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FDA Wants Black Box Warning on Essure Contraceptive Coil

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Washington, DC: The US Food and Drug Administration has issued a new, mandatory clinical study for the Essure contraceptive coil to determine heightened risks for particular women.

Further, the FDA also intends to require changes to product labeling, including a boxed warning and a Patient Decision Checklist to help to ensure women receive and understand information regarding the benefits and risks of this type of device. The mandatory box warning on the product must explain the adverse events that have been associated with these devices, including their insertion and/or removal procedures.

Essure is a permanent form of birth control that involves the insertion of flexible coils through the cervix and vagina into the fallopian tubes. It has been on the market since 2002.

The FDA has received nearly 1,000 "adverse event" reports related to the contraceptive device Essure. According to news reports, 500 of those reports were made in 2013.

The FDA noted in its statement that while it believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications. These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.

Thousands of women across the US have had the coils implanted, and subsequently joined support groups on social media to discuss the side effects and medical problems they believe are caused by the device. The most common side effects include pain, hemorrhaging, headaches, menstrual irregularities, weight fluctuation, device migration and suspected nickel allergy. Some women have reportedly had a hysterectomy or other procedures to remove coils.


 

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Last updated November 29 2020

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