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Viagra Tied to Melanoma Cancer

Viagra and Melanoma – What They Knew, When They Knew It

Viagra (sildenafil citrate) is undoubtedly the most famous “little blue pill” in history. In 2016, Pfizer, the pharmaceutical company that makes Viagra, made $1.14 billion in U.S. sales and over $2 billion worldwide. With so many men taking this prescription, should the bottle carry a warning about the dangerous risk for melanoma (skin cancer)?

What They Knew

A study was published in JAMA Internal Medicine that determine that men who took Viagra had an 84 percent higher risk for having melanoma (skin cancer) than men who didn’t take the ED (erectile dysfunction) drug. Research began in 2000 when doctors questioned 26,000 men about their sexual health, if they used Viagra, how much time did they spend in the sun and if they had any genetic skin cancer risks (which included hair and eye color and mole growth). After ten years, it was found that the men who used Viagra were twice as likely to have melanoma.

So how can Viagra increase the risk for melanoma? One theory is that Viagra helps patients get an erection by suppressing the phosphodiesterase (PDE) 5A enzyme.This apparently mimics the activation of a mutation seen in melanoma. Simply put, if the PDE5A enzyme is lowered from the use of Viagra, there is a potential for melanoma cells to increase.

When They Knew It

While this study linking Viagra use to melanoma was published in 2014, there is still no warning on the label to make patients aware of the risk of skin cancer.  In June 2016, the US Food and Drug Administration (FDA) announced that it will “study the potential link between melanoma and erectile dysfunction (ED) drugs including sildenafil (Viagra)”, but as of yet, there have been no updates from the FDA.

What Can You Do?

If you took Viagra and currently have or have had melanoma, you may be able to receive compensation. You probably have expensive medicals bills and you might have had to take time off of work as a result of many doctors appointments, for recovery time or worse… Pfizer has been aware of the link of Viagra to melanoma for at least four years and they still fail to warn patients of the risk. Contact us today to see if you qualify to make a claim.

Viagra Warnings In The News

6/24/15: Men Who Take Viagra Increase Skin Cancer Risk By 21%: The Little-Known Link Between Money & Sex

A recent study has suggested that Viagra itself does not directly cause melanoma, but rather men who are prescribed the drug are more likely to have high skin cancer risk lifestyles. The finding raises an interesting idea and suggests that our sex lives and spending habits may be intrinsically linked.

The study, which is currently published in the Journal of the American Medical Association, is the product of an analysis of more than 20,000 male medical records. Among these men, 4,065 were found to have malignant melanoma between 2006 and 2012, and of these 435 had taken a drug to treat erectile dysfunction (ED). The data showed that taking an ED drug raised men’s risk of developing melanoma by 21 percent, but more importantly, the team found that the statistical risk of developing malignant melanoma did not increase with men who took more drugs for a longer period of time. As explained in the press release, this “dose relationship” between drug use and disease prevalence would be expected if the drugs were the direct cause of the cancer.

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Filed Viagra Complaints & Damages

7/25/16: Mayer vs. Pfizer Inc.

Unbeknownst to Viagra® users, studies have shown that the cellular activity providing the mechanism of action for Viagra® is associated with the development and/or exacerbation of melanoma. The American Cancer Society states that melanoma is “the most serious type of skin cancer.”

Several studies have linked the mechanism of action for Viagra® to cell mutation cultivating melanomagenesis, or the creation of melanocytes which develop into melanoma. A study published in 2011 found that treatment with Viagra® can promote melanoma cell invasion. Specifically, by inhibiting PDE5, Viagra® mimics an effect of gene activation and therefore may potentially function as a trigger for the creation of melanoma cells. A 2012 study published in the Journal of Cell Biochemistry also found that PDE5 inhibitors were shown to promote melanin synthesis, which may exacerbate melanoma development.

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GET YOUR FREE Viagra CASE REVIEW TODAY

Viagra 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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How to File for Financial Settlement After Injury from an Unsafe Drug or Device

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The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

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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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