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The E-Sisterhood ASHES Seeks to Improve the FDA's Medical Device Approval Process

In addition, the group is focused on helping the tens of thousands of women currently suffering from Essure birth control malpractice and negligence

Friday, February 8, 2019 - Women that have been injured by medical device malpractice have banded together to form organizations on social media. The online group "ASHES" stands for Advocating Safety in Health Care E-Sisters, and is led by Angie Firmalino who is also the focus of the Essure segment of the Netflix documentary film "The Bleeding Edge." The goal of the non-profit organization is to educate women of the reported adverse side effects of the medical device that they are being pushed to use by their doctor. Most recently, the E-Sisters played an important role in organizing women who were suffering from the Essure birth control device which in turn alerted the US Food and Drug Administration to implement stricter regulations on Essure. These stricter regulations are credited with contributing to forcing Bayer to pull Essure from the market worldwide.

Rather than settle for Essure's removal, the group has redirected their efforts toward lobbying for stricter regulations for all medical devices. The goal of the group is to "restore a patient's right to litigation if harmed by a Class III medical device" according to the group's webpage. In order to have one's right to sue restored, The Medical Device's Safety Act must first pass in order to implement the necessary reforms on the FDA's inadequate medical device approval process. Over 90% of the medical devices brought to market today are not required to go through the rigors of human testing and pre-market approval by a scientific panel. All that is necessary to fast track a medical device through the FDA's review is that the product is shown to be similar to one already on the market without regard as to whether or not that product has failed, been recalled, or has been the subject of litigation. If you wish to review and perhaps support the Medical Devices Safety act follow the link below.

The E-Sisterhood is closely linked to the Essure Problems Facebook group where for the last seven years women injured by Essure have shared their nightmarish experiences. Incredible as it may sound, as one reviews the horror stories that women report, one cannot help but notice that many have been told that their pain and suffering was not caused by Essure and that they must be crazy. The uniform denial of Essure symptoms by Essure-trained gynecologists around throughout the US cannot be dismissed as simply coincidental and surely is part of a larger effort by Bayer to coverup Essure's devastating side effects. Along those lines, the most frequent Essure problem reported seems to be device migration when the Essure coil breaks free from the Fallopian tube and travels to a woman's uterus. When this happens the uterus naturally but painfully contracts. Rather than expel the device, these contractions sink the device deeper into the flesh, causing more contractions in a vicious cycle of pain and bleeding.

If you or a loved one are experiencing abnormal bleeding, extreme sharp stabbing pain, and all of the symptoms that go with the body trying to expel a foreign object such as infection, fever, headaches, body aches, lethergy, and nausea, you should visit Essure Problems Facebook group to get a referral to an Essure removal specialist in your area that you can trust.

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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.