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Label changes coming soon for birth control device


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Label changes coming soon for birth control device

By Kean Bauman. CREATED Dec 3, 2013

Las Vegas, NV (KTNV) -- After hearing complaints from thousands of women across the country, and several here in the valley, the maker of a popular birth control device is making some changes.

Darcy Spears first reported last month on the product called Essure which some patients blame for serious side effects and severe pain.

"The doctor told me it was perforating my intestines and my bowels. So that's why I was having the tremendous pain that I was having daily," said Indi Kaufman. 

Indi and other Essure patients detailed their pain and misery in a group interview last month, telling stories of debilitating side effects they've endured for years since having the Essure coils implanted in their Fallopian tubes. Indi's coils moved or "migrated." So did Jenny Taffel's.

"My left coil had migrated into my uterus and cervix," said Jenny. 

That migration risk is not included in product labeling. But it soon will be, according to the FDA Indi, who got Essure in 2009, said it's unethical and unfair that patients weren't provided that information.

"I wouldn't have got it at all. I know that for a fact. I would not have gotten it at all."

All four women in our original report say they didn't know all the risks.

Darcy asked, "Was this a matter of trusting your doctor for all of you? Nobody raised any red flags? Gave you any warnings? This was supposed to be easy as pie?"

The group answered, "Yes. Yes. Yes. "

In the aftermath Indi said, "I'm glad that, for one, you guys did the story. I appreciate that because that helped get it out more."

Recently Essure's maker, Bayer Healthcare, asked the FDA for changes in product information available to patients. The revisions warn about the risks of chronic pelvic pain and device migration.

So why the change? Bayer sent a statement saying, in part: 

"We continuously review the information available about our products and, when appropriate, work collaboratively with the F.D.A. to update the information available to patients and physicians."

The FDA gave us more details. They explain that:

"This was done to include rare adverse events identified in the Essure physician labeling that was not previously included in the Essure patient brochure."

Indi doesn't understand why doctors got the warnings, but patients did not.

"Let us know. Just put it out there, the warning, this could cause this or that."

The FDA said the new labeling should take effect by the end of this month. Indi wonders what they're waiting for.

"And does that mean that the women who today may decide to get this, the warning is not on there, so they won't know the pain that they're in for."

All the women we spoke to want Essure taken off the market altogether. Indi also wants to see it dropped from the class of medical devices it's assigned to by the FDA, a classification that prevents patients from suing the manufacturer for damages due to injuries.

"And this definitely created a lot of injuries and harm. And they really should be held accountable for that," said Indi.

The Facebook group Essure Problems, where we connected with local patients, now has well over 4,500 members. That's over twice the number since Contact 13 began our investigation.