Severe Complications Related to Essure
No longer accepting claims for this case
When you chose to undergo a permanent birth control procedure, you likely do so with the expectation it will result in a safe and effective means of preventing pregnancy. What you might not know is that procedures involving permanent fallopian tube implants such as Essure® have reportedly caused a host of serious side effects and complications in thousands of women ranging from chronic pelvic pain to death.
Contact an Essure Attorney
If you or a loved one underwent the Essure permanent birth control procedure and experienced one or more of these side effects, please fill out this form or call 1.877.958.8003. Our attorneys have experience representing women alleging harm by defective medical devices, including transvaginal mesh.
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What is Essure?
Essure is a hysteroscopic sterilization procedure, a type of tubal sterilization that does not require an incision. If a woman undergoes the Essure birth control 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 Side Effects
Reports of severe complications following the Essure procedure include:
- Hysterectomy or other surgeries to remove the device and repair internal organs
- Autoimmune response to the device, including fatigue, rashes, hair loss and weight gain
- Chronic pelvic pain
- Life-threatening ectopic pregnancy
- Migration of the device or a device component
- Expulsion of the device
- Perforation or tear of pelvic organs, including uterus or colon
- Severe migraines and allergic reactions to the device or device components
The Essure permanent birth control system was developed by Conceptus, Inc. (now a subsidiary of Bayer) and underwent the FDA’s phase II and Pivotal Study patient testing between November 1998 and June 2001. The system was approved through the FDA’s Premarket Approval (PMA) process in November 2002. In 2013, Conceptus, Inc. was purchased by Bayer AG and became a fully owned subsidiary of the Germany-based chemical and pharmaceutical company.
Complaints about Essure
From the time Essure was approved by the FDA in 2002 to Dec. 31, 2015, the FDA has received 9,900 reports of problems from doctors and implanted women. That data includes 26 deaths, 15 of which were fetal deaths that occurred in women who became pregnant after the Essure procedure. There were also two infant deaths after live birth.
In Feb. 2016, the FDA announced it will require Bayer to conduct a clinical study and potentially add a black box warning to Essure boxes. Black box warnings are the FDA’s highest level and indicate that a product may cause death or serious injury.
Breanne V. Cope (CA) is the attorney responsible for this advertisement. Motley Rice LLP operates in California.
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