A big move was made Wednesday to increase the transparency of medical device dangers.
Texas Congressman Lloyd Doggett joined lawmakers on both sides of the aisle to introduce the "Medical Device Guardian Act."
The bill comes months after a series of reports on medical device dangers by the KVUE Defenders and a week after patients met with lawmakers in Washington D.C.
The Medical Device Guardian Act would require doctors to report problems with medical devices to the FDA.
Right now, there is no such requirement.
"My hope is that we'll have enough citizen outrage over this, enough participation by the victims who've been directly affected along with their families, that we can bring about some change," Rep. Doggett said.
The KVUE Defenders' investigations have shown that most medical devices don't undergo the same kind of testing as pharmaceuticals. And because there are no reporting requirements, countless problems with implanted medical devices remain unknown to the public and to medical facilities across the country.
"It's important that doctors get this information in and that we have the right –everyone has the right – to seek redress for their injuries and that these companies don't hide behind the FDA,” Rep. Doggett said.
Doggett and others are expected to later introduce the Medical Device Safety Act which would mandate a medical device registry.
“I think we need legislation to mandate a registry,” Representative Doggett said. “During last year alone, there were over 27,000 reports of injuries from metal on metal hip implants and 111 deaths attributed to them. This is a serious issue the FDA needs to look at with more effectiveness than it has in the past. As a result of your KVUE investigation, I plan to up that in my priority because I can see how many folks are being harmed by what the FDA is not doing.”
As chairman of the Health Subcommittee on the House Ways & Means Committee, Rep. Doggett plans to sponsor legislation to demand more accountability from the FDA and help victims seek relief.
“Seeing your [KVUE Defenders] stories and how much misery was cost to some individuals and knowing from my own experience many years ago as a judge that I'd see some of these cases come up. I thought it was important to make a difference and to add what I can to partner with some of those who have been hurt the most to see if we can't bring about some change and assure that others don't suffer the same in the future,” Rep. Doggett said.
Similar bills have been proposed before and failed to pass, but this time there appears to be bipartisan support.
"The medical device industry contributes generously to campaigns, and they lobby very effectively so we have a big challenge here. I don't know how this will be received by some of the health care groups. I hope they'll be supportive,” Rep. Doggett said.
The FDA announced last week that it will begin releasing the hidden reports the KVUE Defenders discovered exist for dozens of devices. Those summary reports were released for textured breast implants earlier this year and revealed serious problems, like cancer, that patients could not access.
If you have had experiences with medical device dangers, we encourage you to join the Medical Device Dangers Facebook group.