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Consumers Union to Testify for Stronger Medical Device Safety Oversight at House Hearing Today
Date:2/15/2012

ommittee, Swirsky notes that the recent user fee agreement negotiated by the U.S. Food and Drug Administration (FDA) and the medical device industry, fails to make any patient safety improvements and falls short of providing the resources needed to meet the increasing demands on the agency.  The FDA had previously indicated that it needed between $770 million and 1.15 billion to implement the performance goals pushed by industry.  Instead, the medical device industry has agreed to $595 million in user fees.   

Swirsky's testimony highlights additional concerns about the agreement, including new performance goals for the FDA that may inhibit the agency's ability to get the information it needs to properly evaluate medical device applications.  Her testimony also raises concerns about potential conflicts of interests involving industry-funded patient groups that could be involved in evaluating new devices.  

In addition, Jim Shull of Browns Mills, New Jersey, will testify at the hearing about his experience as a patient harmed by synthetic mesh used for a hernia operation.  Six years after his operation, Shull is living with daily pain from the mesh that has caused severe nerve damage and other debilitating complications.   

"The mesh that was put inside of me has caused so much damage that none of the nerves can ever be repaired," said Shull.  "Now I face a lifetime of pain and struggle because of it.  Surgical mesh and other medical devices should be tested for safety before they are allowed to be implanted into people like myself."   

For more details on the reforms Consumers Union is urging Congress to adopt, see the Safe Patient Project's Improve the Safe
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SOURCE Consumers Union
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