Paragard is a copper intrauterine device that has been on the market for almost 40 years. It is one of the most popular IUDs used today, mainly because it requires no maintenance and can be left in place for up to 10 years.
Though the Paragard copper IUD is billed as an effective, set-it-and-forget-it form of birth control, a growing number of women say that the device broke off in their bodies, causing severe side effects.
Teva Pharmaceuticals first manufactured the contraceptive device. Subsequently, the global medical equipment group CooperCompanies acquired Teva in 2017 for $1.1. Billion.
Since 2013, the FDA registered over 3,000 records of device breakage, and 2,109 of those have been deemed severe, describing disruptive events such as hospitalization, life-threatening complications, related disability, and required intervention.
There are over 40,000 cases of reported Paragard adverse events registered in the FDA database. The high volume of negative reports could convince the agency to take a second look at Paragard’s safety profile, starting a thorough investigation of the device.
40,000+ Complaints Of Copper IUD Side Effects
According to the FAERS - The FDA Adverse Events Reporting System, over 40,000 women suffered side effects and complications while implanted with Paragard. Here are the adverse effects registered for the highest number of cases:
- Device expulsion
- Device dislocation
- Uterine disorder
- Pelvic pain
- Device breakage
- Complication upon device insertion
- Vaginal hemorrhage
- Heavy menstrual bleeding
Therefore, Paragard can put women at risk for various complications stemming from implantation mistakes, incompatibility, and device breakage or failure. These complications include:
Expulsion occurred for over 11,000 women when the copper IUD fell out of the uterus. An IUD may slip out partly or entirely. Although it’s not consistently apparent why a Paragard device is displaced, the risk of suffering this adverse reaction is greater during the menses and in the initial few weeks after insertion. There is also a heightened risk of ejection in women who haven’t given birth. Expulsion symptoms consist of pain, discomfort, severe aching, excessive or unusual bleeding, or an abnormal discharge.
Another frequent complaint - reported by over 9,000 women - is the migration of the Paragard IUD from its proper placement inside the uterus. A displaced copper IUD is usually asymptomatic, although some women complain of cramping or bleeding.
If the copper IUD ends up somewhere near the uterus wall, it may become embedded or fixed. The risk of perforation is also present and higher for breastfeeding women. The copper IUD may move through the uterus wall and cause pain, injury, harm to other organs, infection, bleeding, or infertility.
Embedment and perforation may make the device removal process more complicated and may call for surgery.
3. Uterine Disorder
Over 4,000 women reported getting severe uterine disorders, such as pelvic inflammatory disease (PID) or endometritis, conditions that are generally treated with antibiotics. PID and endometritis can create severe infertility, ectopic pregnancy, bleeding, lesions, and persistent pelvic discomfort. More severe instances may involve surgery and seldom may even lead to death.
4. Pelvic Pain
Over 3,500 women complained of having cramps or discomfort during Paragard insertion and several minutes after. Some also had occasional cramps or difficult periods for a few months after Paragard was inserted. Severe cramps or discomfort that won’t go away soon after insertion could signify that the copper IUD wasn’t set correctly inside the uterus. In such cases, the device could need to be adjusted or removed. In rare cases, carrying an incorrectly placed IUD in the uterus may cause severe infections that lead to life-threatening sepsis.
As already mentioned, over 3,000 women reported incidents of device breakage. The breakage of the IUD arms typically occurs when the medical personnel seeks to take out the IUD. But sometimes, women reported that parts of the T-frame broke off long before the device got removed.
If one or both arms of the copper IUD break off, an invasive procedure may be needed to recover the fragments. And sometimes, specialists cannot extract the parts at all. These fragments may later become fixed in the uterine surface or cervix or move. This event could contribute to difficulties and negative developments, such as heavy menstrual discomfort, inflammatory reactions, infection, organ impairment, or infertility.
Patients then require invasive methods to detect and recover the missing fragments. A typical example of invasive surgery is a hysteroscopy, where the physician introduces an endoscope through the cervix into the uterus. In more extraordinary situations, the injured patient may need either a:
- Laparotomy, a surgery similar to the C-section
- Hysterectomy, or uterus removal that leads to permanent infertility
Did Teva and CooperCompanies Know Of Paragard Side Effects?
Victims of Paragard breakage side effects accuse that Teva and CooperCompanies failed to inform both physicians and users about the significant risk of the device fracturing upon removal. Some patients have filed legal claims against the manufacturers for damage to their health that would have never happened if they’d been fully aware of the copper IUD’s risks.
The evidence of inappropriate labeling could be the Paragard packaging. Its disclaimer does not indicate that the manufacturers fully informed doctors about the actual risk of the IUD breaking during removal and how to best avert it.
Teva and CooperCompanies owe patients an obligation to provide IUD devices that are well-designed and well-made.
Unlike other IUDs on the market, the Paragard IUD has arms that stand out at a solid 90-degree angle from the stem. Arguably, Teva and CooperCompanies should have expected the risk of one or both arms breaking off, particularly during removal. Had the model been more robust, the IUD might stay unbroken. Or, maybe Teva’s and CooperCompanies’ poor construction contributed to the IUD’s T-body becoming brittle, even if the initial model was appropriate.
Women considering an IUD should consult with their doctor to evaluate whether they’re suitable candidates and weigh all the risks before deciding what method of contraception will work best for them.