FDA Dodges Meeting With Essure Women
Next week a much anticipated but difficult to procure meeting is scheduled between Scott Gottlieb, Commissioner of the FDA and Congresswomen Rosa DeLauro, Louise Slaughter and Jan Schakowsky to discuss the safety of Essure, a controversial sterilization device. Despite previously agreeing that two women adversely effected by the device and who are Administrators of the Essure Problems Facebook Group would be allowed to attend, Gottlieb recently reneged and agreed to meet with the Congresswomen only on the condition that women who have been affected by the device not be present. Angie Firmalino, founder of Essure Problems and Amanda Rusmisell, Congressional Liaison for the group were advised today by Representative DeLauro's office that the FDA had rescinded the offer.
The Congresswomen and the two women are extremely disappointed, believing it vital that women with the most knowledge regarding problems associated with the device be present and contribute at the meeting. According to Congresswomen DeLauro, "While I look forward to meeting with Commissioner Gottlieb regarding the safety of Essure, I am disappointed that he will not commit to hearing from women whose lives have been directly affected by Essure."
There have been more than 20,000 adverse event reports concerning the device filed with the FDA. A large portion of these reports detail the need for invasive surgery to remove the Essure due to significant and severe problems, including organ and tissue perforation, migration, auto-immune diseases and unplanned pregnancies. Congresswomen DeLauro emphasized that, "These women's voices and experiences are essential to this conversation. I urge Commissioner Gottlieb to reconsider and hope that he will meet with me and with those whose lives have been turned upside down by this device."
Despite vigorous protests, the FDA has allowed Essure to stay on the market in the U.S. during a five year post-market study which the FDA required Bayer to undertake, but which is in the very initial stages. Essure has been taken off the market everywhere in the world, with the exception of the United States. A previous study released in 2015 by the British Medical Journal, comparing Essure to tubal ligation similar to the current study being ordered by the FDA, found that women implanted with Essure were 10 times more likely to have a repeat operation due to medical complications than women who underwent tubal ligations.
The FDA claims it would be a conflict of interests to meet with the Congresswomen and members of the public effected by the device, stating there was, "a long-standing FDA policy that constituents cannot meet with Representatives at the same time" although it remains unclear exactly why this would be. The FDA certainly failed to assert a conflict of interests during the approval process for Essure when the vice-president of product development at Conceptus (the original manufacturer of the device) Cindy Domecus, also served concurrently on the FDA panel which ultimately approved the device. Seems a little like the pot calling the kettle black.