Oct 23, 2015 5:19 PM

NH1 News Investigates Contraceptive Crisis Part 2: Women putting pressure on FDA, Congress to pull Essure


CONCORD – Did the only type of permanent contraception change the lives of tens of thousands of women, some of them from right here in New Hampshire?

For them, the answer is a painful yes.

“It turned my life into a living hell for two years,” says Danielle Quantello, who had the device implanted years ago.

All she - and more than 750,000 women - wanted was permanent contraception.

It’s called Essure and it’s a pair of nickel coils inserted into the Fallopian Tubes.

It’s billed as a one-hour appointment in their doctor's office with no tubes tied and no cutting.

The women we spoke with thought it was perfect but say that almost immediately, they knew it was all wrong.

Many said they weren't told of the side effects.

They said their doctors told them the rashes, severe pain, and bleeding would go away. But they said it didn’t.

“I wanted permanent birth control,” Deanna Adams said. “I didn't want to be on the pill.”

Adams showed us an X-ray of the Essure nickel coils inserted into her body.

It’s clear to see that the coil on the right has moved and changed shape leaving the potential for it to migrate, she said. It's also caused harm to other organs.

But worst of all, she said, was what she heard from her doctor just one month ago.

“When I called my implanting doctor last month, I was told that I'm the only woman who has contacted them with any complications at all,” she said.

Turns out, she wasn’t alone.

The Facebook group, Essure Problems, has grown over the years from less than 100 to more than 23,000 women.

Now as a group, they are putting pressure on the FDA, the company Bayer - which sells Essure, and Congress.

Just last week, the FDA holding a rare public advisory meeting to hear from patients and now Congress is calling on the FDA to pull Essure off the market.

Dr, Edio Zampaglione of Bayer went to YouTube saying, in part, “The fact is, the adverse events that have been reported in the news and online about Essure are known and are listed in the Essure product information.”

He went on to say the FDA’s review “found that it did not demonstrate any new safety problems or an increased incidents already known.”

The FDA says it will recent studies that found women with Essure had a more than 10-fold higher risk of undergoing another operation compared to other methods of sterilization.

A member of Congress will introduce the E-Free Act in the house later on this month to revoke the FDA's pre-market approval.


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