Women harmed by a form of implanted, non-hormonal birth control were banging on the door of the FDA for nearly 15 years, begging the agency to take a closer look. During this time, the FDA received over 27,000 adverse event reports related to Essure birth control, manufactured by Bayer. These complaints ranged from headaches and fatigue to severe bleeding and crippling abdominal pain. At least eight deaths are linked to the product. Essure is one of five dangerous medical devices featured in the Netflix documentary “The Bleeding Edge.”


In 2016, the FDA mandated a stronger black box warning label, which led to a 70 percent decline in sales. Then, in April 2018, the FDA said it would restrict the sale of Essure “only to health care providers and facilities that guarantee women have been fully informed about its potential side effects.” Despite the stern warnings, the FDA maintained that “the benefits outweighed the risks.” By December 2018, Bayer stopped selling the birth control altogether for “business and financial reasons”.


Who Can File an Essure Lawsuit?


The fact that fewer women will be harmed by the birth control device is some consolation, but many individuals are still suffering from devastating Essure side effects and the associated costly medical bills. Showard Law Firm continues to provide free consultations and contingency-based legal representation to injured Essure birth control patients nationwide. You may be eligible to file an Essure lawsuit to recoup money for medical expenses, lost time off work, and emotional hardship endured.


What Is Essure Birth Control?


Essure is a permanent form of birth control that was on the market from 2002-2018. The claimed benefit was that patients could achieve the same results of a tubal litigation, but without surgery, incisions, anesthesia, or lengthy downtime. As a non-hormonal form of birth control, there should be no impact on the menstrual cycle and no adverse effects like headaches or weight gain typically associated with other classes of birth control. The risk of pregnancy was stated as one in 100, with an ectopic pregnancy the most likely scenario.


Essure birth control consists of two small metal coils, inserted through the vagina and cervix into the fallopian tubes. The coils cause inflammation and build up scar tissue that blocks the eggs from being carried from the ovaries to the uterus. Though mild side effects could be expected immediately following insertion, women were told they could get back to regular activities within one to two days after insertion.


Essure Side Effects and Risks


The product label indicates the following commonly reported Essure side effects and known risks:


  • Mild to moderate pain during the placement procedure.
  • Abdominal pain, vaginal bleeding, cramping, dizziness, nausea, vomiting, lightheadedness, pelvic or back discomfort for several days after the procedure.
  • Long-term side effects were observed in clinical trials: abdominal, pelvic, or back pain; allergic reactions; Essure device migration; perforations of the uterus or fallopian tubes; unintended pregnancy.
  • FDA adverse event reports included persistent problems of headaches, chronic fatigue, weight chances, hair loss, and mood changes, including depression.


According to the FDA, approximately 8 percent of women who undergo the placement procedure cannot rely on the device as an effective form of birth control.


Commonly Reported Essure Problems


Some of the Essure problems are quite serious. The FDA has received over 27,000 adverse event reports related to Essure birth control, including:

  • Achy joints
  • Bleeding and blood clots
  • Cramping
  • Death
  • Depression
  • Dizziness
  • Fatigue
  • Fevers
  • Hair loss
  • Headaches
  • Hives, itching, and facial swelling
  • Miscarriage
  • Nausea and vomiting
  • Severe “stabbing” abdominal pain
  • Weight gain


Essure Complications 


The root cause of these side effects could be related to Essure complications like:

  • The body’s immune system attacking the device as a “foreign object.”
  • Infection contracted during the initial insertion procedure.
  • Device migration and perforation of the uterus or fallopian tubes.
  • Coil shifting into the abdominal cavity.
  • Unintended pregnancy.


Status of Essure Birth Control Lawsuits


More than 19,000 Essure birth control lawsuits have been filed across the country. The original motion in 2016 was to have a Multi-District Litigation (MDL) centered in federal district court in the Eastern District of Pennsylvania under Judge Gerald McHugh, who was already handling 23 cases. Also in the Eastern District of Pennsylvania, 18 cases were consolidated before Judge Patrese B. Tucker, and more than 1,000 cases are scheduled to go before Judge John Padova, who has thrown out at least a dozen lawsuits that fell “outside the state’s two-year statute of limitations” deadline for filing a product liability claim. In California, a petition to consolidate 55 cases involving over 900 women in courts throughout the state was granted before Judge Winifred Smith in Alameda County Superior Court.


The benefit of MDL is to avoid duplicative discovery and conflicting decisions from various judges, which typically leads to more expedient outcomes.


Contact a Defective Device Attorney


Contacting Showard Law Firm sooner rather than later is the best course of action to explore all legal options before time runs out. All Essure lawsuit consultations are free of charge, and there is no fee for our services unless we win your case.


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