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Essure Birth Control Pulled from U.S. Market

What They Knew, When They Knew It

Essure Birth Control and Serious Injuries

Kids are a blessing but they are also a lot of work. Maybe your family is complete and you were looking for a way to prevent additional pregnancies. Or it could be that you have a fulfilling career and homelife and motherhood just isn’t for you. There are many reasons why women have looked to Essure birth control to prevent pregnancies, but now they need to be aware of the serious injuries that are being reported after using this potentially harmful medical device that was voluntarily recalled by Bayer in July 2018.

What They Knew

Essure birth control was put on the market by Bayer in 2002. One of the problems with this medical device is that it’s 55% nickel which causes an allergic reaction in approximately 20% of women. This allergic reaction triggers the immune system and presents like an autoimmune disease with rashes or eczema, chronic pain, brain fog, muscle weakness, hair loss and more. An additional problem is that Essure can break and migrate causing perforations to other tissues and organs causing pain and bleeding. Furthermore, there have been approximately 631 pregnancies and 294 miscarriages or stillbirths after using this product which proves that this device isn’t foolproof. Four deaths have also been reported that are being linked to the adverse effects of an Essure implant.

When The Knew It

Clearly Bayer knew their product was made out of nickel from the beginning and that this metal posed the potential for adverse immune reactions in the body. In 2012, a group of women demanded a meeting with the FDA to share their painful stories of how Essure robbed them of their health. In September 2015, a special hearing was conducted by the FDA who listened to the testimonies of 22 women describing how Essure complications affected their relationships, sex lives and everyday health. In February 2016, the FDA required that Bayer put a black box warning (the highest warning available) onto Essure and also now requires that doctors review a patient checklist which includes potential side effects and outcomes. Nevertheless, Bayer knew from the beginning that a large percentage of women were allergic to nickel and never warned or suggested testing to avoid these harmful results. Additionally, for over five years the FDA and Bayer knew that Essure was harming thousands of women and failed to warn others of the potential for pain, future surgeries and other complications.

What Can You Do?

Currently, more than 5,200 women have petitioned to sue Bayer because of the pain and suffering they endured due to Essure implants. If you are like these women, you may be able to make a claim against Bayer if after having an Essure medical device inserted you:

  • experienced a perforation of the uterus or fallopian tubes
  • had your device migrate putting your health at risk
  • had an unintended pregnancy
  • endured hospitalization as the result of an allergic reaction to nickel
  • had surgery to remove your Essure device – including a hysterectomy – or have a surgery scheduled to remove this device

Bayer continues to claim that this device is safe and that its market removal was due to low sales, but clearly Essure puts women’s lives and their future at risk. Sales were potentially low because of the number of studies that showed the ineffectiveness of Essure and the likelihood of additional surgeries due to complications.

It’s time that we speak out and hold pharmaceutical companies responsible for their carelessness and the painful injuries that they are causing in countless women. You’ve undoubtedly suffered and may have high medical bills or have been unable to work and you lost needed wages. Please contact us today to see if you are able to get the financial compensation that is owed to you.

 

Essure Warnings In The News

BREAKING (7/27/18): CNN Exclusive: Bayer paid doctors millions for questionable birth control device

When Christina Potts was looking for permanent birth control, she said, her doctor was a “cheerleader” for one option and one option only: Essure.

Potts says the device, which is implanted in a woman’s fallopian tubes to block sperm from reaching an egg, left her in terrible pain and extremely fatigued. It was so bad that she had a hysterectomy, removing her uterus and tubes to get rid of Essure.

Read Full Article

 

BREAKING (7/21/18): Essure Birth Control Pulled From U.S. Market

Bayer announced that by the end of this year, they will be no longer selling Essure birth control to the U.S. market. Bayer sites that the reason for this decision was, “based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable.” However, there has been much concern over the safety and effectiveness of this medical device causing the U.S. to be the last country where this product was sold.

