FDA plans to review Essure birth control
PHOENIX (KSAZ) - A panel with the Food and Drug Administration will begin reviewing the safety of the popular birth control implant called Essure, to decide whether its use should be restricted.
The FDA has received mounting complaints about the device's side effects. Thousands of women say Essure has caused them serious health problems, including one woman from the valley. She says the device needs to be taken off the market.
"I suffer every day you know, I wake up, and I think what happened," said Sara Miller.
After having a difficult first pregnancy, Sara Miller was told not to have any more children for her safety, so in 2010 she went with Essure. It's a coil-like device implanted into the fallopian tubes where tissue grows over it, and it eventually blocks sperm from reaching a woman's eggs. Shortly after she began having unusual symptoms.
"I'd say in about six months I started losing my hair in clumps, I had heavy bleeding, pain all the time," said Miller.
The product is marketed as a permanent solution, but Miller says she has proof it is not. In April, she says her symptoms became so severe she had to be rushed to the hospital where doctors told her the coils had lodged into her uterus.
Then came more devastating news. "I had a miscarriage, I didn't even know I was pregnant, I had no symptoms," she said.
Miller has since undergone a hysterectomy, something Dr. Charles Monteith says is not uncommon for women who have used Essure.
"I think it's an imperfect device that's being used imperfectly," said Dr. Charles Monteith.
Monteith is the Medical Director of A Personal Choice in Raleigh, North Carolina. He's one of several medical professionals who will meet with the FDA, hoping to encourage them to re-examine the safety and effectiveness of the implant.
"I think a stronger label needs to be put on it, that deaths have been associated with it. I think a stronger label needs to be put on it that patients need to be aware that up to 1 in 10 women can have side effects at one year. I think patients need to be aware that if patients do have side effects surgery may be required," he said.
The FDA could decide to take action and take the product off the market, or require further testing. Miller says if this happens she and thousands of other women will be filing a class action lawsuit.
FOX 10 reached out to Bayer for a comment, but they could not be reached.