Women seeking a permanent form of birth control have used the Essure sterilization implant, believing it to be safe and effective. However, there have been many lawsuits filed against Bayer, the manufacturer of the device. According to the Mayo Clinic, not only will 1 out of 100 women become pregnant after using the Essure device, they may also suffer severe abdominal pain, internal bleeding, and perforation. If you’re considering this permanent birth control method, it’s important to understand how Essure works, the Food and Drug Administration’s (FDA) safety concerns, and how to get help if you’ve been injured by the implant.
The Essure birth control device, once considered a breakthrough alternative to surgical sterilization, is made of two metal coils—each one implanted into a fallopian tube. When the device works as intended, the coils cause inflammation, and a woman’s body builds up scar tissue around the small, spring-like device, preventing fertilization. Implanting the device does not require surgery, and it only takes about 10 minutes for a doctor to complete the implantation.
The FDA’s Approval and Warnings
In 2002, the FDA approved Essure, manufactured at that time by Conceptus, Inc. When Bayer purchased that company in 2013, the company continued to sell the device as Essure. However, after receiving complaints of the following adverse side effects, the FDA met with experts in 2015 to discuss safety concerns:
- Perforation of the fallopian tubes or uterus
- Device migration and organ damage
- Internal bleeding
- Ectopic pregnancy
This year, the FDA ordered Bayer to investigate through a clinical study the complaints and safety concerns against Essure. Additionally, the FDA has ordered a “black box” warning label for the device, meaning the device is still appropriate for use in some women, but the label will include adequate warnings of the potential for harm.
Your Story Matters
Although a federal judge recently dismissed the complaints of permanent injury from the device, lawsuits still allege that Bayer failed to warn patients of Essure’s side effects and complications. If you or someone you love had the Essure implant and experienced medical problems, call the team at the Holton Law Firm. We want to listen to your story and help investigate the root of your injuries. Fill out our online contact form to get started.