Defective Devices Used in Knee Recalled
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Defective Devices Used in Knee and Hip Replacements Recalled

A panel of medical experts said the government
should abandon its system for approving most
medical devices in the U.S., because it offers patients
no assurance of safety.Right now, the U.S. Food and Drug Administration
uses a streamlined review, called 510(k), to approve
products that are similar to those it has already a
pproved and are on the market. The streamlined
review, used for about 90 percent of medical device
applications, including those for knee and hip
replacement, takes about 10 months as opposed to
the years a more complex review would take.The Institute of Medicine said in a report released
today that the FDA should instead require each device
maker to prove the moderate-risk (or Class II)
products are safe and effective, and possibly test the
devices on actual patients. Last week, the Government
Accountability office said that a staggering 83 percent
of 700 devices recalled every year are Class II.

Click Here to See if Your Product Was Recalled

“The 510(k) process lacks the legal basis to be a
reliable premarket screen of the safety and
effectiveness of moderate-risk Class II devices and
cannot be transformed into one,” the institute’s report
stated. The institute also urged the FDA to invest its
resources in developing a new system for ensuring a
product’s safety.

The FDA said it stands behind the 510(k) approval
process because it has helped support a “robust
medical device industry in the U.S. and has helped
bring lower-risk devices to the market for patients
who need them.” It will, however, have a public
meeting to discuss the institute’s recommendations.

The device industry’s top lobbying group immediately
dismissed the proposal.

“The report’s conclusions do not deserve serious
consideration from Congress or the administration,”
said Stephen Ubl, president of the Advanced Medical
Technology Association. “It proposes abandoning
efforts to address the serious problems with the

administration of the current program by replacing it
at some unknown date with an untried, unproven and
unspecified new legal structure.”Artificial hips and knees are now a nearly $7 billion
market, with 1 million people getting either knee or
hip surgery every year, according to several reports.
Many of those patients, however, have had to endure
second surgeries, because the devices already inside
them were faulty.Katie Ayers underwent a second surgery in January
after she learned that her hip replacement device had
been recalled.

“It just really seemed like a joke,” she told ABC News
in February. “You don’t recall parts you put in a

But it wasn’t a joke — DePuy Orthopaedics was
recalling its medical devices because of a design flaw
that could leech chromium and cobalt into her body.

“You put your faith in the doctor and the companies
that make these products because they’re the experts,”
Ayers said. “It’s just beyond me to think that things
can get approved that really don’t work. It leaves me

Experts Say FDA Should Abandon Approval Process
Doctors themselves say they are always trying to
improve the quality of the surgery for patients.”As a doctor, and as a surgeon, we are always looking
for the better apparatus,” said Dr. Elton Strauss, chief
of adult reconstruction at Mount Sinai Medical Center
in New York. “We read what has been tested, we read
what we think is going to be an improvement. We read
about how this device has been used in other
countries.”Diana Zuckerman, president of the National Research
Center for Women and Families, found that in 2010
more than 437 million devices were recalled out of
fear that they might kill or permanently harm patients.

“It’s really a gamble. You hope that the product that
you are going to choose or that your doctor is going
to choose is safe and is going to last a long time,”
she said.

Unfortunately, patients don’t have a way of knowing
for certain that the device being placed inside their
bodies is safe. There are, however, some steps that
patients can take to protect themselves.

How to Protect Yourself
Ask your doctor if he or she is paid by the maker of
the implant they’re recommending for you. This is a
big red flag — that your doctor may be more
interested in promoting the device rather than in
doing what’s best for you. Check the device maker’s
website. The device maker must — by law — list all
the doctorsit gives money to.

Click Here to See a List of the FDA’s Recalled

Newer does not always mean better

Is the hip or knee that your doctor recommends new
to the market? If yes, ask your doctor to explain why it
is better than those that have been tested over time. “If
the device has been around for a number of years
with a good track record, it probably is quite safe,”
said Dr. Albert Pearsall, the director of sports
medicine at the University of South Alabama. “If you
Google the prosthesis or manufacturer and there are
no red flags, then probably it’s OK.”

July 29, 2011