After a group of patients affected by Johnson & Johnson’s faulty ASR (articular surface replacement) hip implants — which were globally recalled in 2010 — approached the Union Health Ministry seeking copy of the Ministry’s expert committee probe report, it has been made public.
With it comes the the government’s disclosure that “the firm has neither provided the exact number of the patients who had undergone surgeries/re-surgeries with ASR nor had they stated categorically that they have approached each patient and informed them about the risk associated with the faulty ASR.’’
The Central Drugs Standard Control Organisation (CDSCO), the national pharmaceutical and medical devices regulator, has uploaded the “Report of the Expert Committee to address the issue of faulty ASR hip implants.’’ The report notes clearly that over 3,600 patients with the faulty implants remain untraceable, and that at least four patients with the implants have died.
The company told the regulator that worldwide 93,000 ASR implants were done, with approximately 4,700 in India. Until March 2017, only 1032 patients were registered with the ASR helpline; 254 patients underwent revision surgery; 774 patients were monitored by surgeons.
“The Committee...after deliberation of the issues and review of the documents is of the considered view that the firm has been found to be evasive in providing the information desired by the Committee regarding the design of the ASR, patient details including address, contact, compensation details, details of the usage of ASR, follow-up and adverse drug reaction report. The firm also appears to have delayed in passing on information and awareness about the failure of the ASR,’’ noted the report.
The committee, chaired by Dr. Arun Agarwal, ex-Dean and Professor of ENT, Maulana Azad Medical College, New Delhi, has recommended that the company be made to pay at least ₹20 lakh to each affected patient and that the reimbursement programme for revision surgeries continue until August 2025.
The ASR hip implants were found to be faulty, resulting in higher revision surgeries. The accelerated wear of metal in the implant leads to higher levels of cobalt and chromium in the blood which lead to toxicity. The metal ions damage tissue and further damage body organs and may also cause localised health problems, said the report.
The end result was increased pain and decreased mobility, affecting the patients’ family and social life and negatively impacting their self-esteem and mental health, it said.
To ensure that patients using high-risk medical devices stay on the radar to check for adverse reaction and other follow-up, the committee recommended establishment of an independent registry. It also recommended that provisions be introduced in law for issuing alerts and warning manufacturers.
Union Health Minister J.P. Nadda has said the Ministry is “already looking into matter.’’
J&J’s hip implant devices, manufactured by its subsidiary DePuy Orthopaedics Inc, 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.