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Lenze Lawyers, PLC

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Essure

hysteroscopic sterilization procedure

Essure procedures can result in severe complications including chronic pelvic pain, organ perforation, and even death.

Other side effects of the hysteroscopic sterilization procedure include additional surgeries, ectopic pregnancy, migration and explusion of the device, severe migraines, rashes, hair loss, and weight gain.

A form of permanent birth control, Essure is a hysteroscopic sterilization procedure developed by Conceptus, Inc. and manufactured and sold by Bayer. Approved by the FDA in 2002, Essure is a type of tubal sterilization that does not require an incision. When a woman undergoes the Essure procedure, a soft metal spring-like device wound with synthetic fibers is implanted in her fallopian tubes. The metal part of the device consists of a stainless steel inner coil and an expanding nickel titanium outer coil. The fibers are used to encourage the surrounding tissue to adhere to the device, ultimately creating a barrier of scar tissue intended to block sperm from reaching the eggs.

Essure procedures have caused a host of significant side effects and complications ranging from chronic pelvic pain, organ perforation, and even death. In fact, since the time of the approval of Essure, the FDA has received over 5,000 reports from doctors and women that the device has caused serious side effects. As a result, on February 29, 2016, the FDA required Essure Bayer to conduct additional clinical trials and add a “black box” warning to its Essure permanent birth control product.

The following severe complications have been reported following the Essure procedure:

– Additional surgery, including hysterectomy to remove the device and repair internal organs;

– Chronic pelvic pain;

– Death;

– Ectopic pregnancy;

– Migration of the device;

– Expulsion of the device;

– Perforation or tear of pelvic organs, including the uterus or colon;

– Severe migraines and allergic reactions to the device or device components;

– Autoimmune response to the device, including fatigue, rashes, hair loss, weight gain, and severe menstrual bleeding.

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Lenze Moss is actively pursuing Essure cases. If you or someone you know has experienced complications resulting from an Essure procedure, please contact us.