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See if you qualify for Essure Litigation and the right to potentially significant financial recovery.

The Essure Instant Case Evaluator provides lawsuit qualification information and details regarding your situation.

  1. Were you implanted with Essure?
  2. Did you then develop complications or serious injury?

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According to Bayer, Essure is a “non-surgical” permanent birth control solution for women.

Where is the TRUth?

TRUth – Women who are implanted with Essure are 10 times more likely to need additional surgeries than women who get standard sterility surgery.

TRUth – Studies suggest that as many as 9.6% of women could become pregnant after an Essure implant – that is more than four times the estimated risk after a traditional sterility surgery.

What is Essure?

Essure is a widely used medical device marketed as permanent birth control for women ages 21 to 45. Approved by the U.S. Food and Drug Administration in 2002, Essure is a made of two nickel-titanium and stainless steel coils with a filler made of PET (polyethylene terephthalate) fibers.

It has been estimated that more than 1 million women in the U.S. have had the device implanted.

Latest Essure News

April 2, 2017

Bayer Paying Dearly for Essure Losses

Litigation involving the permanent sterilization device Essure is providing to be expensive for its maker, Germany-based Bayer AG. Over 3,700 women have filed product liability lawsuits in the U.S. against Bayer, alleging harm sustained from the device. Although Bayer had ...
November 3, 2016

California Judge Grants Motion to Coordinate Essure Cases

A California judge has granted a motion to coordinate 55 Essure cases filed against Bayer by women who allege that the company’s permanent birth control device harmed them. In California, civil case coordination allows two or more cases that share ...
October 27, 2016

Legal Loophole Keeping Essure Lawsuits From Being Filed

Although the U.S. Food and Drug Administration has received more than 10,000 complaints and 30,00 adverse event reports connected to the permanent birth control device Essure since its approval in 2002, only a little over 1,000 lawsuits have been filed. ...

TRUth Bayer Figured Out How to Get the Device In… But they Never Figured Out How to Get it Out!

essure birth control device

essure birth control device responsible for lawsuits

Problems with Essure?
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How Does it Work?

Essure is inserted in an OB-GYN’s office in ten minutes or less, according to Essure implant guidance. Removal is generally not discussed, and yet many women will experience complications leading to the removal of the Essure device.

One Essure coil is inserted through the vagina and cervix into each fallopian tube. Over the next several months, scar tissue forms around the coils, creating a barrier that blocks the tubes and keeps the eggs from being fertilized or making their way to the uterus, thus preventing conception.

Women implanted with Essure are required to return three months after the procedure for a follow-up X-ray utilizing dye to confirm that the tubes are fully blocked.

Essure Birth Control Device Implanted

Removing the Essure Device has been a source of much frustration for women experiencing complications from the Essure device. There are very few doctors trained to remove the devices – Bayer has not trained doctors in removal. As more and more women seek removal, several OB-GYNs have emerged as specialists in Essure removal. Women seeking removal are often guided to these specialists through word of mouth and social media support groups.

Removal of the Essure device in tact is very important so that parts of the nickel and steel coils do not remain in the women’s body opening it up to future complications. To do this, the majority of women (75.2% according to a recent online survey of 564 women) require a hysterectomy, with an alarming 44% of these women requiring more than one surgery.

Should you file an Essure Lawsuit to protect your legal rights?

Did you experience complications after being implanted with essure?

Hysterectomy Infection requiring hospitalization
Intestinal Perforations/Obstructions Migration/Explusion of Essure Device
Uterine punctures or tears Ectopic pregnancy
Death Other Serious Injury

If you answered yes to the above question you should look into your legal rights. Fill out our Secure Essure Instant Case Evaluation if you believe you may need to protect your legal rights.

View Your Essure Device Case Analysis Now!

Instant, Secure, No cost/No obligation Analysis of Your Essure Lawsuit

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Background
Did you have essure implanted?
Did you have problems with the implant?
What state was the implant surgery performed in?
Did you have essure removed?
When did you first experience complications that you believe came from the Essure birth control device?
When did you first discover that Essure might be responsible for your injury?
How many Surgeries did you have as a result of your Essure Implant?
Are you a member of the Facebook Group “Essure Problems”?
Side Effects
Did you experience any of the following complications as a result of your Essure implant?(mark as many as apply)
Additional Information
Please add any additional information that will help us determine if you or your loved one qualifies for compensation.
View Report
Receive instant case analysis upon submission of this form.

