title: Medicolegal Review: Essure Lawsuits and Legal Strategies Adverse to Gynecologists.
abstract: The minimally invasive Essure procedure for hysteroscopic sterilization is an ongoing target for litigation. Although efficacious, this device has been scrutinized by the US Food and Drug Administration (FDA) owing to alleged complications. Patients affected by these potential complications are filing lawsuits against Bayer, the manufacturer of Essure. Many of these lawsuits have been barred by preemption, a legal doctrine that limits what can be required of a product by state lawsuits once the FDA approves it; however, in the lawsuits that have been allowed to proceed, the manufacturer has used a legal strategy termed the "learned intermediary doctrine" in an effort to shift blame to the gynecologist to absolve itself of liability. The learned intermediary only requires that a manufacturer inform the gynecologist of the risks associated with the device, and the gynecologist, in turn, must notify the patients through adequate informed consent. To incorporate the necessary components of informed consent, a gynecologist should include what a reasonable practitioner would consider pertinent to the discussion, as well as what a prudent patient would want to know to make a treatment decision. This disclosure entails explaining the risks, benefits, and alternatives, which should be clearly documented in the medical records. Understanding the importance of proper documentation and the legal strategies used in suits will help gynecologists lessen liability exposure when using a medical device, such as Essure, that is being targeted for litigation.
authors.affiliation: Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, Texas.
authors.forename: Amber M
authors.initials: AM
authors.lastname: Klimczak
authors.affiliation: Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, Texas.
authors.forename: Russell R
authors.initials: RR
authors.lastname: Snyder
authors.affiliation: Department of Obstetrics and Gynecology, Johns Hopkins Medicine, Baltimore, Maryland.
authors.forename: Mostafa A
authors.initials: MA
authors.lastname: Borahay
authors.affiliation: Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, Texas. Electronic address: jyphelps@utmb.edu.
authors.forename: John Y
authors.initials: JY
authors.lastname: Phelps
mesh_terms: D005260:Female; D006176:Gynecology / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent; D007434:Intrauterine Devices / Q000009:adverse effects / Q000592:standards; D007603:Jurisprudence; D016365:Liability, Legal; D008499:Medical Records; D013245:Sterilization, Reproductive / Q000009:adverse effects* / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
keywords: Essure; Informed consent; Lawsuit; Sterilization