BOSTON (CBS) — Essure has been marketed as an easy method of family planning. But these tiny coils, which are implanted in a women’s Fallopian tubes, have been causing debilitating side effects in many patients.
The Food and Drug Administration has been conducting a review over the past 14 months and has now issued new guidelines.
The device will come with a Black Box warning, which is the most severe designation before a drug or medical device is removed from the market.
Bayer which manufactures the device must conduct a new safety study.
Finally, doctors will be given a check list of possible side effects to share with each potential patient.
Jessica LaVallie of Palmer is one of the patients who has suffered since she received Essure in June 2011. “I still have pain today, and it’s been five years.”
Like many Essure patients, LaVallie thinks the FDA is not taking strong enough action. They want the device removed altogether. “It was like a slap in the face. What else do we have to do here?”
Many so called “Essure Sisters” are upset the federal government’s top drug watchdog didn’t act more decisively. They are now launching a letter writing campaign on social media.
LaVallie said she is scared for women who might receive Essure in the future.
The Bayer company stated patient safety is their top priority, adding that about a million women have been implanted with Essure worldwide, most with no side effects.