Members of Congress Publish Letter Expressing Concern Over FDA's Inaction on Essure
Three members of Congress recently sent a letter (PDF) to Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb, M.D. expressing deep concerns over the FDA’s inaction on Essure.
The FDA allowed this dangerous product to remain on the market on the condition that its manufacturer, Bayer, conduct a post-market safety study a year and a half ago. However, it remains unclear whether or not Bayer has acted with the necessary urgency to enroll patients, and whether or not the results of the study will be released on time.
“Doctors and patients have filed over 18,000 adverse events reports related to Essure to the FDA describing numerous negative side effects,” wrote Rosa L. DeLauro, Jan Schakowsky, and Louise M. Slaughter. “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.”
Our Houston Essure attorneys at Fleming, Nolen & Jez are committed to providing injured victims with the dedicated and knowledgeable representation they need. If you suffered serious complications known to be tied to this permanent birth control system, call our firm at (866) 977-6671 to discuss your situation with an attorney today, or receive a free consultation by filling out our online form.