CONTROVERSY

Hip stir

How faulty hip implants have been slowly destroying lives

20-vijay-vojhala Fighter to the end: Vijay Vojhala with an X-ray of the implant that turned out to be faulty | Amey Mansabdar

If Vijay Anant Vojhala’s life was a motion picture with him as protagonist, the turning point in his struggle would have just happened. Here is a recap: a medical representative with a well-paying job and a happy family is suddenly diagnosed with a medical condition and undergoes a major surgery. Later, he realises he was wronged and takes on the 'bad guys'. After years of struggle and anguish, there is some vindication now.

The need for a national joint replacement registry was highlighted several years ago. But the country's drug regulator did not act on it. Dr Raju Vaishya, senior joint replacement surgeon

This is life for Vojhala, a resident of Mumbai. Until 2008, all was well. "As a product manager with a multinational healthcare company, I had a five-star job," he recalls. Things began to change when Vojhala was diagnosed with avascular necrosis—death of bone tissue due to interruption of blood supply that leads to severe pain. Doctors advised him to go for a hip replacement surgery, and soon, an unsuspecting Vojhala lay on the surgeon's table, unaware of the turn of events that were to follow.

After surgery, Vojhala was advised bed rest for six months. But, even after he resumed work, he did not feel at ease. "I felt giddy, had frequent headaches and my dentures started to give trouble, too. I thought, maybe, I was just born to suffer," he said.

It was only in 2011 that Vojhala realised that it was not fate. The reason for his discomfort and the limping was because of a faulty hip implant that was releasing toxic chemicals into his bloodstream. The implant, DePuy ASR (acetabular surface replacement), was sold in India by DePuy International, a unit of US pharma giant Johnson & Johnson. It was approved by the Indian drug regulators in 2006. Prior to that, it received approvals in countries like Australia, but it was not approved by the Food and Drug Administration in the US.

In 2009, the company recalled the implant in Australia, and in 2010, it initiated a global "voluntary recall" of the product, given the high failure rates. According to the Union health ministry’s expert committee report submitted in February, the company admitted that the implant’s faulty design caused metal wear debris, and led to an elevated release of chromium and cobalt in the body. This, according to the report made public in August, may cause both localised and systemic health problems, such as dizziness, hearing loss, decreased mobility and even organ failure. The report contains other damning revelations including the fact that despite having evidence of the implant's faulty design and its side effects from Australia and the UK, crucial information was concealed from the Indian drug regulator. Experts also found the company to be "evasive" in providing details of affected patients, follow-up drug reaction reports and design of the implant. "The firm also appears to be delaying in the passing of the information and awareness about the failure of the ASR," the report reads. Dr C.S. Yadav, professor in the department of orthopaedics, All India Institutes of Medical Sciences, told THE WEEK that he had had concerns about the implant as early as 2005-06. "I never used it because Dr Ross Crawford [professor of orthopaedic research, School of Biomedical Engineering, Queensland University of Technology] had advised me against it, based on certain data about its effects. Besides, it was expensive, too. But, several surgeons, including some top names in the field, used it. They are not wrong, and the company is right in claiming that not all implants have failed. But, since there were concerns, perhaps doctors could have waited," said Yadav.

However, he conceded that there is an unholy nexus among doctors and medical device companies that might have a bearing on deciding which implant to use.

Vojhala says that his job required him to work with doctors, but most were either unaware or did not warn him about the health issues associated with it. "It was only in 2011, at a conference in Nagpur, where one of the orthopaedics pointed out that my limp was not normal. He told me to get a blood test, and that is when I realised I could probably be one of the victims of a metal-on-metal implant by Johnson & Johnson," he said.

Vojhala's blood reports showed abnormal levels of cobalt and chromium, and he was advised a revision surgery. "The thought of another surgery was traumatic. Also, I had to fight a lot with the company, before they agreed to pay for my revision surgery," he said. Despite the surgery, things got worse. "If I had a stomach ache, it was too much. If I had a headache, or I was giddy, that would also be too much. My family life was disturbed, I could not manage my job [which involved a lot of travel]. Now, I cannot sit for too long, squat, run or walk properly," he said.

Defect's effect: A component of Vojhala's hip implant | Amey Mansabdar Defect's effect: A component of Vojhala's hip implant | Amey Mansabdar

These setbacks, however, did not keep him from fighting for justice for himself, and for others such as him. Globally, 93,000 patients received the implant, of which, around 4,700 are in India. In the health ministry’s report, the company claimed that until March 2017, a total of 1,063 cases were registered with the company’s helpline, out of which 1,032 were found to have the implant. Of those, 254 patients have undergone revision surgeries and the rest were being monitored, a step that the committee found inadequate. Besides, no compensation was handed to Indian patients, in stark contrast to the money that the company had shelled out to settle the lawsuits in the US and Australia.

