Four Medical Implants That Escaped FDA Scrutiny

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

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.

Image Sources: Reuters, The Associated Press, Wikimedia Commons,
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