Test subjects will also continue to receive the Essure contraceptive “in advance of its full discontinuation from the U.S. market” and to submit “more frequent” reports on the study’s progress, according to FDA Chief Dr. Scott Gottlieb.
“We believe that this new, revised study plan will help provide more long-term information regarding complications that may be experienced by patients who have Essure, despite reduced enrollment,” Gottlieb wrote in the posting.
Free Confidential Lawsuit Evaluation: Our lawyers are currently wishing to speak with anyone who had problems after receiving Bayer’s Essure birth control IUD. If you had serious side effects after receiving the contraceptive, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Bayer in July announced its decision to pull Essure off the U.S. market, citing decreased sales and the date of Dec. 31, 2018, to have completely halted sales and distribution of the IUD.
In addition to the post-market study, FDA will “continue its efforts to monitor Essure’s safety and effectiveness since its approval in 2002 by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency.”
Do I Have an Essure Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Essure lawsuits. We are handling individual litigation nationwide and currently accepting new Essure side effects cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one suffered adverse health complications following Essure implantation, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.