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The Medical Devices Guardians Acts Will Force Doctors to Report Essure Patient Complaints

It is time for Essure doctors to stop lying to patients and report patient complaints immediately and thoroughly to the FDA

Friday, July 26, 2019 - Essure women have been and continue to be infuriated at their doctor's lack of candor and objectivity when they return complaining that Essure is causing extreme pain. Virtually every Essure woman that complains to her gynecologist about pain and discomfort are told that they are crazy and that the pain is in their heads by Essure doctors that appear to be reading from a script. Essure doctor's unwillingness to admit Essure failures has caused investigators to look into the financial relationship between Essure doctors and Bayer, maker of the Essure birth control device. What they found is that a number of doctors have received hundreds of thousands of dollars in unethical, under-the-table payments accounted for as educational training and speaking fees although when pressed, no doctor could actually produce evidence that any speaking engagement or educational class was ever conducted. Such payment could be more accurately categorized as commission payments for selling Essure and also to as an incentive to make sure that they did not admit Essure was the cause of a patients medical problems. If the MDGA passes, that will all change in a big way. Essure lawsuit attorneys represent families and women harmed from Essure side effects and offer a free consultation.

The Medical Device Guardians Act - H.R.2163, will treat Essure doctors as covered device users, and force them to report significant adverse patient experiences including Essure patient complaints directly to the US Food and Drug Administration immediately as they occur. The Act amends the Federal Food, Drug, and Cosmetic Act. According to NBC News.com, "The FDA (has admitted) that over 15 years - Nov. 4, 2002, when Essure was approved, through December 2017 - it received 26,773 reports of problems, including pain, heavier periods and irregular bleeding, headaches, and fatigue. Patients also reported that the device had become dislodged or had broken" MedTruth.com summarizes the act as "Hospitals, nursing homes, and surgery centers are already required to report unsafe devices, or "adverse events," and the legislation would add doctors and doctor's offices to the list of mandated reporters."

One might estimate that hundreds of thousands of Essure women's complaints have been met with doctors being unwilling to admit Essure could be the cause of a patient's pain and suffering. With millions of women having had Essure implanted over the course of the last decade, more and more are sure to fail, and thousands will seek medical treatment for the complications they are suffering. Essure doctors will now have to at least report the incidents to the FDA. Essure is a small and flexible, spring-like coil that is wrapped in polythylene fibers (PET) that are designed to cause irritation on the inner walls of the Fallopian tubes leading to scar tissue development to encapsulate the device and hold it in place thereby blocking fertilization. Women have described Essure as being about as comfortable as having two rusty nails in their bodies.

Essure women reading this are urged to join the 42,000 member-strong Facebook group and to write about their experiences with Essure. They can also read other's Essure horror stories and get referrals and recommendations on doctors in their area that have a good reputation for successfully removing Essure.

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OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. OnderLaw has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.