Does Hormone-Free Mean Danger-Free in Case of IUDs?
Navigating the complicated realm of different kinds of contraception is often an emotionally taxing experience for many women who want what’s best for themselves. But, unfortunately, you don’t always know what’s right for you when there are so many options.
Perhaps you were thinking about getting an IUD instead of taking a pill because it’s lower maintenance. And you probably didn’t want an IUD with extra hormones because you heard they might not be safe. Or you may have been through so many hormonal options that you wanted something gentler than the hormonal birth control devices you had before.
The Paragard copper birth control seemed like the perfect answer: an easy, low maintenance, hormone-free form of long-term birth control. All you wanted was to make sure you are protected from pregnancy and use a safe medical device, right? But, unfortunately, we hate to say it: Paragard can come with some serious adverse side effects.
It might be that Paragard injured you even when you’ve done all your homework before trying it and read through every single page of the fine print before signing on the dotted line.
Unfortunately, the copper IUD can have the same side effects as hormonal birth control options and has been associated with other serious health issues, such as breaking during removal.
A Tiny Device Turned Into A Big Deal
Manufactured by Teva Pharmaceuticals, the Paragard IUD is the only non-hormonal option on the market. It is presented as flexible, safe, and manufactured by a reputable company – all good qualities when you’re looking for an effective birth control device.
As such, for decades, women have been implanted with Paragard. They and their doctors trusted that Teva Pharmaceuticals was honest and forthright about its safety.
Then the reports of severe injuries and health complications came pouring in. More than 3,000 women have reported the Paragard IUD broke in their bodies to date. But, chances are, these reports are just scratching the surface since they only account for those who felt compelled enough to take time and file their complaints.
You might be one of the women who thought they knew every potential risk associated with having a Paragard – but then something went wrong. Something the manufacturer never warned could happen: your Paragard IUD broke, and you needed a procedure to get it out.
When the Paragard breaks during removal, it often requires invasive and expensive surgery to remove the broken pieces, which can perforate the uterus wall. In addition, these injuries can lead to other problems such as scarring, infections, or damage to nearby organs. It can even cost a woman her ability to bear a child after being forced to have a hysterectomy to remove the broken IUD from her body.
Here Are the Important Ways to Use Your Voice When a Paragard IUD Hurt You
When Paragard was put on the market, Teva Pharmaceuticals had a long list of warnings of problems it could cause. The most severe were:
- Ectopic and intrauterine pregnancy risks
- Life-threatening infections
- Pelvic inflammatory disease
- Embedment into the uterus wall
- Perforation during insertion
- Changes in the menstrual cycle pattern
Despite this list, women found the actual packaging did not list all the dangers. For example, no one warned that the Paragard could break, and in fact, often did break. Furthermore, no one warned that when it broke, either before removal or during removal, it could cause severe damage, often permanent damage.
What happens when you have an adverse effect that was not in the warnings? How do you know if other women had the same problem as yourself, or is this simply an issue on a personal level? The short answer is: through the FDA.
Suppose you or someone in your family experienced a severe reaction to Paragard. In that case, you can either report the issue to:
- Your doctor
- Directly to the FDA using its online reporting form
Unfortunately, most women don’t know that they can be the person that notifies the FDA when they have an adverse reaction to an IUD, and they can help bring about change by asking the FDA to modify the Paragard warning labels.
One person alone most likely won’t make an impact, but when more and more people notify the FDA of an issue, real change occurs, and other women can be warned of the problems. As a result, warning labels can be changed, and harmful products can be taken off the market.
The FDA staff reviews all these reports, and eventually when enough similar problems are reported, the FDA will begin reviewing the issues and take action by initiating label changes with new warnings or, if severe enough, get the product recalled.
Another option is to file a lawsuit to tell the manufacturer that hurting you was not okay. In the instance of Paragard, recent product lawsuits have come to light based on the IUD’s defective design and manufacturer’s failure to warn about the risk of device breakage. After suffering in silence, many women are suing for compensation to cover their medical expenses, pain and suffering, as well as lost wages from their injuries.
About the Author:
Hilda Oltean is a case manager at Atraxia Law. She helps injured women find out if they can file a Paragard claim. In addition, Hilda organizes and supports clients as they gather relevant information to evaluate their rights for compensation.