FDA investigates permanent birth control Essure after receiving thousands of complaints

RALEIGH, N.C. (WNCN) — The FDA is investigating a permanent form of birth control called Essure after receiving thousands of complaints from women.

When Tess Schulman, of Clayton, was 38, she decided she wanted a permanent form of birth control and approached her doctor about a tubal ligation.

“They said, ‘That’s great.  We’ll schedule you in but the doctor will probably talk to you about Essure,’” she said.

Essure consists of two coils placed into the fallopian tubes, during a non-surgical procedure in a doctor’s office. Once the coils are in the body, scar tissue forms around them and blocks the tubes – preventing pregnancy.  Wanting to avoid surgery, Schulman opted for Essure. She signed a handwritten consent form before the procedure.

“My consent was basically: the patient and the husband are here together and reviewed the procedure and the permanent nature and we both agree on no kids,” Schulman said.

A follow–up X-ray a few months later showed the device worked.

“Probably about two months after that X-ray, my very first symptoms were gastrointestinal,” Schulman explained.

“Just excruciating abdominal pain,” she added.  “I went to the ER. I was in so much pain I could not sleep could not eat. I had no idea what was going on.”

Over the next six years, Schulman says  her symptoms increased, she developed migraines, and severe allergies to everything from foods, to medications, to metals

“I can no longer wear any of my jewelry including my wedding band,” she said.

Numerous tests showed no problems.

“I had the abdominal bloating,” she added.  “I looked nine months pregnant.”

She said doctors didn’t know what was wrong.  “They would look at me and go, ‘We see something’s wrong but the tests are normal so we don’t know.’”

“Some days, I honestly thought one day I’m just not going to wake up,” she added.

After seeing a news story about other women who’d had issues after getting Essure, Schulman  wondered whether the permanent birth control could be the source of her problems..

A Facebook support group linked her to thousands of other women who believe they’re also suffering from side effects related to Essure.

Michelle Morton is also a member of the site.

“You almost felt like you were losing your mind,” she said.

Morton said she had severe abdominal pain for nearly five years after Essure was implanted,

“I had CAT scans and colonoscopies and different gynecological procedures,” she added.

She finally linked her pain with essure after finding the Facebook group, but said she got few answers from doctors

“They’re not trained when there are complications,” she said.

According to Essure’s website about 750,000 of the devices have been sold worldwide, and in a video statement posted on YouTube in February , Bayer, the manufacturer of Essure acknowledges some women who use the device have experienced issues, though the maker does not recognize any causal link between essure and those problems.

In the video, a woman identified as Dr. Patricia Carney:  Director  U.S. Medical Affairs for Women’s Health Bayer, Board Certified OB-GYN,  says in part, “We have great sympathy for anyone who may have experienced problems following an Essure procedure, regardless  of the cause of those problems.”

Bayer referred us to OB-GYN Dr. Vijay Sheshadri with Triangle Physicians for Women in Cary. He’s  performed numerous Essure procedures over the past decade.

“I have had one person with chronic pain,” he explained, adding, “She and I are working together to remedy that. I’ve had one or two devices that have migrated, but overall, that’s about it. It’s a handful of people in many procedures.”

He says overall he believes his patients have been happy with the device.

“I think it’s very safe and it’s been used very effectively,” he said.

Schulman showed pictures of what her internal organs looked like after six years with Essure.

“You can see the coil in my tube,” she said. “It was starting to erode through my fallopian tubes.”

“That tissue has fused my uterus my tube my ovary my bowel all together,” she added.

The pictures are from her surgery to have Essure removed. She and Morton both decided to have hysterectomies. Morton is also part of a lawsuit against Bayer.

“The decision to have a hysterectomy is very emotional and it’s a very hard decision to make,” Morton said.

Schulman said, “The irony is I chose this device to avoid a band-aid surgery, a tubal ligation, and wound up having an incredibly invasive major surgery and losing organs.”

After their  surgeries to remove Essure, both Schulman and Morton said their symptoms eased

“I’m honestly not kidding that I woke up from surgery feeling better than I had in six years and ever since that day everything has improved,” said Schulman.

The FDA has ordered additional clinical testing for Essure and  will soon require a box warning on the device as well as a patient decision checklist doctors must go over with anyone considering Essure.  Dr. Sheshadri says he discusses risks and benefits with patients before implanting Essure. Bayer says it offers trained specialists to answer questions by phone.

Bayer issued the following statement about Essure:

“Bayer stands by the positive benefit-risk profile of Essure. It is critical that the science-based, data- driven regulatory process already in place at FDA guides the path forward.

“We are aware that there are women using social media to share stories of issues they have had following the Essure procedure. We take all adverse events seriously. Most of the adverse events that have been reported about Essure are known and included in the Essure Instructions for Use. We continuously collect and analyze all adverse event data we receive and work closely with FDA in monitoring the safety profile of Essure.

“We are particularly concerned about statements that may be creating an atmosphere of unfounded fear, or that may be encouraging women who are not experiencing adverse symptoms from Essure to seek removal of Essure.  The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-surgical procedure, is supported by more than a decade of science, as well as real world clinical experience, with the product studied with more than 10,000 women since Essure was first developed.”

To see Bayer’s complete video statement, click here: https://www.youtube.com/watch?v=2sp9qTB4ZFE

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