9 Investigates: Birth control warnings

CHARLOTTE, N.C. — Some women in the Carolinas have joined more than 900 others across the nation in blaming a popular birth control device for their pain, fatigue and suffering.
 
Eyewitness news anchor Peter Daut investigated Essure-- a birth-control method hundreds of thousands of women have used.
 
"It's pretty upsetting," said Anne Barmer, a former Essure patient. "I thought it was supposed to be something easy, quick, non-painful."
 
Heather Huskey, another former patient, said, "I started having headaches, nauseous daily, dizziness."
 
Eyewitness News spoke with seven women who blame these health problems on Essure.
 
"I feel like I'm 80 (years old), and I'm 32 and I've just never felt this bad before," said Stacey Hodge.
 
 "Sometimes the pain gets so bad that in order for me to get to my kids, I have to crawl down the hallway," Nicole Newton, who currently uses the method, said.
 
Essure was approved by the Food and Drug Administration in 2002.
 
The company behind it, Bayer, touts it as quicker and easier than tubal ligation.
 
During the procedure, doctors place coils made of nickel and polyester fibers into a woman's fallopian tubes and eventually, tissue grows over the coils, blocking the tubes and preventing pregnancy.
 
"It is emotional," Lilian Neira, former patient, said.
 
Neira had the Essure coils inserted four years ago and then last year had them removed.
 
She said her problems after having Essure implanted included severe fatigue and memory loss.
 
"I was in so much pain and I didn't understand what my body was trying to tell me," she said.  These women learned that because the FDA approved Essure as a class-3 medical device, winning a lawsuit is very difficult.
 
Class-3 devices have undergone the agency's most rigorous review and federal law gives the FDA authority to determine a device's safety,
 
Still, all these women joined a Facebook group with more than 7,000 members and have signed a petition headed by activist Erin Brockovich to demand more studies.
 
The FDA said it's received 943 complaints about Essure since 2002.
 
Gynecologist Heather Gibbons has performed the Essure procedure and believes some of the problems happen after women, who use a hormone-based birth control like the pill, discontinue it.
Essure has no hormones.
 
"They don't know that all these years the birth control pill was masking a problem that they had. And now they've had this done, and the problems are still there," Gibbons said.
 
Gibbons says it's important for doctors to focus on the whole history of the patient.
 
"I would take my time with them and work with them to see if it was really related to the device, which it could be," Gibbons said.
 
But Erica Davis said it's like a slow death.
 
Bayer would not agree to an on-camera interview with Channel 9 but instead sent a video statement.
 
"We are saddened to hear of any patient who has been harmed by one of our products, regardless of the cause," said Dr. Edio Zampaglione, Bayer Corporation. "Essure is one of the most effective contraceptives and has been on the market for over 10 years. To date, approximately $750,000 women worldwide have used Essure.
 
The women we spoke with said they've spent tens of thousands of dollars on medical bills due to problems and they blame them on Essure.
But they insist they do not want money.
 
 "I want more research," said Amanda Rusmisell, former patient. "I want it pulled from the market until more research is done."

WSOC