FDA to Review Concerns on the Essure Sterilization Procedure

We would like to point out that Essure may not be so “sure” after all—or so safe After receiving thousands of complaints of adverse side-effects, the FDA has decided to conduct a hearing on the safety and effectiveness of Essure. The controversial sterilization implant involves pushing micro coils made of nitinol (a nickel-titanium alloy) and polyethylene terephthalate (PET) fibers into a woman’s fallopian tubes via a hysteroscope and catheter. This scars the fallopian tubes and seals them shut. Originally developed by Conceptus, the Essure system was approved by the FDA in 2002. Bayer HealthCare, a subgroup of Bayer AG and one of the largest pharmaceutical companies in the world, acquired Essure in 2013. Bayer AG reported a gross profit of almost EUR 22 billion in 2014. Bayer claims Essure to be 99.83% effective in preventing pregnancy if placed correctly. Women who do become pregnant with the Essure implant, however, have a significantly higher risk of having an ectopic pregnancy. Ectopic pregnancies, where the fertilized egg implants outside of the womb, can be life-threatening. Over the past 12 years, the FDA has received over 5,300 complaints from women using Essure. The reports include 482 cases of device migration, 259 cases of device breakage, and 133 malpositions. Other women reported suffering from abdominal pain (3,353 cases), menstrual irregularities (1,408 cases), and weight fluctuation (936 cases). Other victims reported experiencing debilitating sharp chronic pain or cramping, hair loss, chronic bloating, headaches, mood swings, dizziness, nausea, vomiting, chronic back pain, fibroids, painful intercourse, and perforated organs. The manufacturer claims that local anesthesia is generally sufficient for the Essure procedure, but admits that some...