Johnson & Johnson already in trouble over their talc powder in US, has been indicted in another fraud, that of “suppressing” key facts on the harmful after result of surgeries conducted on hundreds of patients in the country using “faulty” hip replacement systems it imported and sold.
These findings are reported by an expert committee set up by the Union Ministry of Health & Family Welfare to investigate complaints on the hip implant devices sold by the company in India.
The report states that over 3,600 patients with the faulty implants remain untraceable, and that at least four deaths have been reported from those who underwent surgeries using these devices.
The report has recommended that J&J be made liable to pay at least Rs 20 lakh to each affected patient.
Details about the case:
It is concerned with the J&J, which imported and sold ASR XL Acetabular Hip System and ASR Hip Resurfacing System in the country — these devices were globally recalled in 2010.
The committee concluded: “…the ASR hip implants were found to be faulty, which resulted in higher revision surgeries”; the “…accelerated wear of metal on metal implant leads to higher levels of cobalt and chromium in the blood which lead to toxicity… these metal ions damage tissues and further damage body organs” and “may also cause localised and systematic health problems”.
The panel found, “results in increased pain and decreases mobility affecting their family and social life” and has “a negative impact on their self esteem and mental health”.
The mentioned devices were first cleared by the United States Food and Drug Administration (USFDA) in 2005. Following red flags on the rising number of revision surgeries, the firm recalled the devices on August 24, 2010.
Many patients reported that they had to live a restricted lifestyle with a compromised physical state, thus putting them at pain and agony throughout their life, which will also have a bearing on their dependents apart from loss of work”.
The company also did not inform the national regulator about the exact number of patients who used these devices, the adverse reports following such surgeries and the corrective operations subsequently conducted. It also “did not provide any compensation” to those affected.
Majority of implants remain untraceable.
The firm has reported about 4 deaths of the patients who had undergone ASR surgery in the past but suppressed facts on revision surgery.
The use faulty implants leads to poor results, which in turn creates a trust deficit between the doctors and the patients as the assured results are obtained.
So it advisable for the doctors to go in the details of the implants or the material that they are going to use to ensure desired results.
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