FDA Experts to Review Safety of Essure Birth Control Implant

The FDA called an outside panel for reviewing the safety of this device recently since thousands of women were complaining of a number of complications.

The company declared on Monday: “While there are risks with all medical devices and and procedures, Bayer’s highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure”.

The device is inserted into the fallopian tubes, and after some time, tissue grows around it and blocks the way to prevent sperm cells from reaching the egg cell.

The FDA approved the implant in 2002, but because of recent complaints, the agency was compelled to conduct a review, which is scheduled for Thursday, ABC News reports.

Essure has been available for 13 years, but since 2013 the FDA has received a surge of complaints from women implanted with the device, which is marketed as the only permanent birth control method that doesn’t require surgery. “We will continue to work with these individuals as we continue our efforts to better understand their experiences with this device”.

Bayer, the company that produces the implant, has acknowledged some possible side effects, such as pelvic pain, rashes, or the migration of the implant.

The agency even reported that in the last 2 years, the FDA has seen a major increase in the adverse events which have been submitted relating to this device. Many women complained that they have suffered from other unlisted side effects of the implant.

One woman, 37-year-old Melanie Goshgarian, said when she had Essure implanted, she felt “a metal taste in her mouth” and she experienced heavy bleeding, according to ABC News.

Bayer officials have said they appreciate the opportunity to discuss the matter with the FDA.

The Food and Administration Program said that the number of complaints is alarming, with as much as 20,000 of them being shared only on social media sites.