After Pain Reports, FDA Petitioned to Cease Essure Sales
The FDA approved Essure about 13 years ago
HealthDay News -- Bayer's contraceptive implant Essure can cause serious complications, including back and pelvic pain, and should be taken off the market, says a citizen's petition filed with the Food and Drug Administration.
The FDA approved Essure about 13 years ago after a review process that was fast-tracked because the device was the first alternative to surgical sterilization for women who did not want more children and offered patients a quick recovery, The New York Times reported.
However, since approving Essure, the FDA has received more than 4,000 reports of serious complications, including severe back and pelvic pain, coils that pierced the fallopian tubes and lodged in other organs, and heavy prolonged menstrual periods, The Times reported.
Thousands of women who say they were seriously injured by the implant want the FDA to take Essure off the market and to issue a public warning about its complications. Both the FDA and Bayer say the device's benefits outweigh the risks, The Times reported.