DeLauro, Slaughter, and Schakowsky Request Additional Information from FDA Regarding Essure Remaining on the Market
WASHINGTON, DC (October 30, 2017) — Today, Congresswomen Rosa DeLauro (CT-03), Louise Slaughter (NY-25), and Jan Schakowsky (IL-09), sent a letter to Food and Drug Administration (FDA) Commissioner Scott Gottlieb requesting additional information regarding his decision to allow Essure—a dangerous medical device—to stay on the market despite an ongoing post-market study to investigate prevalent negative health outcomes for women.
“Despite widespread safety concerns, the FDA has allowed Essure to remain on the market even while mandating that the manufacturer, Bayer, conduct an additional post-market safety study,” wrote the Members. “However, a year and a half after the study was initiated, it is unclear whether Bayer has acted with urgency to enroll patients, or if the study results will be delayed. The FDA cannot continue to allow Bayer to drag its feet on this post-market study while women are continuing to suffer.”
“Doctors and patients have filed over 18,000 adverse events reports related to Essure to the FDA describing numerous negative side effects,” continued the Members. “In over half of the incident reports, women were required to have invasive surgery to remove the Essure sterilization coils because of severe problems such as pregnancy, auto-immune disease, and device migration leading to organ and tissue perforation. Many women had to undergo full hysterectomies based on the damage done by Essure. However, many of these adverse effects occurred beyond the original 3-year post-market study required by the FDA.”
The full letter is available here.