After receiving tens of thousands of complaints about painful and debilitating side effects of Essure, and learning of a plethora of Essure lawsuit plaintiffs, the FDA is acting to help prevent women from unknowingly risking these severe complications.
Essure is a permanent birth control device that is marketed as a natural barrier against pregnancy. The device consists of two flexible coils that inserted in the fallopian tubes. The body reacts to the coils and produces scar tissue that fills the fallopian tube, essentially blocking fertilization. The device is hormone-free and can be inserted in the doctor’s office with no general anesthesia or surgical incisions.
Unfortunately, many women who have received the device say they experienced side-effects and complications from the device including back pain, anxiety, cramping, heavy bleeding, and nausea. But women are also finding that the device can travel from the fallopian tubes to elsewhere in the body and are having to undergo procedures to find and retrieve the drive from the body. At least four deaths have been associated with the device for air embolism, infection, uterine perforation, and suicide.
FDA Requires Essure Patients to Sign an Acknowledgement of Risks
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To ensure women who are considering using Essure understand the increased risks of serious side-effects and complications, the FDA has restricted sales of the devices to only those physicians and facilities who agree to provide their patients with a Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement. This booklet details the complications and side effects that have been associated with the device to give patients a better understanding of the device risks. Patients must also sign a three-page consent form saying they understand the risks.
Women and girls across the country are accusing the manufacturer of failing to provide the medical community with adequate warnings about the risks and dangers of the Essure birth control device. The patients say that the maker also failed to inform doctors about how best to remove a coil that broken, migrated from its position, or punctured organs.
We Can Help
These patients are seeking justice through the legal system with the help of experienced Essure injury attorneys. Our firm has fought for the rights of patients harmed by medical devices for decades and we stand ready to fight for you now. Contact us today to learn about your options and whether you are entitled to significant compensation for your injuries.