FDA Investigating Complaints On Birth Control
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MIAMI (CBSMiami) -- Essure is the only permanent birth control you can get with a non-surgical procedure. Now, the Food and Drug Administration (FDA) has received thousands of complaints about it and the victims are demanding to be heard.
It's been available for more than 10 years. About three quarters of a million women use the device.
"I'm in pain. I can't sit down," said Melissa.
"I had to have a hysterectomy at 33," said Cassandra.
"I was in pain all the time," said Debra
These women are talking about Essure, a popular form of permanent birth control. Small coils are placed in the fallopian tubes causing scar tissue to develop and prevent pregnancy.
"My procedure was promised 20 minutes.. and it was three hours.. it was horrible," said Rebeka.
There are reports of botched placement procedures, coils migrating in the abdomen, and even pregnancy.
"I had to make the hardest decision of my life," said Marissa. "I was so scared of what I had read of what could happen to me and to the baby. I couldn't handle it."
Some of the women said beyond the physical, it's also impacted them emotionally.
"It was horrible.. I almost lost my marriage because of it," said Leah.
"It's done a lot.. I wasn't ready for a hysterectomy at 37," said Rebeka.
"Doctors will not believe you. That's the crazy thing," said Debra.
When they reported their symptoms to their doctors, they got little help.
"Once you mention,'I think Essure is my problem' the door gets shut in your face," said Leah.
So they took their frustrations online and found other 'E-sisters,' the national Facebook page 19-thousand strong.
"I love the Facebook page. I love that there is support from other women who've gone through the same thing," said Megan.
Not every woman is going through this with Essure. Bayer makes the device and reports that about 750-thousand women world-wide rely on it.
Doctor Kristi Keil is one doctor who offers Essure.
"I think it's a great procedure.. personally I haven't seen any problems with my patients.. Patient safety is always number one," said Keil.
The FDA reported getting 5,093 adverse reports on Essure. That's less than 1 percent of the women with the implant over the years..
The FDA has added warnings to the product including concern about sensitivity to nickel in 2011 and risks of chronic pain and device migration in 2013.
Doctor Jennifer Hyer has been offering the implant for more than 10 years. She says she's only seen a few patients have problems.
"Overall most women are very happy with the procedure," said Hyer. "I think it's a great product for many women but I also accept that there are women who've had complications."
The FDA plans to hold a meeting in Washington about Essure with a Facebook group of women who have experienced negative side effects. It's raising eyebrows, because the meeting is set for September 24th, the same day Pope Francis will give the first ever papal address to the U.S. Congress, an event likely to draw all media attention away from the FDA-Essure meeting.
