Local Woman Wants Birth Control Device Off Shelves; FDA reviews Essure
BUNCOMBE COUNTY, N.C. -- An FDA advisory committee held a meeting on Thursday to review a medical device called Essure.
The FDA approved Essure in 2002. A doctor can implant the device in women as a method of permanent birth control. The FDA has received complaints about safety concerns, and one local mother says it should be taken off the shelves.
The FDA estimates more than 750,000 women worldwide have gotten Essure, and the FDA has received more than 5,000 complaints. The majority of the complaints are about abdominal pain.
Kristiana Burrell tells a story much worse.
"If a baby doesn't take a breath, you don't get a birth certificate. You only get a death certificate. So, I only have a death certificate with her name on it, because she didn't take a breath," said Kristiana Burrell.
Ariel Grace Burrell died June, 8. Kristiana was unknowingly 25-27 weeks pregnant.
"I thought I was just having a miscarriage, because I had no idea I was as far along as I was," Burrell said
The Burrells have six kids. Kristiana did not want more, so she got Essure. The device's website says it is a permanent birth control, 99 percent effective, and women don't get need surgery to get it.
Burrell got it in December, 2013. Five months later, her doctor found her left Fallopian tube was not blocked. She continued to take a second form of birth control. She was not having her period. Then on a Friday in June, she felt a kick in her belly.
"I was so surprised! As soon as I took it, it was positive. I was like oh my goodness. What are we going to do? This is supposed to be permanent. It's not supposed to happen," said Burrell.
By the end of that weekend, Burrell's water broke. She started hemorrhaging and went to the ER. A doctor told Burrell part of the coil was exposed, rupturing the placenta, and cutting off the blood supply to her baby.
"It was the worst, worst thing that could ever happen. It was the worst time of my life," Burrell said.
She keeps a memory box of for Ariel. It contains things like her footprints, a butterfly, a picture of an outfit they picked out for her, and the death certificate.
"My husband's not a big talker. His way of dealing with things is not dealing with things. We've had to, I've had to do a lot of bereavement counseling. It's really taken a toll on on our marriage and really taken a toll on my physically and mentally," said Burrell.
She wants the device banned so other women don't have to suffer. She still needs to have surgery to have Essure removed. She hates that it's still in her body.
The FDA will review the advisory committee's recommendation before making any decisions.