Board has received 12 recalls in connection with hip implants

The Irish Medicines Board has said it has received reports about 12 incidents connected with hip implants which have been recalled.

It is thought up to 3,500 Irish patients may have received the ASR hip system since it became available six years ago.

Up to 12% of patients who received the implant worldwide have needed it replaced.

Thousands of hip replacement patients could face scans, blood tests or surgery amid fears they were fitted with a faulty product, health bosses said today.

The Health Service Executive (HSE) has written to all hospital orthopaedic units advising them to stop using a device produced by US-based firm DePuy Orthopaedics.

The move follows a worldwide recall of two of the company’s ASR hip products over concerns about the number of patients requiring revision surgery after they were implanted.

Since it became available in 2004, around 3,500 patients around the country have received the ASR Hip System device as part of a hip replacement procedure.

Many are now expected to undergo blood tests, MRI scans and ultrasounds to determine if they require further surgery.

“Data recently received by DePuy shows that after five years, approximately 12% of patients who received the ASR hip require replacement of their implant, a higher rate than expected, and this has led to the recall,” an IMB spokeswoman said.

“Patients who have been implanted with the affected devices will be contacted in the coming weeks for review.”

The HSE said all devices involved in the product recall had now been removed from circulation.

Plans are being made to set up a special HSE helpline for concerned patients.

DePuy Orthopaedics has also produced a guide on its website for people who may be affected by the product recall.

“Hospitals have been advised that this product should not be used in any hip replacement surgeries with immediate effect,” a HSE spokeswoman said.

“The HSE is now identifying all patients who may have received this device as part of their hip replacement.

“Hospitals will be contacting all affected patients directly and will take all steps necessary to ensure patients receive appropriate follow-up.

“We will be liaising closely with the Irish Medicines Board and the manufacturers DePuy as part of this ongoing process.”

Labour health spokeswoman Jan O’Sullivan said the helpline needed to be set up as soon as possible.

“There is a lot of anxiety out there and a helpline will provide vital information to people.

“They need to be informed if they are affected by this and if they may require corrective surgery.”

She added: “The Irish Medicines Board and the HSE need to contact patients who had been implanted with the affected devices as quickly as possible.”

Catherine Byrne, Fine Gael spokeswoman on older citizens, called on Health Minister Mary Harney and the HSE to say why the implant was not recalled sooner.

“Complaints concerning two types of faulty hip implants were made to the Department of Food and Drug Administration in the United States over two years ago, so why has the HSE only become aware of the problem this week?” she said.

“The HSE needs to act immediately to calm the fears of patients who may have received this particular implant, and to clarify whether or not they will require further surgery.

“The Department needs to quickly identify the patients who have had these hip devices fitted and the Minister needs to clarify that these patients will be assessed as soon as possible.”