Seeking recourse for what he says was a criminal offence, Vojhala ran from pillar to post, notifying various government ministries, but would "only get angry responses".

For Ramandeep Chawla, a government school teacher in Faridkot, Punjab, things are more complicated because he is not “eligible” for reimbursement for a revision surgery. In May 2017, when Chawla reached out to the company via a helpline, he was told that since it was over ten years since his surgery in 2007, there was nothing they could do for him. "The damage in my body happened slowly over the years, not suddenly like a heart failure," he said. "How can the company deny responsibility?"

Chawla was 29 when he was advised a bilateral hip replacement at the Indian Spinal Injuries Centre in New Delhi. The surgery cost him 05 lakh. "Doctors told me that this implant was especially good for young people, and would last for 25 years," he recalls.

But things started to go awry in 2015 when Chawla started feeling pain in his right hip. It took two years for doctors to finally pin it down to the faulty implant. Last December, Chawla finally got a revision surgery that cost him another 05 lakh. When doctors sliced into his hip, what they saw frightened them. "The area around the implant had gone black from the leaking metals," he said.

Today, Chawla still finds it difficult to walk, and fears what lies ahead, since one of the faulty implants is still present in his body, and hurts like "tiny needles being pressed into flesh". His case for compensation is now in National Consumer Disputes Redressal Commission, and the demand for damages is Rs 1 crore.

Dr Raju Vaishya Dr Raju Vaishya

"The company’s claims that the patients are doing this for 'windfall gains' is ridiculous," says Neela Gokhale, the advocate fighting for Chawla and other patients. "Johnson & Johnson has settled for millions of dollars in the US. And here, they are denying people any compensation."

When contacted by THE WEEK, Johnson & Johnson responded with a statement, saying, "J&J instituted an unprecedented patient reimbursement programme in August 2010. In light of the recent committee report, we are cooperating with the Indian government to develop an appropriate process for providing further support and compensation for patients in need."

J&J added: "Our goal has always been to make sure that as many ASR patients in India as possible were aware of the voluntary recall and understood the support available to them. DePuy does not, however, have access to data on patients who have received an ASR hip implant due to patient confidentiality regulations.... We have sent several communications to surgeons who implanted ASR hips, informing them of the recall, available support, clinical and scientific support information and the reimbursement process."

For victims such as Vojhala and Chawla, things took a dramatic turn after the expert committee report was made public in August. Under duress from media reports on the issue, the Union health ministry accepted the recommendations made in the report, and constituted a central committee to decide on the amount of compensation.

But Vojhala says that unless patients themselves are made part of the process, the entire exercise would lack credibility. The legal basis for handing out the compensation—Rs 20 lakh has been proposed as a base amount—needs to be clarified, too.

Doctors point to the lessons learnt from the crisis, especially since joint replacement surgeries—hip and knee—are on the rise in the country. "This is a landmark case for us, given the scale of the crisis, and has served as a learning curve for us," said Dr Arun Agarwal, ex-dean, Maulana Azad Medical College, New Delhi, and chairman of the expert committee that wrote the report.

Agarwal said that the blame for the crisis lay with doctors, hospitals and the medical device company. "We are not saying that the company did not try. It set up a portal and paid for revision surgeries, too," he insisted. "But they could have done better. We need a robust follow-up system in our hospitals. Doctors need to keep track of their patients, too. The drug regulator needs to strengthen its materiovigilance programme,” he said.

The drug regulator ought to make data from clinical trials on medical devices public, said a government official who did not wish to be identified.

Doctors say the crisis underscores the need for a national implant registry to keep track of the performance of devices. "The need for a body such as a national joint replacement registry was highlighted several years ago. But the country's drug regulator did not act on it, despite being aware of the implants issue since 2010," said Dr Raju Vaishya, senior joint replacement surgeon, Indraprastha Apollo Hospital, and president of Indian Cartilage Society.

Dr Pradeep B. Bhonsale, founding member of the Indian Society of Hip and Knee Surgeons, said that response to the Society's implant registry had been slow. "Only 2-5 per cent doctors have responded to it because sharing data is a time consuming activity," said Bhonsale, director, arthritis and joint replacement surgeries, Nanavati Hospital, Mumbai.

For Vojhala, though, it is time to get ready for a fresh battle for compensation, one that will entail a fresh round of negotiating with bureaucracy, and arguments around what is just and adequate. "This is not a joke. It is about the ten years of my life that I have lost already. Can they bring that time back? Can Rs 20 lakh compensate for that?" he asks.

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