AUSTIN, Texas — A Texas Congressman is pushing for change following a KVUE Defenders investigation into implanted medical devices.
“We need legislation and we need to demand accountability,” said Texas Congressman Lloyd Doggett.
Congressman Doggett watched the KVUE Defenders investigation and said he will sponsor legislation to address the lack of FDA regulations for medical devices.
Doggett said hearing Frances Scott’s experience shed a light on this issue and made him do more research on the topic.
“The patient ought not to be the guinea pig here and that seems to be what has happened,” he said. “There needs to be better testing and a thorough registry so that physicians and patients can find out specifically what risk they are assuming when they get an implant.”
Scott had a double hip replacement at the age of 39, a metal-on-metal hip that she and thousands of others say poisoned them.
“I never would have guessed that this could happen,” said Scott.
No medical device registry
The KVUE Defenders discovered that unlike pharmaceutical drugs, most medical devices are not tested in humans. And finding information about the dangers is nearly impossible because there is no medical device registry.
Sharing her hip replacement surgery experience has not been easy for this wife and mother of three, but it's already making a difference.
“I think we need legislation to mandate a registry,” said Congressman Doggett, who will sponsor the Medical Device Safety Act which will create a comprehensive FDA registry for patients. “During last year alone, there were over 27,000 reports of injuries from these 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.”
Medical devices do not undergo the same kind of testing as pharmaceuticals.
As chairman of the Health Subcommittee on the House Ways & Means Committee, Doggett plans to sponsor legislation to demand more accountability from the FDA and help victims seek relief.
“We rely on the civil judgment system to provide relief and that has some good effect, but we need prevention," he said. "We need a system in place that provides more information to everyone involved before these devices are put out there and have someone who follows up to see how they are working in the field, and that's not happening.”
Patients describe lasting effects
Last year, Scott found a doctor to remove her metal-on-metal hips, but she still suffers from soft tissue damage. It makes it difficult to walk, bend and she suffered a hip dislocation this past summer.
“That’s the other thing people don’t realize," she said. "The bad hip, it destroys your soft tissue, so even when you get a new good hip, you don’t have the muscles to hold the ball in the socket. So you start dislocating all the time. The benign tumors that develop around your hip are not cancer, but they destroy the tissue.”
But despite it all, Scott remains hopeful.
“The least I can do for all of these other people is to say this is real, this happened," she said. "The laws are such that it can happen again and try to get it changed.”