(CBS) — Tens of thousands of women are calling for a birth control to be taken off the market.
The FDA is now ordering its strictest warning for Essure, marketed as a permanent birth without surgery.
Many say after unintended pregnancies and severe health issues, a warning isn’t enough, CBS 2’s Audrina Bigos reports.
Colleen Carro says, “It seemed like a really good thing” until her birth control ruined her life.
“I’m in chronic pain,” Carro said. “I have been for the last three years.”
She suffered from skin rashes, allergies and severe back problems. She says it was all a result of Essure.
X-rays taken in 2013 show two coils placed in her fallopian tubes. Since then, she says doctors cannot locate one of the coils, so they can’t take it out.
Colleen is one of more than 27,000 women part of a Facebook group – calling for Essure to be taken off the market, blaming the device for stomach pain, hair loss, blood transfusions, unintended pregnancies, miscarriages and much more.
Dr. Jessica Shepherd of the University of Illinois Chicago does not think the Federal Drug Administration should take the product off the market.
“I have put this device in many women who have great outcomes and really don’t have any of the side effects or the symptoms that some of these women are coming forward with,” Dr. Shepherd said.
She does want to see extensive studies done to prove or disprove a correlation between the women’s symptoms and the device.
“We can’t all be making this up,” Carro said. “We have the medical documentation to back up what we’re saying.”
The FDA is requiring the manufacturer Bayer to conduct a study of 2,000 patients looking at the complications and the risks of Essure, but Bayer stands by the product and says it will continue to work closely with the FDA.