The Paragard IUD is a one-inch T-shaped plastic device that is inserted into the uterus. A copper wire wrapped around the device produces an inflammatory reaction that is toxic to sperm and eggs (ova), thereby preventing pregnancy. Most evidence suggests that prefertilization effects are the primary means by which Paragard prevents pregnancy. Generally, the copper ions prevent sperm movement, viability, and maturation, destroy the ovum and induce a sterile inflammatory response in the endometrium, which lines the uterus.
Once inserted, the Paragard IUD is effective immediately, without the need for a backup method after insertion, and can be left in the uterus for up to 10 years. According to the American College of Obstetricians and Gynecologists practice bulletin on implant and intrauterine devices, the copper IUD has a reported failure rate at one year of 0.8 per 100 women, and a 10-year failure rate comparable with that of female sterilization (1.9 per 100 women over 10 years). ACOG also states that the copper IUD is the most effective method of emergency contraception when inserted no later than five days after unprotected sex.
Paragard is one of five different IUDs marketed in the United States and is the only non-hormonal option available in the U.S. It’s the only IUD that has been approved by the FDA for since 1984. Paragard is manufactured by CooperSurgical, which purchased Paragard from developer Teva Pharmaceuticals in 2017 for $1.1 billion.
Side effects associated with Paragard include bleeding between periods, cramps and severe menstrual pain and heavy bleeding, particularly during the first two to three months after insertion, according to the device label.
Other common side effects include:
- Anemia (low red blood cell count)
- Pain during sex
- Vaginal irritation
- Heavier, longer and/or more painful periods
- Vaginal discharge
Also according to the label, serious side effects include:
- Ectopic pregnancy and intrauterine pregnancy, if a pregnancy occurs while using Paragard
- Life-threatening infection and septic abortion
- Pelvic inflammatory disease, infection or inflammation of the uterine lining, also known as endometritis
- Attachment to the uterine wall, or embedment, which may require surgical removal
- Perforation or puncturing the wall of the uterus or cervix
- Adverse reactions after placement or removal, such as dizziness, slowed heart rate or seizures
Hypersensitivity to any component of the Paragard device, including copper or any trace elements present in the copper components of Paragard, is also listed as a contraindication. Copper toxicity is not listed as a potential side effect or adverse event on the device label.
There is no clear evidence that Paragard causes copper toxicity or significantly increases the risk of copper toxicity in the blood, unless one already has a condition that affects the liver’s ability to process copper. Wilson’s disease, for example, is a rare hereditary disorder that causes copper to accumulate in the liver, brain and other vital organs.
“Women with copper allergies or Wilson's disease, of course, are not candidates for this IUD, but copper does not seem to have any other negative impacts,” Dr. Anita Nelson, professor of obstetrics and gynecology at the David Geffen School of Medicine Harbor-UCLA Medical Center and co-author of a 2011 review of Paragard’s safety and effectiveness, told MedTruth.
Studies + Science
Nelson notes that with millions of users, rare events associated with copper IUDs, like perforation and breakage, are to be expected and can be resolved by a trained clinician. When copper IUDs do break, the occurrence is usually discovered during IUD removal. Removal involves a patient reclining on their back with knees bent and apart, as a clinician inserts a speculum into the vagina to widen the opening, then removes the IUD by pulling the device strings that should be hanging from the cervix (the device’s “arms” usually fold up as it slides out). Dr. Nelson said that “removing the remaining parts” of the broken device inside the patient’s uterus usually resolves the issue.
The following studies and papers chronicle some of the evidence on Paragard and other copper IUDs available outside the United States, including the incidence or rates of perforation.
A 2003 prospective follow-up study among women who had a copper IUD inserted at a family planning clinic found the incidence of uterine perforation was 2.2 per 1000 insertions. The study examined IUD insertions of T-380A IUD (Paragard) at various times of insertion: postplacental (within 10-15 minutes of placental delivery), 0-3 months postpartum, 4-6 months postpartum, 7-12 months postpartum, and more than 12 months after childbirth. The rate of perforation increased significantly in women who were 6 months postpartum (including 0-3 months) and dropped with increasing time since insertion. Meanwhile, a higher number of births caused a 96% decline in the perforation risk, while an increase in the number of abortions caused a twofold higher risk of perforation.
Another 2003 study of a different copper IUD found a rate of perforation of 1.6 per 1,000 cases. The study looked at “real-life clinical use” in 16,159 women in New Zealand who had the Multiload Cu375 IUD inserted between 1991 and 2001. The authors noted that 86% of the cases of perforation were not diagnosed at the time of insertion, with some going undiagnosed for several years.
