For women wanting a long-lasting contraceptive device without worrying about the hormonal fluctuations of birth-control pills or the hassle of remembering to take contraceptive pills every day, ParaGard promises to be a quick, easy, and effective solution for birth control, the only one, in fact, approved by the FDA that does not contain hormone-altering ingredients.
But for thousands of women, ParaGard has been anything but a birth control paradise. As of this writing, at least 60 ParaGard lawsuits have been filed in federal court. Many more ParaGard lawsuits are likely. Since 2013, the FDA has received on its self-reporting adverse events reporting system at least 3,000 reports of device breakage, with at least 1,900 of such events having been deemed serious, over 100 of which have been either life-threatening or required hospitalization.
In light of the numerous reports of device breakage, some public health advocates are recommending that FDA investigate copper IUDs.
Before examining why ParaGard lawsuits are mounting, let’s review ParaGard basic facts….
What Is ParaGard And How Does It Work?
Approved by the FDA in 1984 and available for purchase in the US since 1988, ParaGard is a T-shaped intrauterine device (IUD) that prevents pregnancy for up to a decade.
Inserted into the uterus, the latex-free device is made with plastic. Copper is wrapped around the stem and arms of the “T”. The two parts of the “T” have white threads attached to it. The threads are the only part of the device that a woman who has had the device implanted should be able to feel.
The copper in ParaGard prevents sperm from reaching or fertilizing the egg, and may also prevent the egg from implanting in the uterus. The device does not hinder a woman’s monthly ovulation, however.
How Is ParaGard Inserted?
A healthcare provider first determines the position of the uterus. Then, after the vagina and cervix are cleaned, the uterus is measured for accurate insertion. To insert the device, a plastic tube containing the IUD is placed in the uterus. The tube is then removed.
The two white threads that dangle from the base of the stem of the “T” extend into the vagina. In order for women to be able to administer a self-check to make sure the device is still in place, the threads are trimmed to a length that’s long enough for the fingers to feel the threads.
How To Check If ParaGard Is Still In Place
It’s recommended that women visit their healthcare provider one month after having the device inserted. Women can also administer a self-check by inserting clean fingers into the vagina to feel for the threads. However, do not pull on the threads. Should you be unable to feel the threads or more of the device than just the threads, the device has not been inserted properly; visit your OB-GYN as soon as possible to have the device properly fitted.
What Are The Side Effects Of ParaGard?
There are three instances in which ParaGard may cause side effects: 1) immediately after the device has been inserted; 2) at any time while the device remains in the uterus, and 3) when the device is removed.
The individual lawsuits against the manufacturer of ParaGard stem from faulty removal of the device. This will be explained in further detail…
Immediate Side Effects
The insertion of the device may cause cramping or pinching. Faintness, nausea or dizziness may also occur shortly after the device is inserted. It’s recommended that women remain in a lying down position for several minutes after having the outpatient procedure.
Side Effects After ParaGard Is Inserted
After ParaGard is inserted, over time, the most common side effects are menstrual cycle imbalances, which may include heavier, longer periods and spotting. However, these side effects are thought to diminish after just a few months.
More serious but less common side effects include Pelvic inflammatory disease (PID), which is an infection of the uterus, tubes, and nearby organs. PID is most likely to occur in the first few weeks after placement.
During placement of the device, there is a rare chance of uterine perforation. When this occurs, the device needs to be removed and surgery may be needed.
Additionally, the device may be partially or completely expelled from the uterus. Expulsion is more likely to occur in women who have never been pregnant.
Other reported but rare side effects include anemia (low blood count), backache, pain during sex, allergic reaction, vaginal infection, and vaginal discharge.
Dangerous ParaGard Removal Side Effects
When ParaGard is removed, either because the device has reached its expiration point, or because there is a problem with the device, or because a woman wants to conceive, serious complications may arise…
In some women, the IUD has proved very difficult to remove. Most troubling is when the “T” arms become weak, stiff and don’t flex upwards for easy removal. Consequently, tiny pieces of plastic break and may lodge in the uterine wall or other parts of the reproductive anatomy.
If the tiny pieces are not surgically removed—or unable to be removed, the plastic fragments may cause the uterine wall to rupture, impacting adjacent organs. This can lead to chronic pain, infertility, infection, and pelvic inflammation.
Unfortunately for scores of women, removal of a ParaGard device is very difficult, requiring invasive surgery. A C-section-like surgery is one of two options. The only other alternative is a hysterectomy, which removes the uterus and makes future conception an impossibility. In some instances, when the T-arms are broken, an endoscopic camera can locate the fragments. But if the fragments are already lodged in the uterine wall, it may be impossible to remove the plastic pieces this way.
Can Women Who Experienced a Fractured ParaGard Device File A Lawsuit?
If your ParaGard device fractured during the removal process, you may be entitled to compensation. The amount you may be entitled to will depend on the severity of your complications. The highest compensation tier may pay up to $200,000, based on the history of similar medical device settlements.
A ParaGard multidistrict litigation (MDL) was created in December 2020. ParaGard cases already filed in the federal court system have been transferred to the MDL in the northern district of Georgia. Judge Leigh Martin May is overseeing the MDL.
According to the United States Judicial Panel on Multidistrict Litigation (US JPML), “the Paragard intrauterine device (IUD) has a propensity to break upon removal, causing complications and injuries, including surgeries to remove the broken piece of the device, infertility, and pain. The actions thus implicate questions concerning the device’s development, manufacture, testing, labeling, and marketing.”
Defendants named in the MDL include: Teva Women’s Health, LLC, Teva Branded Pharmaceutical Products R & D, Inc., The Cooper Companies, Inc., and Cooper Surgical, Inc.
The true number of women harmed by ParaGard removal is likely much higher than the 3,000 or so self-reported cases filed on the FDA’s Adverse Reporting System, which is notoriously difficult for individuals to navigate. If you’ve been harmed by ParaGard removal, there is a Facebook support group for affected women.