FDA updates info on postmarketing surveillance study of Essure


Consistent data on Essure

An FDA search of the Manufacturer and User Facility Device Experience (MAUDE) database in January of 2020 revealed 47,856 medical device reports of Essure between November 2002 and December 2019. The most common adverse events observed during this period were:

  • Pain or abdominal pain (32,901 cases).
  • Heavy or irregular menses (14,573 cases). Headache (8,570 cases).
  • Device fragment or foreign body in a patient (8,501 cases).
  • Perforation (7,825 cases).
  • Fatigue (7,083 cases).
  • Gain or loss in weight (5,980 cases).
  • Anxiety and/or depression (5,366 cases).
  • Rash and/or hypersensitivity (5,077 cases)
  • Hair loss (4,999 cases).

Problems with the device itself included reports of:

  • Device incompatibility such as an allergy (7,515 cases).
  • The device migrating (4,535 cases).
  • The device breaking or fracturing (2,297 cases).
  • The device dislodging or dislocating (1,797 cases).
  • Improper operation including implant failure and pregnancy (1,058 cases).

In 2019, Essure received 15,083 medical device reports, an increase from 6,000 reports in 2018 and 11,854 reports in 2017.

Dr. Catherine Cansino, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis

Dr. Catherine Cansino

To date, nearly 39,000 women in the United States have made claims to injuries related to the Essure device. In August, Bayer announced it would pay approximately $1.6 billion U.S. dollars to settle 90% of these cases in exchange for claimants to “dismiss their cases or not file.” Bayer also said in a press release that the settlement is not an admission of wrongdoing or liability on the part of the company.

In an interview, Catherine Cansino, MD, MPH, of the department of obstetrics and gynecology at the University of California, Davis, said the latest adverse event reports show “consistent info from [the] MAUDE database when comparing 2019 to previous years, highlighting most common problems related to pain and heavy or irregular bleeding.”

She emphasized ob.gyns with patients who have an Essure device should “consider Essure-related etiology that may necessitate device removal when evaluating patients with gynecological problems, especially with regard to abdominal/pelvic pain and heavy/irregular bleeding.”

Dr. Cansino reported no relevant financial disclosures. She is a member of the Ob.Gyn. News Editorial Advisory Board.


Next Article: