Permanent birth control implant Essure has caused thousands of women serious complications that were not warned about by the device manufacturer, Essure patients allege.

As a result, nearly 5,000 women have filed adverse event reports with the FDA. While many might wish to take legal action against Essure maker, Bayer Healthcare, Essure is protected from product liability claims due to the premarket approval it was given by the FDA.

Five Essure lawsuits have already been filed, which seek to challenge this protection. If they are successful in proving their claims against Bayer, then these and other Essure lawsuits may be filed and help plaintiffs win compensation for Essure complications.

About Essure

The birth control implant was originally created by Conceptus and given premarket approval in 2002. When a product is given this kind of approval from the FDA, it means that approval was granted based on one large clinical trial.

Essure is a permanent form of birth control. It consists of two coils, which when inserted into the fallopian tubes, work as birth control implants. As time passes, tissue grows around the coils and prevents conception from taking place.

Essure coils are often permanent. While the device, if effective and safe for a user, can remain in a woman’s body for the rest of her life, some patients who have suffered from Essure complications have been unable to have the implants removed.

Essure complications have caused about 4,800 women to file complaints with the FDA. This is most likely only a small percentage of Essure complication cases as not all adverse events are reported to the FDA. Side effects from the birth control implant may include:

• Bloating
• Rashes
• Allergic reactions
• Excessive bleeding
• Organ perforation
• Pelvic pain
• Miscarriage
• Ectopic pregnancy

Essure Lawsuits

Five Essure lawsuits have been filed against Bayer claiming that the device should not be protected by the premarket approval status granted by the FDA.

Currently, Bayer and one of the Essure plaintiffs are in the process of filing motions and responding to said motions. Bayer has until June 30 to decide if they want to respond to fraud allegations and the claim that Essure lawsuits should be able to be filed. If Bayer decides to respond, then the judge will be responsible for issuing a ruling following that response.

Bayer could potentially face thousands of Essure lawsuits claiming that they failed to warn against the serious side effects associated with the birth control implant. Plaintiffs could potentially win compensation for the serious injuries caused by Essure birth control, including the cost to remove the device if necessary.

A statement from Bayer claims that the trials and studies performed support Essure birth control safety.