Health Canada released a statement warning physicians and patients of the dangerous complications associated with Essure, a permanent birth control implant. The device, manufactured by Bayer A.G., has led to thousands of reports of adverse events in the United States alone.
After Canadian women also reported similar side effects, including excessive bleeding, unintended pregnancy, chronic pain, perforation, and device migration, among others, Health Canada had enough evidence to issue a warning. However, for 184 women in Quebec, Ontario, this is not enough.
An Essure class action lawsuit has been filed against Bayer for failing to warn doctors and patients of the risks associated with the device. For Susan Hill, a 38-year-old mother of two, knowing the risks would have deterred her from getting the device.
Hill suffered from chronic abdominal pain and bleeding rashes on her hands, torso, and ankles for over three years before she had the device surgically removed. Now Hill is part of the lawsuit trying to hold Bayer responsible. Hill says she’s speaking out because she wants to help protect other women from the pain and suffering she experienced.
While neither the US Food and Drug Administration (FDA) nor Health Canada have recalled Essure, the FDA has given the device a black box warning label, the strongest warning it issues before recalling a medical device. While the FDA is still looking into the safety of the device, legislators like Representative Mike Fitzpatrick from Pennsylvania are fighting to reform the medical device approval process to help protect women from harmful devices.
A recent study showed that several high-risk devices approved by the FDA for obstetrical and gynecological procedures were significantly less studied than other devices. The study left many wondering if women should be more wary of medical devices than men.