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Congress Members Press FDA to Revoke Approval for Essure Birth Control System

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In the next few weeks, 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.

If passed, the bill calls for withdrawing Essure’s approval within 60 days, ABC station WRIC in Richmond, Virginia reports.

The Essure system 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 them and preventing pregnancy. Essure is marketed as an alternative to a surgical procedure to tie the tubes. But, since the device’s approval, the FDA has received more than 5,000 complaints about Essure. The complaints include pain and bleeding, allergic reactions to the nickel in the coils, to organ perforations and even deaths.

In addition to Rep. Fitzpatrick’s proposed legislation, Connecticut Congresswoman Rosa DeLauro has written to the acting FDA commissioner, Dr. Stephen Ostroff, to express deep 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 DeLauro says, “Essure’s benefits do not outweigh the risk and it should be withdrawn from the market.” The letter to the FDA cites four adult deaths “related to the device,” and five fetal deaths in women who became pregnant after implantation Essure. The letter also notes women’s 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 convened its Obstetrics and Gynecology Devices Advisory Panel to discuss the concerns surrounding Essure. 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 the Essure label 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. The women say the coils perforated the uterus or fallopian tubes or migrated elsewhere in the abdomen. In some instances, the coils were expelled from the 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.

breakinglawsuitnews.com disclaimer: This article: Congress Members Press FDA to Revoke Approval for Essure Birth Control System was posted on Tuesday, October 20th, 2015 at 7:53 am at breakinglawsuitnews.com and is filed under Uncategorized.

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