Paragard

The Truth 

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
• Backache
• Expulsion
• 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. 

Regulation Recap

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).

Next Steps

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.