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Lawmakers Push FDA to Ban Essure Sterilization Device

Lawmakers Push FDA to Ban Essure Sterilization Device

October 22, 2015 — A growing number of lawmakers are working to get Bayer’s sterilization device Essure off the market by revoking approval.

U.S. Representative Mike Fitzpatrick (R-Pa.) will introduce legislation (PDF), called the “E-Free Act,” to revoke approval for Essure.

He is not alone — Congresswoman Rosa DeLauro (D-Ct.) sent a letter (PDF) to the FDA demanding that Essure be withdrawn from the market. She said she was “deeply disturbed” by adverse event reports and said “Essure’s benefits do not outweigh its risks.”

Essure is a non-surgical outpatient sterilization device. It is marketed as an alternative to minimally-invasive “tube tying” procedures. Studies comparing the procedures show that Essure is less effective and 10X more likely to require follow-up surgery.

Essure was invented by Conceptus and received “pre-market approval” in 2002, which protected the company from lawsuits based on adherence to strict research protocols. Bayer HealthCare bought Conceptus in 2013 and is now accused of concealing falsified medical records and adverse events that Conceptus hid from the FDA before Essure was approved. Bayer vigorously denies these claims.

According to the FDA, long-term risks of Essure include:

  • Unintended pregnancy, including ectopic pregnancy
  • Chronic pelvic pain
  • Migration of Essure through the fallopian tubes into the abdomen and pelvis
  • Perforation of the uterus or fallopian tubes
  • Rash and itching associated with possible nickel allergy

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