Rep. Mike Fitzpatrick Announces a New Bill “E-Free Act”
E-Free Act to remove a permanent contraceptive device “Essure”
The new bill (E-Free Act) directs the US Food and Drug Administration (FDA)’s Commissioner of Food and Drugs to issue an order withdrawing approval for “Essure” system, Bayer’s permanent birth control (contraceptive) device.
WITHDRAWAL OF PREMARKET APPROVAL FOR ESSURE SYSTEM
Not later than 60 days after the date of enactment of this Act, the Commissioner of Food and Drugs shall issue an order under section 515(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)) withdrawing approval for Essure System.
FDA’s Review of Reported Problems
Some women have reported to the FDA that they have experienced pain or other health problems after Essure placement. Problems have also been reported in clinical studies, and they are addressed in the Essure product information (labeling for physicians and patients).
Other reports describe symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain. The FDA relies on a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices.
The FDA conducted a thorough review of the available information about Essure and the experiences of patients who have had Essure since the FDA approved it in 2002. This includes experiences of patients who have had positive outcomes with Essure as well as those who have experienced problems.
The FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database. From Nov. 4, 2002, Essure’s approval date, through May 31, 2015, the FDA received 5093 medical device reports related to Essure. The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants.
The most frequently reported patient problems during this period were pain/abdominal pain (3353), heavier menses/menstrual irregularities (1408), headache (1383), fatigue (966), and weight fluctuations (936). Most of the reports received listed multiple patient problems in each report. The most frequent device problems reported were patient device incompatibility (941) (for example, possible nickel allergy), migration of the device or device component (482), device operating differently than expected (301), device breakage (259), and malposition of the device (133). Multiple device problems can also be listed in each report.
- For this review, visit the FDA here >>
About the Essure Procedure
Last Updated: 201511-05
Comments are closed.