Essure is permanent birth control device that does not require surgery. It was approved by the FDA in 2002 is currently used by over 750,000 women. The procedure is performed by inserting metal coils through the vagina and the cervix and into the fallopian tubes. Approximately three months after the procedure, a tissue is formed around the fallopian tubes that prevents semen from reaching the eggs.
Essure Related Injuries
The metal coils of the device have caused severe pain and injuries to many women who have undergone the procedure. Women have suffered from perforation to their fallopian tubes and other organs, skin rashes from nickel-titanium poisoning, unplanned pregnancies and severe bleeding from the migration of the device. Other dangerous side effects associated with the Essure device include: allergic reactions, hair loss, abdominal pain, excessive bleeding, pelvic pain, miscarriage and ectopic pregnancy.
The FDA Preemption Clause and the Difficulty of Filing a Suit
Essure is approved by the FDA’s preemption law and is protected under the Medical Device Amendment Act. Manufactures protected by FDA preemption are exempt from civil torts claims. Preemption was making it difficult for women to hold the manufacturer liable for physical injuries that the device caused them. Currently women are filing law suits on the claims that Bayer Pharmaceuticals was negligent in their manufacturing and risk management and under claims of breach of express warranty and fraudulent manufacturing.
FDA Mandates Essure Black Box Warning
More than 5,000 lawsuits filed by women across the nation, countless reversal surgeries, and serious health injuries have prompted the FDA to mandate a Black Box Warning on all Essure Devices. FDA Black Box labeling is the strictest labeling put on prescription devices when there is reasoning to believe that they are linked to serious hazards. In addition to the mandate, the FDA demanded that Bayer Pharmaceuticals conduct a surveillance study highlighting the benefits and the risks associated with using the device. The FDA has given Bayer 30 days to draft a study plan and 15 months to begin conducting the study. The consequence of not complying would mean that the device would become misbranded by the FDA and could potentially lead to discontinued sales.
Can I file a Lawsuit?
If you or someone you know has suffered from Essure related complications contact us at the Davis Law Group to learn about your legal options. Our award winning lawyers have over 20 years of experience handling personal injury and wrongful death claims and have worked on several class action suits. After speaking with our case investigators we will schedule you for a free confidential legal consultation. Call us today at (206) 727-4000.