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For months the medical device industry has been lobbying Congress to keep lax safety oversight over medical implants, including heart valves, replacement joints and surgical mesh. To make sure elected officials hear from Americans who’ve been harmed by outdated safety laws, Consumers Union’s Safe Patient Project brought 10 activists from seven states to Washington D.C. to share their medical device experiences and demand improvements.
And it had a huge impact! Activists had more than 20 meetings over two and a half days with key decision-makers. And many Congressional staff told us it was the first time they heard from ‘real people’ about this issue.
Our D.C. event was preceded by more than 160,000 messages from constituents to Congress – generated by Consumers Union – in support of key safety reforms. And it all comes at a crucial time – the medical device oversight law is reviewed every five years by Congress and we have only until September to get lawmakers to adopt important safety improvements.
One critical improvement is to make sure implantable or life-saving devices are safety tested before going on the market, rather than allowing manufacturers to merely show that their new device is similar to one already on the market. Over 90 percent of devices are cleared without safety testing.
Many of those who traveled to Washington D.C. were harmed by devices that were never safety tested prior to being sold. Among them — Jim Shull, of Brown Mills, N.J., who told congressional staffers that his implanted hernia mesh hardened and destroyed tissue in his groin that required painful surgeries to remove. Shull says he continues to live in constant pain and must use a cane to walk. Unfortunately, his experience is far too common.
As a result of our efforts, Shull and Consumers Union were invited to testify before the House Energy and Commerce Committee on device safety, telling members that the fast and furious pace of approving medical devices should not trump safety and effectiveness. (You can watch their testimony here.)
With continued support of consumer activists, Consumers Union will work to make medical devices as safe and effective as possible. We will counter the industry claims that FDA safety standards impede innovation. After all, a medical device is innovative only if it works and doesn’t harm people.
A Senate draft of the legislation is expected soon, and we will count on consumers to join us in raising their voices so Congress will put the interests of patients first. The best way to do this is to be sure they hear from people harmed by untested medical devices. If you or someone you know has an experience to share, please take a moment to tell us about it.