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After Essure birth control coils went missing inside her body, a Georgia woman has filed a product liability lawsuit against Bayer, alleging that the manufacturer failed to warn about the risk of severe complications associated with their product.
The complaint (PDF) was filed by Pamela Graves in the U.S. District Court for the Northern District of Georgia on March 2, claiming that Bayer sold a defective and unreasonably dangerous device.
Essure is marketed as a safe and effective form of permanent birth control, involving coils implanted in the fallopian tubes, which cause scar tissue to form and prevent pregnancy. However, thousands of women have reported suffering painful and debilitating Essure complications, where the coils migrated out of position, caused severe allergic reactions or other problems.
Graves indicates that she had Essure coils implanted in May 2009. However, she quickly gained about 80 pounds, and developed constant pelvic pain, heavy bleeding, pain during intercourse, headaches and other problems. She also reported being able to feel the device if she lay on her stomach.
In April 2016, she underwent a hysterectomy to have the Essure coils removed, after she learned about problems with the device that matched her symptoms. However, doctors discovered that one of the coils had migrated out of position and they were unable to locate it. There is a large chance that the errant coil is migrating through her body, where it could do further damage to internal organs, according to the complaint.
The case joins several thousand other Essure lawsuits pending nationwide, each raising similar allegations that Bayer knew about issues with their product for years, yet withheld information from consumers, doctors and federal regulators.
In November 2016, the FDA announced new Essure warning label changes in the United States, which included a “black box” warning, as well as a patient checklist that must be given to women considering the permanent birth control, to ensure they understand the potential risk of complications.
Approximately 750,000 women worldwide have been implanted with the device, and Bayer estimates that 70% of those have been implanted in women in the U.S.
As Essure injury lawyers continue to review and file claims for women nationwide, it is expected that thousands of additional cases may be filed in the coming months and years for women who still have the birth control coils in their body.