A bill intended to help women suffering from complications due to the permanent birth control device, Essure, has made it to the house floor. The bill known as Ariel Grace’s Law was filed with the intention to hold medical device manufacturers responsible for any complications, injuries or deaths associated with their product. Ariel Grace’s Law is named after the stillborn child of a woman whose Essure device did not function properly.
This bill is historic in that it will allow patients to pursue their rights in court and to hold manufacturers of defective devices liable and accountable. Civil litigation is needed to compensate patients who have been injured by defective devices and to keep manufacturers in check to ensure that the products they put into commerce are safe. This law will not serve to stifle innovation of new products, but simply to ensure products are both effective and safe.
The FDA reports that an estimated 10,000 complaints have been filed on behalf of Essure patients. The statement “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report” was released on the FDA’s website, but the complaints kept coming in. The FDA held hearings regarding the adverse effects of the implanted Essure, where doctors and patients alike testified about their negative experiences. Based on concerns over serious complications, the FDA mandated that a special “black box” warning must be added to packaging for the Essure implantable birth control device. Also, the FDA ordered Bayer to conduct a post-market study to gather more data about Essure’s benefits and risks.
A second bill was filed called the Medical Device Guardians Act, which aims to give physicians a more direct route to report issues about medical device complications to the FDA. This bill was composed after women suffering from complications due to Essure came together to help doctors relay important information regarding medical device complications.
A third bill was introduced, the E-Free Act, with the hopes of pulling Essure off the market. However, the manufacturer of Essure, Bayer, still claims the birth control option is safe for most women and the benefits outweigh the risks.
Unglesby + Williams at the Forefront of Essure Litigation
“Bayer not only deceived these women, but also their physicians,” explains our very own Lance Unglesby of Unglesby + Williams. “Doctors and patients weren’t armed with the same data that Bayer had. I know a lot of gynecologists who have stopped using Essure as a result of the FDA’s suggested boxed warning.”
The lawsuits Unglesby + Williams are bringing concern Bayer’s decision to knowingly deceive doctors and patients about the alleged-safety of its products. “We have developed a strong failure-to-warn claim against Bayer, and our team is looking forward to advocating on behalf of thousands of women,” added Unglesby.
While fighting Bayer in the courts on behalf of over 1000 women, we have continued to uncover more and more alarming data about Essure, Essure Problems, and how Essure Problems are being reported by Bayer to the FDA. If you or someone you know has been injured or experiencing side effects from the ESSURE Birth Control Implant, contact Unglesby + Williams TODAY or call 844-ESSURE-LAW.
Unglesby + Williams is at the forefront of Essure Litigation, and we will fight for you to get the compensation you deserve.