Since 2010, the FDA has received over 2,800 reports of the Paragard device failures including:
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Since 2010, the FDA has received over 2,800 reports of the Paragard device unexpectedly breaking inside the uterus, migrating out of position, or causing perforation of the uterus. In many of these cases, women were severely injured or required surgery as a result.
A number of women have experienced severe complications and injury during the Paragard removal process. Paragard’s website states that the removal process is usually quick and easy, but that: “In rare cases, Paragard may be hard to remove because it is stuck in the uterus. Surgery may sometimes be needed to remove Paragard.”
Recent studies claim that Paragard, the 380 product models in particular, may cause serious injuries and complications. The Paragard IUD specifically can migrate throughout the body and/or get embedded or lodged in various parts of the body, like the uterus.
Many women have reported that the device can also break during the removal procedure and that the broken pieces must be painfully removed one by one with a complicated surgery to avoid organ damage.
In some instances, the fragments can become embedded so deeply inside the woman’s tissues that a full hysterectomy (removal of the uterus) is required, with devastating psychological and physical consequences.