By Emily Cox
Atlanta, GA — A woman has filed a product liability lawsuit against Bayer after one of its controversial Essure birth control coils went missing inside her body.
Pamela Graves filed the complaint in the Northern District of Georgia earlier this month. She is claiming that Bayer sold a defective and unreasonably dangerous device and that the company failed to warn about the risks associated with the Essure birth control coils.
According to her lawsuit, Graves had the Essure birth control coils implanted in May 2009. Following implantation, she gained approximately 80 pounds and suffered constant intense pelvic pain. She also experienced heavy bleeding with large clots, painful intercourse, and headaches. Graves alleges she could feel the coils poke her when she would lay down on her stomach.
In April 2016, Graves underwent a hysterectomy to remove the Essure birth control device. However, doctors were only able to remove one of the coils. They could not locate the other coil, as it had migrated outside of the fallopian tube into Graves’ body. It remains inside of Graves to this day.
Essure Birth Control Complications
Essure birth control coils are implanted in the fallopian tubes. They cause scar tissue to form and prevent pregnancy. Bayer continues to market this device as a safe and effective form of birth control. However, tens of thousands of women have reported serious Essure complications to Bayer and the FDA. These complications include severe pain, unintended pregnancy, and allergic reactions, as well as coil migration and perforation. Furthermore, most doctors cannot remove only the coils, and insurance does not cover the procedure. Consequently, the only treatment option for most women is hysterectomy.
After receiving 10,000 Essure adverse event reports between November 2002 and December 2015, the FDA mandated Essure warning label changes in November 2016. Some of the most severe complications included four adult deaths, 15 lost pregnancies, and two infant deaths, as well as, 631 reports of unwanted pregnancies. In 96 of these cases, the
pregnancies were ectopic, which can be life-threatening.
These label changes included a “black box” warning, as well as a patient checklist that must be given to women considering Essure birth control to ensure future patients are aware of the severity of the risks associated with the device.
Graves joins several thousand other women who have filed similar lawsuits against Bayer, alleging that their birth control device caused serious harm and that Bayer misrepresented Essure’s safety and efficacy.