11/25/2014

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KATU Investigators

Birth Control Backlash: Women claim medical problems related to Essure

Birth Control Backlash: Women claim medical problems related to Essure

PORTLAND, OR. -- Nicola Cook considers herself one of the lucky ones.

For three years after she was implanted with a permanent birth control device, called Essure, she didn't have a single side effect. For Nicola, her husband Jack, and her two healthy children, life was good.

"Taking birth control all of the time is a pain," Cook said. "There is always a higher chance cause you could miss a pill and something can happen. So I thought this was a great choice."

"I was like 'heck yeah!'"

Essure is touted as a safer, less expensive and less invasive alternative to women getting their tubes tied.  There's no anesthesia, no incisions, no scarring. Women are typically out the door of their doctor's office in under 30 minutes.

During the procedure, a metal coil is placed inside each fallopian tube. Over the next three months, scar tissue builds around the coils, blocking the egg and sperm from meeting. Three months later, doctors test to verify that the tubes are completely blocked. Essure was approved by the Food and Drug Administration (FDA) in 2002 and according to the company's website, it's 99.83% effective.

It sounded perfect - Jack wasn't excited to get a vasectomy, and Nicola could be back to work the next day.

"I was like, heck yeah," Cook said. "Rather than (Jack) be down for a couple days and have to (have a vasectomy), I can go in the office and have this done in less than a half hour and be to work the next day and not have to worry anymore.

So that's what we went with."

Nicola had that follow-up test. Doctors told her that her fallopian tubes were blocked.

But last month, Cook was stunned when she got the most life-changing 'side effect' of all: she was pregnant.

"I about died. I was like shaking. I screamed my husband’s name and was like, 'You've got to get in here," Cook explained after taking a pregnancy test. "I was thinking, this can't really be happening. This is a bad dream."

Nicola Cook says she now feels deceived.

"I think that's the worst thing," Cook continued. "You go through all of these emotions and it's like 'this shouldn't be happening.'”

The E-Sisterhood

In a panicked search for answers to explain her new pregnancy, Cook started researching online and found she's not the only one dealing with problems. She stumbled onto the Essure Problems Facebook page formed last year. The page has more than 3,400 members who call themselves "E-sisters."

Collectively, their stories turned into a grassroots campaign to raise awareness.

In the last year, consumer advocate Erin Brockovich joined the fight.

Yes, that Erin Brockovich, whose fight against an electric company became a Julia Roberts movie.

She started her own website for women who had the Essure procedure so they could share their stories and concerns as well as initiate change.

After extensive testing, the FDA said Essure was safe and put it in a class that exempts manufacturers -- in this case, Bayer -- from lawsuits. Brockovich is taking on the company and the law on behalf of women who say they are suffering.

User Complaints

The On Your Side Investigators found Cook also joins hundreds of women who’ve filed complaints with the Food and Drug Administration. In the Northwest, and across the country, women are claiming Essure is causing severe medical problems like extreme bloating, excruciating pain, skin rashes and broken coils to allergic reactions to the nickel in the coils. One woman who reached out to KATU showed a picture of a coil puncturing her fallopian tube.

The On Your Side investigators examined hundreds of such complaints filed officially with the FDA. We discovered 943 women, doctors, and health care facilities filed complaints of "adverse events" about Essure since the procedure was approved in 2002.

More than 600 complained of pain. Another 116 said the coil had moved around inside their bodies. There were 113 reports of bodies rejecting the coils. And in 37 cases, people said the coils broke inside the body. 

Questions and Answers

We reached out to medical professionals for their take on the controversy. Dr. Richard Rosenfield, the medical director and founder of the Pearl Women's Center in Portland, has been performing the procedure for more than 10 years.

"We need to reassure our patients that we just have not seen trouble with this particular procedure over the last decade of use," he said. He maintains it's safer than traditional methods of birth control, like tubal ligation.

Both Bayer and the FDA maintains the product is safe and effective. The FDA says Essure is 99.83 percent effective when used correctly and stated that there should be no complications from those pregnancies that do occur.  

"Based on data from prospective and post-market studies of Essure, the rate of serious adverse events associated with Essure is low," the FDA wrote in an email to KATU.

"It's not that it's an unplanned pregnancy, it's that it was planned against"

Cook is finding her pregnancy to be a serious adverse event. 

"Am I going to carry this baby all the way and then lose it because these coils are inside me when I wasn't supposed to get pregnant in the first place?" Cook said.

It's especially difficult for the Cook family when their search for permanent birth control came after two difficult births. Her first child, Ethan, was born with complications. His esophagus was not attached to his stomach. He needed surgery.

Her second pregnancy, three years later with Kayleese, was high risk. Cook developed gestational diabetes, a special type of diabetes experienced only during pregnancy, and it forced Kayleese into the world three weeks early. She was born with jaundice. She too required special medical care before her parents could bring her home.

It's why, when her OBGYN recommended Essure, Cook thought it was the answer to her worries.

"It's hard because I've come to the point now where I'm happy, and I'm like 'I'm going to have this little baby and I've come to terms with it," she said. "It's been a month, and things are still going OK. But it's still like, what are we going to do?" 

Nicola now says she stays away from the Facebook page because it tends to make her focus on the negative. Right now, she's focused on her kids, Ethan, 7, and Kayleese, 3. Both are healthy.

And that's the only thing she hopes for - for the new baby on the way.

"I just keep my focus on - this baby can be OK," Cook said. "And I don't know what I would do if it wasn’t."

 

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