Issues with J&J Hip Replacement Treatment

Why in news?

Union health ministry’s panel has recommended Johnson & Johnson (J&J) to pay compensation of $28,500 to hip replaced patients.

What is a hip replacement treatment?

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.
These are metal on metal, with cobalt, chromium and molybdenum as major constituents, these were being manufactured and sold for several years by Deputy International Limited (DePuy), UK, a subsidiary of Johnson & Johnson.

What is the issue with Johnson & Johnson?

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.
Many patients implanted with ASR worldwide experienced serious adverse reactions, some requiring revision surgery to replace the ASR implant with another kind.
Because of this, J&J recalled the product in 2010.

What are the concerns with Indian patients?

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.

While more than 3,600 of the 4,700 patients could not be traced, the committee sent letters to 101, of whom 22 responded.
Some of the patients had reported that they had to undergo excoriating pain during all these and more particularly after the implant.
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.

What are the recommendations’ of the government panel?

Amid concerns worldwide, the Health Ministry set up an expert committee in 2017 to examine issues arising out of faulty ASR implants in India.
The committee has recommended the company should be made liable to pay at least Rs 20 lakh to each patient with such complications, and the reimbursement programme be extended until August 2025.
It has recommended that the maximum amount be at par with the maximum granted for clinical trial-related death and permanent disability as per rules and guidelines of the Drug Controller General of India.
Provisions for compensation should be included in Medical Device Rules if any serious adverse event or death is caused due to the sole use of a medical device.

Source: Indian Express, Business Standard