DePuy to pay medical costs of patients affected by faults

US FIRM DePuy Orthopaedics has promised to cover the costs of any medical treatment needed by patients who received potentially faulty hip implants manufactured by the company, which are the subject of a voluntary global recall.

DePuy, which manufactures a range of artificial hips and knees, said it intends to cover all reasonable and customary costs of monitoring and treating affected patients.

It is estimated that up to 93,000 people worldwide, including 3,500 patients in the Republic, have been implanted with the affected products.

“We are committed to assisting patients and healthcare providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall,” said David Floyd, president of DePuy Orthopaedics.

DePuy said it had decided to voluntarily recall the ASR XL Acetabular System and its ASR Hip Resurfacing System because new research had shown that more people than expected who had received such implants would require further surgery.

The company admitted that it had been aware of issues surrounding the products “for a while” as it had already issued a number of advisory notices to health authorities since last year. The ASR was withdrawn from Australia in December 2009 and the US last March.

However, a new study has revealed that one-in-eight patients who had received either of the two hip implants manufactured by DePuy experienced pain and other symptoms which required a second operation on their hips within five years of the original surgery.

Few of the hip devices remain on the market as the company ceased production last year due to falling demand and a focus on new products.

DePuy insisted patient safety and health were a top priority and the company was continually evaluating data about its products. It stressed that most ASR hip replacement surgeries have been successful.

However, it acknowledged that a small number of patients might develop progressive soft tissue reactions to debris from wear on metal parts without showing any obvious symptoms. DePuy said the debris could cause soft tissue damage over time, which would require patients to have revision surgery.

It has recommended that patients fitted with the affected implants should have an annual check-up for the first five years after ASR hip surgery to ensure they are working well – even if no adverse symptoms have been recorded.

The company said it was working closely with healthcare professionals around the world to notify patients who might be affected by the recall.

It has advised orthopaedic surgeons to carry out ultrasound scans on any patients they may be concerned about to determine if further operations are needed. Patients who have had hip replacements are being advised to contact their orthopaedic surgeon to determine if they received an ASR hip implant.

They are also being asked to sign a medical release form which will allow information on their condition to be shared with DePuy.

Doctors will be given €40 by DePuy for every patient release form completed and submitted.

A spokesperson for DePuy’s parent, US pharmaceutical giant Johnson & Johnson, said it was still evaluating the financial impact of the recall.