Read Full Article

BREAKING (7/20/18): Sales of Essure birth control implant halted by Bayer; U.S. was last to sell controversial device

Pharmaceutical giant Bayer said Friday that it will halt sales of its controversial Essure birth-control device in the United States at the end of the year, bringing to a close a protracted battle over an implant that thousands of women blame for serious problems, including persistent pain and perforations of the uterus and fallopian tubes.

In a statement, the company said, “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable.” It said it stands by the safety and effectiveness of the device, and added that women who currently have Essure in place can continue to “confidently” rely on it.

Read Full Article

4/9/18: Essure Permanent Birth Control System by Bayer Healthcare: Announcement - FDA Restricts the Sale and Distribution

The FDA is aware that some women have received the Essure device without being adequately informed of Essure’s risks. In order for this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information.

On April 9, 2018, the FDA restricted sales of the Essure device to only doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”. Sale and distribution of Essure is limited to healthcare providers who agree to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation.

Read Full Article

4/1/18: This Birth Control Device Kept Making Women Sick. The FDA Kept It On The Market.

Last month, Food and Drug Administration Commissioner Scott Gottlieb met with a group of women who’ve been knocking on the agency’s door for years.

Online, they’re known as E-sisters: women who were implanted with the permanent “non-incisional” contraceptive called Essure, which consists of metal coils that are implanted into the fallopian tubes and contain nickel. The E-sisters believe Essure has caused them ― and tens of thousands of others ― a constellation of health problems, from bleeding, bloating and pelvic pain to more obscure symptoms like rashes, tooth loss, joint pain and fatigue associated with an allergic or autoimmune reaction.

Read Full Article

8/23/17: FDA Warning: Essure Permanent Birth Control

Essure is a a permanently implanted birth control device for women (female sterilization). Implantation of Essure does not require a surgical incision. In the procedure, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.

Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure. Reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies.

Read Full Article

2/29/16: FDA Orders ‘Black Box’ Warning Label on Essure Long-Acting Contraceptive

A special “black box” warning should be added to packaging for the Essure implantable birth control device, based on concerns over serious complications, the U.S. Food and Drug Administration announced Monday.

The FDA also ordered Essure’s manufacturer, Bayer, to conduct a new clinical study to gather more data about the health risks the device might pose for “in a real-world environment.” Essure is a permanent and nonsurgical form of birth control for women. It consists of flexible coils that are inserted through the vagina and cervix into the fallopian tubes, the FDA explained in a statement.

Read Full Article

Filed Essure Complaints & Damages

5/5/16: Bailey V. Bayer Corp. Et Al

This Complaint is brought by Plaintiffs who relied on express warranties of Defendants before being implanted with a female birth control device, known as “Essure.” In short, the device is intended to cause bilateral occlusion (blockage) of the fallopian tubes by the insertion of micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage.

This Complaint is brought by Plaintiffs with respect to the same occurrence (implantation of Essure, reliance on the same representations prior to implantation, Defendants’ failure to warn Plaintiffs of the same adverse events, and subsequent injuries due to Essure) and which has several questions oflaw and/or fact common to all Plaintiffs.

Read Full Case

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Essure Birth Control Tied To Serious Injuries

Bayer recently announced that they will no longer sell Essure birth control in the United States by the end of 2018. They claim a fall in sales, but facts prove otherwise.

To get more information on the dangers of Essure, or learn if you could be eligible to receive compensation for your losses, call 1-800-844-0246 now.

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5 Little Known Facts About Essure

Did you know that thousands of women have had hysterectomies due to bad Essure implants? If you have this medical device, find out what warning signs to watch for to protect your health.

If you or a loved one have been harmed by Essure, call (800) 511-3838 now to see how we can help.

GET YOUR FREE Essure CASE REVIEW TODAY

Essure 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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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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The Step-By-Step Guide To Taking Action

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

LATEST ARTICLES

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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