Pennsylvania Congressman Mike Fitzpatrick plans to introduce legislation to revoke the approval the Food and Drug Administration (FDA) granted to the Essure birth control system in 2002.
The bill calls for withdrawing Essure’s approval within 60 days, ABC station WRIC in Richmond, Virginia reports.
The Essure system is considered permanent birth control. Essure consists of small, flexible metal coils that are inserted through the vagina into the fallopian tubes in a procedure in a doctor’s office. Scar tissue forms around the coils, blocking the tubes and preventing pregnancy. Essure is marketed as an alternative to a surgical procedure to tie the tubes. But since its approval in 2002, Essure has racked up more than 5,000 complaints with the FDA. The complaints include severe pain and bleeding, allergic reactions to the nickel in the coils, organ perforations and even deaths.
Connecticut Congresswoman Rosa DeLauro has written to Dr. Stephen Ostroff, acting FDA commissioner, to raise concerns “about the severe adverse health effects of Essure,” according to 8News. DeLauro says, “Essure’s benefits do not outweigh the risk and it should be withdrawn from the market.” Her letter to the FDA notes four adult deaths “related to the device,” and five fetal deaths in women who became pregnant after Essure placement. The letter mentions reports of debilitating pain, allergic reactions, device migration, and other “serious adverse effects caused by the device.” Some women have become pregnant even after implantation of Essure.
Bayer HealthCare Pharmaceuticals, which acquired Conceptus, the maker of Essure, in 2013, maintains Essure is safe: “The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-surgical procedure, is supported by more than a decade of science, as well as real world clinical experience, with the product studied with more than 10,000 women since Essure was first developed.”
Late last month, the FDA’s Obstetrics and Gynecology Devices Advisory Panel met to consider the concerns surrounding Essure. The FDA had collected written information prior to the meeting and on September 24, the panel heard presentations from doctors and scientists, and reports from women who say they had been harmed by the device. The panel was asked to consider possible changes to Essure labeling and whether further clinical studies should be conducted, Reuters reports.
A Facebook group, “Essure Problems,” has drawn posts from 17,000 women who describing injuries and complications they attribute to Essure. The women report chronic pain, heavy bleeding, fatigue and allergic reactions, according to Reuters. Some women say the coils perforated the uterus or fallopian tubes or migrated elsewhere in the abdomen. In some instances, the Essure coils were expelled from the woman’s body. Some women experienced ectopic pregnancies, where the embryo implants outside the uterus, in a fallopian tube or on an ovary. Ectopic pregnancy can be life threatening, WebMD explains, and requires emergency treatment.