FDA: Act On Essure®
Bayer designed the Essure® device to insert a metal coil known as a “micro-insert” into each of a patient’s fallopian tubes. Once released, the micro-inserts are supposed to expand and anchor into the fallopian tubes, and fibers in the micro-inserts elicit tissue growth, ultimately blocking the fallopian tubes and preventing pregnancy. The metal coil “micro-insert” that is implanted in the patient’s fallopian tubes looks like this:
Patients’ physicians implanted the micro-inserts with a “disposable delivery system” that included a handle for the physician to control the delivery and release of the micro-inserts, which were attached to the handle with a wire. There is a disposable delivery system utilized by physicians to implant the micro-insert.
Bayer markets the Essure® system as a permanent birth control device that is safe and effective. Bayer’s brochures say in part: “Essure® is a gentle, hormone free permanent birth control procedure – without surgery, burning or the risks of getting your tubes tied.”
Experience has shown that Bayer’s Essure® birth control procedure is anything but safe and effective. There have been numerous reports that Essure®:
- Perforates the fallopian tubes
Migrates from the fallopian tubes to the:
Complications can result in complete hysterectomies involving taking out
- The ovaries
- The fallopian tubes
- The uterus
Births have occurred that include:
- Unwanted pregnancies
- Stillborn babies
- Babies with birth defects
The FDA needs to take Essure® off the market but the FDA has been slow to act. On February 29, 2016, the FDA proposed a black box warning as follows:
The FDA also proposed a “patient decision checklist” which patients are required to read and initial that warns patients (1) there is still a small possibility that you may become pregnant; (2) that you may be at risk for a pregnancy occurring outside of the uterus (“ectopic pregnancy”) which may result in serious and even life-threatening complications; (3) that cramping, mild to moderate pain, nausea/vomiting, dizziness/lightheadedness, and vaginal bleeding may occur; (4) that device puncture of the uterus and/or fallopian tubes (“perforation”) may occur; (5) that movement of the device into the abdomen or pelvis (“migration”) may occur; (6) that removal may require a hysterectomy (“removal of the entire uterus”).
On February 29, 2016 in an FDA news release William Maisel, M.D., M.P.H., the Deputy Director for Science and the Chief Scientist at the FDA Center for Devices and Radiological Health stated:
“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure® is right for them.”
Indeed. It would have been nice if Bayer had reported malfunctions and serious health problems associated with its Essure® device in a timely fashion pursuant to FDA regulations. But Bayer didn’t do that. If they would have, the FDA could have considered taking this off the market or adding the black box warning and patient decision checklist long before February 2016.
However, the comment period on the FDA black box warning and patient decision checklist has been over for a long time now. It is time for the FDA to act. Either take this defective product off the market, or attach a Black Box warning with a Patient Decision Checklist to Essure®. The FDA needs to do that, and they need to do it now!
You can help. Email the FDA at: DICE@fda.hhs.gov. Tell the FDA that for the safety of women, take Essure® off the market or adopt and implement the Black Box warning and the Patient Decision Checklist.
Fleming, Nolen & Jez is a law firm in Houston that represents numerous women who have suffered due to the Essure® device. Requests for information regarding Essure® or this blog can be made at (866) 977-6671 or you can use our online form.