A BBC Newsnight report, prepared in conjunction with the British Medical Journal (BMJ), has made faulty hip replacement claims against the manufacturers of metal-on-metal hip replacement systems and accused the Department of Health of failing in its duty of care to almost 50,000 hip implant patients.
The program, which was aired last night on the BBC, claimed that problems with metal-on-metal hip implants had been known for many years, but no action had been taken to inform orthopaedic surgeons or patients, or to stop the use of faulty hip replacement systems in the UK. The report claimed that all “large head” (≥36mm) metal-on-metal hip replacement systems had a high failure rate due to friction between the ball and cup causing metallic ions to enter the blood stream and cause tissue necrosis and other complications.
Evidence of the claims was produced using the DePuy Pinnacle hip replacement system as an example, which was introduced into the country without any clinical tests, and that was producing test results as early as 2008 which indicated up to fifty times the normal level of chromium in the blood streams of patients having to undergo revision surgery. It was reported on the program that the Medicines and Healthcare products Regulatory Agency (MHRA) said on Tuesday around 49,000 patients in the UK were in a high-risk category due to potential system toxicity.
The MHRA – the Department of Health agency responsible for ensuring that medical devices work and are acceptably safe – was also attacked on the program for allowing the faulty hip replacements to be introduced into the UK without any clinical testing, and for accepting the recommendations of a benefit/risk assessment panel established in 2008 which included consultants and a director of product development from the faulty hip replacement manufacturing companies.
In response to the faulty hip replacement claims, Professor Sir Kent Woods – MHRA´s Chief Executive Office – said that there were fundamental differences between the way the drugs and medical devices were introduced into the healthcare market, and his agency would continue to work with the British Hip Society and British Orthopaedic Society to analyse the rate of wear of metal-on-metal hip implants according to the data collected on the National Joint Registry.