Crystal Mesh: The inside story of how women’s health was traded for quick cash Get The Book

(800) 511-3838 |

What They Knew

Aearo Technologies originally manufactured the Dual-Ended Combat Arms Earplugs and then was sold to 3M in 2008. As stated in the name, the product was intended for use in combat and was specifically intended to protect United States Air Force (“USAF”) service men and women from damaging and disabling noise during combat and other military missions. It had a dual purpose with each end of the plug providing a different kind of protection; one to be used to hear speech and the other side to completely block out sound.

In a lawsuit brought against 3M by the U.S. military, it was stated that the earplugs were too short to be properly inserted into the soldiers’ ears and that the device could come loose without the soldier realizing it. When the military first issued solicitations, they explained the minimum requirements the earplugs had to meet, including that the earplugs be “suitable for use as hearing protectors for military personnel in chronically noisy environments.” However, the Combat Arms Earplugs 3M supplied did not meet these requirements and 3M knew this at the time it sold the earplugs. Aearo Technologies and 3M were accused of knowing about the design flaw but not disclosing this information to the military. In July 2018, the Department of Justice announced that 3M agreed to pay the U.S. military $9.1 million.

When They Knew It

According to the lawsuit, it is suspected that Aero Technologies knew about the problematic design as early as 2000 and that 3M was made aware of the problem but failed to notify the U.S. military.  The Environmental Protection Agency requires manufacturers like 3M to test and label the Noise Reduction Rating of hearing protection devices like the Combat Arms Earplugs. 3M did not commission an independent lab to conduct the testing as required by federal law and military solicitations but instead conducted the testing in-house. 8 out of 10 of the earplugs didn’t pass the tests and were deemed “defective”. An investigation revealed that that the Combat Arms Earplugs were too short and that the flanges on one side of the earplug interfered with the proper fit of the opposite side to offer proper sound protection. If the flanges were folded back a certain way, researchers found that the earplugs would become more secure. However, soldiers weren’t warned that this product was defective nor were they told how to properly use them for maximum sound blockage.

Equally concerning is that 3M was the exclusive supplier of this type of product for the U.S. Defense Logistics Agency which may have been used in the following military events between 2003 – 2015:

  • The Iraq War
  • War in Afghanistan
  • War in North-West Pakistan
  • War in Somalia
  • Operation Ocean Shield in the Indian Ocean
  • American-led intervention in Libya, Iraq, and Syria
  • Yemeni Civil War


What Can You Do?

If you served in the military during 2003 – 2016, used CAEv2 earplugs, and are now experiencing permanent or semi-permanent hearing loss or tinnitus (ringing or buzzing in the ears), you may be able to file a claim. Dangerous sound levels are involved with training and in combat, and the makers of these poorly designed earplugs allegedly withheld this important information from the government. 3M needs to be held accountable for deliberately and needlessly putting our servicemen and women at risk. Contact Periscope Group today at (800) 511-3838.

 

Image Source

3M Combat Earplugs Warnings In The News

8/27/18: Tinnitus Anyone? 3M Covered Up Its Defective Military Earplugs Since 2000

In a settlement worth a paltry $9.1 million, 3M agreed to pay the government after being caught covering up its defective earplugs called dual-ended Combat Arms Earplugs, Version 2 (CAEv2).

The company sold its earplugs to the US military without disclosing problems with its effectiveness. Basically, the earplugs would come loose in the ear canal and not perform as well. Those curious about the lawsuit should look up United States ex rel. Moldex-Metric v. 3M Company, case number 3:16-cv-1533-MBS (DSC). (Note: I grabbed a photo of the earplug type from the 3M website, but the photo above may not be exactly the same earplug variant.)

Read Full Article

7/30/18: Contractor settles for $9.1 million after providing defective earplugs for servicemembers

A contractor has agreed to pay $9.1 million to the U.S. government for selling defective earplugs issued to thousands of servicemembers deployed to Iraq and Afghanistan from 2003 to 2015.

Known as “selective attenuation earplugs,” 3M’s Combat Arms earplugs would “loosen in the wearers ear, imperceptibly to the wearer and even trained audiologists visually observing a wearer, thereby permitting damaging sounds to enter the ear canal by traveling around outside of the earplug,” according to the whistleblower lawsuit complaint, which was settled Thursday.

Read Full Article

7/27/18: 3M settles defective combat earplug case for $9.1 million

Without admitting liability, 3M Co. has agreed to pay $9.1 million to settle allegations that it supplied the U.S. military with defective earplugs, Department of Justice officials announced late Thursday.

The settlement, which involves the second version of 3M’s “dual-ended combat arms earplugs” (CAEv2), resolves a whistleblower’s allegations that 3M violated the federal False Claims Act by selling defective earplugs to the U.S. Defense Logistics Agency, Justice officials said in a statement.

Read Full Article

7/26/18: 3M Company Agrees to Pay $9.1 Million For Defective Dual-Ended Combat Arms Earplugs

The Department of Justice announced today that 3M Company (3M), headquartered in St. Paul, Minnesota, has agreed to pay $9.1 million to resolve allegations that it knowingly sold the dual-ended Combat Arms Earplugs, Version 2 (CAEv2) to the United States military without disclosing defects that hampered the effectiveness of the hearing protection device.

“The Department of Justice is committed to protecting the men and women serving in the United States military from defective products and fraudulent conduct,” said Acting Assistant Attorney General Chad A. Readler of the Department’s Civil Division. “Government contractors who seek to profit at the expense of our military will face appropriate consequences.”

Read Full Article

GET YOUR FREE 3M COMBAT EARPLUG CASE REVIEW TODAY

3M Combat Earplug cases are now being reviewed, 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.

Free Guide Download

The Step-By-Step Guide To Taking Action

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

Free Guide Download

The Step-By-Step Guide To Taking Action

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

LATEST ARTICLES

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

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.

##
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.

HON Code Certification

© All Rights Reserved • 2019 • Periscope Group, 4155 Blackhawk Plaza Circle, Suite 100, Danville, CA 94506 Legal Disclaimer

Protected by Copyscape

© All Rights Reserved • 2019 • Periscope Group, 4155 Blackhawk Plaza Circle, Suite 100, Danville, CA 94506 Legal Disclaimer

HON Code Certification

Pin It on Pinterest