Can Your Hip Replacement Kill You?
When a Dr.'s right hip gave out in 2006, he asked his surgeon to
implant an artificial one — specifically, a metal-on-metal hip called
the ASR XL, made by a company. He knew what he was talking
about: As an orthopedic surgeon, the Dr. specializes in complex hip
replacements. But what he knew wasn’t enough to protect him from a
defect in the device.
Five
years after his surgery, and in excruciating pain, the Dr. underwent
more surgery, this time to have the device replaced. When the surgeon
sliced into his hip, what he saw looked like a crankcase full of dirty
oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR
hip had caused a condition called metallosis, destroying not only local
muscle, tendons and ligaments, but harming Dr.'s heart and brain
as well.
Despite
Dr.’s repeated efforts to warn his colleagues and the company
that the implants were harming patients, the company continued
to market metal-on-metal hips. While it withdrew the ASR XL model
from the market in 2010, citing slow sales, it continued to sell
another, similarly problematic model, the Pinnacle, until 2013.
More than 9,000 patients filed suit against the company, and on Nov. 16, six New York patients won a 247million $ verdict
for serious harms caused by the Pinnacle hip implants and for failing
to warn doctors and patients about its dangers. These suits and others
are pulling back the curtain on what some doctors call the Wild West of
medicine: the untested and largely unregulated medical device industry.
About
32 million Americans — or about one in 10 — have at least one medical
device implanted, from artificial joints to cardiac stents, surgical
mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses
in eyes, heart valves and birth control devices.
These
devices have helped countless people, and some have saved lives. But
many others are harmed — and doctors and patients are at the mercy of
manufacturers’ claims about the safety and efficacy of the devices.
Medical interventions are now the third-leading cause of death in the
United States, and devices play an increasing role in that statistic.
Many
people assume that the Food and Drug Administration requires rigorous
testing of medical devices before they are approved, the same as the
lengthy approval process it requires for new drugs. In fact, most
high-risk devices on the market, including implants, have undergone no
clinical testing at all.
Although
the standard for approval of a new drug usually calls for two
randomized, controlled clinical trials, the standard for many medical
devices is no standard at all. Since medical devices didn’t come under
regulatory control until 1976, the agency simply
grandfathered in all devices that were already on the market under a provision known as 510(k),
which allows manufacturers to sell most new devices without requiring
any clinical testing as long as the manufacturer says its product is
“substantially equivalent” to an existing device.
In addition to the 510(k) pathway, medical device companies can avoid clinical testing for the highest risk devices through the supplement pathway
by telling the agency, they made a minor change to a previously approved
device. The use of these loopholes is widespread: A study published in
2009 found that only 5
percent of high-risk implanted cardiac devices even partly met the
standard for drug testing.
Metal
hips are far from the only devices with catastrophic consequences. In
October 2007, a leading medical device manufacturer, recalled
the lead wires in its defibrillator after they were
found to fracture and misfire, harming or even killing patients. The
devices had not been clinically tested and were approved for sale by the
F.D.A. through the supplement pathway. But in this case, the “minor
change” was a fatal one; the new wire was thinner and prone to fracture.
By
the time of the recall, 268,000 leads had been implanted in patients
worldwide. After the recall, many
patients rushed to have the devices removed, but removal posed its own
dangers, causing major complications in 15 percent of patients.
Even
when devices are subjected to trials, the agency sometimes ignores
danger signs detected by those studies. In 1997, during the approval
process of the vagus nerve stimulator, a device made by a company to
treat epilepsy, an adviser voiced concerns about a high death
rate noted in patients with the device. But the agency didn’t stop the
device from going to market. Instead, it awarded conditional approval,
meaning that the company would have to conduct safety studies after the
device was on the market.
The
agency didn’t even require the company to inform patients that there was
concern about the death rate, or that they were effectively being made
unwitting guinea pigs. When the company finally submitted five studies
that it said proved the device was safe, it failed to include death data
for any of the studies, a move the agency defended, saying the agency
hadn’t asked the company to count deaths, only to “characterize” deaths.
How it’s possible to characterize deaths without including any actual data on deaths is anyone’s guess.
With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls,
which the agency defines as indicating “a reasonable probability” that a
device will “cause serious adverse health consequences or death.” In
2016, that number rose to 117, affecting hundreds of thousands of
patients.
Loose
oversight of devices poses a threat to public health. This presumes
that such speed and innovation is actually lifesaving or life-enhancing.
The number of device-related deaths shows how dangerous that
presumption is.
The
fact that the agency has allowed lax practices like the 510(k) loophole
to continue, despite calls for reform by institutions, poses the question of why the agency would put
profits ahead of safety.
Returning
to a system in which the agency commissioners are civil servants is perhaps
a first step, but it needs to be the first of many. As a government
agency, the agency is supposed to serve as a bulwark between corporate
profiteering and the public welfare. Its continued allowance of
regulation loopholes like 510(k), despite the significant demonstrated
cost to public welfare, calls into serious question the agency’s
fulfillment of its stated mission to protect public health by ensuring
safety, efficacy and security.
THIS IS ONLY FOR INFORMATION, ALWAYS CONSULT YOU PHYSICIAN BEFORE
HAVING ANY PARTICULAR FOOD/ MEDICATION/EXERCISE/OTHER REMEDIES.
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Labels: black, Brain, cobalt, destroys, devices, heart, hip replacement surgery, leaking, ligaments, metal-on-metal joint, metallosis, muscle, tendons, tissue
posted by G S Iyer at 9:46 AM
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