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Essure Permanent Birth Control System Discontinued by Bayer

July 27th, 2018

According to a recent article, Bayer has discontinued its controversial Essure product—an implanted system for permanent birth control. After December 31, 2018; the device will no longer be available in the U.S.

Approved by the FDA in 2002, Essure is a permanently implanted contraceptive that forms a barrier to prevent sperm from reaching the patient’s egg. In recent years, the agency has received reports by some women of adverse side effects following Essure implantation. These included:

  • Perforation of uterus/fallopian tubes
  • Migration to abdominal/pelvic cavity
  • Persistent/severe abdominal pain
  • Allergic/hypersensitivity reactions

In 2016, the FDA required that Bayer add a Boxed Warning and patient decision checklist to product packaging. In April 2018, the Agency restricted sale and distribution of Essure after learning some women were not adequately informed of associated risks. In a press release, Bayer indicates the decision to discontinue Essure followed declining U.S. sales—and was not based on changes to the product’s risk-benefit profile.

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