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Essure Lawsuits Cite Issues Similar to Mirena IUD Complications


When Essure hit the market 13 years ago, the contraceptive was considered a major innovation for women who didn’t want to have more children. However, thanks to serious side effects, similar to reported Mirena IUD complications, it is now under investigation by the FDA.

Essure is manufactured by Bayer Healthcare Pharmaceuticals Inc. It received FDA fast-track clearance on November 4, 2002, because it offered the first alternative to surgical sterilization and promised a quick recovery. It is the only sterilization option that doesn’t require a skin incision for women who want permanent birth control. Soft flexible inserts are placed into the fallopian tubes, which carry the eggs from the ovaries to the uterus. After about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, preventing conception.

Adverse events detail Essure complications

A total of 943 reports of adverse events related to Essure were reported from its November 4, 2002 approval date through October 25, 2013.

The most frequently reported events were:

  • Pain (606)
  • Hemorrhage (140)
  • Headache (130)
  • Menstrual Irregularities (95)
  • Fatigue (88)
  • Weight Fluctuations (77)

Patients using Essure reported the following complications:

  • Migration of the Device or Device Component (116)
  • Patient Device Incompatibility (113)
  • Device Operating Differently Than Expected (73)
  • Malposition of the Device (46)
  • Device Breakage (37)

Women who have been harmed by the device are urging the FDA to take it off the market and warn the public about its potentially serious side effects. Several have pursued Essure lawsuits, claiming the device seriously injured them.

In total, the FDA has received more than 4,000 reports of serious complications related to the device. According to a citizens’ petition filed with the FDA, an overwhelming 16,047 complaints were made to the original manufacturer, Conceptus, from 2011 to 2013, when Bayer acquired a majority interest in the company.

Essure is sold in at least 23 countries, according to Bayer officials, and approximately 750,000 devices are used across the world.

Essure lawsuits filed alleging defective design

Many patients claim the side effects they suffered from Essure were completely unexpected. After receiving the implant in 2009, Angie Firmalino, a 42-year-old mother of four from Tannersville, NY, experienced severe pain and nonstop bleeding for two years. Eventually, doctors found that the coils had lodged in her uterus and broken apart. She was forced to have several operations, including a hysterectomy, to remove the coils.

Kim Hudak was a 28-year-old mother of a 7-year-old son in 2000 when she volunteered to participate in an early trial of the device. However, she developed a sharp pain in her right hip that didn’t go away as soon as she received the implant. Her menstrual periods became very painful and she developed a number of symptoms, including fatigue, migraines and joint pain that caused her to be unable to sustain a full-time job. She has filed a $1 million claim against Bayer for her injuries and lost wages.

Problems similar to reported Mirena IUD complications

Bayer’s Mirena intrauterine system is markedly similar to Essure and patients have complained of similar issues. The device is inserted in a woman’s body by her physician and can remain in the uterus for up to five years at a time. The Mirena label does not warn women of the potential for the spontaneous migration of the device, but only states that migration could happen if the uterus becomes performed during the insertion process, which is described as unusual.

However, many women have sued Bayer, claiming the manufacturer has overstated the effectiveness of the device and understated its safety. Other side effects women have complained of include weight gain, decreased libido, breast pain, infection and the risk of infection in the event that pregnancy does occur.

Hundreds of women have filed Mirena lawsuits against the company, citing a number of severe complications such as adhesions, embedment in the uterine wall, abscesses, infertility, intestinal and bowl perforation, ectopic pregnancy and Pelvic Inflammatory Disease (PID).