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# CDRH Approves Bayer Essure Study Plan
- URL: https://www.fdaweb.com/cdrh-approves-bayer-essure-study-plan/
- Published: 2016-09-06T12:00:00.000Z
- Updated: 2026-09-14T21:29:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136699

CDRH says it has approved an updated postmarket study plan submitted by Bayer to assess safety and efficacy issues involving its controversial birth control device Essure. The study was ordered by the agency [earlier this year](http://www.fdaweb.com/login.php?sa=v&aid=D5134904&searchWords=essure%20postmarket&cate=S&stid=%241%24d%2F1.if2.%24.Wj5xsc.J1rsUd55N.409.) to determine heightened risks for particular women. FDA believes that “results collected from the approved study plan will help the agency better understand complications associated with the Essure device, as well as the underlying reasons inhibiting the completion of the three steps of the Essure System method (device insertion/placement, use of alternative contraception for three months, and a confirmation for proper location/occlusion),” an [updated notice](http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm?ref=fdaweb.com) says.

The study is designed to provide important information about the risks of the device in a real-world environment, the agency says. It should also compare the risks to laparoscopic tubal ligation. The study findings will need to include the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. It will also evaluate how much these complications affect a patient’s quality of life. “Additionally, it will collect information to identify reasons for why some patients don’t have a confirmation test to ensure that Essure has been properly placed three months after insertion,” FDA says. “The FDA will use the results of this study to determine what, if any, further actions related to Essure are needed to protect public health.”  
  
According to the agency, the study will involve 2,800 women — 1,400 subjects who choose to undergo either hysteroscopic sterilization (Essure) and 1,400 subjects who choose laparoscopic tubal sterilization. It will include follow-up visits for 36 months The main effectiveness endpoint is preventing pregnancy. The main safety endpoints are:

• Chronic lower abdominal and/or pelvic pain  
• Abnormal uterine bleeding (new onset or worsening)  
• Hypersensitivity and allergic reactions, and autoimmune disorders (new onset) or autoimmune-like reactions  
• Invasive gynecologic surgery including Essure removal  
• In the event of a device removal or event of interest, additional data collection may include bloodwork, pathology, histology, and metallurgic testing, as appropriate