Federal health officials have received thousands of reports of women whose Paragard copper IUDs broke when they were being removed. Hundreds of women with broken Paragard IUDs have filed lawsuits against the manufacturers of the device alleging that the IUD was defectively designed because of its tendency to break during removal.
Paragard is a T-shaped intrauterine device, or IUD, that can be worn for up to 10 years to prevent pregnancy. Unlike other IUDs, which use hormones to prevent conception, Paragard relies on copper wires that are wound around the device in order to prevent women from becoming pregnant. After 10 years have elapsed, or when a woman wishes to become pregnant, she can have Paragard removed from her body by visiting a health care professional.
Thousands of Women Report Broken Paragard IUDs to FDA
However, according to data from federal health officials, Paragard may be more likely to break when it is removed than other IUDs. The FDA's Adverse Event Reporting System (FAERS) has received at least 9,000 reports of women whose Paragard IUDs broke when they were being removed. These reports represent nearly twice the number of reports involving broken IUDs received by the FDA for hormonal IUDs.
During the first six months of 2023, the FDA received more than 900 reports of women whose Paragard IUDs broke when they were being removed, putting the device on pace to double the number of reports submitted to the agency in 2022.
Because FAERS is a voluntary reporting system, some health experts believe that these thousands of reports concerning Paragard IUDs may significantly undercount the true number of women whose copper IUDs have broken during removal.
Complications Caused by Broken Paragard IUDs
When the T-shaped arms on Paragard IUDs break – either when they are being removed or still in use – it can put women at risk of suffering other serious and potentially deadly health consequences, including severe pain, organ damage, organ perforation, and infertility.
Some women may be forced to undergo a hysteroscopy or other invasive surgeries in order to remove the broken pieces of the IUD from their body. Women who experience significant damage to their uterus from a broken Paragard IUD may be forced to undergo a hysterectomy in order to remove their uterus.
Out of the thousands of reports of broken Paragard IUDs that have been submitted to the FDA, at least 4,800 were deemed by the agency to be “serious”. At least 15 cases involving broken Paragard IUD resulted in the death of the woman who was implanted with the birth control device.
Paragard Lawsuits Filed Over Broken Copper IUDs
Hundreds of Paragard lawsuits against Teva Pharmaceutical and CooperSurgical, the manufacturers of the device, have been filed by women whose copper IUDs broke while being removed.
These lawsuits have alleged that ParaGard is defectively designed or defectively manufactured because of its tendency to break when the device removed, and that Teva and CooperSurgical were negligent for failing to properly warn women about the risk of serious and potentially deadly complications they may face from a broken copper IUD.
Women who were implanted with a Paragard copper IUD that broke when it was being removed may qualify to file a lawsuit against Teva and CooperSurgical and receive compensation for their injuries and medical expenses.
In order to begin the process of filing a claim, it is important to seek the assistance of an attorney with experience in birth control litigation. An experienced attorney can help you determine whether you are eligible to take legal action, and guide you through the steps that are involved in filing a claim.
