Updated
The Paragard T 380A IUD is a non-hormonal intrauterine device with a 99%-plus effectiveness rate at preventing pregnancy. However, many women have experienced fracturing of the device during removal – resulting in the broken pieces embedding in their body and causing painful and dangerous complications, including ectopic pregnancies, miscarriages, and infertility.
Women injured by the device are now bringing Paragard IUD lawsuits against Teva Pharmaceuticals and CooperCompanies seeking large settlements for creating a defective product and for failing to warn doctors and patients about the risks.
In this article, our Paragard IUD lawyers discuss:
- 1. How does Paragard T 380A IUD prevent pregnancy?
- 2. How effective is it at preventing pregnancy?
- 3. What are the side effects and complications?
- 4. How long can it stay in?
- 5. Can the Paragard T 380A break?
- 6. Do Paragard’s defects cause infertility?
1. How does Paragard T 380A IUD prevent pregnancy?
Like most intrauterine contraception devices, the Paragard IUD is a small T-shaped contraption with monofilament threads available by prescription that an ob/gyn places in the uterus during an office visit. Unlike most IUDs, it is hormone-free and does not stop ovulation. Instead, its copper wires do the work of preventing sperm from traveling through the Fallopian tubes and reaching an egg. The IUD can also help prevent implantation.
2. How effective is it at preventing pregnancy?
Paragard T 380A IUD is over 99% effective at preventing pregnancy (as long as it stays in place).1 This is more effective than birth control pills or emergency contraception. The only other birth control methods with comparable efficacy are hormonal IUDs like Mirena and Skyla (which typically use progestin / levonorgestrel), hormonal implants, and sterilization.
But if the Paragard travels, breaks, and/or perforates the uterus, then it loses its contraceptive effectiveness, and the failure rate becomes higher. People who get pregnant with the Paragard implanted are at higher risk of complications. Some of these include an ectopic pregnancy (where the fertilized egg implants outside the uterine cavity), miscarriage, and even death.
If the Paragard gets removed completely and safely, then the woman should be able to get pregnant right away from unprotected sex (unless there are unrelated issues such as age or underlying conditions that reduce fertility).
3. What are the side effects and complications?
The nonsurgical implantation of the IUD usually takes just a few minutes. But some women experience discomfort during placement, including pinching, cramping, nausea, faintness, and dizziness. Patients are given a follow up appointment about a month later to check placement.
The IUD is supposed to be painless once implanted. All women should feel are the monofilament threads (IUD strings) with their fingers during their monthly at home self-check.
During the first three months, some women experience heavier and longer periods as well as vaginal bleeding / spotting. But then the menstrual cycle should go back to normal. If they do not, women should contact their doctors. According to Paragard’s prescribing information, other side effects may include:
- anemia (low blood count)
- painful sex
- menstrual cramps and pelvic pain
- backaches
- Infection of the vagina
Rare but potential complications include:
- PID (pelvic inflammatory disease). This is when the uterus, Fallopian tubes, and adjacent organs become infected. When PID does occur, it is usually within the first 20 days. Antibiotics may cure it. Otherwise, PID can be devastating for reproductive health. PID may lead to infertility, chronic pain, an ectopic pregnancy, and possibly death. Some patients need surgery and perhaps full removal of the uterus (hysterectomy). Signs of PID include fever and/or chills, heavy bleeding, vaginal discharge that is untypical or odorous, severe pain in the pelvis or abdomen, and pain during sex.
- Organ perforation. This occurs when the device migrates and embeds in the uterine wall or other organs. Perforation can lead to pelvic infection, scar tissue, and other damage. And once the uterus is pierced, the risk of pregnancy from unprotected sex increases.
- Expulsion. In some cases, the device falls out of (“expels from”) the uterus. This is more likely in women who have never been pregnant. If this happens, the woman is not protected against getting pregnant.
- Pregnancy. Anyone who believes they are expecting despite having the IUD should seek out a healthcare provider right away and take a pregnancy test. It may be necessary to try to remove the device. Otherwise, the patient may get an infection or an ectopic pregnancy, have a miscarriage, or experience premature labor. It could even cause death.
4. How long can it stay in?
The Paragard T 380A IUD has been approved by the FDA to remain implanted for up to 10 years. This makes it very a long acting form of birth control for family planning.3
5. Can the Paragard T 380A IUD break?
Yes. The Paragard IUD has been known to fracture, especially during the removal process. And in some cases, doctors are unable to retrieve the remaining pieces.
The broken pieces that remain behind can cause severe complications, including pain, heavy periods, inflammation, infection, scar tissue, organ damage, ectopic pregnancy, miscarriage, and infertility. Some women have reported having to get invasive procedures and surgeries due to complications from a broken Paragard.4
6. Do Paragard’s defects cause infertility?
Some women have reported becoming infertile due to a defective copper IUD as a result of:
- Damage to the reproductive organs caused by broken IUD fragments that embedded in the tissue;
- A hysterectomy to remove the damaged uterus; or
- A decision to get a “tube tie” from the emotional trauma of having broken Paragard pieces embedded in the uterus
Obviously, unwanted infertility and invasive medical procedures can be an enormous drain on women’s health not only physically but also mentally.5
Legal References
- Paragard website (official site).
- Michelle Llamas, Why Lawyers Are Talking About the Paragard IUD, Drugwatch (April 7, 2020).
- Paragard website (official site). Note that the Mirena lawsuits are out of New York.
- See notes 1 and 2.
- See notes 1 and 2.