The Essure System was first submitted to the FDA in April of 2002 as a form of permanent birth control by Conceptus, which was subsequently bought by Bayer. The FDA gave the system approval in November of that same year. The Essure system consists of nickel-titanium and stainless steel coils, which are wrapped in polyethylene terephthalate and inserted into the fallopian tubes. The devices cause irritation to the area, developing fibrous scar tissue which creates a blockage, preventing the descent of eggs.
The FDA imposed several requirements on the maker, including an adequate, physician training program and a warning label concerning information about failure and success rates. The FDA also required the manufacturer to gather and evaluate data, from use by physicians and clinical trials. Even though the FDA had required Conceptus to complete its study within five years of approval, a target date of 2007, the results were not published until April 24, 2015. Not only was it eight years too late, it was not done properly. Only 70% of the patients had been followed for the required five-year period.
Adverse Reactions and Injury to Thousands of Women
It was becoming apparent over time, even without the report, that the stainless steel could rust and the nickel could form an oxide causing an immune reaction. The device could also leak toxic byproducts into the system. Thousands of reports of injured women who used Essure were found in a review of the FDA's Manufacturer and User Facility Device Experience (MAUDE).
A search of the MAUDE data base was conducted by the FDA. From Nov. 4, 2002, Essure's approval date, through Dec. 31, 2015, there were 9,900 device reports received, related to Essure. Recent reports received since 2013 showed that the majority were voluntary from recipients of the Essure implants. The most frequently reported problems were:
· Abdominal pain - 6989
· Abnormally heavy bleeding or menstrual irregularities - 3210
· Headache - 2990
· Fatigue - 2159
· Weight Fluctuations 2088
Most of the individual reports listed multiple patient problems.
The most frequent problems reported were:
· Patient-device incompatibility such as possible nickel allergy - 2016
· Migration of the device or part of the device - 854
· Device operating differently than expected - 490
· Breakage of the device - 429
· Device removal difficulty - 280
· Malposition of the device - 199
· Insertion difficulty - 187
Multiple difficulties could be present in each report
Through December 31, 2015 there were 26 deaths correctly coded by the submitter. Of those, six related to four adult deaths, 18 reports related to 15 losses of pregnancy and two related to infantile death following live birth.
The FDA has received reports of 631 pregnancies in patients with Essure implants. A live birth resulted from 150 of these; 250 did not indicate birth or loss of pregnancy; and 294 resulted in pregnancy loss. There were 96 reported ectopic pregnancies and 43 elective terminations.
Options for Removal of Essure
Essure can be successfully removed if a woman has an adverse symptom or, in some elective cases, if she wishes to continue to have children. Each surgeon has their preferred method ranging from a simple outpatient procedure to extensive surgery, including hysterectomy in many cases. Sometimes multiple surgeries are required if the device has broken up and migrated. The surgeon's opinion will be guided by the condition and positioning of the device in the woman's body. If removal is being considered it is wise for a woman to consult with several different physicians and to consider their qualifications.
Filing an Essure Lawsuit
Lawsuits against Bayer related to Essure are not class action suits but are being handled individually for now. They have been consolidated into test cases in several states. If you have had your Essure device removed due to adverse reactions or injury, or need to do so, you may be entitled to compensation. Contact a Vititoe Law Group for a free evaluation of your claim. Vititoe Law Group specializes in defective medical devices liability. Do not hesitate as statutes of limitation apply. You will pay nothing unless you win.