FDA OKs Hip Resurfacing System
Metal Devices Used to Replace Parts of Damaged Hip Joint
May 11, 2006 -- The FDA has approved a hip resurfacing system for people
with hip damage.
The product is called the Birmingham Hip Resurfacing (BHR) System. It's
designed to relieve hip pain and improve hip function by replacing parts of the
hip joint while conserving more bone than in traditional hip
The system is made by Smith &amp; Nephew Inc. of Memphis. A Smith &amp;
Nephew news release notes that the system is the only FDA-approved hip
resurfacing system in the U.S. It was first introduced in July 1997 in the U.K.
and has now been implanted in more than 60,000 patients in 26 countries.
Smith &amp; Nephew says it will train 50 U.S. surgeons in the first phase of
the system's U.S. introduction. "Training will be provided in the U.S. and
Europe, with the first U.S. surgeries expected to take place this summer,"
states Smith &amp; Nephew's news release.
How It Works
The system has two parts: a metal cup that replaces the damaged surface of
the hip socket and a cap that covers the resurfaced ball-shaped bone at the top
of the thigh (femoral head). The cap has a small stem that is inserted into the
"The cap moves within the cup," says the FDA. "The surfaces that
rub against each other (the bearing couple) are made from highly polished
"The BHR System relieves hip pain and improves hip function by replacing
the parts of your hip that have been severely damaged by degenerative joint
diseases," says the FDA. Those degenerative joint diseases include osteoarthritis
The FDA says that the BHR System is "intended for patients who, due to
their relatively younger age or increased activity level, may not be suitable
for traditional total hip replacement due to an increased possibility of
requiring future hip joint revision."
Not for All Patients With Hip Problems
The FDA notes that the BHR System "should not be used" in patients
- 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
- Have conditions that may prevent following instructions during the recovery
- 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
- 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.