Thousands of women have filed adverse event reports with the FDA, documenting the widespread occurrence of serious and unanticipated Essure problems. As a result high Essure complications rates, numerous countries have issued bans or warnings on the device, ultimately resulting in Bayer withdrawing Essure from all global markets except the United States. Women who suffered from Essure problems were not warned of the risk, and may be entitled to compensation through filing an Essure problems lawsuit against Bayer.
Essure is a medical device which is permanently implanted in women for the purpose of sterilization or permanent birth control. The device consists of flexible metal coils which are made of nickel titanium alloy and synthetic fibers made of PET (polyethylene terephthalate). Essure is placed in the fallopian tubes through a simple procedure utilizing local anesthesia. Over the course of approximately three months, tissue forms around the inserts and serves to block sperm from reaching the ovaries. The device is meant to be implanted permanently and is a minimally-invasive option favored by women seeking permanent birth control without hormonal treatment.
Experts believe that had the device been subject to more stringent pre-market safety testing, Essure problems could have been detected in advance. Well over 750,000 women have been implanted with Essure, the majority of whom live in the United States.
Essure has been available in the U.S. since it was approved by the FDA in 2002. Originally developed by Conceptus, Essure was acquired by Bayer in 2013 at which time a new Essure warning was added to the product's label to caution consumers of the risks of serious Essure problems including device migration, perforation, and persistent pain.
Essure complications include persistent and chronic pain, perforation of the uterus and fallopian tubes, irregular internal and uterine bleeding, and allergic and hypersensitivity reactions. Some patients have been forced to undergo one or more surgical procedure to repair damage caused by Essure problems or remove parts of the device. Women also report becoming pregnant long after the device should have been effectively preventing conception.
Once available to women in many countries, Essure is now only sold in the United States. Citing changes in consumer preferences, Bayer announced a withdrawal of Essure from all markets except the U.S. in 2017. Falling short of an Essure recall, this move indicates the Essure warnings issued in many countries have had an effect on the economic viability of the product. Essure has been banned in Brazil and Essure problems warnings were issued in the EU and Canada.
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