An Essure lawsuit states that Bayer knew or should have known that its Essure birth control device can cause women pain, bleeding and allergic reactions. It can also puncture the uterus. Bayer announced July 20, 2018 that it would stop selling Essure in the U.S.. Thousands of women have sent Essure complaints to the FDA prior to the announcement, but Bayer claimed it was halting Essure because of weak sales. The Big Pharma giant halted European Essure sales in 2017.
The FDA placed several restrictions on the Essure device after legions of women reported pain, bleeding, and allergic reactions. FDA also received reports of Essure puncturing the uterus or shifting out of place. In May 2018, the FDA said doctors must show women a checklist of Essure’s risks before implanting it.
More than 16,000 U.S. women are suing Bayer over Essure side effects.
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.
Essure Side Effects
Many women have also attributed other problems to Essure, including mood disorders, weight gain, hair loss, headaches. Those “side effects” are listed in the FDA’s labeling for Essure, though the agency qualifies the list thus: “It is unknown if these symptoms are related to Essure or other causes.”
Reports of severe complications with Essure implant include:
- More surgery, including hysterectomy to remove the Essure device and repair internal organs
- Autoimmune response, including fatigue, rash, hair loss, weight gain
- Chronic pelvic pain
- Life-threatening ectopic pregnancy
- Migration of the device or a component (the device may ‘disappear’ and becoming undetectable even to scanning)
- Device expulsion
- Perforation or tearing in pelvic organs, including the uterus or colon
- Severe migraines and allergic reactions to the device or its components
Essure has been the target of complaints and calls for its withdrawal since it was approved for sale in 2002 for the U.S. market. Bayer acquired Essure in 2013.
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.
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.
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.
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.
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.