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FDA Approves Bayer’s Essure Postmarket Surveillance Study

FDA approves Bayer’s updated post-market surveillance study plan for the Essure permanent contraceptive.

The U.S. Food and Drug Administration (FDA) has signed off on Bayer’s updated postmarket surveillance study plan for the Essure permanent contraceptive, which has been linked to at least 4 patient deaths, 15 reports of pregnancy loss and 631 pregnancies in women implanted with the device.

Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications from a birth control device, 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?

September 5, 2016Bayer’s study will look at 2 groups of 1,400 women between the ages of 21 and 45 years who have not been pregnant within the previous 6 weeks and who chose either Essure or laparoscopic tubal sterilization (“tubes tied” procedure) as their method of birth control.

The final report on the study will not come until 2023, though in March 2017, a 6-month report will be released and in September 2017 a 1-year report will be released, according to the Regulatory Affairs Professionals Society (RAPS).

The study’s main safety endpoints will include chronic abdominal / pelvic pain, bleeding, allergic reactions and surgical removal of the Essure birth control device. Secondary endpoints include additional data on bloodwork, pathology, histology and metallurgic testing, while the contraceptive’s effectiveness will be determined by its ability to protect against pregnancy.

Although the FDA has not issued a recall for Essure, the agency in February required the device to carry a boxed warning “designed to call attention to serious or life-threatening risks.” From November 2002 through December 2015, FDA said it received nearly 10,000 adverse event reports associated with Essure.

The most frequently reported patient problems included:

  • Pain/abdominal pain (6989 reports)
  • Heavier menses/menstrual irregularities (3210 reports)
  • Headache (2990 reports)
  • Fatigue (2159 reports)
  • Weight fluctuations (2088 reports)

The most frequent device problems were:

  • Patient-device incompatibility / possible nickel allergy (2016 reports)
  • Migration of the device or device component (854 reports)
  • Device operating differently than expected (490 reports)
  • Device breakage (429 reports)
  • Device difficult to remove (280 reports)
  • Malposition of the device (199 reports)
  • Device difficult to insert (187 reports)

Multiple device and patient problems were noted in many of the above reports.

Do I Have an Essure Lawsuit?

The Medical Device 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 accepting new injury and death cases in all 50 states.

Free Confidential Case Evaluation: Again, if you were injured by the Essure contraceptive, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

Free Confidential Case Evaluation

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