Essure Picture from (c) RobinOlimb as first appearing in Teen Vogue – APR 8, 2016 @ 7:35PM EDT.
The Essure permanent birth control issues continue to mount, as more women come forward to tell their story.
When a woman sought permanent birth control but couldn’t afford to miss work for the full tube-tying procedure, there’s what sounded like a safe, easier option: Essure, a permanent birth control method that doesn’t require surgery to implant. The method involves a doctor inserting flexible coils through the vagina and cervix, and into the fallopian tubes where the body’s tissue envelops it and forms a barrier that prevents sperm from reaching your eggs.
“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.
But Bayer, the maker of Essure, is now facing multiple lawsuits after a number of women have reported intense pain, bleeding, and long-term health issues after having the device implanted. A judge recently dismissed a number of the counts in the suits, reported DrugWatch, but has allowed others to go forward, including claims of negligent risk management and fraudulent manufacturing.
Bayer, on the other hand, says it stands by the FDA’s previous statements that “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control,” and that the “design, manufacturing method, warnings and instructions for use for Essure were approved by FDA under the agency’s pre-market approval (PMA) authority, which subjected Essure to the highest level of scrutiny that exists in the federal regulatory system,” Mass Device reported.
Essure has been on the market since 2002, but reports of problems associated with the device only caught the attention of the FDA in the last few years thanks to the Facebook group “Essure Problems,” reported Wired. Women have reported stillbirths, ectopic pregnancies, and miscarriages after having the device implanted. One researcher even said there were 10,558 reports of adverse events related to Essure, Broadly reported
In February, the FDA announced it would put a black box warning — a way for the agency to tell you the drug could cause serious or life-threatening reactions — on Essure, and ordered Bayer to conduct further safety studies. The public has until May 3 to weigh in on the FDA’s decision to put the warning on Essure, Refinery29 reported.
As the FDA continues their investigation based on new information, Unglesby + Williams is taking the fight against pharmaceutical giant Bayer to the courtroom. These women deserve to have their story heard, specifically through their day in court.
But some women are saying that’s not enough. Jessica Smith, who had Essure implanted in 2013 but then experienced years of pain and bleeding, had to visit multiple doctors before figuring out that the device was the cause of her health problems, Broadly reported. She had to undergo multiple surgeries to try to remove the device (which the FDA says is not intended to be removed), and ultimately had to have her uterus, cervix, and fallopian tubes removed. Now, Jessica is calling for a third-party investigation into the device, rather than one by the company that manufactures it.
If you or someone you know has been injured or experiencing side effects, 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.
