Four Medical Implants That Escaped FDA Scrutiny
by Lena Groeger
ProPublica,
Today, 11:32 a.m. (Graphs/photos omitted.)
Medical devices sustain and improve the quality
of life for millions of Americans. But as the over $100 billion-a-year industry
pushes thousands of devices to market every year, reports of faulty devices,
repeat surgeries, and recalls have increased. The FDA and the industry maintain
that a speedy approval process gives patients faster access to life-saving
devices. But critics say that unlike drugs,
a substantial number of risky devices are cleared without clinical testing, and
receive almost
no oversight once on the market.
We've taken a closer look at four types of
implantable medical devices that have drawn the most criticism.
Hip Implants
Hundreds of thousands of people with advanced
arthritis get total hip replacements each year, surgically replacing their hip
joint with a prosthetic. Typically, implants are made up of a metal head that
rotates inside a plastic cup. But in 2005, Johnson & Johnson's DePuy
Orthopaedics introduced a new all-metal design. Maintaining that the new device
was substantially equivalent to older models, DePuy got
clearance for the hip device without conducting any clinical trials
to test how it would perform in patient's bodies. The company was able to do
that through an FDA process called 510(k), which doesn't require clinical data
as long as manufacturers can show that their new device is "substantially
equivalent" to one already on the market.
In the case of DePuy's hip implant, that testing
began once the implants went to market.
According to the British Hip Society, the failure
rate of the DePuy implant was so high that almost half of all patients who got
the implant required surgery
within six years to fix problems. The metal was eroding, releasing
metallic particles into the blood and surrounding tissue of the joint and
causing tremendous pain (the New York Times has an explanatory
graphic of this failure.) After thousands
of complaints and lawsuits, the device was recalled in 2010, after
it had been implanted in almost 100,000 people. DePuy said the company continuously reviewed data about the hip implant
while it was on the market, and initiated the recall as soon as new information
confirmed a problem.
Last year the Institute of Medicine reviewed the
clearance process for medical devices and called for the 510(k)
process to be eliminated altogether because it could not guarantee safe
devices. They found that from 2005 to 2009, three out of
four recalled high-risk devices had not been approved with clinical
data, but rather had gone through the 510(k) clearance process or had been
exempt from review altogether.
Furthermore, a Government Accountability Office
report found that once recalled, many of the
highest-risk devices are not corrected or removed from the market.
Surgical Mesh
Implantable surgical mesh acts a reinforcement
structure for internal organs, and is often used to treat pelvic organ prolapse
or stress urinary incontinence in women.
The FDA first cleared vaginal mesh in the late
1990's based on its similarity to earlier products used to fix internal
hernias. Despite using a different method of implantation (inserted through the
vaginal wall, rather than with abdominal surgery) and for an entirely different
part of the body, surgical mesh "kits" were advertised as a new and
improved method to treat urinary incontinence.
In 1999, Boston Scientific voluntarily recalled
its surgical mesh product called the ProteGen Sling, after numerous complaints of pain, infections, and
injuries. Over a decade later, Johnson & Johnson faced hundreds
of lawsuits over a surgical mesh device that was substantially
similar (in fact had been cleared based on its similarity) to the ProteGen
Sling.
In 2008 the FDA said that surgical mesh
complications were serious, but rare. Over the next two years, complaints grew
to the thousands, and doctors and patients reported five times as many mesh
complications as previous years. According to a 2011 FDA report, total
"adverse event" reports for all medical devices – not just mesh –
have risen an average of 15 percent a year for the past decade.
In the case of vaginal mesh, the most common
problem was mesh eroding and sticking through the walls of the bladder or
vagina, causing burning and pain. A study in the journal Obstetrics and
Gynecology found that 15 percent of the women treated with vaginal mesh had
complications, and that the mesh was no more helpful than other repair
treatments. Boston Scientific has repeatedly stated that mesh is a safe and effective treatment option.
In July 2011, the FDA said that serious
complications with mesh are "not rare" and may expose
patients to more risk. In January of this year, the FDA finally ordered
manufacturers to conduct studies of surgical mesh.
Heart Valve Rings
An annuloplasty ring is a circular device used to
repair faulty heart valves, by pinching together two flaps that normally
prevent blood from leaking back into the lungs or another heart chamber. Given
their critical role in sustaining life, the rings were originally classified in
the highest risk class. For these very high-risk devices, manufactures often go
through a premarket approval (PMA) process, which requires clinical data that a
device is safe. But the FDA also clears
dozens of high-risk medical devices each year through the less
stringent 510(k) process – and over the past
decade, that number has increased dramatically.
.In
1997, after being petitioned by manufacturers, the FDA brought the heart valve
rings down to a lower risk class, alongside hearing aids and glucose monitors.
With a lower risk, manufacturers could more quickly — and cheaply — gain
clearance.
In the case of a heart ring
called the Myxo ring, the manufacturers Edwards Lifesciences didn't
seek clearance through the 510(k) — or any other
process. Starting in 2006, the device was implanted in over a hundred
people without FDA clearance, which current regulations allow.
According to the agency, manufacturers with a cleared device on the market can
make changes or modifications to the product without needing to submit an
entire new application.
While patients didn't report any major complaints
with the ring, many were troubled by the fact that a life-sustaining device
could be on the market without any FDA supervision. Edwards Lifesciences
maintained the ring was safe, but voluntarily recalled the device and applied
for clearance.
In April 2009, after the Myxo ring had been
subject to an FDA investigation and a Senate
inquiry, the FDA retroactively cleared the device under a new name,
saying it was safe. The agency said that Edwards Lifesciences should have
sought clearance, but that they made an " honest attempt"
to interpret the regulations.
Defibrillator Leads
An x-ray picture of a defibrillator device and
lead
Implantable defibrillator leads are wires that
connect defibrillators (devices similar to pacemakers) to the heart.
Defibrillators automatically monitor and administer shocks to the heart, and a
malfunction can cause the device to fire unexpectedly, or fail to fire when a
patient's life depends on it. Over the past decade, the $10 billion dollar
heart device industry has seen several high profile cases of malfunctioning
products that posed severe risks to patients.
The most recent
episode concerns the St Jude's Riata lead, which has been implanted
in approximately 79,000 people in the United States. Last year the
device was recalled after it became clear that electrodes inside the
lead could erode out of their lining, exposing electrical wire to the body and
potentially causing a short circuit. Manufacturers had known about the problems
with the Riata for a while. In fact, a full year before the recall, St. Jude
stopped selling the device and sent a letter to doctors describing the problem.
A recent study found that the Riata lead was
prone to yet another type of failure (malfunctioning at high voltages) and had
been responsible for at least 20 deaths. St. Jude disputed the accuracy of the
study, saying it was based on incomplete data. In a recent
statement, the company said it has made significant design changes
to its newer lead models to address these safety issues, and is also currently
conducting an evaluation study of the Riata lead.
Critics point to the Riata lead as an example of FDA failure to
adequately monitor devices once they go to market. A Government Accountability
Office report found multiple problems with FDA oversight, including a passive
system dependent on voluntary reports and a lack of complete information about
how devices are used and who uses them.
The FDA says it is currently working on a national
surveillance strategy.
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