fda meeting over Essure Study

The recent controversy surrounding Essure heats up as a new study published in the June 2016 issue of Obstetrics and Gynecology found “significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices.” The study analyzed data used by The Food and Drug Administration (FDA) to approve high-risk obstetrics and gynecology devices, including permanent sterilization devices such as Essure. The serious injuries suffered by women across the country has been the subject of thousands of Essure lawsuits as more and more women come forward with complaints.

What is the FDA Doing to Remedy the Issue?

New Essure StudyAfter receiving over 9,900 reports of complications associated with Essure, the FDA recently ordered a post-market surveillance study to be conducted by Bayer, the manufacturer of Essure. This required study is in addition to the box label warning explaining the risks and complications associated with the device. Essure will remain on the market during the study.

The study will assess 2,800 women between the ages of 21 and 45 who have chosen to undergo Essure sterilization or laparoscopic tubal sterilization and have not been pregnant within the six weeks prior. The group will be closely monitored for the side effects which have been repeatedly reported to the FDA including:

  • Chronic abdominal and/or pelvic pain
  • Abnormal bleeding
  • Allergic reactions
  • Onset of autoimmune disorders or autoimmune like reactions
  • The need for invasive gynecologic surgery to remove the Essure device

What Did This Essure Study Find?

fda-testingThe findings indicated that in many instances clinical trials prior to approval were insufficient to establish clinical benefits and address safety concerns. Several devices were subsequently taken off the market due to the concerns of potential injuries to patients. The study further suggested the need for “specialty group involvement” in order to develop safe and effective devices for women prior to FDA approval.

Bayer will release multiple reports on the findings of this new “specialty group” study. A six month report is scheduled to be released in March 2017, and a one year study will be available in September 2017. The final report will not be released until the year 2023.

Contact an Experienced Essure Lawyer

Defective Medical Device lawyer meeting victim of EssureOur law firm is working with experienced Essure lawyers, who are investigating these cases. If you have suffered a serious injury after using Essure, you may be entitled to compensation for your medical bills, lost income and pain and suffering, among other losses. There is no fee unless you receive an award or settlement. Call our toll free number at 1-800-992-6878 or fill out a contact form online for a free (no obligation) case evaluation.