Updated
Removal of the Paragard T 380A IUD has caused the contraceptive device to break in some women. This can require surgery to remove the broken pieces and may result in severe complications, including severe pain, infection, and inability to become pregnant. Women injured by the Paragard IUD are suing Teva Pharmaceuticals and CooperCompanies for large settlements for creating a defective product and failing to warn doctors and the public about its risks.
In this article, our Paragard IUD lawyers discuss:
- 1. Does the Paragard IUD break during removal?
- 2. How can it break?
- 3. What injuries do broken IUDs cause?
- 4. Can the broken pieces be removed?
- 5. How do doctors remove the Paragard IUD?
- 6. How does the Paragard IUD differ from other IUDs?
1. Does the Paragard IUD break during removal?
The copper IUD is supposed to remain in one piece during the explant procedure. But some doctors and patients have reported cases where one or both arms of the T-shaped device broke off during IUD removal, leaving the broken piece(s) behind in the uterus.1
Women getting their IUD removed should insist on seeing the device after explant. Sometimes healthcare providers neglect to inspect the device to make sure it is intact.
2. How can it break?
To remove the Paragard IUD, doctors gently pull on the monofilament threads hanging down from the uterus into the vagina. The two arms of the device – which are constructed of flexible polyethylene plastic – are supposed to bend upwards while being pulled through the cervix.
But some doctors have reported one or both of these arms breaking off while they are pulling the device out. Presumably, the plastic had become brittle and did not easily bend like they were designed to do.3
There have also been reports of the contraceptive breaking on its own in the uterus without being removed at all.
3. What injuries do broken IUDs cause?
Fractured pieces of the Paragard medical device which are left behind in the uterus may embed in the uterine wall, perforate the uterus, or travel to other organs, such as the Fallopian tubes. This can create an increased risk of various women’s health problems, including:
- Acute and chronic abdominal pain
- Unusual vaginal discharge
- Light bleeding to heavy bleeding during menstrual cycles
- Vaginal bleeding between periods
- PID (pelvic inflammatory disease)
- Pelvic infection
- Infertility
- Ectopic pregnancy, miscarriage, or premature birth if the woman then becomes pregnant
Even if the broken pieces do not embed anywhere, their copper wires can still hinder the woman’s fertility.4
Women who had their Paragards break have also reported intense emotional trauma. They feel angry they were not warned ahead of time that breakage was a risk. They feel invaded by having broken remnants of the device stuck in their bodies. They are inconvenienced time-wise and financially by the additional medical procedures they may need, which could include X-rays, ultrasounds, ER visits, and/or surgery. And this experience caused some victims to completely rethink their family planning decisions about whether to have children.
4. Can the broken pieces be removed?
Sometimes. Doctors may first attempt retrieval through a hysteroscopy, an invasive procedure where an endoscope is inserted through the cervix into the uterine cavity. But these are not always successful, especially if the pieces are stuck or embedded.
In the broken pieces are causing severe complications, it may be necessary to resort to more extreme measures. This may include:
- a larasocopy (which requires a small incision), or
- a C-section type surgery called a laparotomy to remove the pieces, which may require the patient to abstain from pregnancy for two years, or
- a full hysterectomy (especially in cases involving a uterine rupture), which will cause permanent infertility.5
5. How do doctors remove the Paragard IUD?
When everything goes right, explanting the device takes under ten minutes during a routine office appointment. The ob/gyn widens the vagina with a speculum and gently pulls on the IUD strings, and the device slides in one piece out of the uterus, through the cervix, and into the birth canal.
For some this nonsurgical procedure is painless. Others may experience such side effects as cramping and pelvic pain. Ibuprofen may help curb any discomfort.
Once the device is removed, doctors can conduct another IUD insertion right away. Or else women can commence using different birth control options to prevent pregnancy. Otherwise, women should be able to get pregnant immediately from unprotected sex (unless there are other, unrelated circumstances hindering their ability to conceive).6
6. How is the Paragard IUD different from other IUDs?
Paragard is a hormone-free method of birth control that relies on copper to prevent fertilization. The copper thickens the consistency of the cervical mucus, greatly hindering sperm motility. Since there are no hormones, the woman continues to ovulate.
Other intrauterine devices on the market are hormonal. Examples of this form of birth control include the Mirena IUD, Kyleena, Skyla, and Liletta, which rely on progestin (levonorgestrel) to prevent fertilization. These birth control methods are inserted and removed in the same manner as the Paragard IUD.
The Paragard is also a long-term birth control option. The FDA approved it to stay in the body for 10 years. In contrast, hormonal types of IUDs must be removed after three to six years, depending on the brand.
Both hormonal and non-hormonal IUDs are more than 99% effective at preventing pregnancy. No IUDs can prevent against sexually transmitted infections.7
Legal References
- See Michelle Llamas, Why Lawyers Are Talking About the Paragard IUD, Drugwatch (April 7, 2020).
- Paragard website (official site); Full Prescribing Information.
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