Most Medical
Implants Never Tested For Safety
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 that 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.
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.
Ref:
http://www.consumerreports.org/cro/consumer-reports-magazine/May-2012/medical-devices.html.
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