medical device failure IUDIf you or a loved one suffered an injury from the Paragard intrauterine device (IUD), you might be eligible for financial compensation. Contact Gray & White Law to have one of our experienced medical device attorneys review your case.

What Is the Paragard IUD?

The Paragard IUD is a non-hormonal birth control device designed to work for up to ten years. The United States Food and Drug Administration (FDA) approved the Paragard IUD in 1984, and, starting in 1988, the device has been marketed as long-lasting, hormone-free birth control that is over 99% effective at preventing pregnancy. Teva Pharmaceuticals manufactured the device and sold it to The Cooper Companies for $1.1 billion in 2017.

The Paragard IUD uses copper to produce a reaction that prevents pregnancy. The copper wires coil around the plastic T-shaped IUD to produce an inflammatory reaction while continually releasing small amounts of copper into the uterus to prevent the sperm from reaching the egg. The device must be implanted and removed by a medical professional. Paragard IUDs are intended to be reversible, allowing women to get pregnant after they are removed.

Paragard IUD Complications

While the Paragard IUD has been marketed as a safe and effective birth control option, women have reported suffering from painful and severe injuries. Many of these injuries occur during the removal of the device. Since 2010, the FDA has received over 1,600 reports of the copper IUD breaking or fracturing, including at least 700 serious injuries.

Our medical device attorneys are investigating potential lawsuits for women who have suffered the following complications after implantation or removal of the Paragard IUD:

  • Fractured or broken device
  • Serious infections
  • Migration of the device to other parts of the body
  • Embedded device in the uterus
  • Damage to the uterus or other organs
  • Perforation of the uterine wall
  • Ectopic pregnancy
  • Surgery to remove the device
  • Hysterectomy

This list is not exhaustive. If you have suffered from any severe complications due to the Paragard IUD, contact our attorneys as soon as possible for a free consultation to review your case.

The Danger of Broken Paragard IUDs

The Paragard IUD is supposed to remain intact, in one single piece, during the removal procedure. However, several doctors and patients have reported one or both of the arms of the T-shaped device breaking off during the IUD explant procedure. To remove the Paragard IUD, a doctor gently pulls on the monofilament threads which hang down from the uterus into the vagina. When the doctor pulls on the monofilament threads, the two arms of the Paragard, which are made out of polyethylene plastic, are supposed to bend upwards while being pulled through the cervix.

The issue that has been repeatedly reported with the Paragard IUD is that the arms of the device are not bending easily like they were designed to do. The plastic that the arms are made out of is presumably too brittle, causing the arms to break off or fracture upon removal. There have also been reports of the Paragard IUD breaking on its own in the uterus without any attempt of removal.

When the arms of the Paragard IUD break, the fractured pieces left behind in the uterus can cause serious health risks. The broken pieces could become embedded in the uterine wall, perforate the uterus, or migrate to other organs. These risks could create various health problems for women, such as:

  • Bleeding
  • Acute and chronic abdominal pain
  • Abnormal vaginal discharge
  • Pelvic infection
  • Pelvic inflammatory disease (PID)
  • Infertility
  • Organ damage
  • Complications with the fetus or during birth if the woman becomes pregnant
  • The need for a hysterectomy

Additionally, many women who have had their Paragard IUDs break also suffer from the emotional trauma of not being warned of the possibility of the IUD breaking and the feeling of being invaded by having fragments of the IUD stuck in their bodies.

In some cases, doctors can remove the IUD's broken pieces through a hysteroscopy, which is an invasive procedure where the doctor inserts an endoscope through the cervix into the uterine cavity. Unfortunately, these procedures are not always successful, especially when the broken IUD pieces become stuck or embedded. Sometimes more extreme procedures, including exploratory surgery or a full hysterectomy, are required to remove the pieces if the pieces are causing severe complications.

Broken Paragard IUD Reports

In 2015, independent researchers published The 'Broken' IUD: Its Detection and Clinical Management in the Open Journal of Clinical & Medical Case Reports. The study describes seven cases of Paragard IUD users who presented problems relating to a broken IUD, all of which were treated at one medical facility. The documented cases occurred between 2012 and 2014 and included the following patients:

  • 32-year-old: embedded arm of the IUD which broke during an attempted removal six years after it was implanted
  • 38-year-old: embedded arm of the IUD which broke during an attempted removal 6½ years after it was implanted
  • 48-year-old: broken ring holding strings during the removal of the embedded IUD ten years after it was implanted
  • 40-year-old: embedded arm of the IUD which broke during an attempted removal seven years after it was implanted
  • 28-year-old: embedded IUD during an attempted removal seven years after it was implanted
  • 31-year-old: broken IUD during removal seven years after it was implanted
  • 33-year-old: embedded arm of the IUD which broke during an attempted removal 8½ years after it was implanted

Six out of the seven cases required a hysteroscopic removal of the IUD or its broken pieces. In one of the cases which required a hysteroscopic removal, the IUD was unable to be completely removed.

The researchers concluded that the length of time the Paragard IUD stays in place might influence the likelihood of fracture during its removal, as all of the cases ranged from six to ten years of use. They note that it is likely a fracture may be unavoidable in most cases. The findings at this single institution of the Paragard IUD fracturing or breaking during removal suggests this complication is likely underreported.

Our Defective Medical Device Attorneys Are Ready to Help

If you or a loved one suffered an injury while using the Paragard IUD or after removal of the device, we recommend you seek legal representation as soon as possible. You may be eligible to file a lawsuit to recover money damages, such as medical bills, lost income, loss of future earnings, and pain and suffering. Our experienced attorneys are currently investigating potential Paragard IUD lawsuits and may be able to help you seek financial compensation.

Schedule a free consultation now to have our medical device injury attorneys review your case. Our attorneys provide legal services on a contingency fee basis, so there are no upfront fees or out-of-pocket costs. We take no payment unless we win your case. There is no risk or obligation to pursue legal action after a consultation. If you have a valid case, it is up to you to decide how you wish to proceed.

Matthew L. White
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Founder & Partner of Louisville Personal Injury Law Firm Gray & White Law