US experts to scrutinise MoM hips in two-day meeting
This article was originally published in Clinica
The US FDA will be holding a two-day meeting in June to assess the risks and benefits of metal-on-metal (MoM) hip systems and evaluate potential guidelines for patients and practitioners on the use and management of these devices.
The meeting, held on 27-28 June, will see experts from FDA's orthopaedic devices panel discuss issues including failure rates and modes; metal ion testing; imaging methods; local and systemic complications; patient risk factors; and considerations for follow-up after surgery.
The meeting follows the recent escalation in the controversy surrounding MoM hips. These devices have been the subject of concern for some time, after it was discovered that they had a relatively high risk of failure rates. Johnson & Johnson had to issue a worldwide recall of its MoM hips as a result of the high level of revision surgery among patients who have received these devices, and studies have indicated that the metal debris from the implant could cause potential problems in the surrounding tissue, while metal ions could enter the blood stream and cause more systemic side-effects.
Last month, UK regulatory authority called for tighter blood testing and diagnostic imaging screening of patients with MoM implants and experts in the country asked for an outright ban of the devices (www.clinica.co.uk, 29 February 2012 and 13 March 2012).
In the US, the FDA issued an order in May last year for manufacturers of MoM hip systems to conduct post-market surveillance studies to collect more safety data on these devices, including data related to metal ion concentrations in the bloodstream.
The agency is currently considering whether to make MoM hip systems subject to more rigorous testing and premarket review requirements.
“We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations to patients and their health care providers,” said William Maisel, deputy director of science at FDA’s Center for Devices and Radiological Health.