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Essure

Permanent sterilization is the most effective means of birth control.  It is extreme, but 27% of American women practicing birth control opt for this measure, according to the Centers for Disease Control and Prevention.

The traditional method used for female sterilization is a tubal ligation, which is a surgical procedure – generally through laparoscopy – where the fallopian tubes are cut or sealed.  Blocking these tubes prevents eggs from traveling from the ovaries to the uterus for implantation.

In 2002, a nonsurgical device was approved for sterilization called Essure.  Essure, developed by Bayer, is a flexible device comprised of a stainless steel coil surrounded by an expanding nickel titanium outer coil, with fibers wound about the inner coil.  This device is inserted through the vagina and placed in the fallopian tubes. Once placed, the outer coil expands, and the fibers encourage tissue in growth to completely block the fallopian tubes.

Soon after Essure’s release, the FDA received reports of serious complications from the device, such as:

  • chronic pelvic pain;
  • migration of the device, even the point of “disappearing” in the body;
  • expulsion of the device;
  • perforation of organs, including colon and uterus;
  • severe migraines;
  • allergic reaction to device components.

There were even reports of additional surgeries necessary to remove the device and repair damaged organs, as well as life threatening ectopic pregnancies and deaths.

In 2016, the FDA required Bayer to add a black box warning to Essure’s label, which warns consumers that a product may cause death or serious injury.  Sales plummeted, and in July of 2018 Bayer announced that it would stop selling Essure in the United States by the end of the year.

By this time, thousands of women had been harmed by the device, and lawsuits filed. In August 2020, Bayer announced it would pay $1.6 billion to end virtually all of the U.S. Essure lawsuits involving women who claimed the birth control device caused serious health complications. Bayer admitted no wrongdoing or liability in the settlement agreements.

If you or a loved one underwent the Essure permanent birth control procedure and experienced harmful side effects, please contact Putnam Law at 402 505-3555 as soon as possible.  A statute of limitations may limit the amount of time you have to file the claim.