How Johnson and Johnson hip implants system went wrong


Aug 30, 2018

An expert committee set up by the Health Ministry has indicted Johnson & Johnson for “suppressing” key facts on the harmful effects of the company’s “faulty” hip replacement systems, withdrawn globally after complications required many patients to undergo revision surgery. A look at the concerns raised in India and elsewhere:

How is hip replacement done?


The hip joint consists of a ball and a socket, which are covered with cartilage and surrounded by a lubricating membrane to protect against wear. In total hip replacement, all components are replaced with prosthetic components. While a metal stem is placed into the hollow centre of the thighbone (femur), the prosthetic ball, socket and cartilage can be made of strong plastic, metal or ceramics. The commonest hip implants are metal on polythene, and ceramic on polythene.


What kind are the implants at the centre of the current controversy?

These are metal on metal, with cobalt, chromium and molybdenum as major constituents. Called ASR (Articular Surface Replacement) XL Acetabular System and ASR Hip Resurfacing System, these were being manufactured and sold for several years by Deputy International Limited (DePuy), UK, a subsidiary of Johnson & Johnson.

What problems arose with these?When the prosthetic ball and socket rub against each other, it causes wear. If the implant is metal on metal, this can sometimes releases metallic debris into the bloodstream. This can lead to complications, sometimes requiring revision surgery. Of the 93,000 patients implanted with ASR worldwide, many experienced serious adverse reactions, some requiring revision surgery to replace the ASR implant with another kind. Because of this, the company recalled the product on August 24, 2010.

In India, the company got the licence to import the device in 2006. By the time it was recalled worldwide, an estimated 4,700 ASR implants had been done in the country. Amid concerns worldwide, the Health Ministry set up an expert committee in 2017 to examine issues arising out of faulty ASR implants in India. Headed by Dr Arun Kumar Agarwal, former Dean and Professor of ENT at Maulana Azad Medical College, the committee reviewed action taken by the company to replace faulty ASR implants, and reviewed compensation provided to those who had suffered.


While more than 3,600 of the 4,700 patients could not be traced, the committee sent letters to 101, of whom 22 responded. The committee concluded that not only did patients undergo revision after first surgery, but “in some cases, more than one revision surgeries have been performed”.

About the adverse effects, it observed: “Some of the patients had reported that they had to undergo excoriating pain during all these and more particularly after the implant. Many patients reported general fatigue or local issues such pseudo tumour, pain walking, metallosis (increase in Cobalt and Chromium levels, Asthenozoospermia (reduced sperm motility), cyst in kidney, claudication pain.”

Besides physical problems, it noted: “Some of them informed that they are still having difficulty in carrying out their routine activities and are confined to bed which has led them to mental turmoil and agony. These patient also informed that the cost of revision surgery was reimbursed either by the company or the insurance firms. The patients are still sceptical about their future with the implant in their body.”

Has the committee suggested how these issues should be addressed?

 

“Are these foreign companies are responsible for what they have done ? There mere goal is to earn money !!” – Editor, Vedic Upasana Peeth

 

Source : The Indian Express 



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