Consumers Union
Real People, Real Medical Device Stories:
It’s Time To Include Devices in the FDA’s Sentinel Initiative To Identify Early and Ongoing Problems That Cause Harm
“A few
weeks after my elbow prosthesis was surgically implanted, during movement it
would make a popping or creaking sound. Four months later, the elbow was blue
green and I was in extreme pain. I am now in medical and legal purgatory.”–
Steven Baker, Bloomington, MN
In
May 2008, Steven Baker, a proud Air
Force veteran and father of two middle school children, had an elbow
replacement surgery hoping to regain function and eliminate pain from his right
arm that had been damaged in a 2001 work accident. But the implant failed after just four
months.
Steven
had to undergo “revision” surgery to address the device failure but his extreme
pain has persisted and his elbow joint now locks up unpredictably. Steven's health was severely compromised
by the revision surgery. He takes maximum dose, long term prescription
medication to help mitigate the pain. The pain medication has caused his teeth to
rot because of "dry mouth" making eating and talking difficult. And
Steven may never be able to get his elbow fixed.
A few thousand elbow
replacement surgeries are done each year in the U.S. Patients like Steven
with elbow implants require close monitoring and face the prospect of needing
to have them surgically removed. Design flaws can cause poor function and other
complications for patients, such as dislocation of the device following surgery,
joint stiffness and the need for additional surgeries.
Consumers
Union urges Congress to adopt the Senate provision of the FDA User Fee Act that
includes medical devices in the Sentinel Initiative. Both House and Senate
versions of the bill include devices in this important post-market surveillance
program. However, the House removes current law that requires the Secretary to
use critical information from adverse event reports from people like Steven in the
agency’s post-market risk identification and analysis system. We believe this
information is critical for monitoring problems with devices on the market and
should remain in the law.
For
information contact Lisa McGiffert at lmcgiffert@consumer.org
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