Essure patients testify at Congressional Briefing, highlight ‘flaws' in FDA approval of the device

CONGRESSIONAL BRIEFING

Women who say they were harmed by the permanent birth control device, Essure , testified Thursday before a Congressional Briefing in Washington, D.C.

Cleveland resident Kim Hudak, 42, told her story to a panel of Congressional aides and officials as part of a Hill Briefing called, “Reforming the FDA: The Impact of Proposed Changes on Patients and Health Policy.”

At age 28, she said she enrolled as part of the clinical trial for a birth control device that was, at the time, called STOP. She had one child and decided she didn’t want more.

The birth control device, now called Essure, consists of two metal coils that are inserted into a woman’s fallopian tubes in order to block conception. It’s billed as a cheaper, non-surgical alternative to tubal ligation, or getting your tubes tied.

But, Hudak said getting Essure began fourteen years of debilitating health problems for her that will likely never be completely resolved.

“Within the first year, I was diagnosed with fibromyalgia, connective tissue disorder, chronic fatigue and restless leg syndrome,” Hudak said. She said she had no previous medial issues.

To read Hudak’s complete speech, click here.

A ‘FLAWED’ CLINICAL TRIAL?

The ABC15 Investigators began reporting on Essure nearly a year ago, when dozens of women across the state came forward to talk about their issues after getting the device . Common complaints include bloating, excessive bleeding, rashes and chronic pelvic pain. Women also told us about serious issues they say resulted from Essure, such as miscarriages and ectopic pregnancies.

After our reporting, the manufacturer, Bayer Health Care, added warnings to the product label , and the Food and Drug Administration (FDA) conducted a review of the Adverse Events reported about the device.

Hudak said she obtained her medical records years after participating in the Essure clinical trial, and what she found shocked her.

She said her information had been altered to reflect that she was doing well with the coils. But, she said she had complained of issues the entire time. The issues were documented in the medical exam, but not in the study information, Hudak said.

It’s what Dr. Diana Zuckerman, President of the National Center for Health Research , called a “huge flaw in how problems are reported” to the FDA. She attended the briefing with Hudak and another representative of the more than 8,300 women who have united on the “Essure Problems” Facebook page .

“The patients are reporting problems to the company, and the company isn't reporting them to the FDA,” she told ABC15. “They're saying, ‘Oh that terrible side effect of horrible pain is not related to the device.’”

But, when women have Essure removed by partial or full hysterectomy, she said, most of them feel much better.

FDA spokesperson Jennifer Rodriguez told ABC15 the agency has reviewed reports of problems with the device, including online testimonials and adverse event reports submitted to the FDA, as well as a five-year post-approval study and the clinical trial literature to determine what long-term complications may be associated with Essure.  

"To date, there is no literature reviewed by the FDA that has indicated any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement," Rodriguez said in a statement.

See the FDA's complete statement below.

FIGHTING FOR OTHER WOMEN

Hudak had a hysterectomy to remove the Essure coils, but said the operation left parts of the coils inside of her.

“It's scary. I don't know some days when I go to bed if I'm going to wake up the next morning because some days I'm really, really sick,” she said.

Now, she’s fighting for the other thousands of women she said are experiencing the same symptoms she has been for more than a decade.

She said she hopes the coils will be removed from the market. But, if they aren’t, she said the FDA needs to thoroughly review the device to determine its safety.

“I don’t want to see these women continue to get sicker,” she said. “I want to see them get help before it’s too late to undo the damage that’s been done.”

If you have had an issue with a medical device, you can report an Adverse Event to the FDA by clicking here .

Bayer told the ABC15 Investigators they have read the stories from the women who are sharing their experiences with Essure, but they do not believe they represent the hundreds of thousands of women who have gotten the Essure coils implanted since the device was approved by the FDA in 2002.

Bayer provided ABC15 with the following statement and this video link from Edio Zampaglione, MD, FACOG, US Medical Affairs, Bayer HealthCare: 

https://elmcity.sharefile.com/d/s754aaca247445f48

(To download the video, only use the link provided.

 No email or password is required.  If it asks you for that, please reopen your server and try the link again.)

Bayer's Full Statement:

At Bayer, our mission is to create drugs and devices that help people.  Patient safety is very important to us, and we have great sympathy for anyone who is experiencing pain, regardless of the cause. We have also read the stories from women who are sharing their personal experiences with Essure. These stories, while compelling, are not representative of the hundreds of thousands of women who have relied on Essure since its FDA approval in 2002.

As the manufacturer of this product, we have a responsibility to share the facts about Essure with you and your viewers:

·         We take all adverse events seriously. Most of the side effects that have been reported recently about Essure are known and included in the Essure Instructions for Use information. This was confirmed by the FDA which found that “[a]lthough there is evidence of complications, as there are with all medical devices, overall results from [a five year safety] study did not demonstrate any new safety problems or an increased incidence of problems already known.”1(http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ucm371014.htm )

·         Essure has more than a decade of research and development in addition to a decade of real world experience.  More than 750,000 devices have been sold worldwide.  Essure has been shown to be highly effective in preventing pregnancy (99.83% based on a 5 year study) and the safety profile has been documented through numerous clinical trials. The American College of Obstetricians and Gynecologists (ACOG) has recognized that “hysteroscopic tubal occlusion for sterilization [Essure] has high efficacy and low procedure-related risk….”2

·         More than 600,000 tubal ligation procedures are performed in the United States each year.3  We stand by the benefit-risk profile of Essure as an important option available to women who want non-surgical permanent contraception.

No form of contraception is without risk, should be considered appropriate for every woman or is 100 percent effective. As with any drug or device, it is important that women discuss the risks and benefits of any birth control option with their physicians.

 

Complete statement from the FDA:

The Essure clinical trial design and outcomes were discussed in detail during a day-long public meeting of the FDA’s Advisory Panel for OBGYN Devices, where the recommendation of the expert Panel was that FDA approve the Essure device. Essure has been shown in a rigorous prospective clinical trial with 5-year follow-up to be extremely effective at preventing pregnancy, which is the intended use of the device. The device labeling (physician and patient) describes risks of the procedure. The currently available alternative to Essure for permanent female sterilization requires at a minimum laparoscopic surgery (including a skin incision and general anesthesia).

The FDA has reviewed Essure patient reports of problems (including web-based testimonials) and adverse event reports submitted to the FDA from a variety of sources, including doctors, patients, and the manufacturer of Essure, Conceptus, Inc. The agency also reviewed the results from a five-year follow-up post-approval study conducted by Conceptus that was required by the FDA as part of the product’s 2002 approval. In addition, the FDA evaluated the available clinical literature to determine what long-term complications may be associated with Essure. To date, there is no literature reviewed by the FDA that has indicated any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement. We take reports of problems with Essure very seriously and will continue to review them carefully. We will continue to monitor the safety of this product to make certain its benefits of providing women with a non-surgical sterilization choice continue to outweigh the risks of the device.

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