Women report IUD, Essure pregnancies

Posted at 11:46 PM, May 24, 2016
and last updated 2016-05-25 11:06:32-04

Our 5 On Your Side Investigation reveals a rare, but shocking side effect of popular forms of birth control.

We found thousands of women using birth control devices, including IUDs, reported pregnancies. 

5 On Your Side Investigators reviewed several years of FDA reports about Mirena, Paragard and Skyla, which are IUDs, as well Essure, a sterilization device.


"You don't worry about it. And then, one second,  "Boom, there it is," said Amanda Lama, a Northeast Ohio mother.

Lama discovered she was pregnant with her fourth child after she got Essure. The device is supposed to be a permanent form of birth control.

Essure's metal coils are inserted into the fallopian tubes to block conception.

Since 2012, the FDA reports 631 women have reported pregnancies with the device, including 294 miscarriages.

IUD Pregnancies

IUDs are tiny, T-shaped devices inserted into the uterus to prevent pregnancy. They've become increasingly popular because they can remain in place for years and require little maintenance.
Five On Your Side Investigators reviewed adverse event reports filed with the FDA about three of four IUDs currently on the market.

We found 62,651 complaints about pregnancy involving Mirena, Paragard, and Skyla between 2010 and 2016.
A fourth IUD, Liletta, was introduced in 2015. So far, no pregnancies have been reported to the FDA.

"It was shocking at first. For sure," said Hannah, a Colorado mom who got pregnant after while using the Mirena IUD.
"It was actually right after I'd gotten married.  Like less than month after, I gotten married," she said.
She eventually gave birth to a son. In spite of the failure, she said she would use an IUD again.
IUD Pregnancy Risks
Doctors, manufacturers, and the CDC said the chances of pregnancy with an IUD are rare and report the failure rate as less than one percent.
However, when pregnancies occur, there are increased risks.

"It's potentially dangerous," said Dr. Kimberly Gecsi, an OB/GYN at University Hospitals in Cleveland.

Miscarriages and ectopic pregnancies, where the embryo grows inside the fallopian tube, become more likely.
"If a pregnancy happens in a tube, that is a potentially life-threatening diagnosis for a patient and she would need to have treatment for that," said Gecsi.
Overall Risks
However, Gecsi said the overall risks of using an IUD or Essure are low and said the devices are safe.
Gecsi told us she routinely recommends IUDS to her patients.
"If you want to have what's going to work best, a long acting reversible contraception like an IUD or sterilization are your best bets," she said.
They're also reliable. According to the CDC, the failure rate of IUDs is less than one percent.
However, Gecsi said she has seen pregnancies occur with every form of birth control, including IUDs.

"Nothing in life is 100%. Including contraception," she said.

Manufacturers' Response

5 On Your Side Investigators reached out to Bayer, which manufactures Essure, Mirena, and Skyla.

A spokesperson sent us the following statement:

"No method of birth control is 100% effective. The efficacy rates of our products are included in the labels, just as with every FDA-approved birth control option. I am happy to provide what you need if you have any specific questions."

5 On Your Side Investigators also reached out to Teva Pharmaceuticals Ltd, which manufacturers Paragard.

A spokesperson sent us the following statement:

Thanks again for making Teva aware of your IUD story and giving us the opportunity to provide information regarding PARAGARD®.

Teva is committed to providing safe and effective medicines for patients. Paragard® (intrauterine copper contraceptive) is one of the most effective forms of birth control available. When used as directed, PARAGARD® has demonstrated in clinical trials to be more than 99 percent effective at preventing pregnancy.

Although uncommon, pregnancy while using Paragard® can be life threatening and may result in severe infection, shock, premature labor and delivery, loss of pregnancy or fertility. A pregnancy with Paragard® in place has a greater than usual chance of being outside of the uterus (ectopic).  Women should not use Paragard® if they are pregnant or suspect they may be pregnant. If a woman thinks she may be pregnant while using Paragard®, she should contact her healthcare provider right away. Women should call their healthcare provider if they have any concerns about PARAGARD®, including if they miss a menstrual period.

Teva takes all reports of adverse events associated with the use of PARAGARD® very seriously. Our drug safety department conducts follow up and evaluation of all such events and reports findings to the FDA.

It is also important to note that following Paragard® placement, a woman should return to her healthcare provider after her first menses to check the strings and confirm proper placement of the IUD. A woman should also do a monthly string check to make sure the Paragard® is still in her uterus."