Essure: local women describe serious side effects of permanent birth control device

DETROIT (WXYZ) - (WXYZ)  Thousands of women across the country are speaking out about their experiences with a form of permanent birth control called Essure.  Many of the women who came forward to the 7 Action News Investigators say it was one of the worst decisions they've ever made and they want Essure taken off the market.

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"Just trying to get a doctor to believe that you're having the symptoms and it's because of Essure is really hard," said Kimyatta Harper, a 33-year-old old mother of three from Detroit.

"To me, it's almost like a death sentence," said Darlene Taylor, a 43-year-old mother of four, also from Detroit.

"I suffer on a daily basis from constant, severe back pain, abdomen pain," said 31-year-old Katrina Stock, a mother of two from Mt. Pleasant.

These women say they're dealing with chronic pain, severe allergic reactions, intense bleeding and more--all because of a permanent birth control device called Essure.

It's marketed as being safer, less expensive, and less invasive than tubal ligation, commonly known as having your tubes tied.

"My hair started to fall out, and my joints started to hurt to the point where when I get out of bed in the morning -- it's almost impossible to walk," said Janice Terry.  She's only 27, but she says she feels like she's 97.

The mom from Roseville says she was looking to get her tubes tied after giving birth to her third child.  But then she saw a brochure for Essure in her doctor's office.

"I stupidly didn't do any research because I trusted my doctor, she said it was great," said Terry.

To implant Essure, a doctor places small metal coils inside the fallopian tubes to block conception.

It's been around since 2002.  According to the manufacturer, about three quarters of a million women have had it implanted.  It was originally manufactured by Conceptus, which Bayer recently purchased.

After Janice Terry got Essure in 2011, she says she started getting extremely bloated, in addition to several other symptoms that she couldn't explain.  Frustrated, Janice says she "Googled" Essure, only to find hundreds of similar stories online.

"I was like oh my gosh, I'm not crazy!  There are so many other women having the exact same problems who are like, ‘Yep I look seven months pregnant too, oh yeah my hair is falling out too," said Terry.

That's when she joined the thousands of women who are sharing their experiences on Facebook.

There are Facebook pages dedicated to issues with Essure. On one of them, you see woman after woman, many with the exact same symptoms, telling nightmare scenarios.

Most of the comments and photos detail side effects from an allergy to nickel, which is a component of the coils.  Originally, women were required to test for that allergy, but the Food and Drug Administration removed that requirement a few years ago.

In July of 2011,  Conceptus (the original manufacturer) petitioned the FDA to have its stronger contraindication removed and was successful.  Click here to see the press release from Conceptus about removing the skin test recommendation.

The 7 Action News Investigators found more than 838 women and doctors have filed complaints with the FDA since 2004.  There were 150 complaints where the coils broke or miss-fired, and even more where the device moved or punctured the fallopian tube, 80 women became pregnant, and 91 reported having hysterectomies to remove the device.

"Is the federal government doing enough," asked 7 Action News Investigator Heather Catallo.

 "No.  Absolutely not.  Not at all," said a group of six women who gathered for a group interview for our investigation.

All of the women we spoke to say they want to know why the FDA allowed Essure's original manufacturer to remove the warning telling women to get the skin test to see if they're allergic to the nickel in the coils.

"It makes me sick.  It's wrong," said Stock.

Stephanie Nagy says after she was implanted with Essure, her nearly fatal allergic reactions were so severe she had to use an EpiPen and be rushed to the hospital by EMS – with her terrified children watching.

"It's made my children loose me for weeks at a time where I cannot drive, I can't even drive them to school," said Nagy, a 40-year-old mother from Mason, Michigan.

Lenni Wilkins, a 34-year-old mother of three from Clinton Township, said her symptoms only vanished after a hysterectomy to remove the coils.

"I woke up from surgery and I had no hives.  I went into surgery and I had hives.  Just by taking the coils out, it fixed it," said Wilkins.

A spokeswoman for Bayer, which now owns Essure, told us the device is safe and the current label does warn about possible nickel allergies.

"At Bayer, we care about patients and take the safety of our products very seriously.  We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective

of the cause," said Rosemarie Yancosek.

However, the company feels the problems reported reflect a small percentage of the more than 750,000 women who have received the device worldwide.

"A successful outcome is largely dependent in that conversation that you have with your patient," said Beaumont OBGYN Dr. Sangeeta Kaur.  Dr. Kaur said tubal ligation also carries many risks – so patients must ask a lot of questions.

"I think overall, Essure is a good choice for people… If at the end of the day, if a patient chooses to want to have a permanent birth control method, there's going to be risk to either procedure," said Dr. Kaur.

But for the small percentage of women who do have complications with Essure, often a hysterectomy is the only option.

"I'm 33 years old.  I don't want to go into menopause.  And I don't want to have a hysterectomy," said Kimyatta Harper. 

A spokeswoman for the FDA says they have been monitoring the reports of problems with Essure very closely, but they still believe the benefits outweigh the risks.

Some women would like to sue Essure's manufacturer but they can't…  because Essure has a special status called "preemption" with the FDA.

That's why famous consumer rights activist Erin Brockovich has taken up their cause.  Click here to see Brockovich's website.

Here is more information that was provided to us from the Bayer spokeswoman:

"At Bayer, we care about patients and take the safety of our products very seriously.  We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause.  Essure was approved by the FDA in 2002, and has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure's safety, efficacy and cost-effectiveness.  Approximately 750,000 women worldwide rely upon the Essure procedure for permanent birth control.  A recent practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) has recognized that hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk, cost, and resource requirements. 

All Essure studies that are either planned or active are listed on ClinicalTrials.gov .  Bayer is developing the next generation Essure and is in the process of planning the clinical trial program. 

Per your question regarding the nickel warning, I want to note that the use of a nickel titanium alloy in Essure remains as a warning in the product label.  It can be found on page 1 of the Essure Information For Use insert in the Warnings section.  The language is pasted below:

From Warnings Section:

·         The Essure micro-insert includes nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. In addition, some patients may develop an allergy to nickel if this device is implanted. Typical allergy symptoms reported for this device include rash, pruritus, and hives.

In regards to the classification of Essure, the US Food and Drug Administration, not the manufacturer, classifies medical devices based on the level of control necessary to assure the safety and effectiveness of the device.  Devices are classified into one of three categories—

Class I, Class II, and Class III.

Class III devices are subject to the highest level of regulatory control.  For Class III devices, such as Essure, a premarket approval (PMA) application is required by the FDA before they are marketed.  Through the scientific and regulatory review of the PMA application, the safety and effectiveness of Class III medical devices is evaluated by the FDA.

No form of birth control is without risk or should be considered appropriate for every woman.   It is important that women discuss the risks and benefits of any birth control option with their physicians."

Click here to report an adverse event with the FDA.

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