FDA Receives Complaints Over Bayer's Essure: What You Need to Know About the Permanent Birth Control Implant

The Food and Drug Administration (FDA) has received more than 5,000 complaints over Essure, a permanent birth control device used in the U.S.

The FDA is planning to discuss the controversial birth control device by pharmaceutics giant, Bayer Healthcare Pharmaceuticals Inc., after receiving thousands of complaints from women, according to Reuters.

The meeting is set to take place on Sept. 24 by the Obstetrics and Gynecology Devices Panel where discussions risks and benefits of the birth control device will be made.

Some of the complaints received by the federal agency include severe pain, ectopic pregnancy, pregnancies that result in premature births, and implant migration that required surgical removal among many others, reports PR Newswire.

There have also been cases of five pregnancies that resulted in deaths, four deaths from infection and uterine perforation, and one death from suicide, according to the statement released by the FDA.

According to the manufacturer's website, Essure works by placing flexible inserts made of nickel-titanium alloy directly to the fallopian tubes through the natural pathways of a woman's vagina and cervix.

The inserts are permanently implanted by doctors and keep pregnancies at bay by forming a "natural barrier that keeps the sperm from reaching the eggs."

FDA's announcement came a few months after founders of the Essure Problems Facebook group met with FDA representatives to investigate Essure and its proposed removal from the market.

"The FDA takes reports of safety concerns seriously," the agency released a statement as reported by ABC 15. "Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement."

Meanwhile, Bayer HealthCare, the company that bought Essure in 2013 told the news site that they are willing to discuss the issues of the birth control device on FDA's upcoming meeting in the fall.

Bayer has been in communication with the federal agency and defended the device by saying that Essure is the only non-invasive FDA-approved permanent birth control method supported by science and research.

"Women chose to have this procedure without being informed of the debilitating and in many cases, life altering side effects," said Robert Arentz, co-founder of Arentz Law Group.

The Arentz Law Group is offering help to women who suffered from the negative side effects of Essure. They are currently offering free legal consultations from all women in all 50 states in the U.S. Essure victims are encouraged to call the law group at 1-800-305-6000 for more legal options.