Essure Birth Control Injury Lawsuits
Essure is a very popular, permanent birth control device that does not require invasive surgery in the way that tubal ligation – also known as ‘getting your tubes tied’ – typically does. It was approved by the FDA in 2002 is currently used by over 750,000 women.
The procedure typically involves a doctor inserting a device equipped with special metal coils through the vagina and the cervix and into the Fallopian tubes. Approximately three months after the procedure, scar tissue begins to form around the Fallopian tubes and helps to prevent semen from passing through and reaching the eggs. This helps prevent pregnancy from ever occurring, though it is clear that there are potentially serious side effects that women should be aware of.
Injuries & Complications from Essure Birth Control
The metal coils of the device have been found to be one of the primary causes for the severe pain and injuries that many women are experiencing from Essure. Women have reported a range of side effects including perforation to their fallopian tubes and organs, skin rashes from nickel-titanium poisoning, unplanned pregnancies, and even severe bleeding resulting from 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.
If you or a loved one has suffered injury after undergoing the Essure birth control procedure, it is in your best interests to have a complete understanding of your legal rights. Consumers who are injured by a defective medical device may be entitled to financial compensation for their injuries and other damages under the law. Consulting with an attorney may give you a better idea of whether you may have a valid personal injury case.
FDA Preemption Clause: A Challenge to Filing a Lawsuit
Essure is approved by the FDA’s preemption law and is protected under the Medical Devise Amendment Act. Manufactures protected by the FDA preemption are exempt from civil torts claims. Preemption was making it difficult for women to hold the manufacturer liable for damages that the device caused them.
Currently, thousands of women are filing lawsuits 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. It is believed that there are many other women who have not yet come forward about the injuries they have suffered from Essure.
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 devises 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 devise would become misbranded by the FDA and could potentially lead to discontinued sales.
Who Can File an Essure Lawsuit?
There is no obligation to hire a lawyer if you contact us, and there are no up-front fees in order to hire an attorney. We work on a contingency basis, which means all attorney fees are deducted at the conclusion of your case, after we have successfully recovered compensation on your behalf.