Essure Birth Control Implant under FDA review after complaints

By Caribbean Medical News Staff
After numerous complaints, the Food and Drug Administration (FDA) said it will review a popularly used birth control implant device called Essure at a panel meeting this week. The device was approved by the regulatory body in 2002. Essure is a small metal spring, which is designed to be placed in the fallopian tubes, so that no egg can pass through.
Scores of women have been complaining about suffering deleterious side effects after using the device; consequently, the FDA has planned a follow up meeting to discuss the safety of the device.
A statement issued by the FDA said: “Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement. We will continue to work with these individuals as we continue our efforts to better understand their experiences with this device.”
Though Bayer, which produces Essure has specified side effects such as pelvic pain, migration of the device/ rash, some of the women have alleged they have experienced additional unpublicized symptoms.
One of the women complained of heavy bleeding and a “metal taste in her mouth” since getting the device implanted. She went on to explain: “I felt like a shark was on the side of my body and wouldn’t let go. My whole body started to change. … I was itchy, my arms were tingling and my legs were tingling. … I was confused all the time.”
The FDA discovered over 20,000 complaints from women who shared their stories on social media sites. In a review of the device before the meeting, the FDA said “significant limitations must be taken into account when reviewing the data,” on the device.
An FDA spokesperson said: “While there are risks with all medical devices and procedures, Bayer’s highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure. We continue to be committed to maintaining an open dialogue with any patient who has questions or concerns about Essure.”
Bayer said that 10,000 women were studied with the device before it was approved.