DeLauro Pushes FDA Commissioner to Meet with Women Affected by Essure
WASHINGTON, DC (December 1, 2017) — Congresswomen Rosa DeLauro (CT-03) released the following statement after Food and Drug Administration (FDA) Commissioner Scott Gottlieb agreed to a meeting on the safety of Essure—a medical device that is supposed to be a permanent form of contraception—on the condition that women who have been affected by Essure not be present.
“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. Doctors and patients have filed more than 20,000 adverse event reports with the FDA, with many of these reports detailing their need for invasive surgery to remove the device due to severe problems such as pregnancy, auto-immune disease, and organ and tissue perforation.”
“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.”
The FDA has allowed Essure to stay on the market in the United States despite an ongoing post-market study to investigate prevalent negative health outcomes for women. A study released in 2015 comparing Essure to tubal ligation, the same procedures being evaluated in the current post-market study, found that women with Essure were 10 times more likely to have repeat operations due to medical complications than women who had comparable sterilization procedures.
In September, Bayer announced they will be removing Essure from all foreign markets across Europe, South America, as well as Canada.