The dangers behind implanted medical devices | KVUE



seven million people have some kind of medical device implanted in their bodies a joint a pump a piece of wire or mesh now we expect these devices to undergo rigorous testing but the KVUE defenders uncovered the FDA does not require the same standards for medical devices as it does for pharmaceuticals here's investigator Terry guca the make the model the serial number any kind of problem ever reported is easy to find online when it comes to most any product car seats cars toys but as one Austin mom discovered finding that information on a device that is implanted in your body is difficult they bring me a lot of joy and they remind me not to be afraid and knowing that they used to be used in the industry to test products I can just really relate we were without our own consent made to be guinea pigs when hope is fading and dreams seem dashed sometimes you have nothing left to lose sharing this part of life is not easy for Francis Scott but for ten years it was her life good afternoon from the Raleigh eyewitness News Center I'm Francis Scott and once a successful television anchor in North Carolina an active mom in her 30s with a husband and three kids building a good life when hip pain took over they said basically we think you were born without sockets and then when you stood up to walk the sockets formed in the wrong place doctors recommended a double hip replacement I had been a runner and athlete really active I'm not a sit still kind of person so I'd put high miles on my hips so to speak she says her surgeon suggested the pinnacle with ultimate liner a state-of-the-art metal-on-metal joint made by Johnson & Johnson to view a major surgery for a 39 year old mom but doctors said she'd be back on her feet in a few months I just never got out of pain I was trying to go back and be on camera go back to work and I had these using boils all over my face that's when I started notice noticing the tinnitus a hearing loss and memory loss I was driving on the interstate the main road and I I couldn't figure out how to get back to work for you know two or three minutes and it was terrifying frustrated she searched for answers but in the u.s. there is no medical device registry I could find more out about my child's car seat than I could find out about what's implanted in my body she did find research from England where patients with the same implant were suffering from metal poisoning I kept wondering but everyone I saw kept saying nah Pinnacle's great it's great hip I can't I can't help you and then they stop taking my appointments so I knew I was on she lost her jobs forced to sell her home and move her family to Texas it's a tragedy attorney mark Lanier does not represent Francis but has successfully represented hundreds of people against the makers of metal hip replacements the pinnacle and Johnson & Johnson de PUE included the experiences have had a wide range some people have experienced everything from hearing loss and what are called systemic problems as those metal ions and the metal debris goes throughout the body some of experienced heart issues some have experienced memory issues most experienced pain around the implant and a loss of muscle and and ligaments ahead of Johnson & Johnson depew's development team warned company leaders of issues with metal and metal implants in 1997 before implanting the pinnacle with the ultimate liner in people this memo filed in court shows metal on metal was a bad engineering design wear is a major problem in simulator testing performance is unpredictable working well for a period of time before suffering a sudden catastrophic breakdown which includes releasing a large volume of debris the FDA oversees all medical devices and drugs but the approval process is very different drugs have to undergo human trials most medical devices do not so many of our doctors that we've put under oath and talk to about this we're stunned to find out that the company never tested the device in people essentially just playing a game a whack-a-mole the FDA has known this as a problem admitting it in this video four years ago one device manufacturer can meet FDA requirements and still make a poor quality advice I think a lot of people assume that the FDA itself tests devices and when they find out that the FDA does not then they begin to understand that there are issues Johnson & Johnson de PUE faces more than ten thousand lawsuits across the country and in January agreed to pay 120 million dollars to resolve state attorneys general claims of deceptive marketing and metal on metal hip implants the ultimate liner was pulled off the market in August 2013 2 years after Frances got it inside the ball just last year Frances finally found a doctor to remove her metal hips I would say about 80% of the symptoms that were really troubling me went away within weeks she says she still suffers from hearing and vision loss and because the metal destroyed some of her tissue she dislocated a hip last summer I'm not the worst case by any means as her family time in her 40s is much different than she imagined oh my goodness I got a whole hand somewhere between the loss and the pain what I grieve most you can't give me back Francis Scott found her purpose I want this fixed I want the laws changed I want things change so that this can't happen to other people it's a statement saying it has no greater responsibility than to the patients who use our products and that it is quote confident the evidence will show the company acted appropriately and responsibly the FDA now has stricter requirements for metal on metal hips but there are currently no FDA approved metal and metal hips on the market for the K V Defenders I'm Terri grappa

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