The permanent contraception device Essure will no longer be sold in the U.S. beginning in 2019. While Bayer will not admit this, it appears to be due to the FDA’s decision to require a black box warning and a post-marketing study on the permanent contraception device. The FDA feels women are not properly informed of Essure side effects.
Essure and the FDA
Essure was approved by the FDA in 2002, and at the time was manufactured and marketed by Conceptus, Inc., which was acquired by Bayer in 2013. This permanent birth control contains two nickel-titanium coils that are inserted into the fallopian tubes to create scar tissue which blocks the eggs from being fertilized.
Essure has a long regulatory history of label changes due to post-market studies and complaints from patients. In 2016, the FDA required Bayer to include a black box warning naming these adverse events, including the risks of perforation, abdominal pain, and allergic reactions that patients could experience with the implant.
Bayer has decided to stop marketing Essure as of December 31, 2018. The pharmaceutical company claims this is because of the decline in sales rather than the FDA threatening the company with civil and criminal penalties if they failed to warn patients about the adverse Essure side effects.
Claims in the Essure Lawsuit
Thousands of women have reported Essure side effects. There are over 16,000 lawsuits filed against Bayer. The FDA estimates that 750,000 patients have been implanted with Essure since its approval in 2002. Bayer has marketed Essure to be a permanent birth control device and claims the procedure is minimally invasive. Unfortunately, many women are experiencing severe pain, allergic reactions, uterus and/or fallopian tube perforation, fetal deaths, and other serious side effects. In April 2018, the FDA issued an order to restrict the sale and distribution of Essure because women did not have the proper risk information to decide whether to have the device implanted.
The lawsuits include claims for negligence, strict liability, and failure to warn. They also allege that many serious side effects had been reported to Bayer but they failed to report them to the FDA in violation of state and federal laws.
Essure Side Effects
The known side effects include:
- Perforation of the uterus
- Perforation of the fallopian tubes
- Allergic reaction to nickel
- Device migration
- Hysterectomy to remove the coils
- Severe or chronic pain
- Fetal death
Thousands of women have joined the Essure lawsuit after experiencing these side effects. There have been hundreds of women filing suits on behalf of the fetal death of their child. Other women are suing because of the pain and suffering and medical bills they have endured. These are serious injuries that can cause further damage to patients.
GoldenbergLaw Can Help
It isn’t right that Bayer marketed Essure as a safe product but did not warn about the dangerous risks. If you or a loved one was implanted with Essure and experienced any of the side effects, contact GoldenbergLaw. Our experienced attorneys are leaders in defective drug and device litigation. We want to help you get the compensation you deserve. Contact us. Leave the sleepless nights to us.