Pennsylvania Congressman Mike Fitzpatrick says he will introduce a bill on November 4, 2015, that would revoke FDA approval for the contraceptive device Essure. It’s called the E-Free Act, and if it passes it will require the U.S. Food and Drug Administration (FDA) to issue an order withdrawing approval of Essure within 60 days of enactment of the act. The bill is to be introduced on the 13th anniversary of Essure’s premarket approval by the FDA.
Pressure to Withdraw Essure
Fitzpatrick is just one among many who are pushing for withdrawal of Essure as a result of thousands of reports of serious harm caused by the contraceptive device, including several deaths. On October 9, 2015, Connecticut Congresswoman Rosa DeLauro sent a letter to the active commissioner of the FDA, stating that Essure should be withdrawn from the market because the benefits do not outweigh the risks.
The FDA says there have been four adult deaths and five fetal deaths caused by Essure. These all involved pregnancies that Essure was supposed to prevent. Side effects of Essure can include:
- Allergic reaction to the nickel in the coil
- Perforation of the fallopian tube or uterus
- Coil that migrate through the tubes
- Ectopic pregnancy
- Vaginal bleeding
- Pelvic pain
- Back pain
Thousands of women who have had Essure implanted complain of many more complications, and they are angry because they were not warned about the risks. Hysterectomy is often required to remove the device, but even that could not reverse all of the problems caused by Essure.
If you have been harmed by Essure, please talk to an experienced defective medical device attorney right away to learn more about your rights.