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The Essure Birth Control Device May Have Unwanted Side Effects

Essure birth control devices can cause a number of serious health complication leaving women permanently unable to have children

Wednesday, November 1, 2017 - When a woman decides that she may no longer want to have more children common methods of birth control are tubal ligation and hysterectomy. During a tubal ligation, a woman's fallopian tubes are clamped, severed, sealed or tied preventing eggs from reaching the uterus. Another name for a tubal ligation is having one's "tubes tied." A hysterectomy is the surgical removal of the uterus, cervix, ovaries, fallopian tubes. A hysterectomy subjects patients to all of the risks to are associated with surgery such as infections, incision healing and pain, and anesthesia. A hysterectomy is permanent and irreversible.

A quicker, easier and seemingly less dangerous option for permanent birth control is the Essure birth control device. While a hysterectomy leaves women unable to have children in the future, the Essure device is supposedly removable when the time is right to start or add to a family. The Essure device consists of two soft flexible inserts which are non-surgically inserted and pass through a woman's vagina and cervix permanently into the fallopian tubes. Over the months following the procedure, scar tissue forms and blocks the sperm from traveling further. The device resembles the spring from a typical ball-point pen.

Problems have developed however and women around the country are writing in to report abnormal monthly bleeding, fatigue, hair loss, tooth decay and many other health problems from the systemic infections caused by Essure. Other women reported allergic and autoimmune complications to Nickel, the metallic compound used in the device. To make matters worse, many of these same women who chose to have the device removed were unable to do so because the scar tissue had grown to encase the device. When that happens, the only option left is to have a hysterectomy, the same dangerous surgical procedure that Essure was intended to replace. Still other women have reported that the device had migrated to other organs in the body causing infections.

Over 20,000 adverse event reports pertaining to Essure have been made to the Food and Drug Administration (FDA). There are currently almost 10,000 instances of emergency hysterectomies having to be performed to remove the Essure device due to complications, contradicting all marketing material representations of the device as simple, safe, effective and minimally evasive. Unwanted pregnancies, miscarriages, stillbirths and over 300 fetal deaths have also been linked to the Essure device.

As a result of complaints to the FDA and also the formation of a 35,000-member Essure Problems Facebook group, the agency ordered a change in the label of a device to reflect adverse side effects. In March of 2016, the FDA mandated a new and serious "black box warning" be placed on packages containing the Essure birth control device. Black box warnings issued by the FDA are reserved for only products and devices that carry serious, life-threatening risks. Many women represented in the Essure Problems Facebook group are outraged that the required warning labels do not go far enough and want the birth control device removed from the market.

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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.