Legal challenges to the permanent, non-hormonal birth control device Essure have reached a boiling point with five new Essure lawsuits filed against manufacturer Bayer Healthcare.
These Essure lawsuits allege that the birth control device should have never been approved by the FDA. However, under a loophole in the Medical Device Regulation Act, the Essure birth control device is supposed to be protected from legal allegations by consumers.
However, a federal judge is about to decide whether thousands of women who have allegedly suffered serious, and sometimes irreparable, damage after using Essure, can sue Bayer for compensation.
What is Essure?
Essure is a non-hormonal birth control product manufactured by Bayer. It was approved for use by the FDA in 2002.
In order to prevent conception and pregnancy, two Essure coils composed of polyester and metal are inserted into a patient through their vagina and uterus. The coils are then placed inside each of the fallopian tubes, and over the course of a few months, scar tissue will form around the coils, preventing pregnancy.
While many women have found success in preventing pregnancy with this birth control device, more that 4,800 consumers have filed FDA adverse events reports, claiming Essure side effects, complications, and injuries.
Some serious complications linked with Essure use include bloating, rashes, allergic reactions, excessive bleeding, organ perforation, pelvic pain, miscarriage, and ectopic pregnancy.
Essure Allegations
Bayer is facing allegations that include fraud concerning Essure’s clinical trials, including one lawsuit brought by Kimberly L., who was implanted with Essure 15 years ago during the original Essure clinical trial that led to Essure’s FDA approval. According to Kimberly, “I reported the excessive pain from day three all the way until they dropped me from the study.” She claims to still suffer from pain stemming from these Essure complications.
Mesha H. was also implanted with the Essure device and claims, “My uterus felt like it was on fire, everything, my side, it was on fire. The pain radiated not just from my pelvis, it radiated down my legs, and my hair started falling out.” She states that she would never recommend the birth control device.
The five new Essure lawsuits against Bayer further allege that Conceptus, the original Essure manufacturer, breached warranty with its consumers, meaning the device should no longer receive protected federal status that disallows Essure lawsuits.
Because Essure was given pre-market approval by the FDA, it is shielded from personal injury lawsuits like the kind many Essure victims would like to file. However, should the judge decide to let the Essure lawsuits go forward, this would no longer be the case.
The judge is awaiting Bayer’s legal response to the five Essure cases.
In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.
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Join a Free Essure Class Action Lawsuit Investigation
If you or a loved one were injured by Essure birth control complications, you may have a legal claim. See if you qualify to pursue compensation and join a free Essure class action lawsuit investigation by submitting your information for a free case evaluation.
An attorney will contact you if you qualify to discuss the details of your potential case.
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