FDA-approved Essure facing complaints from Houston women

Permanent birth control option under scrutiny by women

By Haley Hernandez - Health Reporter

HOUSTON - A permanent birth control option is under scrutiny by thousands of American women who claim it destroyed the inside of their bodies.

The device is called Essure and a group of Houston women spoke to Channel 2 about the drastic options they've had to endure in order to lead healthy lives again.

The company that makes Essure said none of the claims are linked to the device.

"I still felt an excruciating amount of pain," Christine Cervantes said about the procedure.

Despite being on heavy medications, Cervantes claimed she was jumping off the doctor's table in pain.

"I have constant pain. It feels like there's barbed wire in my abdomen," Trysha Yargee said.

All of the women had similar reasons for why they chose this birth control option and all had painful stories.

"It's supposed to be a safer, permanent alternative to a tubal ligation," Alfa Nunez said. "That's why I chose it."

Essure consists of two coils, which are inserted into a woman's fallopian tubes. In theory, that creates a barrier of tissue to prevent pregnancy. The insertion is done in-office without anesthesia, promoted as a 10-minute procedure, and it's often covered entirely by insurance.

However, the Houston women said it has cost them their health.

Cervantes chose Essure, because insurance covered the cost for her, where it would have cost her husband about $800 for a vasectomy. She said the device that was chosen as cost effective proved to be problematic when she got X-rays.

"One tube had migrated and was in my abdomen," Cervantes said.

After the birth of her second child, Kandi McLean, 36, decided Essure was right for her. But, after the device was implanted, she got pregnant. It was a painful and stressful pregnancy.

"All my test results while being pregnant came up red flagged," McLean said.

She and two of the other women interviewed wanted the coils removed. They were left with little choice but to have a hysterectomy. All three women agreed a hysterectomy was instant relief.

OB-GYN Dr. Daniel Mundy said he has placed hundreds of Essure devices without any complications. He hasn't treated these women, but said he doubts it's the device causing their pain.

"Placement is probably the most critical part of whether there's movement of the coils," Mundy said. "If it's not properly placed, that might be the reason some of these patients are having issues with migration."

The FDA tracked complaints about Essure from 2002 through 2013 and found 943 adverse events, or reports of complications, during that time.

Channel 2 Investigates looked at the reports for the last 15 months and found triple the amount of complaints since the FDA study was concluded.

Bayer, which manufacturers Essure, said it is aware of those findings. As a result, the company has updated Essure's long-term risks.

In a video statement sent to Channel 2, Dr. Edio Zampaglione, with Bayer, said, "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 ... This fact has been confirmed by the Food and Drug Administration, whose review of our five-year safety data for Essure found that it did not demonstrate any new safety problems."

"It's just really frustrating. I want them to pull it," McLean said when she heard that statement.

"It cost me four years of my life," Nunez said.

The Houston patients have now joined thousands across the U.S., including famed activist Erin Brockovich, calling for the device to be pulled from the market.

Essure received a form of FDA approval that exempts the manufacturer from liability for personal injuries. However, a woman in Pennsylvania is challenging that exemption, and if successful, her suit could open the door for many other women who have had problems with Essure.

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