A patient advocacy group for women affected by the Essure contraceptive has asked congress to investigate the U.S. Food & Drug Administration’s alleged lack of oversight on the device.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications or trauma after being implanted with the Essure contraceptive, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
April 28, 2016 – Essure Problems recently sent a letter to U.S. House Committee on Oversight and Government Reform leader Jason Chaffetz (R-UT) requesting an investigation into the FDA’s regulation of Bayer’s Essure permanent birth control implant. The letter cited multiple reasons why Congress should probe the agency’s oversight on the contraceptive, stating that clinical trials for Essure “were inadequate and inappropriate from the beginning.”
The device’s premarket approval (PMA) was based on a pair of studies which included a total of 926 test subjects, according to Essure Problems. And only 197 (25%) of those women were followed 2 years after the trial was complete.
Additionally, the agency failed to acknowledge complaints of adverse health complications associated with Essure. “As long ago as 2010, the FDA was aware of thousands of complaints regarding Essure made to Conceptus, but which were never reported to the FDA,” the group said, as well as approximately 10,000 side effect reports filed with the agency, a number that is “well recognized under-reported,” according to Essure Problems.
In February, FDA added a “black box” warning (PDF) to the labeling of Essure, and required Bayer to conduct a large observational study enrolling at least 2,000 women over a period of 3 years, comparing Essure recipients and patients who underwent tubal ligation to identify the risks associated with both procedures.
The fact that FDA is allowing Essure to remain on the market while Bayer performs the research is “irrational and illogical,” the group said, as well as putting “a whole new group of unsuspecting women on a path to being harmed by the device with absolutely no legal recourse.”
Essure Problems’ letter comes amid a sweeping pushback over the device’s safety. Rep. Mike Fitzpatrick (R-PA), a vocal critic of Essure, recently sent a letter to the FDA questioning its reporting of complications associated with the contraceptive. Last year, Fitzpatrick proposed a bill that would outlaw Essure in the U.S.
Meanwhile, Canadian health officials are scrutinizing the device after getting thousands of complaints from women who received the implant, according to the Toronto Star. Health Canada ordered a safety review last year, and a final report from the agency is expected next month.
Do I Have an Essure Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Essure lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you suffered problems from Essure, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.