1.2 lakh, the cost of the procedure ranges from ₹2.5 lakh to ₹4 lakh.
Failure of regulatory bodies
The Maharashtra Food and Drugs Administration (FDA) was the first Indian agency to pull up J&J. In 2011, it lodged an FIR against the company for not making a serious effort to inform patients about their defective implant. The then FDA commissioner, Mahesh Zagade, also flagged the issue to the Central Drugs Standard Control Organisation (CDSCO), asking it to take corrective action. The CDSCO was thus in the know of things as early as 2011. But it took the drug regulator 24 months to finally put out a ‘medical device alert’ on its website. Also, it was only in February 2017 that the Ministry of Health and Family Welfare formed a committee to probe the issue.
The 11-member committee, headed by the former Dean of Maulana Azad Medical College, New Delhi, Arun Agarwal, submitted its report in January 2018. Based on the exhaustive report, which found J&J “evasive and delaying the passing of information about the failure of ASR”, the Ministry has now formed national and State-level committees to track patients and decide on compensation. The government committees will evaluate each case individually, study the extent of the medical problems and loss of wages, and work out an amount that J&J will be asked to pay. A base compensation of ₹20 lakh has been fixed for all the affected patients.
“The CDSCO did not react with the urgency that was required. It was sheer negligence on their part,” says Zagade. The IAS officer blames the “deep-seated necrotic rot commandeered by the pharmaceutical industry” as the reason for the regulator turning a blind eye. “The pharma company had a commercial motive. The doctors were afraid of the backlash that they might have had to face if they had willingly revealed that the implant they had chosen was a faulty one. But the drug regulator should have risen above all this to get things in order and help the patients in distress,” he says.
No gatekeepers
If the regulators failed to do their due diligence and the company remained evasive, the medical fraternity maintained an eerie silence on the issue. In 2014, the CDSCO had written to M.S. Dhillon of the Postgraduate Institute of Medical Education and Research, Chandigarh, and S.K. Marya of the Medanta Hospital in Gurugram. Dhillon was an office-bearer in the Indian Arthroplasty Association and Marya was president of the Indian Orthopaedic Association (IOA). In its letter, the CDSCO had asked them to circulate the ASR device alert to all members of their respective associations and design a protocol to receive complaints about the implant and ensure patient safety.
Marya claims that his tenure as president got over in 2013. “I have never received any communication from the CDSCO,” he says, adding that he doesn’t recall the IOA circulating any brief on ASR implants to the IOA members. Says Sudhir Kapoor, the IOA’s 2016 president, “We have not circulated any email to our members. But we have widely discussed this issue during our annual conferences attended by over 6,000 doctors.”
In contrast, the IOA’s U.K. counterpart, the British Orthopaedic Association (BOA), was prompt in contacting its members and asking them to see their patients each year and investigate them for cobalt and chromium in their blood. The BOA also recommended using an “MRI scan to look for changes in the tissues, including those muscles around the hip replacement that may indicate the body reacting to the presence of metal debris released by the metal ball of the hip [implant] rubbing on the metal cup”.
Mumbai-based hepatobiliary surgeon Sanjay Nagral, chairperson of the Forum for Medical Ethics, says that medical professionals ought to be the gatekeepers of the healthcare system. “Unfortunately, Indian doctors and associations don’t see themselves as gatekeepers or guardians of patients’ interest. Associations have to start seeing themselves as independent voices,” he says. “This case is a classic example of how an important issue has been brought up by patients while the medical professionals remained silent.” Activists also blame this silence on the deep-rooted doctor-pharma nexus, huge kickbacks on devices, and pharma sponsorship for conferences and seminars.
The absence of a monitoring system is seen as another reason for the lack of accountability. More than one lakh joint replacement surgeries are carried out in India annually. Of these, an estimated 70,000 to 80,000 are knee replacements, and 20,000 to 30,000 are hip replacements. However, the joint registry established by the Indian Society of Hip and Knee Surgeons (ISHKS) has recorded only 1.71 lakh knee and 14,000 hip replacement surgeries since it began collecting data in 2007.
