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Gadolinium Tied to Brain Injury

Gandolinium’s Scary Adverse Effects – What They Knew, When They Knew It

MRI’s are intimidating. It can be scary to have to have an MRI in the first place because it means that your doctor suspects that something might be wrong and he or she needs to take a closer look inside of you. Secondly, that long tube is claustrophobic and the various clicks and knocks easily can test your sanity.

Now there is something else to consider before you get an MRI: the contrast agent gadolinium that is injected into the body so that the doctors can see the images clearly. This chemical has been in the news lately because of the dangerous adverse effects that many patients are reporting.

What They Knew

Gadolinium is a rare metal that alters the magnetic properties of water molecules that are nearby in the body to show clearer pictures. Usually this metal leaves the body quickly, but researchers have noticed that long-term gadolinium deposits have been found in brain tissue. In fact, researchers from Japan noted signal changes in areas of the brain following multiple doses of this substance and doctors from the Mayo Clinic confirmed these results. While both studies acknowledge that this metal can stay in the brain for an indefinite amount of time, both are uncertain of what this finding means for patients and what specific risks are involved.

Furthermore, a Danish study reported that gadolinium-based contrast agents (GBCAs) could cause nephrogenic systemic fibrosis (NSF) – a thickening and scarring of skin and connective tissue – in patients with acute or chronic kidney disease.

When They Knew It

The study in Japan and at the Mayo Clinic occured in 2013 while the NSF study was conducted in 2006. However, most patients aren’t made aware of the potential risks that are associated with gadolinium. Many radiologists avoid using this process in patients with poor kidney function, in children or in patients with chronic diseases (such as multiple sclerosis), but the average patient is not warned of the risks.

What Can You Do?

There is little data on patients who are suffering from gadolinium because it has been misdiagnosed for so long. As this issue comes to light, more people are sharing that after having an MRI, they were struggling with horrible pain and a burning sensation throughout their body, violent shaking, numbness or tingling, weakness, kidney damage, difficulty breathing or brain fog.

If you have experienced any of these adverse effects after having an MRI that included using gadolinium, you may be eligible for financial compensation. You weren’t made aware of the possible harm to your health and therefore you weren’t able to make an educated decision. Contact us today to see if you may be able to make a claim.

Gadolinium Warnings In The News

BREAKING (5/21/18): Important Drug Warning for All Gadolinium-Based Contrast Agents

This letter informs you of important updates to the prescribing information for all the gadolinium-based contrast agents (GBCAs) listed above. GBCAs are approved by the U.S. Food and Drug Administration (FDA) for use in magnetic resonance imaging (MRI). New information about gadolinium retention is provided in the Warnings and Precautions, Adverse Reactions, Pregnancy, Clinical Pharmacology and Patient Counseling sections; a medication guide has been added.

Read Full Article

11/8/17: Chuck Norris Claims His Wife Was Poisoned During MRI Scans, Sues for $10 Million

In a lawsuit filed last week in San Francisco Superior Court, Chuck and Gena Norris argued that gadolinium, a metal used as a contrast agent in MRI scans, caused Gena to sustain gadolinium deposition disease, experiencing “multiple, debilitating bouts of pain and burning throughout her body” and suffering long-term damage.

The Norrises are seeking more than $10 million in damages from companies they say should have warned them of risks.

Read Full Article

11/1/17: Chuck Norris Sues Claiming MRI Chemical Poisoned His Wife

Action star Chuck Norris took on medical device manufacturers in a lawsuit filed in California on Wednesday alleging a chemical used in MRI imaging scans poisoned his wife.

Gadolinium that doctors injected into Gena Norris to improve the clarity of her MRIs have left her weak and tired and with debilitating bouts of pain and a burning sensation, the suit filed in San Francisco Superior Court says.

Read Full Article

Video: Chuck Norris Says Wife Was Poisoned With Mri (via Cbs News)

Filed Gadolinium Complaints & Damages

12/22/17: Young-Smith v. Bayer Healthcare LLC et al

GET YOUR FREE Gadolinium CASE REVIEW TODAY

Gadolinium settlements are now being negotiated, but there is a limited window to pursue help. If you think you, a friend, or a family member may qualify, get your free case review today… before it’s too late!

  • * Submit now to learn if you may be eligible for a cash settlement or call (800) 511-3838 now.

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Crystal Mesh – Audiobook

Dr. Chris DeArmitt, who is a consultant to the top technology firms in America, told Sky News: “I see an absolute disregard for proper testing. Testing is way less than you would see on a vacuum cleaner or a washing machine. It’s shocking. I’ve never seen anything like it in my career.”

