Essure Lawsuits
What You Need to Know
Essure lawsuits were filed after thousands of women suffered devastating side effects from the birth control device. These lawsuits claim that Bayer, the manufacturer of Essure, failed to adequately warn the public and the FDA about serious risks associated with the product, such as device migration, perforated organs, and device breakage. Women allege that these complications caused severe pain, bleeding, allergic reactions, and, in many cases, permanent damage.
Essure was approved for use in the United States in 2002 and was marketed as a non-surgical, permanent birth control solution. Bayer acquired the device in 2013, but mounting reports of adverse effects began to surface shortly after. Thousands of complaints were sent to the FDA, detailing horrific side effects that women endured after using the device. These reports included cases where the device moved from the fallopian tubes, punctured nearby organs, or broke into sharp fragments that damaged internal tissue.
Due to the growing concerns, the FDA implemented tighter restrictions on Essure in April 2018. These restrictions required doctors to show patients a checklist outlining the risks of the device before implantation. Amid increasing safety concerns and declining sales, Bayer announced on July 20, 2018, that it would stop selling the device in the U.S. The company, however, stated that the decision was driven primarily by weak sales trends. Prior to halting U.S. sales, the device had already been removed from the European market in 2017.
Today, more than 16,000 women pursued lawsuits against Bayer, claiming the device caused life-altering injuries. These lawsuits continue to shed light on the long history of issues linked to Essure, emphasizing the alleged company negligence that has impacted thousands of lives.
Explore your legal options today by calling (888) 923-7001 or contacting us online.
We may file or settle a claim individually or as part of a group on a case-by-case basis.
Whether your claim is filed individually or as part of a group fighting the same defendant, our goal is always to provide each of our clients with individual attention.
Essure Problems on Facebook
Members of a 27,000-member Facebook group “Essure Problems” expressed disappointment at the FDA’s announcement. The group, as well as consumer watchdog Public Citizen, has been pushing for a ban on the device.
Sarah Sorscher, an attorney for Public Citizen, said in an email: “The FDA unacceptably puts patients at risk by allowing the device to continue to be marketed as this surveillance study proceeds.”
Bayer estimates there some 750,000 women are using Essure worldwide, about 70 percent of them in the U.S.
Essure Litigation
Bayer has reported that more than 16,000 lawsuits have been filed against the company over Essure in both federal and state courts across the U.S..
Essure Multidistrict Litigation
No federal multi district litigaton (MDL) court has been established for Essure. California and some other states have established protocols to coordinate Essure cases using processes similar to those used in the federal MDL system. Given the high number of Essure actions being filed, an Essure MDL could be created somewhere in the future.
FDA Adverse Events and Actions
The FDA originally approved Essure as a Class III medical device in 2002. FDA then required Bayer to submit regular reports related to Essure’s efficacy and safety. It also wanted reports of adverse events. Despite the FDA’s requirements, Bayer was cited several times by the agency for violating those conditions.
- June 2008: The FDA discovered Bayer had been making Essure implants in an unlicensed factory since at least 2005, and Bayer had failed to document its procedures.
- January 2011: FDA cited Bayer for using unapproved materials in Essure, which violated its premarket approval that required approval for any design changes.
- February 2016: FDA ordered Bayer to conduct a new clinical trial to determine any heightened risks for certain women, based on adverse event reports FDA had received.
- November 2016: FDA required a black box warning be added to Essure labels indicating the risks of perforation, abdominal pain, allergy, other potential complications.
- April 2018: FDA restricted Essure sales to medical centers and doctors who promised to give patients a checklist of (updated) Essure dangers before prescribing the device.
What is Essure?
Essure is a hysteroscopic sterilization procedure, a type of tubal sterilization which requires no incision. Women who undergo the Essure birth control procedure are inserted with a soft metal, spring-like device wound with synthetic fibers. The device is inserted in the fallopian tubes. The device’s metal part consists of a stainless steel inner coil inside an expanding nickel titanium outer coil. The fibers are intended to encourage the surrounding tissue to adhere to the device by creating a barrier of scar tissue intended to block sperm from reaching the eggs.
Bayer received FDA approval to sell Essure in 2002. The company promoted Essure to women as the only non-surgical option for permanent birth control. Due to the large number of reported complaints, FDA added its most serious warning to Essure in 2016. The agency also ordered Bayer to conduct a 2,000-patient study of the device.
FDA Commissioner Scott Gottlieb said on July 20, 2018 that FDA would work with Bayer to continue the study. The study was designed to follow patients for three years to better assess complications, but Mr. Gottlieb noted that, “Bayer will not be able to meet its expected enrollment numbers” for new patients. Essure’s original label warned that nickel in the implant can cause allergic reactions such as itching and hives.
We're Ready to Fight For You!
-
“Matthews & Associates is one of a kind.”
Matthews & Associates is one of a kind. They treat you with respect. They support you when needed. Plus they have locations in Texas and California with wonderful customer service. Bilingual service is always available.- Sorangel T. -
“Matthews and Associates are very informative. Kept me up to date on what was happening with my case.”
- Ron S.Matthews and Associates are very informative. Kept me up to date on what was happening with my case. They were always polite when they were talking to me. Very professional and polite.
-
“Always available & answers questions promptly.”
I've been working with Matthews & Associates for 2 years. I am impressed that the firm is always available and answers questions promptly. I am very satisfied with the services they provide and would recommend them.- Kweli Y. -
“Very professional from the beginning”
- Jeffrey E.Very professional from the beginning. always answered questions and had amazing follow through on insuring data submitted was accurate
-
“They are so helpful, kind, and knowledgeable.”
I love these guys! They are so helpful, kind, knowledgeable, smart, and good with people. They answer all your questions and if they don't know the answer, it doesn't take them long to get you the answer! I wouldn't want anyone else to handle my suit. They are AWESOME!- Genie S. -
“Very informative and professional.”
- Lydia C.Very informative and professional. Answer thoroughly all my questions and concerns.
Could Draconian Preemption Laws Quash Essure Lawsuits?
Bayer has tried to have many Essure lawsuits dismissed by using certain Draconian laws known as federal “preemption” – in which medical device makers claim immunity by virtue of FDA approval. Bayer claims that because FDA examines medical devices’ “rigorous testing” by their makers before approving them, Bayer can’t be held liable for Essure’s side effects.
That preemption argument is problematic for Bayer. The company did not always follow its postmarket regulatory obligations for Essure. Nonetheless, Bayer has successful had some product liability lawsuits dismissed through that argument; some others have been allowed to move forward, often with modified complaints.
.2401221447135.jpg)
Free Legal Consultation
If you believe that you or someone you love was injured by an Essure implant, contact our law firm for a free legal case consultation regarding a potential Essure lawsuit.