As intrauterine devices (also known as IUDs) grow in popularity among doctors and their patients as a method of birth control, more women are reporting a rare and potentially life-changing side effect: unintended pregnancy.
"In December I started having symptoms of pregnancy. I was tired all the time. And I didn't even think, 'Oh, I'm pregnant.' Because I had the IUD. It's just logical that's not going to happen," Melody Reh, a Colorado mother, told Denver7 Investigates.
Reh discovered she was indeed pregnant, but miscarried before she could see her doctor. She started researching IUDs online and joined a Facebook support group with thousands of members who believed they were suffering from wide-ranging side effects from the birth control devices.
"I think anybody taking any method of birth control intrinsically knows that there's probably a failure rate. But with the IUDs it's such a rare outcome," said Dr. Kristina Tocce, an associate professor of obstetrics and gynecology at the University of Colorado.
"Probably a lot of women who are watching this have a friend who got pregnant on a birth control pill. But hardly anyone has a friend who got pregnant with an IUD in place. So I think that that sort of peer-to-peer, friend-to-friend conversation doesn't exist for the IUDs yet. Hopefully, as IUDs are taken up more and people are talking about them more, that will be something that will be more on the forefront on patients' mind," she said.
IUDs are small, T-shaped devices inserted into the uterus by doctors to prevent pregnancy. They can remain in place for years.
Denver7 Investigates obtained adverse event reports filed to the FDA regarding the four IUDs on the market today: Paragard (a copper hormone-free device) and the three hormonal devices: Mirena, Skyla and Liletta. (Liletta was introduced to the market in 2015 and the FDA report did not include any pregnancies.)
Mirena and Paragard have been on the market the longest, and Denver7 requested four years worth of reports from the FDA.
In that time period, the FDA had record of more than 11,000 adverse event reports regarding Paragard, which included a wide range of problems including uterine perforation, IUDs moving out of place, devices falling out, and infections. More than 800 reports detailed unintended pregnancies, some with potentially-life threatening complications.
The same report for the Mirena (which doctors told Denver7 is the most widely-used) included more than 50,000 adverse events including more than 2,800 involving pregnancy. The Skyla report included close to 1,100 adverse events, nearly 150 of them pregnancies. (The FDA includes a number of disclaimers with these reports, noting: "Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events. Because FDA may receive reports on the same patient from more than one source, some of these cases may be duplicate patient reports.")
Doctors tell Denver7 the different devices prevent pregnancies in different ways: the copper ions in Paragard work as a spermicide, while the hormone-releasing devices thicken cervical mucus to prevent sperm from entering the uterus.
Doctors and IUD manufacturers say pregnancies with the devices in place are extremely rare and happen in less than 1% of patients. But those rare pregnancies can come with potentially life-threatening complications, so doctors advise seeking medical attention right away if women suspect they are pregnant with IUDs in place.
"The first thing we need to do is rule out an ectopic pregnancy. That's a pregnancy that develops in the fallopian tubes instead of the uterus," said Dr. Tocce.
Ectopic pregnancies are not viable and can potentially rupture, endangering the woman's life.
"We are able to recognize that patients who conceive with an IUD in place, if that IUD stays in place during the pregnancy, they have a higher risk of certain complications. Those complications include premature rupture of membranes, so the water breaking before full-term, premature delivery, and infection in the uterus during the pregnancy," Dr. Tocce said.
Denver7 Investigates obtained detailed case reports from the FDA involving complicated pregnancies with IUDs in place. In one report, a woman detailed discovering she was nearly five months pregnant with the Paragard IUD after experiencing cramping pains. A few hours after learning she was pregnant, her water broke during the celebration dinner. "The doctor told me I had a severe uterine infection that took my son's life. An infection caused by the IUD."
Another report says a woman delivered 24 weeks prematurely. Her child survived only 74 days.
"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," Michelle Larkin, a spokesperson for Paragard manufacturer Teva, told Denver7 Investigates in a statement.
Dr. Tocce told Denver7 Investigates removing the IUD from a pregnant mother sometimes causes a miscarriage, but it reduces the risk of complications later in the pregnancy.
"Although patients are often very concerned about that risk, I try to reassure them that often a miscarriage does not occur, and if the pregnancy is maintained, it has a much better chance of being a normal full-term pregnancy if we get that IUD out," she said. "The data that we have available is very clear that that risk is outweighed by the benefit of decreasing later risks."
Despite the risks, many women have uncomplicated pregnancies, like Hannah, a Colorado graduate student studying medicine. (She declined to use her last name.)
"Less than a month after I'd gotten married, I missed a period. I was thinking that was strange and took a home pregnancy test and found out I was pregnant," Hannah told Denver7 Investigates. "It was shocking at first ... Luckily we were in a financial and professional place where it was an OK outcome for both of us. So in that way we were really lucky with it and decided to continue the pregnancy."
Hannah's son, Max, was born healthy at full-term. He is nearly 2 years old. She said she will consider getting an IUD again in the future, despite the device's failure to prevent her pregnancy.
"I think it works well for most people who use it, despite my individual outcome," Hannah said. "I'm definitely an exception but an exception that I think needs to be, I guess, known about. That it does happen."
As for Melody, she says she wishes she had never had the device placed in the first place. She had problems with the IUD from the start, including the insertion, which she said was especially painful.
"The things I've gone through as a woman, just as a person, it absolutely has scarred me for life," Reh said.
Reh said she felt like the IUD was poking her but when she mentioned the issue to medical professionals, they brushed it off. Ultimately, after her miscarriage, she had to go to a specialist to have the device removed because it had moved out of place and embedded in the wall of her uterus.
Facebook support groups for IUD users are filled with stories from women saying their doctors will not listen to their concerns about what they believe are side effects of their birth control devices. Some even say their doctors will not remove the devices for them, and some post they have even decided to remove the device on their own.
"I would not advocate for that because you're not always successful in getting it out yourself," Dr. Tocce said. "It really pains me that patients are not being respected in terms of what they want. If someone comes to us in our practice and wants their IUD out for whatever reason, we take it out. We respect our patients' wishes and remove it. If any patient has that occurring I would urge them to get another opinion and seek another physician."
Teva, maker of Paragard, told Denver7 in a statement its product information includes warnings of the rare potential side effects of the device.
"Teva is committed to providing safe and effective medicines for patients. Paragard 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," a spokesperson wrote.
Dr. Tocce said most of her patients have a positive experience with the IUD.
"The majority of patients do so well. And it's just a really great method. And I just hope that as we get the word out more, more patients will talk to their doctors and get more information and make a choice that they're comfortable with," she said.
"Stories that point out complications that are very rare might scare people away from using these devices but I really hope patients will really hear the overarching message here that they are extremely safe, extremely effective, and although there are very small numbers of patients who experience adverse outcomes, that can be said for anything in medicine. High blood pressure medicine, diabetes medicine, any type of surgical procedure. There are always a small percentage of patients who are going to have a less than optimal outcome. But I think the benefits of getting more information out there for patients to have, process, and then go talk to their doctors about is the most important thing we can do."
Denver7 asked what women can do to help ensure they have the best outcome. Dr. Tocce recommended women who want to get IUDs go to a gynecologist or family planning clinic where staff are accustomed to placing the devices on a daily basis. Teva also encourages women to do monthly string checks to ensure their IUD is still in place.