With the recent release of the FDA’s revised checklist and label update for the Essure contraceptive device, many women are revamping their efforts to get the device removed from the market. Thousands of women harmed by the device believe it is unreasonably dangerous and that the FDA isn’t taking sufficient action to keep patients safe.
One such woman is Maura Howley-Mitchell. When Mrs. Howley-Mitchell and her husband decided they were done having kids, Mrs. Howley-Mitchell visited her gynecologist’s office and decided the non-hormonal, non-surgical Essure device was the best choice. Initially excited to receive the device, just two days later, Mrs. Howley-Mitchell couldn’t believe what she was feeling. She recalls, “I woke up in blinding pain. I’ve never felt anything like this. I’ve given birth without meds, and I’ve had back surgery, and I have never felt this intensity of pain in my life before.”
For some women harmed by Essure, the side effects were not immediate. This was the case for Joy Taylor who had the device implanted for approximately one year before suffering debilitating side effects. Ms. Taylor recalls suffering, “Rashes all over my body, bleeding about 25 days of the month, severe stabbing pains, hot flashes, and dizzy spells that would make me pass out.”
Despite these instances of crippling side effects, some doctors still recommend the placement of Essure for contraceptive. Essure’s manufacturer, Bayer A.G., and some doctors believe the instances of side effects are extremely rare, but the vast number of complaints paints a different picture.
The FDA received an alarming number of reports of adverse events related to the Essure device. The agency received more than 5,000 reports of side effects, but this pales in comparison to the number of complaints Bayer received directly. Bayer received more than 40,000 Essure complaints.
Women harmed by the device found support in several legislators, who have introduced Bills that would not only take Essure off the market, but also help hold Bayer responsible for producing a dangerous and defective device. In addition to legislative efforts, lawsuits have been filed around the country against Bayer, alleging the company failed to warn women of the risks associated with this medical device.