They will now include “additional information on risks of chronic pelvic pain and device migration” in the information provided to patients.
Bayer told the ABC15 Investigators they continuously review available information about their products, and “when appropriate…work collaboratively with the FDA to update the information available to patients and physicians.”
PATIENTS TO BE WARNED
The FDA approved those changes just a few weeks later. The FDA told the ABC15 Investigators the approved changes were “done to include rare adverse events identified in the Essure physician labeling, but not included in the Essure Patient Brochure.”
Essure is marketed as permanent birth control you can get without having surgery. It’s meant to be cheaper, easier and safer than getting your tubes tied. During the procedure, two metal coils are placed inside the fallopian tubes. Over the next three months, scar tissue is supposed to amass around the coils, blocking conception.
Essure has been on the market since 2002. According to the manufacturer, about 750,000 women have had it implanted to date.
There are now more than 3,700 women sharing their health issues with Essure on the “Essure Problems” Facebook page – and the numbers keep growing.