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.
Essure
"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
We found 62,651 complaints about pregnancy involving Mirena, Paragard, and Skyla between 2010 and 2016.
"It was shocking at first. For sure," said Hannah, a Colorado mom who got pregnant after while using the Mirena IUD.
"It's potentially dangerous," said Dr. Kimberly Gecsi, an OB/GYN at University Hospitals in Cleveland.
"Nothing in life is 100%. Including contraception," she said.
Manufacturers' Response
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."
