U.S. regulators said they would review a popular birth control implant device at a panel this week following multiple complaints.
The implant, called Essure, was approved by the U.S. Food and Drug Administration in 2002. The small metal spring is designed to be placed in the fallopian tubes, so that no egg can pass through.
The FDA is scheduled to have a follow up meeting on Thursday to discuss the safety of the device after numerous women have said they faced debilitating side effects.
“Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement,” the FDA said in a statement on Monday. “We will continue to work with these individuals as we continue our efforts to better understand their experiences with this device.”
While Bayer, which produces Essure, has acknowledged side effects including pelvic pain, migration of the device or rash, women have said they have experienced other unlisted side effects.
Melanie Goshgarian, 37, told ABC News she had heavy bleeding and a “metal taste in her mouth” getting the device implanted.
“I felt like a shark was on the side of my body and wouldn’t let go,” she told ABC News. “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 said it found 20,000 complaints from women who shared their stories on Facebook and Twitter. In a review of the device before this week’s planned meeting, the FDA said “significant limitations must be taken into account when reviewing the data,” on the device.
The agency also reported that “over the past 2 years, FDA has seen a dramatic increase in the number of adverse events submitted in relation to the Essure device.”
Bayer officials have said they appreciate the opportunity to discuss the matter with the FDA.
“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,” the company said in a statement on Monday. “We continue to be committed to maintaining an open dialogue with any patient who has questions or concerns about Essure.”
The company said 10,000 women were studied with the device before it was approved.
Dr. Karen Ashby, an obstetrician and gynecologist at the University Hospitals Case Medical Center, told ABC News that long-term pain and itchy skin can be a problem because the device is difficult to remove.
“Some of the big things I’ve seen in my patients is pain,” she said. “There’s always a possibility that they’re allergic to the metal.”
Dr. Deborah Bartz, obstetrician and gynecologist at Brigham and Women’s Hospital, said that for some women the Essure device is the best option for permanent birth control.
“There are indeed some women in whom other birth control options are not ideal,” Bartz told ABC News. “There are some women with complex medical conditions in whom having a more involved surgery to [tie their tubes] is a risky endeavor.”