General advancements in surgery and prostheses, combined
with a lack of medicines for osteoarthritis, have caused
doctors to perform more hip and knee replacements recently.
Although the procedures are still mostly performed on
people over 65, there is a growing population of
individuals who range from 38 to 56 who are getting hip and
knee implants or prostheses.
According to the American Academy of Orthopedic Surgeons,
individuals aged mid-thirties to late fifties had 35,000
hip replacements or 21 percent of the total procedures in
2003, the last year for which figures are available. That's
up from 26 percent of all procedures in 1997. Additionally
individuals in this age group had 48,000 knee replacements
or 15 percent of the total 2003, up from 22 percent in 1997.
Many doctors estimate that over 90 percent of joint
replacements are done because of osteoarthritis, which
affects nearly 21 million people and is the most common
form of arthritis.
Osteoarthritis is a degenerative disease characterized by
the breakdown of a joint's cartilage, and is caused by a
variety of factors including injuries, obesity and
genetics. The breakdown causes bones to rub against each
other, resulting in pain and loss of movement.
The incidence of arthritis increases as people age. In
2002, the latest year that statistics are available, the
U.S. Centers for Disease Control and Prevention (CDC)
estimated that 43 million adults reported being told by a
doctor that they have some form of arthritis, rheumatoid
arthritis, gout, lupus, or fibromyalgia.
Also 23 million adults reported chronic joint symptoms
(possible arthritis) but had not been diagnosed with
arthritis. One in five, or 21 percent, of adults report
having doctor-diagnosed arthritis.
In total 51 percent of adults 75 years and over reported an
arthritis diagnosis. The CDC estimates that by 2030,
approximately 64.9 million of Americans aged 18 years or
older will have doctor-diagnosed arthritis.
A decade or so ago, doctors and patients chose to put off
implants as long as possible because prostheses would only
last about 10 years and replacement surgery becomes less
effective and more dangerous each time it is done. Now some
prostheses are expected to last 25 years, but there are
still risks associated with implants and with the surgery
in general.
Artificial joints or prostheses are medical devices; they
must be cleared or approved by the Food and Drug
Administration (FDA) before they can be marketed in the
United States.
In addition, FDA permission is required before a company
can test a new or redesigned prosthesis in human studies.
The data gathered in these studies, which take place in
specific hospitals, may then be used to support a company's
application for marketing its prosthesis to surgeons and
hospitals. The product or device must be proven safe and
effective.
The FDA assures safety and effectiveness through different
means depending on the risks of a particular device and the
technology that it presents. For devices with a history of
safe and effective use, frequently those using established
technology, the FDA relies on a set of general controls to
determine which devices can be deployed.
The general controls are augmented with special controls
such as standards or standard test methods. However, for
devices that involve new uses or advanced technology the
FDA often requires that a particular device be demonstrated
to be safe and effective through clinical trials.
As has been proven with some devices in the past these
clinical trials do not always identify all of the potential
issues that may be associated with a new type of hip or
knee prostheses.
In addition just like any surgery, hip and knee joint
replacement carries certain life-threatening risks, such as
infection, blood clots and complications from anesthesia.
Other complications include nerve damage, dislocation or
breakage after surgery, and wearing out or loosening of the
joint over time.
After hip replacement surgery, one leg may be shorter than
the other. Infection is an ongoing risk for people with
joint replacements. Not only can it occur in the hospital,
but also it can happen years later if bacteria travel
through the bloodstream to the replacement area. In the
rare case that an infection spreads to the new joint and
does not clear up with antibiotic treatment, the joint must
be replaced. This usually requires two surgeries--one to
remove the infected joint and another surgery later to
insert the new joint.
An individual's choice of device and surgeon to repair hip
or knee injuries is critical to avoiding serious future
complications. If problems relating to prosthesis exist the
person should in many cases seek legal advice.
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