CONSUMER REPORTS Investigates: Dangerous
medical devices
Most medical implants have never been tested for
safety
Consumer Reports magazine: May 2012 (FiDA blog bold)
Tens of millions of Americans live with medical devices implanted in
their bodies—artificial joints, heart defibrillators, surgical mesh. And it’s a
safe bet that most of them assume that someone, somewhere, tested the devices
for safety and effectiveness.
But that is rarely the case. For
most implants and other high-risk devices brought to market, manufacturers do
nothing more than file some paperwork and pay the Food and Drug Administration
a user fee of roughly $4,000 to start selling a product that can rack up many
millions of dollars in revenue. Often, the only safety “testing” that occurs is
in the bodies of unsuspecting patients—including two of the three people
whose stories are told in this report.
As for the smaller number of high-risk products for which advance safety
studies are required, government rules allow them to be sold based on studies
that are smaller and less rigorous than those required for prescription drugs.
“Standards for devices exist, they just don’t make sense,” says Diana
Zuckerman, Ph.D., a vocal critic of the current system and president of the National Research Center for Women &
Families, a nonprofit advocacy organization.
In 2011, a panel from the prestigious Institute of
Medicine said the FDA
should overhaul its device regulatory system because it fails to ensure patient
safety before and after products go on the market. Instead, Congress is
now debating a new law that would keep the present system virtually intact and
ratify an agreement between the FDA and industry to get devices on the market
even faster.
The FDA believes “the program has served American patients well,” says
Jeffrey Shuren, M.D., director of the agency’s Center for Devices and
Radiological Health. “As a responsible guardian of public health, the FDA
believes it’s a challenge to eliminate a program without having a better
alternative.”
But an investigation by Consumer Reports, which included interviews with
doctors and patients and an analysis of medical research and a device-safety
database maintained by the FDA, shows the following areas of concern:
•
Medical devices often aren’t tested before they
come on the market. “What they’re doing is conducting clinical trials on the
American public,” says Dan Walter, a political consultant from Maryland. His
wife was left with heart and cognitive damage from a specialty catheter,
cleared without testing, that malfunctioned during a procedure to treat an
abnormal heartbeat.
•
There’s no systematic way
for the government, researchers, or patients to spot or learn about problems
with devices. “A coffeemaker or toaster oven has a unique serial number so if a
problem is found, the company can contact you to warn you. Your artificial hip
or heart valve doesn’t,” Zuckerman says. “Your doctor is supposed to notify you of a problem
but may not be able to if he has retired or passed away.”
•
Without major changes in the system, there’s not much that patients can do to protect themselves.
Below are stories from three people, injured by three very different
devices, that highlight the dangers consumers face in the current marketplace.
Surgical mesh: No testing
Janet Holt was “in such pain I couldn’t sit, I
couldn’t stand, and I could hardly walk.”
Photo by: Alexander Aleman
In 2007, Janet Holt of Floresville, Texas, felt swelling in her pelvic
area. She went to her gynecologist, who told her that her bladder and uterus
had prolapsed—dropped out of their normal position within her pelvis. The
doctor recommended a hysterectomy and bladder lift.
“He talked about building a little bird’s nest to hold my bladder up,”
Holt recalls. “He said I’d be back at work in two weeks.” She has yet to return
to work full-time on the cattle ranch and small chain of restaurants she runs
with her husband.
The “bird’s nest” turned out to be a sheet of synthetic mesh that was
implanted by instruments inserted through the walls of her vagina. In the weeks
and months after surgery, she says, “I was in such pain I couldn’t sit, I
couldn’t stand, and I could hardly walk.” Over time, the mesh shrank and
shifted, eventually working its way back out of the vaginal wall, an experience
Holt likens to “open cigarette burns with each step you take. It’s complete
torture.”
Today, after eight surgeries to adjust and remove the mesh, Holt, who is
suing the device manufacturer, says she has been left with painful nerve damage
in one leg. “I’m 54 years old and it has totally ruined my life,” she says.
Holt is one of hundreds of thousands of women implanted with
transvaginal mesh for prolapse repair and bladder support since the first such
products came on the market in the early 2000s. Manufacturers marketed the mesh
packaged in a “kit” with tools for insertion and marketed them to doctors as an
easier way to do a surgery that had traditionally required special additional
training.
“The companies were saying, ‘The salesman will show you how to do it,’ ” said Lewis Wall, M.D.,
professor of obstetrics and gynecology at Washington University in St. Louis. Despite thousands of reports of adverse
events, repeated alarms by women’s-health and consumer-health advocates, and
multiple lawsuits, these products are still being sold—and are still classified
as “moderate risk” devices.