No Testing, Fast Approval, Injured Patients: Is the FDA Finally Listening to Mesh Survivors?

You might be wondering “Testing for what?” You would probably be shocked to find out that “more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to FDA clearance for distribution or sale,” shares Consumers Union project director Lisa McGiffert in an article from the Fowler Tribune.

This loophole in the FDA is called the 510(k) process and it has allowed millions of patients to be irreparably harmed – and even killed – by the very device that was intended to help them. Now after several decades of patient injuries, billions of dollars being fought over in court, and countless devices being pulled from market (too little, too late, we might add), the FDA is only now looking into changing this horrific flaw in their system.

What is the FDA’s 510(k) Process?

The FDA’s 510(k) process allows medical devices companies to quickly fast-track a product to market based on a pre-approved product. This idea came about decades ago with the purpose to promote innovation but has instead become a way for big companies to slip their products to market for high profits while avoiding expensive testing. This has caused several inexcusable problems to arise. Here’s one tragic example: 

Transvaginal Mesh

A medical device can be approved for market based on a previous model, even one that was recalled. This is what happened in the huge debacle involving vaginal mesh. Protegen was the first vaginal mesh product on the market, but was recalled due to patient harm. However, even after it was pulled, dozens of additional mesh devices were sold and implanted in patients based on this poor design. Currently, hundreds of thousands of women are suffering from mesh and many will have to live with chronic pain, the impossibility of holding down a job, and the inability to have sex with their partners for the rest of their lives. 

But this story includes many more products beyond vaginal mesh-like IVC filters to prevent blood clots, Essure female sterilization devices, hip replacement products, and countless others.  The New York Times reports that these fast-tracked devices have caused 80,000 deaths and more than two million injuries.

Change is in the Air 

Fortunately, with documentaries like The Bleeding Edge, social media groups criticizing the FDA’s process, and advocacy groups, the FDA is reevaluating how it approves devices for market. According to the JAMA (Journal of the American Medical Association) Network,

“For premarket review of 510(k) devices, on February 1, 2019, the FDA released a Final Guidance Document for the ‘Safety and Performance Based Pathway.’ This optional pathway consists of using criteria that involve conformance to FDA-recognized consensus standards, FDA guidance, and/or special controls. It enables 510(k) clearance for certain medical devices if the device meets these specific criteria, which should include safety and effectiveness (as opposed to the often ill-defined ‘substantial equivalence’ to predicate devices). The decision to use this new pathway is determined by manufacturers, although the FDA can disagree with this determination.”

While this is a step in the right direction by requiring device companies to prove safety and effectiveness, many think that these changes don’t go far enough towards protecting patient health. For instance, JAMA suggests that “legislation should mandate that 510(k) devices show improved safety and effectiveness compared with marketed devices for the same clinical purpose, using meaningful clinical criteria to gain clearance. Although these criteria will differ based on the intended use of the device, all criteria should be based on patient-oriented clinical outcomes.”

Additionally, once a product is approved for market, many times the post-market surveillance falls to the wayside. Medical devices should have a registry so that patients can know what devices are implanted in them, doctors can properly treat problems that may arise, and companies can monitor their products more effectively. Car parts are meticulously tracked, shouldn’t medical devices be all the more!?!

Too Little, Too Late

It’s great that the FDA is reviewing it’s 510(k) process that has been grossly overused and under monitored for decades, but what about those who have already been harmed by an agency that favored billion-dollar medical device companies over the health and wellness of patients?

One way that this FDA change was brought about was through the voices and bravery of those who were injured by these faulty medical devices. If you or a loved one had vaginal mesh and had corrective surgery, your voice needs to be heard. Please call Periscope Group today at (800) 511-3838. It’s time to hold medical device companies accountable for the unbearable pain they caused you. We want to hear your story and we want to help you if we can.

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Sources
“Vaginal mesh: Tests on plastic material ‘way less’ thorough than on washing machine”. Sky News. Accessed August 5, 2019. https://news.sky.com/story/vaginal-mesh-tests-on-plastic-material-way-less-thorough-than-on-washing-machine-11772530?fbclid=IwAR0ieT27Sh1V8q53Vt7y3BH2PK1M9akqoLCAFvnf1JskMeAOu10yvzgEi20
“Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices”. JAMA Network. Accessed August 5, 2019. https://jamanetwork.com/journals/jama/fullarticle/2744408?fbclid=IwAR04Fkrn-A1NbJDUkuOOOU-EhA55G5kkXUYJWGIb8y-MftOdFTQ0hrk_Bl0
“Medical Device Testing: Too Much, or Not Enough?” ADMET. Accessed August 5, 2019. https://www.admet.com/medical-device-testing-too-much-or-not-enough/

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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