Essure Birth Control Lawsuit

Essure Birth Control Lawsuit
A number of women have filed Essure birth control lawsuits alleging that the contraceptive coils are far riskier than tubal ligations. These lawsuits claim that Essure has severely injured thousands of women since coming to market in 2002.

Essure Lawsuit Reviews

Bernstein Liebhard LLP, a nationwide law firm that represents the victims of defective medical devices, is investigating product liability lawsuits on behalf of women who may have suffered serious injuries due to their use of Essure birth control coils. To learn more about your legal options, please call (888) 994-5118.

Essure Allegations

Essure birth control was developed by Conceptus Inc., which was acquired by Bayer in 2013. The system consists of two flexible coils made of stainless steel, nickel titanium and polyethylene fiber, which are inserted into the fallopian tubes by a doctor during a procedure that takes about 10 minutes. The coisl then promote the development of scar tissue over the next thee months, making it impossible for sperm to reach any unfertilized eggs released by the ovaries.

Bayer claims that Essure is nearly 100% effective in preventing pregnancy and touts the birth control system as only the “FDA-approved permanent form of birth control with a procedure that can be performed in an office setting without general anesthesia.” However, plaintiffs in Essure lawsuits claim that thousands of women have suffered serious injuries following implantation of the coils, including:

  • Hysterectomy
  • Migration of device outside of fallopian tubes
  • Pain
  • Bleeding
  • Fracturing of the device
  • Perforation of fallopian tubes
  • Miscarriage
  • Ectopic pregnancy
  • Unwanted pregnancy

Research Questions Essure Safety

In recent years, several reports and studies have raised concerning questions about the safety and effectiveness of Essure:

  • 2014: A study published in the journal Contraception found that nearly 10% of women who used Essure could become pregnant. “That is four times the risk of pregnancy after tubal ligation, or getting tubes tied, which is the more traditional method of permanent birth control in women,” the authors of the study noted. Read More
  • 2015: An analysis that looked at more than 300 women who were involved with Essure’s clinical trials found that, at five-year follow-up, 15% had required hysterectomy; 38% had experienced unusually heavy periods; 5% had recurrent pelvic pain; and 4% reported painful intercourse. Read More
  • 2015: The FDA reported that its adverse event database received 5,093 reports of Essure complications from November 2002 to May 2015. Five fetal deaths were reported, as were four deaths among Essure users that resulted from infection, uterine perforation, air embolism and suicide. The agency also uncovered 20,000 complaints from women who shared their stories on social media.
  • 2015: The British Medical Journal reported that women who received Essure were 10 times more likely to need follow-up surgery compared to women who get their tubes tied. Read More
  • 2016: The FDA mandates a new Black Box Warning for Essure regarding its potential to cause serious complications. However, the device will be allowed to remain on the market, angering many who say an Essure recall is needed. Read More

Federal Essure Plaintiffs Seek Establishment of Multidistrict Litigation

As of July 2016, 30 Essure lawsuits involving more than 1,000 plaintiffs had been filed in federal courts around the U.S. That month, plaintiffs petitioned the U.S. Judicial Panel on Multidistrict Litigation to centralize the federal Essure docket in the U.S. District Court, Eastern District of Pennsylvania. Among other things, the motion points out that the underlying claims all arise from the same device, assert the same, or similar, claims, and cause the same, or similar, injuries. Read More

A month later, the Essure plaintiffs withdrew their Motion for Transfer. Their new motion noted that a judge in the U.S. District Court, Eastern District of Pennsylvania has since ordered that the 11 Essure cases pending in that jurisdiction be consolidated for discovery and pretrial proceedings. Read More

Preemption an Issue in Essure Lawsuits

Despite the reports linking Essure to serious complications, women allegedly harmed by the coils may not be able to recover compensation due to a legal principal called preemption. Preemption protects a medical device manufacturer from liability when a device has gone through the FDA’s premarket approval process. However, Essure lawsuit plaintiffs claim that Conceptus forfeited this protection by violating the terms of the FDA’s premarket approval and withholding data from the agency.

Injured by Ensure? Contact an Attorney Today.

Bernstein Liebhard LLP is offering free legal evaluations to women who may have been harmed by Essure birth control. To learn more about filing an Essure lawsuit, please call (888) 994-5118.

  1. Chicago Tribune (2014) “New study: Essure less effective than tubal ligation at preventing pregnancy”
  2. Journal of Minimally Invasive Gynecology (2015) “Hysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study”
  3. FDA (2015) “FDA’s Review of Reported Problems”
  4. British Medical Journal (2015) “Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study”



Last Modified: August 19, 2016

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