Essure-d mom gets surprise pregnancy, serious pain - FOX 26 News | MyFoxHouston

Essure-d mom gets surprise pregnancy, serious pain

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HOUSTON (FOX 26) -

By all accounts, Hope Faith shouldn't be here today.  The two-year-old shouldn't be the apple of her mom's eye or the lovable, pesky little sister to her brother Isaac.

Kandace McLean, 33, said that plate included two other children she could barely afford.  That's why she underwent Essure in 2007.

"I was a single mom at the time, and I had a lot on my plate already," McLean said.

Essure is a process of inserting a metal coil into the fallopian tube.  The procedure is supposed to prevent pregnancies.  McLean said her physician guaranteed she couldn't conceive.

"I was shocked when I found out I was pregnant, and he was shocked," McClean said.  "He had no answers for me.  He said it was a paradox and an enigma which means a miracle that can't be explained."

McLean found herself in that less than one percent group.  In all of Essure's literature, company officials said their procedure is 99.83 percent effective.

McLean and a Facebook page full of women complain the procedure created by Essure's parent company Conceptus didn't work and now they have children.  The women also complain about excruciating pain during their cycles as a result.

"It's disabling," McLean said.  "I'm in so much pain, I can't even move, the headaches, nausea."

While Essure indicates there's less than a one percent chance of a woman getting pregnant after the procedure, studies show the number could be at least two percent, OBGYN and attorney Dr. Susan Raine said.

But Raine said she uses Essure with patients and called it a good product.  She said doctors should reinforce that risk to patients.

"I think we all try really hard to make sure they understand that because there will be women that come back with a pregnancy after they've had that procedure," she said.

No one understands better than McLean does.  She has her two-year-old as proof, but she wants to remove what she calls the pain-causing Essure coil.  

She received it free under Medicaid, but she said the state won't pay for the removal since she also had her tubes tied.  It would cost $46,000 out of pocket to get rid of the coil.

"I just wish I would've had a regular tubal ligation, but I trusted my doctor because he said this was best for me and I did it," she said.

Conceptus, the maker of Essure, stands behind its product, saying:

"The Essure procedure has been FDA-approved and available in the US since 2002 and more than 660,000 women worldwide have undergone the procedure.  When performed properly and all protocols are followed, including a three-month confirmation test, Essure is 99.83% effective. While no form of birth control should be considered 100% effective, Essure is the most effective method of permanent birth control available based on a comparison of five-years of clinical data - making it even more effective than tubal ligation and vasectomy. Following an Essure procedure, during the three-month waiting period until the woman receives the results of the confirmation test, she must continue to use another method as her primary form of birth control. At three months she must undergo an Essure Confirmation Test to verify that she is fully protected from unplanned pregnancy."

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