In an August 2011 petition asking the FDA to take transvaginal mesh off
the market, the consumer advocacy group Public Citizen called it “a
‘poster-child’ example of the fundamental failure ... to protect the public’s
health and welfare.”
How did it happen? The mesh manufacturers took advantage of a loophole
in the law that allowed them to grandfather their products onto the market
without any advance safety testing.
Related Topics
Here’s how it works: Before 1976, a manufacturer could sell virtually
any medical device at will. That year, a new law for the first time classified
medical devices into three risk categories, with clinical data required only for devices in the highest-risk category,
Class III.
The FDA has yet to fully
enforce even that minimal testing requirement. The agency routinely clears new devices in
all three risk classes without clinical testing as long as manufacturers can
show they are “substantially equivalent” to a device that has already been on
the market.
And that’s exactly what the makers of transvaginal mesh did. The mesh
kits were cleared based on their “substantial equivalence” to an earlier mesh
used to repair abdominal hernias that was sold as long ago as the 1950s, even
though the kits were designed to be used in a different part of the body and
inserted laparoscopically, not through open surgery.
“You’re putting a foreign object into the pelvis through a contaminated
space, so there’s a very high potential risk of infection,” Wall says. “But
there weren’t any clinical trials done with these products before they hit the
market.”
“The paradox is that
companies go to the FDA and claim that a device is ‘substantially equivalent,’
but when they market it, they claim it’s ‘new and better,’ ” says Rita Redberg, M.D.,
a professor of medicine at the University of California, San Francisco, and
editor of the Archives of Internal Medicine. The clearance process costs
manufacturers next to nothing; they pay the FDA a user fee of $4,049.
It was only in January 2012, about 10 years after the first kits hit the
market, that the FDA took action. It ordered 33 companies to conduct the
first-ever post-market safety studies of the products. The agency is thinking
of reclassifying those mesh kits to the highest-risk Class III.
But Shuren, at the FDA, notes that with the government’s rule-making
process, “from the time the FDA decides
to upclassify a device to the time it can actually do it can take years.”
Lap-Band: Minimal testing
Lisa Wilson's weight-loss device had to be removed
after it cut into her stomach.
Photo by: Inti St. Clair
In 2009, after many unsuccessful diets, Lisa Wilson, then 46, a pharmacy
technician from Seattle, received the Lap-Band adjustable gastric band.
The implanted band constricts the size of the stomach to make it
difficult to eat large quantities of food. In fact, the opening left to
Wilson’s stomach was so small that she had difficulty eating even small amounts
of food. It also caused her to throw up almost every day.
But she stuck with it, losing 70 pounds, until a routine endoscopy in
December 2010 revealed that the band had cut into her stomach lining and would
have to be removed immediately. She developed a post-surgical infection that
resulted in a partially collapsed lung and an eight-day hospital stay. Wilson
says she has regained half of the weight she lost.
More than 650,000 Lap-Bands have been sold worldwide, according to the
2010 annual report from its manufacturer, Allergan. It’s among the minority of
devices so novel that manufacturers can’t find an older product for
grandfathering.
Those products usually have to undergo advance testing for safety and
effectiveness to get the FDA’s approval for marketing. But the tests aren’t nearly as rigorous as those
required for prescription drugs, even though, as Redberg notes, “if you have a problem with a drug, you can
just stop taking it, but you can’t do that for a device implanted in your
body.”
And the FDA charges device
manufacturers only $220,050 to review a new device, compared with the $1.84
million it charges to review a new drug application.
If Lisa Wilson had seen the lone study on which the approval was based,
she might not have been surprised by her problems. Of the 299 people in the
study, 51 percent reported nausea, vomiting, or both, and 25 percent had their
bands removed before the end of the three-year study because of complications
or failure to lose enough weight.
“Imagine if a car had a
recall rate that high,” says John Santa, M.D., director of the Consumer Reports
Health Ratings Center. “Consumers and regulators would be up in arms. But in
the world of medical devices, these things often stay hidden.”
The Lap-Band clinical trial was fairly typical of such pre-marketing
studies. Redberg and colleagues looked at 123 studies done on high-risk
cardiovascular devices that received FDA approval between 2000 and 2007. Only
27 percent met the gold standard of being randomized clinical trials, according
to the report, published in December 2009 in the Journal of the
American Medical Association.
Metal hips: Missed alarms
Stephen Tower, M.D., was injured by the same
artificial hip he implanted in patients.
Photo by: Clark James Mishler
If any patient should have gone into a hip replacement fully informed,
it was Stephen Tower, M.D., 55, an orthopedic surgeon from Anchorage, Alaska.
Instead, he became the victim of another device that was grandfathered onto the
market without clinical testing.
In this case, it was an artificial hip introduced in 2005 by DePuy, the
orthopedic division of Johnson & Johnson. Called the ASR XL (shown at the
top of this page), it was distinctive because both components—the ball at the
top of the femur and the socket liner inside the pelvis—were made of
chrome-cobalt metal.
