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Bayer's Essure Defense Press Release

Bayer insists that Essure is less risky than other forms of birth control

Thursday, September 27, 2018 - Bayer has expressed genuine concern that the Essure birth control device is getting a bad reputation and that the negative publicity could lead to more harm to women. Bayer, the maker of the Essure birth control device, continues to defend the product's safety profile in spite of tens of thousands of women who have documented Essure's adverse side effects. Over three-quarters of one million women are using Essure currently.

Bayer is concerned that women are being frightened into having the device removed prematurely citing the FDA's statement that adverse Essure event reports can be "incomplete, inaccurate, untimely, unverified or biased." Bayer cites studies showing that 97% of Essure women are satisfied to somewhat satisfied with Essure 5 years after receiving the implant. In "40 published studies involving more than 200,000 women Essure's positive safety profile has remained consistent since it first came to market and, to this day, the U.S. Food and Drug Administration has maintained that Essure's benefits outweigh any potential risks." Premature removal of Essure can have unwanted health consequences. Hysterectomy is generally not required to remove Essure and women should be skeptical of doctors who recommend the procedure. Nowhere in the Bayer press release is it mentioned what happens to Essure in years 6-20 and beyond. Essure is a relatively new form of birth control and the long-term risks remain essentially ignored. The wire does include a black box warning at the bottom of the release stating the following: "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."

The Essure birth control device is a small metal spring that is inserted into the Fallopian tubes, one in each, through the vagina. The spring is intended to cause inflammation and scar tissue to hold the device in place blocking fertilization. Thousands of women have had complications with Essure and suffered irregular periods, heavy bleeding, hair loss, and tooth loss, pelvic and abdominal pain, reduced libido, pain during intercourse. Bayer warns that potential Essure women should refrain from using Essure if "they have, or think they may have, a history of metal allergies, or an allergy to polyester fibers, nickel, titanium, platinum, silver-tin, or stainless steel or any other components of the Essure system." Gynecologists, many of whom are on Essure's payroll, are continuing to recommend Essure to their patients until the withdrawal becomes effective on December 31. Essure birth control attorneys suggest speaking with a qualified experienced lawyers handling Essure birth control cases.

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Onder Law 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. The Onder Law Firm 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.