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Essure Problems Facebook Administrators Take Issue With FDA Handling of Essure Crisis

How can Bayer not understand that Bayer sales are down because the device destroys women's health?

Monday, January 14, 2019 - Consumer health and safety advocates such as the Facebook group Essure Problems are concerned about the health of millions of women using the Essure birth control device now that Bayer has effectively stopped selling the device. The administrators in the Essure health advocacy group are determined to keep the pressure on Bayer as well as the US Food and Drug Administration (FDA) to ensure that these key players are held accountable and continue to support existing Essure patients. That means that in the transition period starting January 1, Essure doctors continue to require their patients to complete the Essure safety checklist explaining the potential health complications women have experienced from using the device. Potential Essure women are encouraged to join the Essure Problems group on Facebook, read the Essure horror stories, and assess for themselves whether the benefits of Essure are worth the risks. Most Essure doctors are on Bayer's payroll for legal yet highly unethical under-the-table payments for ambiguous activities such as Essure public speaking and teaching Essure educational classes, most of which never even occur.

FDA Commissioner Scott Gottlieb, M.D recently issued a public statement reiterating the agency's support for Essure women as well as confirming their responsibility to hold Bayer Inc., accountable for post-market testing of Essure. According to Essure Problems administrators, however, these studies fall short of what should be required of the company in order to objectively determine Essure's risks for women.

The group's administrators feel that Bayer may be unable to meet their enrollment requirements for the study now that the health concerns of Essure women have been made so public with movies such as the Netflix documentary "The Bleeding Edge." Administrators are also very concerned with the fact that "Bayer is running the show" and is unlikely to produce an objective report. Another point of contention is the reduced study size that the FDA is permitting at Bayer's request and that the FDA is "bending over backward" to facilitate each and every request that Bayer makes. According to Essure Problems administrators, "We simply cannot comprehend why the FDA continues to bend over backward for industry while women continue to be implanted and potentially harmed without holding Bayer accountable. The FDA has the authority to order all (Essure) kits off the shelves while women who have already been implanted are independently evaluated and studied, yet it refuses to do so."

Bayer continues to advocate for the safety of Essure by saying that the benefits of the device outweigh the risks and that taking the device off of the market is due to financial considerations, and not the dangers that the device presents. Bayer spokespersons state that the risks of the device have been over exaggerated by the media. This doublespeak flies in the face of the product's website home page which states the extreme, life-threatening dangers of Essure in no uncertain terms. "Essure - IMPORTANT SAFETY INFORMATION WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during a discussion of the benefits and risks of the device.

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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.