Consumers Union on Capitol Hill: Real People

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