• Unsure About Essure: Complaints Prompt FDA Review and Public Meeting
  • August 5, 2015
  • Law Firm: Motley Rice - Mount Pleasant Office
  • On June 24, 2015, the FDA updated its website following a review of the Essure® permanent birth control system in response to reports from women stating “that they have experienced pain or other health problems after Essure placement.”

    Apart from the FDA’s review, several national news outlets have recently begun investigating complaints with Essure and telling the stories of women suffering from the Essure system’s alleged side effects. For example, National Public Radio (NPR) recently profiled a woman in a segment titled FDA to take another look at Essure contraceptive device after health complaints, who eventually sought a hysterectomy due to her chronic pain and discovered that a coil had migrated outside of her left fallopian tube.

    The Essure system, manufactured by Bayer AG subsidiary Conceptus, Inc., is a flexible metal spring-like device with synthetic fibers woven around the coil. The device is inserted in the fallopian tube using a disposable delivery system through a minimally invasive outpatient procedure. Once in place, the fibers are designed to stimulate the surrounding tissue to grow in and around the coil through “a chronic inflammatory and fibrotic response,” ultimately resulting in the growth of scar tissue intended to prevent sperm from reaching the eggs and to hold the device in place.

    While the FDA did not issue any warnings or other safety communications following its review, it did announce that it will hold a public meeting of its Obstetrics and Gynecology Devices Panel on Sept. 24, 2015, “to discuss scientific data regarding Essure’s safety and effectiveness.” Feedback from the public will be welcome during this discussion and will be used by the FDA to help form any recommendations regarding Essure in the future.

    What the FDA review did include, however, was several updates regarding adverse side effect reports formally submitted through the FDA’s database. As of May 31, 2015, the FDA has received more than 5,000 Essure-related complication reports, including for problems ranging from allergic reactions to the metal used to device migration or breakage to fetal deaths.