Several dozen plaintiffs in an Essure lawsuit claim that using the permanent birth control product leads to unintentional pregnancies and other complications, including abdominal pain, headaches, back pain, hair loss, gastrointestinal issues and more.

Essure was first introduced by Bayer Healthcare Pharmaceuticals in 2002 as a form of permanent, non-hormonal birth control. The device’s coils are implanted into each fallopian tube through the uterus. As inflammation and scaring occur, the fallopian tubes are sealed off and conception is prevented. Essure has been marketed as an alternative to tubal ligation.

According to the Food and Drug Administration (FDA), more than 4,500 consumer complaints have been filed with the agency. Earlier this year, the FDA ordered Bayer to conduct a post-market safety study on Essure. The study will monitor 2,000 women implanted with the device for at least three years. In addition, the FDA ordered Bayer to include a warning on its packaging stating that physicians should warn patients about the potential risks of implanting the device.

Essure has been marketed as the “only FDA approved female sterilization procedure to have zero pregnancies in clinical trials.” The plaintiffs dispute this statement, saying that there were four pregnancies reported during clinical trials of Essure and five more during its first year on the market. In addition, the complaint asserts that Bayer received more than 64 reports of unintended pregnancies between 1997 and 2005.

The suit also cites a study that found Essure is 10 times more likely to lead to unintentional pregnancies than laparoscopic sterilization.

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