A massive lawsuit has been filed against Bayer Corp. by ninety women who claim the company’s permanent sterilization device caused them severe Essure contraception side effects.
The Essure device is the only nonsurgical permanent female sterilization device available on the market today.
For many women who desired it, having a way to permanently prevent pregnancy without having to undergo surgery appeared to be the perfect health choice.
What the plaintiffs in this lawsuit and many other women didn’t plan for is that the Essure contraception side effects could be life altering, and in some cases, even fatal.
The Essure device consists of two small metal coils that are planted into the fallopian tubes. For insertion, the procedure accesses the tubes through the vagina during an in office procedure with a physician.
As tissue forms around the coils, the fallopian tubes become blocked and fertilization of the egg is prevented, thereby preventing pregnancy.
The plaintiffs filed the Essure contraception side effects lawsuit following an announcement made by the FDA on February 29, 2016, when the agency informed the public of its plan to educate the public about the risks of using Essure.
The FDA required a black box warning on the Essure label to warn doctors and patients of “reported adverse events, including perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reactions.”
All plaintiffs in the lawsuit who were implanted with Essure stated that they suffered from severe and permanent injuries as a result of Essure contraception side effects.
The Essure contraception side effects lawsuit states that Essure secured Conditional Premarket Approval (“CPMA”) by the Food and Drug Administration and that Bayer failed to comply with the CPMA order as well as other federal regulations.
The lawsuit further states that Bayer’s failure to comply with federal regulations and the CPMA order were not mere allegations but were demonstrated in findings by the FDA, including Notices of Violations and Form 483’s.
The Essure contraception side effects lawsuit goes on to state that Bayer was cited for 17 different violations according to the FDA and the Department of Health.
Some of these violations included failing to report and actively concealing eight perforations that resulted from the use of Essure, manufacturing Essure at an unlicensed facility, failing to report complaints of products migration and failing to disclose 16,047 complaints to the FDA as Medical Device Reports.
“Had Plaintiffs known that Defendants were concealing adverse reactions, not using conforming material approved by the FDA, not using sterile cages, operating out of an unlicensed facility, and manufacturing medical devices without a license to do the same, they never would have had Essure implanted,” the Essure contraception side effects lawsuit states.
The plaintiffs have brought forth to allegations against Bayer including negligent misrepresentation and negligence-failure to warn.
They are seeking compensatory, punitive, incidental and consequential damages including pain and suffering, delay damages, as well attorneys’ fees and costs of the lawsuit.
The Essure Contraception Side Effects Lawsuit is Case No. 2:16-cv-03767 in the U.S District Court for the Eastern District of Pennsylvania.