A woman, along with a number of other named plaintiffs, recently filed an Essure lawsuit against the makers of the permanent contraceptive device alleging it of causing severe adverse effecting including vaginal bleeding, painful intercourse, unusual periods, cramping, and abdominal pain.

Plaintiff Royce A. filed the Essure lawsuit in Pennsylvania federal court. The lawsuit was filed on March 2, 2018.

Royce, a Huntsville, Ala. resident, says that she was implanted with the Essure device at Crestwood Medical Center on Jan. 30, 2012. However, shortly after undergoing the procedure, the Essure lawsuit states, she began suffering from these adverse effects and complications.

She says that she depended on the manufacturer’s claims that the device was a safe and effective contraceptive device. This is what led her to undergo an implant Essure procedure, she says.

Royce claims that she would never have “chosen to undergo the implantation of Essure had she not relied on Defendant’s misrepresentations as to the safety and effectiveness of Essure as a permanent birth control device.”

Other named plaintiffs complain of similar adverse effects as well. Plaintiff Charleen P., a resident of Mobile, Ala., also says that she was implanted with the Essure device. She underwent the procedure on Dec. 29, 2009 at Baystate Medical Center.

According to the Essure lawsuit, however, shortly after undergoing the procedure, she “began to suffer excessive vaginal bleeding, unusual periods, painful intercourse, abdominal pain, and cramping.”

Royce’s spouse, Daniel A., is also one of the named plaintiffs in the case, filing the lawsuit alleging he suffered loss of consortium as a result of his wife’s injuries.

He says that it was soon after Royce became implanted with the device that he noticed a “change in his wife’s demeanor as she was no longer as happy and energetic as she once was prior to undergoing the implantation of Essure.”

Overview: Essure Birth Control

Essure is a permanent, non-surgical birth control device, manufactured by Bayer Healthcare that became approved by the U.S. Food and Drug Administration (FDA) in 2002. When first introduced to the market, it was thought to be a breakthrough contraceptive device for women as at the time, the only permanent sterilization option for women was tubal ligation.

Albeit approved by the FDA in 2002, Essure became prioritized and approved through the agency’s fast track program because the device offered the first alternative to surgical sterilization and promised quick recovery.

But since then, allegations that the device causes death, perforation of fallopian tubes, and severe pain, have risen. Claims purported in the lawsuits contend that Essure was approved too quickly before adequate studies and sufficient testing were done to ensure the device’s safety and effectiveness. Allegations purport that the device’s approval was also based on questionable studies.

Essure birth control problems have ranged from excessive bleeding, organ perforation, pelvic pain, miscarriage, ectopic pregnancy, allergic reactions, bloating, and rashes.

Women who underwent Essure birth control procedures claim that neither they nor their physicians were warned about the severe adverse effects associated with the device.

The Essure Lawsuit is Case No. 2:18-cv-00908-JP, in the U.S. District Court for the Eastern District of Pennsylvania.