Mesh Medical Device News Desk, November 15, 2016 ~ The U.S. Food and Drug Administration has approved a label change on Essure Birth Control that includes the strongest warning a device can carry.
Known as a Black Box warning, the label change will now clearly warn about the significant side effects associated with Essure, including under what circumstances it will need to be removed.
The label change includes a Patient Decision Checklist intended to support patient counseling and understanding of the benefits and risks associated with Essure.
See the FDA decision here.
Essure, made by Bayer Healthcare, is made up of small metal nickel-titanium alloy coils, and is placed in the fallopian tubes. The theory is that scar tissue forms around the implants keeping the sperm from reaching the eggs and preventing contraception.
Approved in 2002, Essure received Premarket Approval by the FDA before it was marketed. It’s estimated more than 750,000 Essure procedures have been performed worldwide since FDA approval in November 2002 through early 2013.
Thousands of women have complained to the FDA, reporting adverse events or complications associated with the use of Essure. Complications include perforation of the uterus, chronic and persistent pain, and perforation of the fallopian tubes, device migration, abnormal bleeding and allergic reaction.
The FDA convened an expert panel last September to hear scientific opinions and patient experiences to assess the risks versus benefit of Essure.
The agency received more than 2,800 comments on a public docket, which were taken into consideration before agreeing to issue the black box warning. Submissions to the FDA included a trade complaint that the product is adulterated or misbranded and should not be introduced into interstate commerce, part of a Citizen Petition.
The petition, filed by a Fort Lauderdale law firm, asserts that the premarket approval process for Essure “was replete with Fraud on the FDA including the altering of medical records of trial participants.” The complaint says participants answers affirming pain, adverse events, and unusual health related events were crossed out and changed by researchers, a violation of federal law.
The Essure Problems Facebook page has been very proactive. Together they petitioned Congress and supported a bill filed by Rep. Michael Fitzpatrick (R-PA). The E-Free Act would force the FDA to pull Essure from the market alleging its benefits do not outweigh the risks. See a MND story here.