Frequently Asked Questions About Essure

Our Essure Lawyers Answer Your FAQs

Essure, a permanent birth control device manufactured by Bayer HealthCare, has been on the market since 2002. Since then, hundreds of thousands of women have received the device. However, the FDA has received thousands of reports of severe complications and side-effects from women who have Essure implants. As a result, Bayer is now facing lawsuits and backlash centered on Essure defects and the company’s alleged concealment of dangerous side effects. In July 2018, Bayer announced that it would withdraw Essure from the market by the end of the year.

Below, our attorneys answer some of the most frequently asked questions about the Essure birth control device and Essure lawsuits. For more information, contact our law firm directly at (888) 985-7228. We are here to help.

Essure FAQs

  1. What Is Essure and How Does It Work?
  2. Is Essure an IUD?
  3. What Are Possible Essure Complications?
  4. What Should I Do If I Am Experiencing Essure Complications?
  5. Why Does Essure Have a Black Box Warning?
  6.  Is There an Essure Reversal Process?
  7. Was Essure Recalled?
  8. What Is the Difference Between a Recall and a Product Being Withdrawn from the Market?
  9. Since Bayer Is Discontinuing Essure, What Do I Do If I Have an Implant?
  10. Can I File a Lawsuit Against Bayer for Essure Problems?
  11. Is There an Ongoing Essure Lawsuit I Can Join Now?
  12. How Long Does an Essure Lawsuit Take?
  13. How Much Can I Recover from an Essure Lawsuit Settlement?
  14. Do I Need an Essure Lawyer to File a Lawsuit?
  15. How Much Does it Cost to Talk to an Essure Lawyer?

What Is Essure and How Does It Work?

Essure is a permanent, non-surgical birth control solution for women. The device is a soft, flexible pair of metal and fiber coils that are inserted into the fallopian tubes by a healthcare provider. The coils are surrounded by PET fibers which encourage scar tissue to form, creating a barrier that prevents sperm from reaching the eggs. This process takes about three months. The scar tissue is meant to permanently prevent a woman from being able to conceive. Three or six months after the implant, a confirmation test is performed to ensure the coils are in the correct place, and the tubes are completely blocked.

The FDA first approved Essure in 2002, and it has been on the market ever since. Essure was initially manufactured by Conceptus, Inc., which was bought by Bayer HealthCare in 2013.

Is Essure an IUD?

According to Bayer, Essure is not an intrauterine device (IUD) because Essure is intended to be permanent. Essure was not designed for removal, and the sterilization process is generally irreversible. IUDs are birth control devices that are designed to be removed.

What Are Possible Essure Complications?

Thousands of women have reported a wide range of complications and side effects associated with Essure implants. These include:

  • Pregnancy
  • Ectopic pregnancy
  • Miscarriage
  • Perforation of the uterus or other organs
  • Migration of the device to the lower abdomen and pelvis
  • Device breakage
  • Malposition
  • Autoimmune disorders
  • Severe menstrual cramps
  • Abnormal and/or heavy bleeding
  • Vaginal infection
  • Bloating
  • Fatigue
  • Skin allergies
  • Hair loss
  • Chronic pain
  • Headaches
  • Muscle weakness
  • Weight gain
  • Depression
  • Death

Many women have reported other health issues related to nickel allergies, as the Essure device contains this metal. In many cases, these side effects are severely debilitating. We understand how these complications can affect your life, and want you to know that if you have experienced any of these side-effects from Essure, you’re not alone. Our attorneys are here to help you.

What Should I Do If I Am Experiencing Essure Complications?

Your doctor can discuss the complications you are having with the Essure device, and may even test to see if the device is correctly positioned in your fallopian tubes. In severe cases, he or she may recommend that you have the device surgically removed.

Why Does Essure Have a Black Box Warning?

