New federal guidelines provide an expansive update for the highly controversial metal-on-metal hip implant devices that have led to growing number of injury reports.
The landmark move made by the U.S. Food & Drug Administration (FDA) updates agency safety information and recommendations. This reflects the regulator’s revised assessment of the hip devices that involved a review of published studies and the findings from its Orthopedic and Rehabilitation Advisory Panel, said Medscape.
The problematic hip devices created a huge, growing debacle that includes reports of serious adverse reactions, global recalls, and regulatory and medical reviews. In fact, some experts say that European and American regulators ensured patients were not made aware of these devices’ risks, said Medscape.
As we’ve long written, research has linked metal-on-metal hip implant devices to an increasing array of adverse events that include tissue necrosis, pain at the implant site that sometimes spreads to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and fluid collection/solid masses around the hip joint. The issue appears to be with the metal used in the construction of the implants, which was touted to last for at least two decades. More and more reports and research indicate that some patients have required painful revision surgeries just two or three years after original implantation.
The FDA’s Orthopedic and Rehabilitation Advisory Panel addressed risks associated with metal-on-metal hip implants, asking 21 manufacturers to conduct post-market safety studies on the devices to assess whether they release dangerous amounts of metal ions into the body. At the conclusion of this summer’s panel meeting, the experts advised that metal hip patients undergo yearly physicals, imaging scans, and possible blood screening for metal ions to detect complications. Some panelists questioned whether or not metal-on-metal hip replacements should be used at all in the future.
The issue is that normal wear and tear impacts the implants’ metal ball and cup, or other implant parts in which two components connect. The rubbing may release metal into patients’ bodies and these tiny metal particles can lead to big problems, said Medscape. The released metal damages 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.
Metallosis may cause pain, loosening of the device or device failure, and the need for revision surgery to remove the device and re-implant the patient with a different device, a longer and more complex surgery. Patients may also suffer from other adverse reactions when metal ions enter the bloodstream and reach other organs, including systemic reactions such as skin rash, cardiomyopathy, and renal function impairment, to name just a few, according Medscape.
In addition to detailed instructions on post-surgical testing, the FDA now recommends that surgeons review the risk-benefit profile of metal-on-metal hip implant devices, comparing the all-metal devices to existing alternatives, such as metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, or ceramic-on-metal devices, said Medscape.
Significantly, makers of artificial hips with all-metal components must now prove to the regulator 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 issued 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.