The FDA was alarmed at the increasing failure rates of hip replacement items, specifically those that were entirely made out of metals, the New York Times report, further detailing the agency’s plan to enforce the use of a medical device identification system. This tool will carry information about the device and its manufacturing details, keeping the patient’s medical information protected.
This resulted from the collaboration of involved patients and their supporters, advocacy groups, medical device manufacturers, and the US regulators. Metal-on-metal hip implants were indiscriminately prescribed by orthopedic surgeons to most of their patients that require hip repairs and replacements after its introduction in the medical market. Adverse events, however, followed in a short span of time after most of the performed hip replacement surgeries that amounted to over 500,000 cases. As the metal wears out, some metallic debris may slough off the device causing infections and damage to certain muscles and tissues. When it leaks into the bloodstream and reaches the heart or the brain, other more serious health issues may result.
Other more common adverse events that may follow a hip replacement procedure include implant loosening or dislocations. Fractures of the bone surrounding the implant may also occur. These trigger physical discomforts which may include pain (of the hip or the pelvic area), inflammation, restricted mobility of the lower extremities, and a possible increase in bone resorption.
Before these medical implants were marketed, they never had to undergo certain clinical trials. The federal agency also did not require medical device providers to watch over patient’s conditions following surgeries. For this reason, doctors believed these products are safe to use. Mostly, because of the products’ sturdier material when compared to other existing implantable hip devices, orthopedists immediately concluded these are better replacements for diseases or fractured hips.
Five metal hip device manufacturers were ordered by the Food and Drug Administration to evaluate patients who have received their implants. So far, only Biomet has submitted an acceptable study plan which the FDA immediately approved. However, it was already ten years (since the first production of these items) that attempts to strategize a clinical study of the implants were initiated. Some experts believe this might be too late to gather some pertinent data.
Depuy, one top provider of metal hip replacements, has somehow managed to keep track of the clinical data from two of their manufactured implants (ASR and Pinnacle). The study started in 2006 and involved 250 patients across the country. This may be very useful especially to those who are looking for more information regarding hip recall law.