A report submitted by Johnson & Johnson to the Central Drugs Standard Control Organisation shows that two out of 10 patients who reported adverse reactions to “faulty” hip implants manufactured by a company subsidiary and underwent revision surgeries were under the age of 40, The Indian Express reported on Thursday.
The patients had to undergo revision surgeries due to severe pain in the hip, inability to walk, destruction of bone and deposition of harmful metal debris of the implant inside body tissue, according to medical device adverse reports of patients.
A medical device adverse report is submitted when suspected device-associated deaths, serious injuries and device malfunction are reported. Under the rules, it is mandatory for the manufacturer to report such events to the CDSCO – the pharmaceutical and medical devices regulator. Based on these reports, the regulator detects potential device-related safety problems and is also relied upon to recall devices from the market.
The hip implant devices, called articular surface replacement or DePuy ASR, are manufactured by DePuy Orthopaedics Inc, a fully-owned subsidiary of Johnson & Johnson. In India, it is represented by Johnson & Johnson Private Ltd. The devices were first cleared by the United States Food and Drug Administration in 2005. Following red flags after rising revision surgeries, the firm recalled the devices on August 24, 2010.
The adverse reports submitted by the company show that doctors had red-flagged the faulty implant. The reports also show that while the company initiated reimbursement programmes across the globe to conduct revision surgeries in 2010, in India, the revision surgeries started only in 2013.
Findings in the reports
At least 50 serious adverse reaction reports filed by the company, which were analysed by the The Indian Express, show that 50% of patients who underwent revision surgeries due to severe pain were under 50 years of age. In a majority of cases, doctors remained silent on the revision surgery. Only two doctors explicitly said they believe “the event is device related”.
The oldest case is that of a 49-year-old woman, who underwent hip replacement in July 2004. She then underwent a revision surgery 10 years later in 2014. Twenty-seven male patients reported adverse reactions and underwent revision surgeries while 16 female patients underwent revision surgeries.
Compensation for patients
The Ministry of Health and Family Welfare has asked the Central Drug Standard Control Organisation to set up committees in states to receive complaints from patients who were affected by the faulty devices, reported The Times of India.
Drugs Controller General of India Dr S Eswara Reddy said usually the life of an implant is 15 years and reimbursement and compensations will continue for any disability reported by at least 2015-’17. The base amount recommended by a government committee is Rs 20 lakh, but cases will be evaluated individually.
A report published an expert committee set up by the Union Ministry of Health and Family Welfare showed that over 3,600 patients with the faulty implants were untraceable, and at least four people had died after undergoing surgery to implant the devices.