Is Paragard safe?
A record 4.4 million, or 7.8% of all women in the United States now use intrauterine device (IUDs), such as Paragard. Paragard was first introduced to the marketplace in 1984, and has been touted as a safe, effective “no hassle, low maintenance birth control” that can be placed by a healthcare provider in minutes.
Manufacturers, however, failed to warn about the Paragard’s tendency to break or fracture. Since 2010, there have been 2,800 reports to the FDA of unexpected Paragard breakage. Paragard is made of plastic and wrapped in a thin layer of copper. The plastic has been found to deionize over time, which leads the arm of the device to break on its own, or during the removal process.
Unfortunately, when Paragard breaks or fractures, it can lead to perforations of the uterus, infections, scarring, organ damage, and severe pain. In addition, if the device punctures a woman’s abdominal wall, she may need to wait one to two years before she can become pregnant. In order to remove the broken arm of the device, a woman must undergo invasive surgery, such as hysterectomy, c-section, or hysteroscopy.
A Brief History of Paragard
Paragard was developed by Teva Pharmaceuticals and was first approved by the FDA on November 15, 1984 through a New Drug Application (NDA). Between June 2016, and June 2017, Paragard had sales of $168 million. On November 1, 2017 The Cooper Companies announced the purchase of Paragard from Teva Pharmaceutical Industries Ltd., for approximately $1.1 billion.
What to do
If you or someone you love has been injured by Paragard, please contact us at 877.529.3707 877.529.3707 as soon as possible.
The Paragard lawyers at Cowper Law LLP have a deep knowledge of IUD lawsuits, medical devices, FDA law, and products liability. The firm has a passion for issues facing women. We currently represent 600+ women in the Essure permanent sterility device litigation where we are one of five law firms sitting on the Plaintiffs’ Steering Committee. We also represent700+women in the Allergan breast implant litigation and siton the Plaintiffs’ Steering Committee.
Call us at 877.529.3707 for a free evaluation of your ParagardIUD case today.