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Hip and Knee Procedures on the Increase
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.
Author: Peter Kent
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Keywords :Hip and Knee Prostheses, Complications
from Prostheses. FDA, FDA process for medical Devices,
knee implant, hip surgery, Knee Prostheses, complications
from hip surgery, Centers for Disease Control, Hip Prostheses,
knee surgery, CDC, Medical Devices
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