It seems the FDA has given up doing much about Essure other than adding a misleading black box warning (misleading because it implies perforation, migration, and allergic reactions are uncommon) and signing off on a weak post-marketing surveillance study. The Essure lawsuits continue to pile up and will continue to do so for the foreseeable future until Essure is recalled or withdrawn from the market. So, without further ado, below are the top 23 articles and online resources I’ve collected on Essure in my time since getting involved in the litigation. If you’re considering an Essure, get to know the facts first.
At the FDA:
- Essure Permanent Birth Control
- Essure Benefits and Risks
- FDA Activities regarding Essure (see also FDA Signs Off on Bayer Study of Essure Following Numerous Adverse Events, Deaths)
- Regulatory History of Essure
- FDA takes additional action to better understand safety of Essure, inform patients of potential risks
- Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement — Label Changes
- Essure Problems, Women Behind FDA Birth Control
- Computer model reveals Essure’s pregnancy risk
- Bayer’s one-sided, incomplete news release on Essure study
- Woman questions her medical records from Essure birth control clinical trial (see also Clinical Trial Patient Criticizes Study That Led to FDA Approval of Essure)
- Essure birth control: Thousands of women reporting severe medical reactions to Essure (see also Hundreds of Errors Found in FDA Data on Essure Problems)
- Study: High-risk women’s health devices approved on faulty data
- Essure Sterilization Device Causes ‘Serious Safety Concern’: Study
- Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study
- Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study.
- Radiological assessment of placement of the hysteroscopically inserted Essure permanent birth control device.
- Hysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study.
- Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems.
- Revisiting Essure — Toward Safe and Effective Sterilization