The European Union has instituted an Essure ban after recording an increasing number of reports of serious complaints over the past five years.
British doctors have been asked to halt implanting the device while the European Union has suspended Essure’s commercial license. Still, any of the Essure birth control products already in the supply chain could become implanted in patients. The Essure ban could block future patients from having this option.
Essure is an implantable birth control method that consists of metal coils made of a titanium-nickel alloy that are covered in polyester fibers. The coils are implanted in a woman’s fallopian tubes by way of the vaginal canal. The goal is for the coils to instigate sufficient growth of scar tissue that closes off the fallopian tubes.
Thousands of women around the world have told stories of horrific pain and other adverse side effects after receiving Essure. Even though Bayer promised an easy, safe method to ensure permanent birth control without having surgery, many women accuse the company of peddling an unsafe, untested product that should have never been designed for permanent implantation in the human body.
Women often report never being asked if they were allergic to nickel. Anyone with a nickel allergy could experience the body rejecting the coils, leading to inflammation, joint pain and rashes.
The polyester coating on the metal coils consists of PET plastic, a material known to degrade and release toxic substances at a temperature of 85 degrees. Women who report chronic inflammation, fatigue and extreme joint pain could be experiencing an autoimmune response to the plastic’s release of toxins.
Essure Ban Too Late for Many
Women suffering from so much pain they are unable to get out of bed say they have felt as if something was killing them. The pain has been so severe that some women have said they feel suicidal.
Heavy periods, headaches, cramping, painful intercourse and ectopic pregnancies have all been reported from women who have received Essure.
Because the Essure product is designed to promote the growth of scar tissue, the coils often are embedded in the scar tissue attached to the fallopian tubes. Some women have to have their fallopian tubes and uteruses removed to rid themselves of the Essure complications.
In regard to the Essure ban in the UK, Bayer still says Essure is safe but agreed to request that British hospitals not perform implantations during the Essure ban. The Medicines and Healthcare Products Regulatory Agency in the UK has not said how many adverse event reports it has received.
Whether or not the EU’s suspension of Essure’s commercial license will become a permanent Essure ban remains to be seen.
In the United States, the Food and Drug Administration has imposed new restrictions on Essure. Doctors are required to provide patients with a checklist of risks, and the doctor has to sign the paper after the risks have been presented. The FDA has not banned Essure but indicated the agency is concerned that some women have been unaware of the risks prior to accepting the implantation of the permanent birth control system.
In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.
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