The permanent birth control device Essure was recalled in 2018, after being used by more than 750,000 individuals since its introduction in 2002. Now, women throughout the country are filing lawsuits against its manufacturer, Bayer for issues they suffered as a result of implanting the device, including hysterectomies.
Manufacturers explained that they recalled Essure due to a 70% sales decrease after the US Food and Drug Administration (FDA) required they add a black box warning to Essure. These warnings indicate that the product may have serious and sometimes life-threatening side effects.
What is the Essure Implant?
Essure is a medical implant that was released as the first permanent female birth control option that did not necessitate surgery. Other options, like tubal ligation or hysterectomy, involve general anesthesia and incisions.
The implant is made of metal coils and plastic and is inserted into the fallopian tubes to stimulate the formation of scar tissue to create a permanent barrier. This is different from the temporary implantation of an intrauterine device (IUD) in the uterus, which is reversible and can be removed and replaced fairly easily.
What led to the Essure lawsuit?
As a new and innovative nonsurgical method in 2002, Essure was rushed through a hasty FDA review process. Injury lawsuits state that more testing and training should have been completed before the device was released to the public. More research was needed to determine Essure’s safety, and better education for doctors who may use it. Most aren’t clear about how to best extract the product without surgery, though the recall requires it to be removed from all patients.
As of 2017, the FDA received about 30,000 issue reports about Essure since it came into the market. Lawsuits filed against manufacturer Bayer state that issues detailed in these reports were due to the lack of research into Essure’s safety before it was made public. There is also evidence that showers manufacturers deliberately neglected to report any known injuries to the FDA.
Hysterectomies due to Essure Implants
A lawsuit was filed by an Arizona woman who received the implant in July 2013. She claimed that Essure caused her to suffer from “migraines, severe abdominal, ovarian and pelvic pain, sharp, stabbing pain, pain during intercourse, heavy bleeding, emotional pain, and mental anguish.” She was ultimately left with no choice but to get a hysterectomy in January 2015.
Many women who had Essure implants were also forced to opt for total hysterectomy. In some women, surgeons were able to see the devices via medical imaging and felt they could safely remove it with tubal ligation. However, many individuals had severe pain and bleeding due to pieces of the product migrating from their initial placement. In these cases, doctors view hysterectomy as one of the safest ways to make sure the device was entirely removed.
How We Can Help
Essure customers who suffered injuries from their implant are filing lawsuits for both their injuries and the manufacturer’s negligence. If you or a loved one have had complications from getting an Essure implant, contact our team at Kwartler Manus, LLC. to find out how you can receive the compensation and justice you deserve.
Victims are filing lawsuits against Bayer for their pain and suffering, including hysterectomies and other negative results from Essure, such as:
Breakage of inserts
Migration of inserts
Severe menstrual pain
Severe abdominal or pelvic pain
Heavy Menstrual bleeding
Perforation of the uterus, fallopian tubes, and/or other organs
Manufacturers recalled Essure in 2018, but they still deny any wrongdoing. Our attorneys at Kwartler Manus LLC are dedicated to assisting those who have been negatively affected by these companies’ errors. Contact us online or by phone at (267) 214-8608 today to schedule a consultation and learn more about your rights and what compensation you may be entitled to.