FDA looks into risks of permanent birth control Essure

Abnormal pain, bleeding and allergic reactions —The Federal Drug Administration says those are possible symptoms caused by using Essure birth control.

As much as she tries, Tammy Futrell says she hasn’t been completely herself for the last few years.

"I just don’t ever feel good. I just always feel drained and tired," Futrell said.

She says fatigue is on a long list of health problems she’s had since getting the permanent birth control device. Women with the product get flexible coils inserted into their fallopian tubes.

"I got the Essure and then one thing after the other would happen," Futrell said.

She realized she was one of thousands of women experiencing those problems after discovering an Essure Problems Facebook page dedicated to women’s stories about the product. Women on the page say they experience everything from hair loss to unintended pregnancies. 

"Reading through these women’s comments, it looked like I was reading my own story," Futrell said.

After looking into more than 5,000 complaints, the FDA announced it would take action to make sure the FDA, doctors and patients understand the risks. On Monday, the FDA announced it ordered a mandatory clinical study to learn more information about Essure and the risks of using it. It’s also requiring changes to the product labeling, including a boxed warning and a patient decision checklist to help to ensure women receive and understand information regarding the benefits and risks of that type of device.

Dr. Pamela Hodges with Baptist Health Medical Group says many of the reported problems are also symptoms of a thyroid issue or an allergic reaction to the nickel in Essure.

"There are may women I see through the course of year who have these symptoms and don’t have an Essure," Hodges said.

Hodges advises women experiencing those symptoms to visit their primary care doctor.

"Before you totally blame a method of birth control, I feel a person should have a complete blood workup," Hodges said.

She says it’s about understanding the risks and knowing the product is a permanent solution. Hodges says the only way to remove Essure is by removing a womens’ fallopian tubes. That’s why she says to talk to your doctor to decide if the product is right for you.

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