Govt to track more affected patients

Nearly 4,700 people in India received the implant before 2010, of which 1,080 were tracked and compensated

NEWDELHI: The Union health ministry will establish committees at the Central and state levels to track and compensate patients who received a faulty artificial hip implant that was recalled worldwide by the manufacturer Johnson &Johnson (J&J), in 2010.

Close to 4,700 people with damaged hip joints in India received the implant before 2010, when it was recalled, of which only 1,080 were tracked and compensated. Of them, 275 underwent revision surgeries and the remaining are being closely monitored by their surgeons for side effects.

Following complaints from patients, the health ministry set up an 11-member committee on February 7, 2017 to investigate patient complaints of adverse events against J&J’S metal-onmetal Articular Surface Replacement (ASR) hip implant devicesxl Acetabular Hip System and Hip Resurfacing System.

The committee was chaired by Dr Arun K Agarwal, former dean of Maulana Azad Medical College, and submitted its report on February 19, 2018. It said specialists must assess cases individually for treatment and compensation of at least Rs 20 lakh.

In November, the federal jury in Dallas had ordered J&J and its Depuy Orthopaedics unit to pay $247 million to six patients for not warning them about the potential risks of the defective design of the metal-on-metal hip implants .

While Drug Controller General of India (DCGI), Dr S Eswara Reddy, refused to comment on the matter, people privy to the matter said the process of implementing the committee recommendations has begun. “The committee at the state level will be tracking the affected patients. These cases are old and hospitals don’t have data available on them; close to 100 hospitals were approached but there was no data. State governments will be widely advertising the move to see that affected people approach them,” said a senior official, requesting anonymity.

Each case will be physically and clinically assessed by the state government committee to determine the degree of disability and refer to the central government committee to decide on the compensation amount.

In it response J&J said: “Depuy has fully cooperated with the expert committee in their investigation of the ASR matter. However, the Expert Committee Report has not been provided to the company for review to date, so it would be inappropriate for us to comment on it. We would like to reiterate that we have furnished full facts and data available with us to the expert committee.”

Metal on metal implants are rarely used now, say orthopaedic surgeons. “Metal-on-metal hip implants have been largely discontinued because of the associated complications. With other implants, the revision surgery rate would be around 3-5%, but with this particular brand, it was a higher 10-12 percent,” said Dr SKS Marya, chairman, Bone and Joint Institute, Medanta Hospital. “People complain of pain, which is largely due to loosening of the implant and wear and tear of the metal that would cause collection of metal in the body that it would react to. The best available implant is ceramic cross-linked with plastic polyethylene socket, where head ball is of ceramic and socket of polyethylene, though the cost is slightly more than other implants,” said Marya. Implants are made using different combinations of metal, plastic polyethylene and ceramic.

Used since the 1960s, it wears down over time and may cause bone loss. Revision surgery may be needed after 10-15 years. Allows a greater range of motion and lasts longer, but the metal leeches into the bloodstream, leading to toxicity. J&J’S recalled Depuy ASR XL Acetabular and ASR Hip Resurfacing System were metal-on-metal implants. Expensive and durable, but carries a higher risk of fracture. Cheaper than ceramic balls and sockets, with higher durability than metal implants. It has a long life and lowers the need for revision surgery. Recommended for patients younger than 55 years.