- 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Johnson & Johnson for “suppressing” key facts on the harmful effects of the company’s “faulty” hip replacement systems, withdrawn globally after complications required many patients to undergo revision surgery.
-
- 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.
-
- 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
- The committee has recommended that: * 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.
- A central expert committee and a regional expert committee should be constituted by the Ministry for evaluation of patients’ claims in “respect of disability and suffering caused due to use of faulty ASR”. The regional committee will determine whether there is permanent disability, and whether such disability has affected or will affect the patient’s earning capacity, and then submit its report to the central expert committee.
WhatsApp