The FDA cleared it without clinical testing based on “substantial
equivalence” to earlier devices, though such metal-on-metal hips had long been
on the agency’s high-priority list for requiring advance clinical trials.
The all-metal hips were supposedly a great advance over hips with the
traditional plastic socket liner, Tower recalls. “The main reason hips
traditionally failed was because of plastic wear,” he says. “The metal-on-metal
hip was being promoted not only commercially but in the medical literature as
being a solution for patients like me, who wanted to return to no-holds-barred
physical activity.”
By 2006, Tower’s arthritic hip had forced him to give up practically all
the outdoor pursuits he had moved to Alaska to enjoy. He had a DePuy ASR XL
implanted in May of that year, and “within six weeks I did a double century
bike race,” he says. He was so enthusiastic that within 10 months he had put
various models of metal-on-metal hips in six of his patients.
But by the time a year had passed, it became clear that something was
wrong. His hip was “pretty much constantly painful” and the chromium and cobalt
levels in his blood “were notably high,” he says. Then he started noticing
other problems, such as disturbed sleep, mood swings and anxiety, hearing loss,
visual problems, and tinnitus.
Throughout that period, he says, he repeatedly questioned DePuy
engineers, design surgeons, and sales representatives, “and they’d say, ‘Geez,
Steve, we haven’t heard of this.’ ”
Tower’s symptoms became so severe at times that he was unable to work.
Meanwhile, his research, some of which he has since published in medical
journals, was uncovering evidence that
metal debris from joint implants can cause what he describes as “profound
poisoning.”
After having the hip removed in 2009 and replaced with a new one made of
ceramic and plastic, his symptoms have markedly improved.
In August of 2010, DePuy recalled
all 93,000 ASR XL hips worldwide after it became clear that the device was
failing far more often than average and producing serious injuries. While it’s
unclear how many people actually have had to have their artificial hip removed,
an article in the British Medical
Journal called it “one of the biggest disasters in orthopaedic history.”
Although the hip was invented and manufactured by an American company,
the recall occurred because as early as three years previously—even as DePuy’s
engineers were assuring Tower that the hip had no problems—regulators in Australia, England, and Wales were noticing serious
problems.
They were able to do so because they have national joint registries—a
list of every joint implanted—and the ability to track how patients fare with
various models. There is no such
national registry in the U.S., although Kaiser Permanente has a large
private one.
The FDA has a voluntary system
whereby doctors, manufacturers, and patients can report problems with medical
devices. And though experts estimate that only a fraction of device problems
ever get reported, from 2009 through 2011, the agency received 20,518 reports
of injuries from metal-on-metal total hip replacements. Of those, 15,137
concerned the now recalled DePuy hip. Many of the remaining complaints
concerned several other brands and models that are still on the market in the
U.S.
The 2011 Institute of
Medicine panel concluded that the FDA’s ability to spot problems is so
inadequate
that it’s “impossible to confidently draw broad conclusions about the safety
and effectiveness of products that are on the market.”
How to fix the system
Consumers Union, the advocacy arm of Consumer Reports, agrees with the
Institute of Medicine that the current system of medical-device regulation
doesn’t protect patients from harm. Consumers Union recommends that the FDA:
•
Require that implants and other “life-sustaining”
devices be tested at least as rigorously as drugs.
•
End the practice of “grandfathering” high-risk new implants and
life-sustaining devices.
•
Create a “unique identifier system,” or IDs for implants, so that
patients can be quickly notified about recalls and safety problems.
•
Create national registries so that problems can be spotted quickly and
patients notified.
•
Increase the user fees paid by manufacturers for regulatory review so
that the FDA has enough money to do its job.
Have you had a problem? Tell us about it now. If you’ve had a problem
with an implant or a medical device, please tell Consumer Reports about your
experience. Your information is kept confidential (unless you indicate
otherwise) and your story helps us monitor medical problems, research future
articles, and push for reform.
To help, go to SafePatientProject.org
and click on “Share Your Story” or click on “Act Now” to help us work for
change.
Protect yourself against risks
Here are a few steps you can take to guard against the risks posed by
dangerous medical devices.
Consider alternatives. Ask your doctor what will happen if you don’t get
the implant. Many women who received transvaginal mesh for prolapse repair, for
example, probably never even needed surgery.
“Pelvic organ prolapse is almost never a life-threatening condition.
It’s a quality-of- life issue,” explains Daniel S. Elliott, M.D., assistant
professor of urology at the Mayo Clinic College of Medicine. “The overwhelming
majority of women do not need to have surgery. If you’re not bothered by it,
then don’t do anything. I think many patients weren’t adequately informed about
that.”