Complications With Essure

Migration/Expulsion of Device

Women report migration of the Essure device outside the uterus and can the implant can get lodged in organs or the abdominal wall. Essure devices have also been found in the uterus.

Injuries resulting from migration of the Essure device vary – women have found the coils of the device in many different locations in their body, sometimes puncturing organs. Invasive hysterectomies have been required to remove these devices. Sometimes multiple surgeries are required to remove the devices.

Painful Symptoms / Constellation of Symptoms

Women describe many symptoms that have been explained by their doctors as their bodies learning to accept the coils – some women find the pain does go away but for many women these symptoms continue and even increase.

Some women describe a constellation of symptoms while their body fights to reject the device in their body. These symptoms vary tremendously with the women and include bloating/weight gain, pain with sexual intercourse, incontinence, chronic pelvic pain and cramping, heavy periods and more.

Fetal Deaths Under-Reported

Congressman Mike Fitzpatrick recently revealed 303 fetal deaths caused by Essure, as opposed to the 5 deaths reported to the FDA.

According to a private analyst who combed through the FDA’s public database, the FDA may have greatly underestimated the number of fetal deaths among women who became pregnant after using Essure. The FDA reported a mere five fetal deaths while Madris Tomes, founder and CEO of Device Events, noted there were 303 reports of fetal deaths tied to Essure as reported in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

Etopic Pregnancies

Women implanted with Essure have a higher percentage of Etopic pregnancies. An etopic pregnancy cannot support the life of a fetus for very long and risks the health of the mother if immediate care is not sought.

Women with Essure Devices have a higher percentage of Etopic pregnancies. Etopic pregnancies occur when fertilization of the egg happens outside of the uterus. Etopic pregnancies can’t proceed normally.

Nickel Injuries/Allergies

Originally, Conceptus warned women to test for Nickel Allergies prior to Essure implant. But, proudly had this warning and the required skin test removed from the label in 2011. Many women describe allergy-like reactions to Nickel that include hair loss, dental issues, weight gain, fatigue and more.

Essure is 55% nickel – Many women report side effects that may actually be reactions to nickel in their body. Reported side effects that may be an allergic reaction to nickel include hair loss, dental issues, weight gain, chronic fatigue, and more. The original Essure label required a skin test and warned of nickel allergies, this was removed in 2011.

Top complications

An adverse event is any undesirable experience associated with the use of a medical product in a patient.

Original Labeled – 2002
1 out of 7 women would have improper placement and will require second placement procedure.
Mild to moderate pain
Overabsorption of fluid
Cramping
Vaginal bleeding
Pelvic or back discomfort for a few days
Nausea and/or vomiting
Infection
Temporary changes in menstrual cycle
Essure device may be expelled from body
Broken Essure micro-insert
Labeled as “rare”
Essure device may be expelled from body
Broken Essure micro-insert

FAERS ANALYSIS
TRUth Alert
They tell you about Adverse Events they know of, not whats REALLY happening to you!

Bayer says about 1 million Essure devices have been sold worldwide. More women will be at risk for complications while the FDA continues to study this device.

TRU EDUCATION

What is an Indication? In medical terminology, an “indication” for a drug refers to the use of that drug for treating a particular disease.
TRU Clarification: A drug’s indications are conditions which the FDA has approved treating with this drug.

Safety Information

Essure Black Box Warning

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have reported adverse events, including perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reactions. Some of these reported events resulted in device removal that required abdominal surgery. This information should be shared with patients considering sterilization with the Essure device during discussion of the benefits and risks of the device.

TRU EDUCATION

What is a Black Box Warning:
A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug. The black box warning must be part of physician and patient labeling materials and includes a statement noting the risks associated with the device.

Essure “Decision Checklist”

In lieu of removing the device from the market, the FDA announced a new “decision checklist” that must be signed by a patient and doctor before implantable sterilization devices such as Essure can be implanted.

