You’ve Got Power: Make Your Voice Heard When A Medical Device Hurts You

By January 15, 2021Legal 101

You’ve done all your homework before trying a new drug or getting a surgery. You read through every single page of the tiny fine print before signing on the dotted line. You thought you knew every (potential) risk associated with what you were about to do – but then something went wrong. Something you were never warned could possibly happen. For example: your Paragard IUD broke, and you needed a procedure to get it out.

Well, now what? What happens when you have an adverse effect that was not in the warnings? And more importantly – how do you know if it was just you or if other women had the same problem?

The short answer is through the FDA. In the instance of Paragard, recent product lawsuits have come to light based on both a failure to warn and the IUD’s defective design; both of which have been brought to the attention of the FDA. What most people don’t know is they can be the person that notifies the FDA when they have an adverse reaction to a product, and they can help effectuate change by getting the FDA to alter warnings about the product.  

One person alone most likely won’t make a change, but when more and more people notify the FDA of an issue, then real change does occur and other people can be warned of the issues. Together, they ultimately can help get warning labels changed and bad products off the market.

When Paragard was put on the market, the manufacturer had a long list of warnings of problems it could cause – the most severe being ectopic pregnancy, sepsis, pelvic inflammatory disease, embedment, perforation of the uterine wall or cervix during insertion, expulsion of the device and menstrual cycle pattern changes. 

Despite these warnings, no one warned that the Paragard could break, and in fact, often did break. No one warned that when it broke, either before removal or during removal, it could cause severe damage, often permanent damage, and could even prevent a woman from ever being able to have a child. You see Paragard was intended to be temporary birth control, but the damages it can cause are often permanent – forcing women to have hysterectomies in order to remove the broken IUD from their bodies.

If you ever believe that you or someone in your family experienced a serious reaction to a medical product, MedWatch wants you to either report the issue to your doctor or directly to the FDA using its Online Reporting Form.

**The following are the ways to submit an adverse report to the FDA:

  • Report Online here.
    • Report using the Consumer Reporting Form FDA 3500 B. For instructions see MedWatchLearn
    • Call the FDA at 1-800-FDA-1088 to report by telephone
    • Report through a healthcare professional using FormFDA 3500.

The FDA staff reviews all these reports and eventually, when enough similar problems are reported, the FDA will begin reviewing the problems and take action by initiating label changes with new warnings or if severe enough get the product recalled.

And’s that your true power: helping protect other women from being hurt. Be sure you use that power and report any adverse problems to the FDA ASAP!

And another way you can use that power? File a lawsuit to tell the manufacturer that hurting you was not okay. Contact us here to find out how (at no cost to you!).

-Brooke