We’ve covered the sorry tale extensively in recent months so its only appropriate to update it now. In an announcement made today FDA has confirmed that it will be seeking the views of expert scientists, clinicians, patients and practitioners on the use of Metal-on-metal (MoM) hips. The agency is holding a two-day expert advisory panel meeting on June 27-28, 2012.
According to an FDA press announcement, which can be found here, it will be meeting to discuss all aspects of the situation with a view to clarifying a way forward. The meeting will consider MoM total hip replacements as well as the so-called MoM resurfacing systems.
In May 2011, the agency issued an order 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. By specifically drawing attention to this point, one assumes it will be high on the agenda.
Furthermore, the agency states it is currently considering whether to make MoM hip systems subject to more rigorous testing and premarket review requirements. That’ll no doubt be discussed too.
A recent study noting an increased failure rate related to those systems that utilize large-diameter femoral heads has added to the agency’s existing concerns over the safety of MoM hip systems.
“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, M.D., M.P.H., deputy director of science at FDA’s Center for Devices and Radiological Health (CDRH).