FDA: Use Metal-on-Metal Hips With CautionJan 18, 2013
In a landmark move, the U.S. Food & Drug Administration (FDA) has issued a broad set of cautionary guidelines for the controversial metal-on-metal hip implants.
The problematic devices have been at the center of a massive and growing debacle that includes reports of serious adverse reactions, global recalls, and regulatory and medical reviews. Many argue that European and American regulators colluded in keeping patients unaware of these devices’ risks, noted Medscape. The federal guidelines update FDA safety information and recommendations and reflect its revised assessment of the hip devices, This involved a review of published studies and findings from the agency’s Orthopedic and Rehabilitation Advisory Panel, which met last June, said Medscape.
Metal release has long been believed to be the source of the problems with these devices, which occurs from normal wear and tear as the implants’ metal ball and cup rub against each other. Medscape noted that other implant parts in which two components connect may also release metal into patients’ bodies.
These miniscule metal particles can lead to big problems by damaging the bone and soft tissue in the area of the implant—so-called "adverse local tissue reaction" (ALTR) or an "adverse reaction to metal debris," according to the FDA, said Medscape. This damage may cause pain, device loosening and failure, and the need for revision surgery to remove the device and re-implant the patient with a different device. As we’ve long explained, re-implantation is a challenging and arduous process.
When the metal ions enter the bloodstream and reach other organs, additional illnesses can also occur, producing systemic reactions such as skin rash, cardiomyopathy, and renal function impairment, to name just a few, according to Medscape. To reduce these risks, the FDA said that surgeons should determine the risk-benefit profile of metal-on-metal hip implant devices, comparing the devices to existing alternatives, such as metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, or ceramic-on-metal devices, said Medscape. Patient age, gender, weight, diagnosis, activity level, and propensity toward physical activity increase ALTR risks. People at increased risk for ALTR include those with bilateral implants or resurfacing systems with small femoral heads (44 mm or smaller); females; those receiving high doses of corticosteroids; those with evidence of renal insufficiency, a suppressed immune system, a suboptimal alignment of device components, or a suspected metal sensitivity (e.g., cobalt, chromium, nickel); and those who are severely overweight or who experience high levels of physical activity, said Medscape.
As we’ve explained, makers of artificial hips with all-metal components must prove that the devices are safe and effective before they continue selling existing, similar devices or seek approval for all-new-metal designs. The FDA also expects to issue new guidance to doctors monitoring patients who have received all-metal hips.
From a legal standpoint, these changes are a great step in attempting to hold manufacturers responsible for dangers associated with their products.