Consumers Union Steps Up Campaign to Improve Medical Device Safety

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Consumer Group Teams Up With Patient Safety Activists To Urge Congress

to Strengthen Medical Device Oversight

WASHINGTON, Feb. 7, 2012 /PRNewswire-USNewswire/ -- As the debate in

Congress over reauthorizing the statute governing medical devices

intensifies, Consumers Union is stepping up its campaign to strengthen

the law to better protect patients from potential safety risks. This

week, Consumers Union's Safe Patient Project is bringing eight patient

safety activists from around the country to Washington, D.C. to meet

with lawmakers in Congress and press for improvements in the Medical

Device User Fee Act (MDUFA).

Consumers Union is urging Congress to require more rigorous testing

before all medical implants are allowed on the market and to establish

a better system for monitoring devices after approval, including a

national system for notifying doctors and patients when safety

problems come to light. The campaign is up against a powerful

lobbying effort by the medical device industry, which is using the

MDUFA reauthorization process to try to scale back oversight by the

Food and Drug Administration (FDA).

"Most Americans would be surprised to learn of the lax oversight of

medical implants," said Lisa McGiffert, director of Consumers Union's

Safe Patient Project. "Too many of these devices are allowed on the

market without testing to determine whether they are safe and

effective. Innovation is important but patient safety should be our

first priority. A medical device isn't innovative if it doesn't work

and hurts people."

Among those patient safety activists joining Consumers Union this week

in Washington is Lana Keeton of Austin, Texas, who has endured ten

years of incapacitating pain from the surgical mesh that was implanted

during surgery for a prolapsed bladder. Steven Baker of Bloomington,

Minnesota, who has suffered from a faulty elbow implant, will be

meeting with lawmakers to urge Congress to adopt stricter medical

device safety requirements. And Dan Walter, of Deale, Maryland, will

share the story of his wife Pam, who nearly died from a defectively

designed device used to treat her heart condition.

Unlike prescription drugs, more than 90 percent of medical devices do

not require proof that they have been clinically tested and found to

be safe and effective prior to being cleared by the FDA for

distribution or sale. According to the General Accounting Office, an

average of 700 different medical devices are recalled each year. In

2009 alone, the FDA received reports of nearly 5,000 deaths associated

with medical devices.

In addition, the system for monitoring and tracking what happens with

devices once they are on the market is weak and does not adequately

protect people using them. There is currently no national tracking

system to identify and inform patients when safety problems emerge.

The FDA has just completed negotiations with the device industry over

the shape of MDUFA reauthorization legislation that must be passed

later this year. Industry pressure resulted in an agreement that does

not include important safety provisions supported by Consumers Union,

such as making sure faulty devices aren't used to clear similar

implants and giving the FDA the authority to require clinical trials

after devices go onto market. Instead, the agreement focuses more on

how the FDA can better serve the industry.

"The agreement is disappointing because it fails to include critical

safety reforms needed to better protect patients and falls short of

the resources the FDA needs to keep up with the volume and complexity

of device applications," said Lisa Swirsky, senior policy analyst for

Consumers Union. "This year's legislation will govern the safety and

quality of medical devices over the next five years. Congress should

strengthen the FDA's ability to protect consumers."

For more details on the reforms Consumers Union is urging Congress to

adopt, see the Safe Patient Project's Improve the Safety of Medical

Devices fact sheet.

SOURCE Consumers Union

-0- 02/07/2012

CO: Consumers Union

ST: District of Columbia




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