FDA Announces Essure Ban
The FDA released an announcement that after December 31, 2018, the manufacturer can no longer sell or distribute Essure. This decision follows the agency’s April safety action of restricting sales and distribution. Previously, the United States was the only country that still allowed women to get the device. Every other country recalled Essure.
Essure is a soft, flexible metal spring made from a nickel-titanium alloy. Doctors offer it to women as an alternative to the invasiveness of tubal ligation. Essure typically involves general anesthesia and a laparoscopy in the doctor’s office unlike a tubal ligation, which occurs in a hospital and requires surgery. A doctor inserts one Essure coil into each fallopian tube. Scar tissue will form around the coil to obstruct sperm from fertilizing an egg in the fallopian tubes. Three months after the procedure, women must have a follow-up procedure involving an X-ray and dye to confirm that the tubes are fully blocked.
Bayer, the manufacturer of Essure, claims it is nearly 100 percent effective at preventing pregnancy and is perfecting safe; however, thousands of women disagree.
On July 20, 2018, the FDA announced that after December 21, 2018, Essure will no longer be able to be sold or distributed. Data suggests that 750,000 women have the device worldwide. However, researchers continually linked the permanent form of birth control with serious side effects. These included persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. After the FDA restricted sales of the device in April, there was a 70% decline of Essure use in the U.S. Bayer points to this financial downturn as the reason to pull the device from American shelves. However, since September 2015, the FDA has been investigating the potential risks of the device. In fact, they required new labeling in February 2016. Also, Bayer must continue their postmarket study to better evaluate the safety profile of the device in a real-world setting.
Also in the announcement, the FDA wanted to ensure women already with the device that the agency will continue to monitor safety regulations. In fact, Bayer must continue to enroll new participants in their post-market study. Researchers will follow new participants for no less than three years, and Bayer will continue to submit reports to the FDA on the study’s progress and results.
We Want to Help Essure Victims
Bayer should have told you about the long-term risks of Essure. If you or a loved one experienced an unwanted pregnancy, hysterectomy, allergic reaction, abdominal or pelvis perforation after using Essure, contact us immediately. We want to help send a message that Bayer’s actions of not warning women that this device was dangerous are not acceptable. We are advocates for injured consumers. Likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal. As well as for your physical and emotional suffering. There is no obligation.