A 2005 study conducted in Mexico compared the blood copper levels in 86 users of Paragard to eight nonusers of any type of birth control method. Researchers found that mean blood copper level was significantly higher among users than nonusers (216.63 g/dL vs. 107.47 g/dL), and well above the normal range of 80-160 g/dL.
A 2011 review of literature on the Paragard IUD found that uterine perforation occurs in 1 of 1000 cases, with all perforations starting at the time of placement and being diagnosed later. Rates of perforation were higher with tipped or tilted uterus, a condition where the uterus curves backward or forward in relation to the spine, instead of sitting upright.
More recently, a 2014 study measured copper and zinc levels in 121 women in Tehran using Paragard. It showed that copper levels had risen only slightly in the women after three months of use. Zinc levels, on the other hand, had risen significantly. The researchers noted that the finding about zinc levels warranted further investigation.
A 2016 review of a collection of evidence on adverse outcomes of contraceptive methods among women aged 25 and younger found very low rates of perforation (0 - 0.1%) by IUDs. However, the authors deemed the studies of poor quality, rating them from fair to poor.
A 2017 prospective cohort study examining perforations 12 to 60 months after IUD insertion found perforations were rare, with an overall perforation rate of 2.1 per 1000 insertions. Breastfeeding and time since delivery were associated with increased risk of perforation after 12 months post-insertion.
In 2020, doctors reported two cases where copper fragments from nonhormonal IUDs were retained in the uterus after removal. One IUD was Paragard and the other was a copper IUD available outside the United States. The authors suggested the copper in the devices corroded and “ultimately separated from the device.” The authors advised providers to carefully examine the devices they remove and to counsel patients on this potentially serious complication.
Paragard was first approved by the FDA in 1984 and has been available for use in the United States since 1988. Paragard is effective for up to 10 years.
The FDA approved an updated device label for Paragard in 2005, which removed several contraindications, which are reasons an individual should not use the IUD. These contraindications included never having given birth and a history of a sexually-transmitted disease or PID. However, Paragard is still not recommended for an individual with acute PID or one who engages in sexual behavior that suggests a high risk for it.
After concerns were raised about metals in medical devices, the FDA conducted a comprehensive review of metals used in medical devices, including copper IUDs, published in a 2019 report. The report reviewed some of the aforementioned studies on copper IUDs and others, noting that some studies found higher rates of inflammatory and immune responses in users of copper IUDs.
In one study, the FDA authors noted it was unclear whether inflammation in the uterus from the copper IUD (which is why they are effective as birth control) may lead to inflammation “overspill” or a “possible IUD-related systemic immune activation.”
The report concluded: “A more systematic research approach incorporating all possible clinical manifestations and underlying pathogenetic mechanisms is needed for enabling a timely detection and preventive treatment of adverse outcomes pertaining to implant reactivity.”
In other words, more research is needed to better understand potential adverse reactions and associated mechanisms, as well as identifying individuals at a greater risk for these complications.
A search for reports on the Paragard IUD between 2000 and 2021 in the Manufacturer and User Facility Device Experience database yielded 20 records — one from 2013, four from 2014, nine from 2015, one from 2016, three from 2019 and two from 2020. Note: MAUDE houses reports on medical device adverse events submitted to the FDA by manufacturers, providers, and device users. Reports are submitted voluntarily to MAUDE and are not screened for redundancy by the FDA, nor does the agency confirm whether the product actually caused the reported outcome or reaction.
Of the 20 results, 16 included event descriptions: 12 of those descriptions detailed events in which the arms of the IUD were missing upon removal, three detailed events in which the copper component was missing upon removal and one event detailed the device breaking apart in a patient during outpatient surgery and subsequently being removed (unclear if surgery was related to IUD).
Paragard is a widely used and effective contraceptive method to prevent pregnancy for up to 10 years. Paragard is recommended for all individuals with a uterus regardless of whether the person has given birth.
However, some providers may avoid offering the IUD to those who have not had children. The cervix of individuals who have not given birth is generally smaller, making insertion potentially difficult or uncomfortable for these people. Possible common side effects include heavier, crampier bleeding and abnormal menstrual bleeding, like spotting, particularly during the first few months of use.
Perforation of the organs by and breakage of the Paragard IUD seem to be rare but potentially serious adverse events. If you or someone you know has experienced an adverse event associated with Paragard, the provider in that case can file a report through the FDA’s MAUDE database. If the provider fails to do so, patients can also file their own reports.
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