Controversial Contraceptive: Essure Part 2


Tonight a deeper look into our TV6 investigation on the controversial contraceptive - Essure.

Last week we brought you the stories of three women with unexplained pain and symptoms. They believe Essure is to blame.

Tonight, in part two of the series, doctors say Essure can still be considered a safe device. Especially when used correctly.

As KWQC's Amber O'Brien reports  another woman in the QCA deals with a rare Essure problem.

"I jokingly told a co-worker if I didn't know any better I'd would think I was pregnant." Ellen Hanrahan got on Essure to prevent pregnancy. She was in her thirties and using birth control pills. Her doctor recommended something more permanent.

"I was approaching 35 and my doctor recommended I quit using birth control pills and look at maybe a more permanent method of sterilization," Ellen tells TV6.

One of the most familiar ways to do this: is through tubal sterilization or getting your tubes tied. However,  in recent years a new, popular device called Essure has hit the market.   

"So we kind of reviewed all of our different options and she presented this Essure product as minimally invasive, and easy to recover." For Ellen it was a good and final option. Her doctor told her it's permanent, irreversible and she should make sure that she was 100% done having children. 

The Essure device is a pair of metal coils designed to be inserted or implanted into a woman's fallopian tubes. After several months scar tissue builds up around the coils and then creates barriers to prevent pregnancy. Bayer markets the product as: a simple, minimally invasive procedure that doesn't require any recovery time. According to a doctor we talked to, all of that is true.

"You can walk in as an outpatient and have Essure done and conceivably even go back to work the same day. There's no incision involved, it's done through a hysteroscopy where inserts are placed in each tube, says local OB/GYN Dr. Maurus.

He tells us Essure has particular advantages, especially for women who are obese or have had prior abdominal surgery, or need to avoid anesthetics. In some cases, he may recommend it in place of tubal sterilization. But those who want the device installed do have to jump through some hoops to get it.

"The Essure procedure is a little more complicated, however in many ways simpler. You come and have a minor procedure, you have to use birth control for 3 more months, you have to go through a procedure to make sure your tubes are blocked 3 months afterwards," says Dr. Maurus.

Ellen Harrahan followed all of the steps. "I had the HSG dye study done which confirmed that they were in the correct place and my tubes were blocked," says Ellen. Her doctor confirmed she was sterile.

"The brochure I read before I got it, said there has been zero pregnancies in 5 years of clinical studies, 99.83 percent effective, and everybody says pregnancy is not possible if you follow the guidelines," Ellen explains.

Ellen didn't have symptoms like the other women we first mentioned last week, like extreme fatigue, pelvic pain, or migraines. As far as she knew Essure was working. "The procedure for me was easy. I didn't notice anything was wrong until about a little over a year later. I was extremely tired, exhausted. I just thought I was worn out." Instead…

"I jokingly told a co-worker if I didn't know any better I would think I was pregnant. So before I went to a doctor I decided to actually take a home test to rule it out and then I would go. Except it didn't rule it out, the test was positive."  Ellen was 10 weeks along with a baby girl.

She tells us she was shocked to see the positive test, "I can still think of the feeling now, just how shocking it was for both me and my husband." Ellen explains at that time, no one was concerned about how it happened...  because no one was sure. What they were worried about – was the 10 week old developing normally.

Dr. Maurus tells us anytime a woman gets pregnant after permanent sterilization it is dangerous. "When pregnancies do happen after either of these procedures there has to be great concern."

For Ellen, the concern was the lack of information. "There is no research at all on the health of the mother or the baby and what the coils may do. Could they be somewhere in the body that could affect the pregnancy?" wonders Ellen.

She suffered many scares and health issues during her pregnancy with her daughter. She tells us it was a rocky road. She screened positive for a 1/83 chance for down syndrome. Ellen was also 37 at the time.

But finally baby Leena was delivered healthy

"She's a blessing. Absolutely never one we would have thought," Ellen explains.

Doctors say the chances of getting pregnant while on Essure are very small. "The failure rate is very, very low. Way less than 1 percent," explains Dr. Maurus.

Over 750,000 women nation-wide rely on Essure. However, according to Essure's 99.83 percent success rate over 1,300 women could be or could become pregnant.

 "These things are very rare and I don't think should dissuade women who want permanent sterilization to do them. But like any operation there can be complications and they can be serious," said Dr. Maurus.

He tells us it is extremely important for women, and even men, to do their research before picking a birth control or sterilization. Talking to your doctor is key.

"Properly informed consent. As is with any operation you want to talk about benefits, risks and alternatives"

Two weeks ago Amanda Dykeman, one of the women dealing with Essure in the QCA and a dozen others rallied in Washington D.C. outside of the annual AAGL conference fighting to raise awareness about Essure. AAGL represents thousands of gynecologic professionals world-wide.

Other local women dealing with Essure have contact state representatives and plead their cases. Women with Essure problems are hoping to get the device off of the market and to dissuade anyone from choosing this type of birth control.

If you are looking for support from women with Essure, you can join their "Essure Problems" group on Facebook.

Famed Consumer Advocate Erin Brockovich has jumped on board. She is now soliciting the stories of women who have had Essure complications. However, due to a law passed in the 1970's medical devices like Essure, which go through pre-market testing and are approved by the FDA, are exempt from lawsuits.  Here is a link to her website:

© Copyright 2000 - 2014 WorldNow and KWQC