Thousands of women complain of extreme pain after birth control implant

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ATLANTA - Women in metro Atlanta have joined thousands of others around the country in blaming a popular permanent birth control procedure for leaving them in constant pain with mounting medical bills.

The women are more frustrated because they can't take action against the company that makes the Essure birth control device.  Even more aggravating, they said many doctors don't believe there is a problem.

Angel Gilbert said she's been in pain every day since getting Essure.

"I'm being told by my doctor, ‘It's all in my head,’" Gilbert added.

She had the procedure done in 2009 after giving birth to her fourth child, her only daughter.

"She doesn't get the experience that my boys got, and that hurts sometimes," Gilbert said.  "She doesn't understand that mommy is always in pain."

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Essure is an out-patient procedure approved by the Food and Drug Administration in 2002.  It's touted as a less expensive and easier alternative to tubal ligation.

During the procedure, doctors place coils into a woman's fallopian tubes.  Eventually tissue grows over the coils, blocking the tubes and preventing pregnancy.

The coils are made of nickel and polyester fibers and are supposed to be straight, but flexible.

April Langley showed Channel 2 Action News the coils taken out of her body a few weeks ago.  Both were bent in several directions.

Langley said her doctor told her it was the worst case he had ever seen.

"He said the one on the right was embedded in the soft tissue of my abdomen.  And both of them had perforated through my fallopian tubes," Langley said.  "He said it was no wonder I was in so much pain."

Langley and dozens of women have learned, because of the way the FDA classified Essure as a Class III device, no one can sue the manufacturer.

The women have joined a growing Facebook page, with more than 4,000 members to raise awareness.  They've also signed a petition, headed by activist Erin Brockovich, which is demanding more studies.

Langley said that's not enough.

"I think it should be taken off the market," Langley said.

The Food and Drug Administration has received nearly 1,000 complaints about Essure since 2002.  They include extreme pain, menstrual irregularities, nickel allergies and the coils moving to other parts of the body.

 Gynecologist Heather Gibbons has performed the Essure procedure.  She said she believes some of the problems, like bleeding, pain, bloating and PMS, are the result of women no longer taking a hormone-based birth control, like the pill. Essure does not have 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 is still there," said Gibbons.

Unlike many doctors listed on the Essure Problems Facebook page, Gibbons said she would be willing to talk with patients about removing the coils.

"You have to not just look at the problem, you have to look at the whole history of the patient," Gibbons said.  "So 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, or if it's related to something else."

The doctor who removed Langley's coils was able to do it without removing her fallopian tubes, but that doesn't appear to be the case with many of the women on the Essure Problems Facebook page. 

Because the coils grow into the body, doctors sometimes have to remove the tubes and uterus. Other women are getting complete hysterectomies. Some of the women are in their 20s.

Pharmaceutical company Bayer bought Essure earlier this year from Conceptus.  Bayer just got approval from the FDA in September to add warnings about pelvic pain and coil migration on Essure's patient information booklet.

That's not enough for Gilbert. She wants the company to pay the $7,500 she needs to have her coils removed.

"I would pray and hope that my body and my health would go back to the way it used to be," Gilbert said.

Langley said she was losing her hair, and her fingernails were brittle when she had the coils.  Now that they're out, those problems are gone, and so is her pain and depression.

"My whole family saw a huge difference," Langley said smiling.  "They were even making the comment, wow, we have our Mom back."