FDA OKs Hip Resurfacing System
Metal Devices Used to Replace Parts of Damaged Hip Joint
Not for All Patients With Hip Problems
The FDA notes that the BHR System "should not be used" in patients who:
- Have an infection of the body or blood.
- Have bones that aren't yet fully grown.
- Have conditions that will prevent the artificial hip joint system from remaining stable.
- Have conditions that may prevent following instructions during the recovery period.
- Have bones that aren't strong enough or healthy enough (such as osteoporosis or family history of severe bone loss).
- Are female and of childbearing age. "It is unknown whether metal ions released by the device could harm an unborn child," says the FDA.
- Have a kidney with significantly impaired function. "The patient will need testing before and/or after surgery to test the kidneys," states the FDA.
- Have had reactions to wearing metal jewelry (metal sensitivity).
- Have a suppressed immune system due to diseases such as AIDS or are receiving high doses of corticosteroids.
- Are severely overweight.
The Birmingham Hip Resurfacing System web site states that the resurfacing system "has been in clinical usage for 8.5 years in its current form, during which time patient results have been at least as good as conventional hip replacement in the indicated age group.
"But long-term results of this procedure are not yet known, and the usual risks associated with any hip replacement apply, including infections, damage to blood vessels, dislocation of the hip, thrombosis, anesthetic risk, and your doctor may inform you of other potential risks," states the product's web site.
"Metal on metal hip resurfacing is also associated with an increase of metal ions in the blood and urine," the web site notes. "All evidence to date has shown no correlation with metal ions with the Birmingham Hip Resurfacing System and any health problems. More studies are being done on the effect of metal ions in pregnancy and in patients with kidney disease.
"Most doctors would suggest that metal on metal devices should not be used in these two groups," states the web site.