The FDA recently announced that it will hold a public hearing to determine if any regulatory actions need to be taken to deal with complaints about Essure and whether it is a safe and effective permanent female birth control method.

Essure is a permanent sterilization method for women, and the only non-surgical method to offer this treatment. This device is made up of three coils. When physicians implant the device, its coils are implanted into the fallopian tubes and passes through the woman’s vagina, cervix, and uterus.

This causes scar tissue to form around the coils for over several months, which is supposed to block insemination. But Essure complications have been reported by many women including bloating, rashes, allergic reactions, excessive bleeding, organ perforation, pelvic pain, miscarriage and even ectopic pregnancy.

The FDA stated that the meeting will convene on Sept. 24, with the agency’s Obstetrics and Gynecology Devices advisory panel. This panel will examine the science and concerns surrounding the Essure birth control device, after receiving over 5,000 adverse event reports since the device’s approval in November 2002.

Most of these injury reports, which can include more than one complication, were submitted by women who received the Essure implant. Among the complaints:

• 3,353 reports indicating abdominal pain
• 1,408 reports indicating menstrual irregularities
• 1,383 reports indicating headaches
• 966 reports indicating fatigue
• 936 reports indicating weight fluctuation

Among the reports were four deaths.

A petition was submitted to recall Essure in 2014. In March, the FDA Center for Devices and Radiological Health rejected the petition, stating that the form had been misfiled.

However, the petition and the reports were forwarded to the FDA’s Office of Compliance, which investigates injury complaints.

Bayer Pharmaceuticals, although not the original developer of the Essure device, is receiving the brunt of the product liability claims after acquiring the rights of Essure. Despite the severity of these allegations, Bayer has reportedly downplayed the injury reports, insisting that there are only several cases of Essure complications worldwide.

Any recommendation of the FDA panel is non-binding, but the agency often follows committee directives.