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.”

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/