You may also have non-mesh alternatives. Elliott says he and other
well-trained pelvic surgeons routinely repair prolapses with techniques that
don’t require any mesh at all. On the other hand, people ill enough to need an
implantable defibrillator for their heart may not have another choice.
Research the device. The Food and Drug Administration’s website, FDA.gov, has a wealth of information about
device safety warnings, complaints, and recalls, easily accessible by typing
the name of the device into the site’s search box. It’s also worth searching
Google. If the results include a lot of law firms looking for clients injured
by the device, that’s a sign to ask your doctor some hard questions.
For an optional device like a Lap-Band or breast implant, look around the
Internet for patient forums. Though the information there isn’t validated,
you’ll get a sense of whether patients are reporting trouble with the device.
Write down what you got. If your doctor doesn’t give you information about
the brand name, model, and serial number (if it exists) of your device, ask for
it. If you learn of a warning or safety recall, from the FDA or elsewhere,
you’ll know whether yours is one of the problem models.
Stay alert—but don’t panic. If you learn that there are problems with your
device, contact your doctor and ask what warning signs to watch for. Also go to
the FDA website to read up on official warnings and find out whether it’s safe
to keep the device in your body.
For example, if you have a metal-on-metal hip, call your doctor if you
have pain or other unusual new symptoms, such as heart, vision, hearing,
emotional, or neurological problems, because all of those might be signs of a
reaction to the device. You might also want to get your blood tested for high
cobalt levels, a sign that the hip is deteriorating.
But don’t assume that all problematic devices have to be removed. For
example, pelvic surgeons say they often get calls from worried women who have
had mesh repairs. “If the mesh is not causing any problem, don’t do anything
because getting mesh out is very difficult and dangerous,” Elliott says.
Cardiac devices are risky, too
Automatic external defibrillators have been
recalled 90 times in seven years.
Cardiac devices dominate the list of reports to the Food and Drug Administration
of deaths and injuries. Here are three devices that have had significant
problems in recent years:
Implantable cardioverter-defibrillators. Since 2009, the FDA has
received reports of close to 29,000 deaths or injuries from these devices, by
far the most for any device type, according to our analysis of the FDA’s
database of adverse events. Implanted in more than a half-million Americans
with serious heart disorders, the defibrillators detect abnormal rhythms and
administer shocks to correct them.
The most troublesome aspect of the devices are the leads—wires that
connect them to the heart. There have been two major recalls, in 2007 and 2011,
of defective leads, the Medtronic Sprint Fidelis and the St. Jude Riata, after
they had already been implanted in almost 350,000 patients. Patients with the
device leads require close monitoring and face the prospect of having to have
them surgically removed.
In congressional testimony in 2009, Boston cardiologist William Maisel,
M.D., described what happened to a patient of his: “The simple act of removing his shirt over his head caused his … lead
to fracture. [He] suffered a cardiac arrest in front of his wife.” The
patient survived but never fully recovered.
Vena cava filters. These devices are placed in the vessel that returns blood from the
lower body to the heart to prevent pulmonary embolism, a life-threatening
condition caused by blood clots breaking loose from the leg and traveling to
the lungs. Some 200,000 people get such filters each year.
Many should be removed once the danger of clots has passed, but often
aren’t. In a November 2010 study in the Archives of Internal Medicine,
Pennsylvania researchers found that pieces of the Bard Recovery filter had
broken off and migrated elsewhere in the body in one of four study patients.
One patient needed open-heart surgery.
“Remarkably,” wrote cardiologist Rita Redberg, M.D., of the University
of California, San Francisco, in an editorial accompanying the report, these
filters “were considered Class II by the FDA—the same risk category of mercury
thermometers—and received approval without any clinical data of safety and
effectiveness.”
“The devices were being
used inconsistent with their FDA clearance,” says Jeffrey Shuren, M.D., director of the
agency’s Center for Devices and Radiological Health. “We don’t have authority to do something about that.” If you’ve
received the device, ask your doctor whether it has been removed.
Automated external defibrillators. Found in airports and other public
buildings, these devices are designed so that bystanders can operate them. AEDs
automatically diagnose abnormal heart rhythms and deliver shocks to people in
cardiac arrest.
The problem is, they don’t always work. The industry has conducted about
90 recalls over the past several years, affecting hundreds of thousands of
devices. Between 2009 and 2011, the FDA received reports of 72 injuries, 686
deaths, and 20,667 malfunctions connected with the devices. Arizona researchers
found that in most cases the machines weren’t able to diagnose the abnormal
rhythms properly or failed to deliver the recommended shock.
The FDA is considering whether to downgrade AEDs from the highest-risk
category to moderate-risk. recalled Defibrillators have been recalled 90 times
in seven years.
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