Essure Birth Control Device
June 21, 2016
The FDA has received numerous reports of injury and complications related to the Essure® permanent birth control device. Side effects include:
- Ectopic Pregnancy
- Pelvic Pain
- Migration of the Coils
- Perforation of the Uterus or Fallopian Tubes
- Rash and Itching (nickel allergy)
If you or someone you know was implanted with an Essure® device and has any of these injuries, you may be entitled to bring a lawsuit.
What is Essure?
Essure is a permanently implanted birth control device. The FDA conditionally approved Essure in 2002. Essure was originally marketed by Conceptus. Bayer bought Conceptus in 2003. Essure is the only FDA-approved sterilization device for women who want permanent birth control without undergoing surgery. The Essure System includes the Essure micro-insert, a disposable delivery system and a disposable split inducer. The micro-insert is the device that is implanted in the body. It consists of two metal coils coated with polyurethane fibers, which are inserted into the fallopian tubes. Over a period of time, tissue forms around the coil inserts to create a barrier that keeps sperm from reaching the eggs and prevents conception.
What Injuries does Essure Cause?
Since approving Essure, the FDA has received over 5,000 reports of adverse side effects. The most serious included: ectopic pregnancy, migration of the device through the fallopian tubes to the lower abdomen and pelvis, breakage of the coils, perforation of the uterus or fallopian tubes, expulsion of the device, and nickel allergy or hypersensitivity. Some women had to undergo hysterectomy and hospitalization due to damage caused by Essure.
Mounting concerns raised by women and consumer groups prompted the FDA to hold an Advisory Committee meeting on September 24, 2015. The FDA panel heard from scientific experts about the risks and benefits of Essure. The FDA also heard from dozens of women who shared their negative experiences with the device.
On February 29, 2016, the FDA announced it would require Bayer to strengthen Essure’s safety instructions with a new “black box warning” about the side effects, as well as a Patient Decision Checklist to help ensure that women receives and understands information regarding the risks and benefits of the device compared to alternative forms of birth control. In addition, the FDA ordered Bayer to conduct a safety study to obtain better information about the risks of Essure.
What did Bayer do wrong?
Victims claim that Bayer did not adequately monitor its device for side effects or tell the FDA that the number of injuries from Essure was much higher than stated in the label. Doctors and patients rely on the FDA-approved product label when deciding whether the Essure device is the best option for birth control. Had women and their doctors been told the truth about Essure’s risks, they would have opted for safer alternative birth control and avoided serious injury.
Our Legal Team
For over 50 years, we have successfully represented people seriously injured by dangerous and defective medical products. We pursue each of our clients’ claims with skill and compassion. Our attorneys have several decades of collective expertise in product liability cases. If you, or someone you know, suffered serious complications from the Essure® permanent birth control device, please contact us about a free consultation.