In February 2016, the FDA required Bayer to include a black box warning on Essure devices. This is the most serious warning label that can be placed on drugs and medical devices, and is only issued when there are severe or life-threatening health hazards associated with the product. The black box warning on Essure is intended to alert women to the serious risks of implantation with this device. By April 2018, the FDA restricted Bayer’s sales of Essure to health care providers that agreed to fully inform and review the device’s risks with patients.

Is There an Essure Reversal Process?

According to Bayer, the Essure birth control implant is intended to be permanent. Therefore, Essure reversal generally requires invasive surgery, and these procedures can be risky. The coil implants are fragile and may break during the removal process. As a result, tiny metal fragments may remain in the uterus and/or fallopian tubes after device removal. These fragments may migrate to other areas of the body as well, causing serious issues. In some cases, women experience such intense complications that a total hysterectomy is necessary.

Was Essure Recalled?

Despite the many health risks associated with Essure, neither Bayer nor the Food and Drug Administration (FDA) has issued a formal recall of the device.

In July 2018, however, Bayer announced that it would be withdrawing Essure from the market by the end of the year.

What Is the Difference Between a Recall and a Product Being Withdrawn from the Market?

A recall occurs when the FDA or a company determines that a product, such as a medical device like Essure, contains defects or risks that outweigh the device’s supposed benefits. During a recall, the manufacturing company must proactively inform consumers of the dangers and take steps to recover all unused products from the market.

In the case of Essure, Bayer is voluntarily removing the device from the market by the end of 2018. The company cites declining sales after the black box warning as the reason for this decision. This means there will be no new Essure devices pushed out onto the market. Physicians have not been advised to stop implanting Essure and there has been no effort to recover the unused coils. As a result, more women may still receive an Essure implant.

Since Bayer Is Discontinuing Essure, What Do I Do If I Have an Implant?

In July 2018, Bayer announced that Essure would be discontinued by the end of the year. If you currently have an Essure implant and are experiencing serious side effects, speak with your doctor about your options. Our lawyers are also here to help you determine whether you are able to file an Essure claim.

Can I File a Lawsuit Against Bayer for Essure Problems?

Currently, Bayer is facing over 16,000 lawsuits filed by women who experienced injuries and complications from Essure implants. If you were implanted with Essure and had complications which resulted in the removal of the device, or if your doctor has recommended that you have Essure removed, you may have grounds for a claim. Our compassionate, understanding, and experienced attorneys are here to discuss your situation with you.

Is There an Ongoing Essure Lawsuit I Can Join Now?

Currently, there are coordinated proceedings for 14,000 lawsuits pending in California, as well as other proceedings in Pennsylvania and Illinois. Call us today to speak with one of our attorneys to see if you may be eligible to join the lawsuit.

How Long Does an Essure Lawsuit Take?

The timeline of an Essure lawsuit will depend on a variety of individual factors unique to each case. We are currently investigating cases involving women who had Essure removed or were advised to have it removed due to complications, and are committed to fighting for our clients throughout the litigation process.

How Much Can I Recover from an Essure Lawsuit Settlement?

There have not yet been any major verdicts or settlements in Essure lawsuits against Bayer. However, if you experienced severe complications, you may be able to claim compensation for your medical bills, additional medical care, lost wages, pain and suffering, and more.

Do I Need an Essure Lawyer to File a Lawsuit?

Essure lawsuits are complicated, especially since there have not yet been any major decisions in these cases. If you are thinking of filing a lawsuit, then you need an experienced attorney who understands the medical issues associated with your case, as well as how to navigate the legal challenges in complex medical device litigations. Our lawyers can handle all aspects of filing and fighting your case so that you can concentrate on your health and your family.

How Much Does it Cost to Talk to an Essure Lawyer?

It costs you nothing to speak to one of our lawyers about your Essure complications. Please call (888) 985-7228 to discuss your potential claim with an experienced Essure attorney. We understand that Essure may be negatively impacting your life, and want to help you get the justice you deserve.

More Questions? Call Our Essure Lawsuit Attorneys for Answers

Please contact our attorneys today to schedule a consultation if you have more questions about Essure and how we may be able to help you.

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