Expert Panel Finds DePuy ‘Evasive’ in Providing Data on Faulty Hip Implant

NEW DELHI:
A high-powered committee constituted by the government to look into issues related to faulty hip implants manufactured by J&J subsidiary DePuy Orthopaedics Inc has found the company “evasive in providing information regarding the design of the orthopedic device, patient details, compensation records and follow-up adverse reaction reports”. The 118-page report, submitted by the panel in February, was uploaded by the Central Drugs Standard Control Organisation (CDSCO), the national pharmaceutical regulator, on its website after a group of patients wrote a letter to Health Minister JP Nadda to gain access to it.
The experts committee, which has recommended a “base amount” of Rs.20 lakh as compensation for eligible patients, also moots extension of reimbursement programme “at least till August 2025 since the average lifespan of an orthopedic hip implant is 15 years”.
The report observed that DePuy’s hip implants “were found to be faulty which resulted in higher instances of revision surgeries globally including India. Accelerated wear of the implant leads to higher levels of chromium and cobalt in the blood which may lead to toxicity. When the implants wear at an accelerated rate, the patient will experience local symptoms such as hip or thigh pain. These metal ions can damage tissues and further damage body organs”.
As many as 4,700 patients in India had received DePuy hip implants between June 2004 and August 2010, until a global recall over concerns that the metallic implants could leak toxic cobalt and chromium into patents’ bodies and pose a risk to their health.
“The firm has mentioned identical reasons in almost all of the reports that the medical or surgical interventions were done to prevent permanent impairment to a body function. There is a clear admission on the part of the firm stating that the surgery has resulted in a permanent impairment to a body function,” the report stated.
Globally, the revision surgeries took place within 2-4 years from the date of primary surgery, whereas in India, they were performed after seven years. The panel noted with concern that a lot of patients might be having an aggravated problem with the delayed revision surgeries. “The firm ideally should have approached all such patients and taken proper medical care,” the experts opined.
The probe committee also stressed the need to strengthen the adverse event reporting in the country by promoting the existing materiovigilance programme and establishing a registry to track usage of high-risk medical devices. It also recommended a provision related to compensation to be included in the Medical Devices Rules 2017 and urged the CDSCO to prepare a guidance document for effective recall of medical devices by the manufacturer or importer.