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U.S. FDA Warnings Regarding Paragard IUD

Doctor Looking At Xray Of Pelvis IUD

Widely-Used Paragard IUD May Be More Harmful Than Previously Thought

When it comes to IUDs, ParaGard is one of the most well-known in the American market; Paragard TV commercials have earned the contraceptive broad recognition. Indeed, it's "up there" with other brand-name IUDs such as Mirena and Skyla, though it's touted as a unique option because it is hormone-free. Learn more from a dedicated Paragard lawyer.

Paragard is also popular because it is an effective and temporary contraceptive. This is to say, a patient could have the IUD implanted for a long time and if they decide they want to bear children, they can simply have the IUD explanted.

However, recent cases have shown that this same explanation process, the one believed to be so simple it can be performed in an outpatient clinic, has the potential to cause severe harm. And yet, it seems like this hazard is not widely advertised.

Paragard Safety Warnings

Among Paragard's publicly advertised side effect are:

  • Ectopic pregnancies
  • Life-threatening infections
  • Pelvic inflammatory disease (PID) or Endometritis
  • Embedment
  • Perforation
  • Expulsion
  • Reactions after placement
  • Infertility

The injuries and ailments listed above are quite serious in nature. Yet, it does not appear that the manufacturers make much mention of complications during the removal process. It is, in fact, during this removal step that many health providers found that the IUD would break into multiple pieces. These pieces, now lodged inside the uterus and possibly having pierced it, often require surgical procedures to remove.

Even when surgery is completed, it is not guaranteed that adverse health effects will cease. In fact, many patients have already been forced to undergo hysterectomies after a failed Paragard removal. Terribly, none of these patients will have the ability to bear children again.

Has Paragard Been Recalled By The FDA?

In the year 2014, a "batch" of Paragard devices were indeed recalled by the U.S. Food and Drug Administration (FDA). This recall was done voluntarily by TEVA Pharmaceuticals, one of the IUD's manufacturers. But it was not permanent nor widespread in scope. It appears this recall was more related to a specific batch of faulty devices and not the entire Paragard product line.

Yet, with the rising number of incidents producing health complications during Paragard explantation, the FDA should certainly be keeping a close eye.

This would not be the first time that calls are made for a contraceptive IUD to be recalled. Mirena, another popular contraceptive device, is still involved in complex litigation over the injuries that users of the IUD were suffering.

If No Paragard Recall Has Been Made, Can A Lawsuit Be Filed?

If you or a loved one suffered injuries as a result of using Paragard, you may be wondering which legal options are at your disposal. You may believe that filing a Paragard lawsuit is the just thing to do, but if a government agency such as the FDA hasn't alerted the public, does it mean that the manufacturer has committed no wrongdoing? Not necessarily.

More than 50 other victims have filed individual lawsuits against Paragard as a result of complications from the device. While the litigation is ongoing, it makes it clear that those who have suffered because of the negligence exhibited by Paragard's manufacturers can seek justice.

If you would like to learn more about your legal avenues for seeking compensation, contact our team today for a free consultation. The Product Lawyers are a team of attorneys with experience in defective product (and medical device) lawsuits. They can help you build a strong case and fight for what's right. Don't delay - call today as statutes of limitation may exist.

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Laurence Banville
Date Published: December 22, 2020
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