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National Essure lawyers & attorneys help women file Essure claims.

Have you suffered from adverse health effects after having Essure implanted? Have you undergone a hysterectomy or other surgery to remove the device due to adverse side effects?

If you or someone you love was injured as a result of the Essure permanent birth control device, you may be entitled to financial compensation. Call the top Essure lawyers & attorneys at National Injury Help today to see if you qualify for an Essure Lawsuit.

These lawsuits are currently in litigation in state and federal courts throughout the country, so it is imperative that you act now to see if you qualify for an Essure Lawsuit.

Call 1-800-214-1010 for a free case evaluation or use the form on the right-hand side of the screen.

Essure Lawsuit

Essure has been linked to thousands of reports of adverse health effects since it came onto the market in 2002. Women across the United States have begun filing lawsuits against its manufacturer, Bayer Healthcare, and these lawsuits are currently gaining traction in both state and federal courts.

Essure Lawsuits allege Bayer Healthcare failed to adequately warn the Food and Drug Administration and the public of the device’s potential dangers and adverse side effects, and that Bayer misrepresented the safety and efficacy of the permanent birth control device.

Essure Litigation Updates

August 5, 2016 – A California Judge rules Essure cases in a state court in Alameda County, Calif. can move forward, finding the claims were not “expressly or impliedly preempted under federal or state law.” Read the full story here.

March 25, 2016 – A federal Judge rules Essure cases can move forward on two claims in Philadelphia court, rejecting Bayer’s bid to drop the cases on account of the device’s Pre-Market Approval status, which shields the pharmaceutical giant from litigation under federal preemption laws. Read the story on our News Page.

What is Essure?

Essure is a permanent contraceptive implant made of two metal coils. It has been used by over 750,000 women worldwide since it was approved by the FDA in 2002.

Essure is the only non-surgical option for women seeking permanent birth control – a point exploited by its manufacturer, Bayer Healthcare. Bayer has marketed the device as a safe alternative to traditional tubal ligation and asserts the device is up to 99% effective.

Essure is inserted into a woman’s fallopian tubes, where it causes scar tissue to form and blocks sperm from entering the tubes. Unfortunately, thousands of women have suffered adverse side effects as a result of the metal coils, including unexpected pregnancies due to device failure.

Essure Side Effects

Thousands of women have reported adverse side effects from their Essure devices. Side effects can range from mild to severe; some may even be life-threatening.

Side effects of Essure include:

Additional surgeries, including hysterectomy, to remove the device
Heavy or prolonged menstrual periods
Perforated organs and device migration
Chronic abdominal pain
Pain during intercourse
Allergic reactions and nickel sensitivities

This is only the tip of the iceberg. For a full list of Essure side effects, see our FAQ about Essure.

Why Choose Us? Top Leading Essure Lawyers first to file.

National Injury Help has formed partnerships with prestigious law firms from across the country to ensure our clients have the best attorneys representing them against the pharmaceutical and medical device giants.

National Injury Help is formally working with Grant & Eisenhofer to bring Essure lawsuits to trial in California state court. In August 2016, our firms successfully helped to secure a ruling from a California judge to move Essure cases forward in spite of the device’s Pre-Market Approval status. In August 2016, our firms also asked the same California judge to consolidate all Essure lawsuits together in the state court.

To learn more about National Injury Help, visit our About Us page.

FDA Actions & Warnings

The FDA has had its hands full with Essure, issuing several safety warnings and holding a conference to review the safety and efficacy of the device. The FDA even required Bayer put a “black box” warning on the Essure label, though many are fighting to get the device removed from the market for good.

‘Black Box’ Warning

The FDA announced it would require the makers of Essure to include a black box warning on the device’s label following a panel discussion in September 2015.

Black box warnings are the strongest warnings issued by the FDA short of a recall. The agency asked for feedback on what the warning should say and opened it up to the public for 60 days following its official announcement in February 2016.

Other Actions

March 2016 – FDA says it has received nearly 10,000 reports of adverse health effects related to Essure between 2002 and 2015. The most frequently reported problems included:

Pain/abdominal pain (6,989 reports)
Heavier or irregular periods (3,210)
Headache (2,990)
Fatigue (2,159)
Weight fluctuations (2,088)
Patient-device incompatibility (2,016)
Migration of device (854)
Pregnancy (631)
- 150 live births
- 294 pregnancy loss
  - 96 ectopic
  - 43 terminated
  - 155 other losses
- 204 not indicated
Device operating differently than expected (490)
Device breakage (429)
Device difficult to remove (280)
Malposition of device (199)
Device difficult to insert (187)

September 2015 – The FDA hosts a meeting with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss Essure Safety and Effectiveness. The meeting produced the following actions:

Bayer ordered to conduct post-market surveillance study to obtain more information on Essure’s benefits and risks
Required a black box warning be placed on the Essure label; public given a chance to weigh in on the contents of the black box until May 2016
FDA continued to evaluate claims made by citizen petition, alleging Bayer altered patient medical records in clinical trials prior to Essure approval

2013 – Essure label updated to include risk of chronic pain and device migration

2012 – Essure label updated to warn of risk of pregnancy with the permanent birth control device

2011 – Essure label updated to show the risk of nickel sensitivities due to the device

Essure Controversy – Approved Using Faulty Data?

A study published in June 2016 suggests many women’s health devices, including Essure permanent birth control, were approved based on flawed data.

The study looked at 18 high-risk women’s medical devices approved by the FDA between 2000 and 2015 and found many of these devices – which pose the greatest potential risk to women – were approved using weak trial data.

Essure permanent birth control was found to have been approved using short-term evidence and insufficient post-market follow-up. This paradox rang true for many other devices looked at by the study authors.

Read the full story here.

Essure in the News

June 2016 – A study published in the journal Obstetrics and Gynecology finds many high-risk medical devices, including Essure, were approved by the FDA based on weak clinical trial data.

May 2016 – A meticulous search of the FDA’s adverse event database shows Bayer knew the number of unexpected pregnancies in women using Essure was one-third higher than what was reported to the FDA. Read the full story here.

June 8, 2016 – Rep. Mike Fitzpatrick files two bills in the House of Representatives, including Ariel Grace’s Law, which would allow patients harmed by class III medical devices like Essure to file lawsuits against the manufacturers, essentially overturning the federal preemption laws that protect these high-risk devices from litigation.

Feb. 19, 2016 – The FDA announces it will require Bayer to add a Black Box Warning on the label of Essure. The public is given roughly 60 days to provide input on the language of the warning.

November 2015 – Rep. Mike Fitzpatrick (R-PA) introduces the E-Free Act to the House of Representatives. If passed, Essure’s FDA approval would be reversed and the device would be taken off the market.

September 2015 – The FDA holds an advisory committee meeting to discuss the safety and efficacy of Essure. The expert panel advised the FDA require Bayer conduct additional post-market studies and to include a black box warning on the Essure label.

How to File an Essure Lawsuit

Thousands of women have filed Essure Lawsuits against Bayer Healthcare, alleging the company failed to adequately warn the FDA and the public of the device’s potential dangers and adverse side effects, and that it misrepresented the safety and efficacy of the permanent birth control device.

We intend to hold Bayer Healthcare responsible for the pain and continued suffering of thousands of women who have had the Essure Contraceptive device implanted.
Essure Claims Center Form – click the banner below to see if you qualify:

If you, or someone you love, has had the Essure Contraceptive Implant and has had any adverse side effect, contact our lawyers and attorneys today for a free case review.