The Essure Permanent Birth Control System is a permanent, nonsurgical birth control option for women. Since the Food and Drug Administration (FDA) approved Essure in 2002, the agency has received thousands of complaints about the device ranging from organ perforation, pelvic pain, unintended pregnancies, abnormal bleeding, and even death in extreme cases.
Manufactured by German pharmaceutical company Bayer Corporation, the device consists of flexible coils that are inserted through the vagina and cervix into the fallopian tubes. The device purposefully irritates the fallopian tube tissue, building up scar fiber tissue around the coil and creating a barrier intended to block sperm from reaching the egg as it travels down the fallopian tubes into the uterus. This article discusses the health problems associated with the device, Essure birth control lawsuits, and theories of liability that are being reported by affected patients.
Essure Health Problems
Thousands of affected women have reported mild to severe medical complications related to Essure. Some of the reported side effects include:
As of May 2016, the FDA has not issued a recall of Essure. The device is still on the market and available to women seeking permanent birth control. However, the FDA did convene a meeting with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee in 2015 to consider scientific and clinical opinions as well as patients’ experiences.
As a result, the FDA ordered additional clinical testing for Essure and will soon require a black box warning on the device as well as a patient decision checklist doctors must go over with anyone considering Essure to help make sure that potential users of the device understand the benefits and risks involved.
Essure Birth Control Lawsuits and Preemption
Several women have filed state product liability lawsuits against Bayer. Until recently, a federal law shielded Bayer from state product liability lawsuits over Essure because the device went through a special federal regulatory approval process designed for “high-risk” medical devices known as "Pre-Market Approval" (PMA). The FDA found Essure to be safe and effective through the PMA process.
Keep in mind, if a state and federal law are in conflict, federal law will always trump state law as the Supreme Court has consistently ruled that state law is "preempted" by the federal law. In short, the Essure state court lawsuits had been barred, and Bayer was effectively shielded from liability up until now.
Essure Lawsuits Allowed to Proceed
Despite the FDA’s preemption provision, a U.S. District Court in Philadelphia allowed a handful of Essure birth control lawsuits to proceed in court in March 2016, most notably by plaintiff Heather Walsh who claims her coils migrated to her uterus, requiring hospitalization and a hysterectomy. The lawsuits further claim that Bayer circumvented Essure's PMA process through negligence and deception. Among other things, the suit alleges that Bayer inadequately trained doctors recommending the procedure, failed to report known hazards to the FDA, and used misleading advertising.
Theories of Liability
Although there have been several theories of liability alleged against Bayer for device migration and punctured organs, as of now only two have made it successfully past the preemption challenge. These theories include negligent misrepresentation and negligent failure to warn of the risks in the Walsh case.
Get Legal Help with Your Essure Birth Control Lawsuit
If you or someone you know has developed serious medical complications as a result of an Essure birth control device, contact an experienced drugs and medical devices attorney near you today. An experienced attorney can discuss the strengths and weaknesses of your case and advise you about whether you may be entitled to compensation for your medical bills, emotional distress, and suffering.
Contact a qualified product liability attorney to make sure your rights are protected.