TRU EDUCATION

What is a Patient “Decision Checklist”

According to the FDA, a patient checklist highlights the key risk and benefit information and will be included at the endo of the patient-labeling brochure. The checklist is intended to be reviewed and signed by the patient and physician, and should be printed in a fashion where it can be easily separated from the remainder of the patient information brochure.

The checklist is supposed to list every significant adverse event and patient outcomes. It is also supposed to contain information related to the removal and/or reversal of the device. Each item in the checklist should be accompanied by a line for the patient to initial, acknowledging their understanding of the information.

Furthermore, the checklist should include a summary at the end of the document. This should be followed by signature lines for both the patient and physician. A copy of the Patient Decision Checklist will retained be given to the patient and a copy will also be provided to the patient.

Bayer: Science for A Better Life

Bayer AG was founded in 1863 by Friedrich Bayer and Johann Friedrich Weskott. In 1925, Bayer became part of IG Farben, A German chemical company conglomerate that engaged in human experimentation on Auschwitz prisoners during World War II. After World War II, the allies broke the companies up and Bayer continued to operate as its own drug company.

Marketed as “Science for a Better Life” Bayer has been involved with a number of drugs and devices that have notably had legal issues.

Bayer Logo Essure

A History of Problems for Bayer

[btc_timeline id=”13410″] [glt language=”English” label=”English”] | [glt language=”Spanish” label=”Español”]

The TRUth is, Women who are implanted with Essure are 10 times more likely to need new additional operations as women who get standard sterility surgery. And yet, Bayer continues to market their Essure implant as “non-surgical”.

Bayer Profits From More than 8,000 Essure Implants Each Year While Injured E-Sisters Fight to Have the Device Removed From the Market

Help Share The TRU-Side Effects of Essure!

Report your Essure Problem Now

Regulatory Timeline

History of Problems with Manufacturer

Essure was initially manufactured by Conceptus, a company that began focusing on the design, development, and clinical testing of the permanent form of birth control in 1998. Essure had shown promise by eliminating the cutting, clipping, and burning associated with tubal ligation. After clinical testing, Conceptus began marketing Essure commercially in Australia, Singapore, Europe, and Canada.

Bayer acquired Conceptus Inc. for about $1.1 billion in 2013 to add a permanent contraception device (Essure) to complement the German company’s offerings in women’s health.
Essure Approved by FDA in 2002

When the U.S. Food and Drug Administration (FDA) approved Essure in 2002, the agency required the original manufacturer, Conceptus, to monitor the outcomes of women who were enrolled in the five-year clinical trial upon which the agency’s approval was based. The extended approval time was for an additional four years.

In a May 1, 2015 news release, Bayer released the post-market report on the safety, effectiveness, and tolerability of Essure, a report experts say is one-sided because it:
· Never mentions that nearly one-third of the women originally enrolled in the study dropped out for various reasons.
· Understates the levels of pelvic pain reported by women who did complete the study.
· Does not disclose that the study’s lead author is a paid consultant to Bayer.
Further, according to a Health News Review report, Conceptus failed to report the outcome of the five-year study and the results were submitted for publication a year after Bayer acquired the device.

Bayer continues to market Essure as one the most effective, affordable and convenient means of birth control – ideal for the busy 21st century woman and mother. Company officials say it is sold in at least 23 countries, and at least one million devices are in use worldwide.

Essure Regulatory Timeline

  • 2002
  • Essure Approval

    Nov 04, 2002

    Essure FDA approved as a Class III Medical Device

  • 2011
  • Safety Label Changes

    Jul 01, 2011

    Physician label updated to remove contraindication and to revise a warning regarding nickel sensitivity in physicians label

  • 2013
  • Bayer Purchases Conceptus

    Jun 05, 2013

    Bayer Group purchases 96.4% of Conceptus, Inc. for $1.1 billion. Conceptus owned Essure which had been used by more thatn 750,000 women around the globe by this time.

  • Safety Label Changes

    Oct 20, 2013

    FDA review of Essure – label updated to include risks of chronic pelvic pain and device migration

  • 2015
  • FDA Investigations

    Sep 24, 2015

    FDA holds a public meeting as a result of growing reports of complications.

  • 2016
  • Blackbox Warning & Checklist Required

    Mar 01,2016

    FDA requires “black box” label warning about Essure’s serious side effects, plus a checklist for doctors to discuss potential risks with patients