According to orthopaedic surgeon S.S. Mohanty, who is on the education chair of ISHKS, there are an estimated 10,000 orthopaedic surgeons in India but only 261 submit their data regularly to the registry. This number has increased from 140 in 2016, but it still means that only 2.6% of the surgeons report regularly. A 2013 article in the Indian Journal of Orthopaedics states that for a registry to provide meaningful and validated information, it should have at least 90% participation from surgeons. “Apathy, lack of trust and fear of information disclosure are some of the reasons for non-participation by surgeons,” the article says.
“The aim of a registry is twofold: to track the performance of the implants as well as that of the surgeons,” says Mohanty, adding that doctors in the U.K. are given regular feedback based on the registry data. “If a particular surgeon has high failure rates in a certain kind of implant procedure, he or she can even be stopped from performing those procedures. It’s the same with failing implants as well.” He says the government should make reporting to the registry compulsory.
Dombivali, 10/09/2018: Vijay Vojhala, victim of Faulty hip implant at his residence in Dombivli. (Picture to go with Jyoti Shekar's story) Photo: Prashant Nakwe.
The 39-year-old Swedish Hip Arthroplasty Register, which is the oldest in the world, has more than 98% reporting. “We have had a great focus on implant selection, which has led to a homogeneous use of implants that have good long-term results. For example, only six different stem designs account for more than 90% of all total hip replacements in Sweden,” says register director Ola Rolfson. He adds that MoM implants have been sparsely used in his country. “As the register has close contacts with other registries around the world and tracks world-wide trends, we had observed the failures of MoM implants and recommended against their use among Swedish orthopaedic surgeons.”
Martyn Porter, medical director of the U.K.’s National Joint Registry (NJR), says that the data allow surgeons to readily see how implants are performing across the country and in their own patients. Data from the NJR had led to ASR’s global recall in 2010. “It’s very important to realise that with a NJR, patients with any implant can be identified immediately,” says Porter. “Without this, hospitals would be unable to identify which patients had the implants in question.”
Indian patients get short shrift
According to a J&J spokesperson, an Urgent Field Safety Notice dated August 24, 2010 was sent to surgeons informing them about the higher than expected revision rates involving ASR. This notice directed them to stop implanting the ASR devices and provided full details about the reimbursement process and the ASR Help Line.
“DePuy provided an ASR resource guide containing information about the recall and reimbursement programme. It was sent to all surgeons in India who implanted the ASR Hip System. The guide outlined the comprehensive patient reimbursement process and how patients should register at the ASR Help Line,” says the spokesperson, adding that till date, they have reached out to 400 surgeons in the country and sent nearly 10 ‘reinforcement communications’ to the doctors. But patients say that the company was not cooperative when they reached out to it.
“Call back when you have a severe problem” was the response given to Tardeo resident Shailesh Bachate (47) when he called the ASR helpline in 2011. “I was speaking to someone named Irfan. He told me rudely that my nagging pain was not a big enough problem,” says Bachate, who felt extremely insulted during the conversation. “He made it seem like I should not call till I was made bedridden by the faulty implant.” The driving instructor was implanted with the ASR hip in January 2007 and underwent a revision surgery in October 2016, both under orthopaedic surgeon Darius Soonawalla.
So far, the company has funded revision surgeries of 275 patients in India. But not a single patient has received any compensation. Meanwhile, the company has agreed to pay $2.5 billion to nearly 8,000 patients in the U.S.
The company’s reluctance to take responsibility is also evident in the Health Ministry’s report, where the firm is quoted as saying that patient details were only available with the surgeons and the hospitals. Gawhale, however, points out that that the company has access to patient details through their dealers.
The DCGI, S. Eswara Reddy, seems confident that aggressive measures are being taken. “Our first priority is to set the process of compensation in order, for which two committees have already been formed. J&J had shut down its ASR helpline in 2017. We have got them to re-start it and keep it open till 2025. We are also streamlining a mechanism of materio-vigilance under which such devices will be screened on a regular basis,” he says. The government also plans to make it compulsory for doctors to send data to the joint registry, he adds. “A software is being developed for this.”
But all these developments have failed to impress the patients who have fought a long battle. “It all an eyewash,” says Vojhala. “Let’s wait and watch if there is any further development in the next few months.”
