A non-surgical and effective procedure for permanent birth control for women? Seem too good to be true? We’re quickly learning that it just might be.
The Birth Control procedure Essure is suffering cruel backlash with its controversial side effects. With the FDA’s approval, doctors often praise this expensive and seemingly simple procedure, but Essure is anything but. If the doctor does not insert the device correctly, it can be a serious detriment to your health. Furthermore, even inserted correctly, Essure has been proven ineffective and as having serious side effects that may even lead to a hysterectomy. For some women, what began as a form of birth control resulted in the complete removal of the uterus; an outcome certainly not advertised by Essure. For a few, the Essure procedure was fatal.
When women want to prevent pregnancy or decide they no longer want children, there are a variety of options. Birth control pills, implants, or shots may be one, but others wish to undergo a more permanent method. Doctors often refuse a woman’s request to get their fallopian tubes tied before a certain age. As an answer to this dilemma, along came Essure, a permanent, non-surgical transcervical sterilization procedure for women.
During the Essure procedure, small coils are placed into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus. The insert contains inner polyethylene terephthalate fibers to prompt benign fibrotic reaction. It is held in place by flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil. Once the Essure tubal implants are in place, they are designed to produce tissue growth in and around the implant to form over a time span of three months. The tissue barrier formed by occlusion or blockage in the fallopian tubes prevents sperm from reaching an egg. Unlike other methods of permanent sterilization, Essure does not require the patient going under general anesthetic or an incision in the abdomen.
Essure has been under fire for its very severe and sometimes even permanent side effects. For some women, it is intense pain immediately following the procedure. Often, the pain does not end there and there have been reports of long term side effects of Essure, including, abdominal pain, pelvic pain, persistent bleeding, pregnancy and increased risk of etopic pregnancy, heavy metal toxicity, allergy or hypersensitivity reactions, mood swings, hair loss, teeth loss, depression, anxiety, weight gain, brain fog, eczema, and headaches. Essure has also been responsible for internal injuries such as device migration, migration of a component of the device, perforation of the fallopian tubes, perforation of the uterine wall, device breaking, blood clots, infection, hemorrhage, and more. Unfortunately, some women have had to undergo a hysterectomy… definitely not what they signed up for when consenting to the Essure procedure. Among the thousands of women who have come forward, there are even reports of women dying during the Essure implant procedure.
According to the FDA, their agency is investigating the growing number of reports of adverse events of harm with Essure. On February 29, 2016, the FDA released a press announcement recommending that sterilization devices, such as the Essure procedure, include a Black Box warning label, that contains warnings that the devices can potentially cause death or serious injury as well as explaining the possible side effects.
Most women, prior to the Essure procedure, depended on their doctors’ recommendation and information published and marketed by its manufacturer, Conceptus, Incorporated (Bayer acquired Conceptus on June 5, 2013) that the system was safe and effective in considering whether to have this permanent birth control system inserted. Now, many women experiencing difficulties after having the Essure procedure are being turned away by their doctors because they are unable to figure out what is causing, often times, severe and life altering symptoms or pain.
Many women who have suffered harm from this device have turned to attorneys to discuss filing an Essure lawsuit against the medical giant Bayer with claims of negligent misrepresentation, negligent failure to warn, negligent training, and negligent risk management.
If you have suffered from the side effects of Essure or from another defective product, let The People’s Lawyer help you. We will evaluate the facts of your case to determine if you have a valid legal claim as a result of undergoing the Essure procedure. Contact Brindisi, Murad, Brindisi & Pearlman for a free consultation today.
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