Virtually any joint in either of the extremities can be replaced today. In western countries the most common is the hip joint. In Asians there is a genetic preponderance of knee replacements. The hip joint consists of a ball at the upper end of the femur, articulating with a socket in the pelvis; and hip replacements have undoubtedly brought relief to millions over the years.
By 1953, George McKee introduced the metal on metal design where both the ball and the socket were made of metal. There were numerous innovations in the composition of the alloy. Steel, chromium, cobalt, titanium, and vanadium have all been used in various combinations. By the 70’s the metal on metal concept had been abandoned because of a high failure rate with excessive metal wear causing metallosis. The Charnley design of a metal head articulating with an ultra-high molecular weight polyethylene socket, with bone cement was established. Numerous attempts to reintroduce the metal on metal concept were made based on the theory that modifying the alloy would solve the problem of metallosis.
Using this argument, the reintroduction of the metal on metal took place without the USFDA approval on the grounds that the concept was not new. No trials were conducted to test the new alloy. By 2003, the implant had been cleared for use in the European Union, and Australia. In 2008 it was cleared by the FDA for use in the US. Curiously no laboratory testing was carried out. By 2006 adverse review articles were appearing regularly in both the British and American Journals of Bone and Joint Surgery and steadily increasing.
The evidence against the implant got irresistible, and in 2009, DePuy withdrew the implant from the Australian and New Zealand markets after concerns expressed at the Australian Annual Orthopedic Association meetings. The British Orthopedic Association soon followed suit. In 2009, the UK Medicines and Healthcare products Regulatory Authority (MHRA) issued an alert against the use of such implants. By the end of 2010, this was elevated to a hazard alert and recall notice in the UK and USA. The company now issued instructions to have all implants returned, and the procedure to be followed in case patients developed problems. By now the revision rate had climbed to 13% as per the UK National Joint Registry. (It is now believed to be in the region of 49%). Professor Ashley Blom, from the School of Clinical Sciences, produced data showing that the use of metal-on-metal hip implants had declined from 14 per cent in 2008 to less than 1 per cent in 2012. The group’s research was published in the Lancet bringing the problem to the attention of regulators, the world’s media and the public at large.
Against the background of all this chaos in the international scene over the use of metal on metal hip implants, the situation in India was appalling. The company J&J, and its local subsidiary DePuy continued to sell the implants in India in spite of the serious developments in UK, USA, Australia, NZ and Europe; even as compensation figures were being discussed in the US.
Many of the Indian recipients were under fifty suffering from rheumatoid arthritis, ankylosing spondylitis or accidents. Careers were ruined and families crushed under the financial burden of prolonged treatment, repeated salvage surgeries and disability. 15820 prostheses were imported, records of 4700 surgeries were traced 1295 were returned. That left 9825 unaccounted for. This country neither has a joint registry programme like the UK, nor does it have a culture of publishing failure rates. Corporate hospitals disapprove of such practices because of the adverse publicity it would bring. The Central Drugs Standards Control Organization (CDSCO) has no testing facilities of their own and rely blindly on USFDA directives. Even so the CDSCO failed to respond in time to reports of failures of such implants. Matters attracted public attention only after PILs were filed in courts and the National Consumer Disputes Redressal Commission (NCDRC). The company’s main argument is that with the removal of the implant in revision surgery, the cause of action ceases. This is preposterous. Patients have had to undergo multiple surgeries in some cases. The Justice Srikrishna report that the company used in its defence was challenged by the government experts particularly with regards to the metal on metal causing wear particles of chromium and cobalt which are absorbed and damage tissues and organs. The Union Health Ministry took four years to make its report public in February 2017. To add insult to injury it recommended a Rs. 20 lakh compensation to patients on the rationale that this amount in an FD would provide a monthly income of Rs 13,350. The US in comparison awarded $1 million to each patient. This is reminiscent of the Bhopal Gas tragedy which left the Indian public short changed and the politicians well compensated. J&Js’ answer: “the legal system in the US and India are quite different and cannot be compared”.
In summary, it was criminally negligent of J&J and DePuy to foist on the Indian public a metal on metal hip prostheses with a high recorded failure rate reported more than 40 years back. Its defence that a modification of the alloy made it safer is unacceptable without the back-up of adequate testing. Surgeons in India in their haste behaved unethically in using an implant with known problems ignoring published literature. The government was equally negligent in delaying corrective action; and the compensation recommended is pathetic.
This is certainly not the first incident. Abbots “Absorb” stent, the recall of Rofecoxib and Rosiglitazone are on the “shame sheet” of India. In the late ‘80s a carbon fiber knee ligament replacement caused endless misery due to inadequate research, before being withdrawn. With the SC in the picture, let us hope for a happier ending to this scam.
(The writer is an Orthopedic Surgeon and a founder member of the Voluntary Health Association of India)
