Disclaimer: None of the information in this article constitutes medical advice, and is just the opinion of the writer(s). We recommend that patients follow their doctor’s guidance in regard to birth control and family planning.
Paragard is an FDA-approved contraceptive device. It's a type of device called intrauterine device (IUD), and while commonly-prescribed, has been the subject of a number of lawsuits and an FDA warning letter.
But is Paragard proven to be effective at reducing pregnancy in clinical trials? How does its effectiveness compare with other birth control methods like the pill? Does the device have side effects? And why has Paragard been sued and received an FDA warning letter?
In this article we’ll answer all of these questions and more as we review clinical studies on Paragard to determine if it's effective at reducing pregnancy, compare its effectiveness to other birth control methods, document side effects of the device and share real, unsponsored user reviews of Paragard.
How Much Does Paragard Reduce Chance of Pregnancy?
Paragard has been around for a long time. It was initially approved by the FDA in 1984.
When the device was initially brought to market, it was one of the most effective contraceptive medical devices. A medical review from 1989 details how Paragard was the “most effective IUD to date” because it reduced pregnancy rates to 1/100 after two years of use.
The efficacy of the Paragard device has been well-studied since, and the device continues to be proven effective. A medical review published in 2017 documented the following pregnancy rates for patients using Paragard: 0.7% after 1 year, 1.3% after 4 years and 2.1% after 10 years.
Because pregnancy rates were reported in a cumulative manner, this shows that the risk of unintended pregnancy while using Paragard decreases over time.
Another way to look at the data is that the rate of unintended pregnancy is 0.7% for the first year, then only an additional 0.6% over the next 3 years, and an additional 0.8% for the following 6 years. The per-year failure rate decreases annually, meaning for every year a woman is using the device she’s less likely to experience an unintended pregnancy.
Based on the research, we will conclude that the Paragard is effective at significantly reducing risk of unintended pregnancy.
Many women are curious about the relative efficacy of the Paragard compared with other long-term contraceptive solutions like the birth control pill, which we'll overview in the next section.
Paragard vs. Other Contraceptives
Barrier methods such as condoms are described in medical research as having different failure rates for typical and “perfect” use because the theoretical perfect use of a product doesn’t reflect real-world risk such as breakage or the occasional choice to have sex without a condom that increases failure rates.
A recent study on contraceptive efficacy found failure rates with the male condom to be 13% for typical use and 2% for perfect use.
The same study found failure rates with a female condom to be 21% for typical use and 5% for perfect use.
Failure rates for hormonal contraceptives like the birth control pill were reported as less than 1% with perfect use and 7-9% with typical use.
As we documented in our Lo Loestrin Fe reviews article of another birth control medication, long-term, internal birth control devices like IUD have been shown to be around 20x more effective than other birth control methods in clinical research.
The main reason for this is because there is no chance of human error with an internal device. It's easy to forget to take the pill once in a while or forget to (or choose not to) use a condom once in a while, but once Paragard is installed the only risk is device failure and not forgetfulness.
We consider Paragard to be significantly more effective than most other birth control methods, but not necessarily any more effective than other IUDs.
Paragard Side Effects
A medical review of the side effects of various IUDs reported that side effects from Paragard use were relatively infrequent.
Increased bleeding occurred at a rate of slightly over 1 per 100 women using the device, and slightly over 3 women out of 100 stopped using the device due to discomfort overall.
The FDA data on Paragard indicates that perforation (tearing) of the uterine wall or cervix occurs 0.2% of the time upon insertion of Paragard. This is a significantly more severe side effect than the others reported, and lactating women especially should speak with their doctor about this risk, because it appears to be increased when a woman is lactating.
Because the Paragard is copper, it tends to have a lower risk of side effects than hormonal IUDs or oral birth control, because it doesn’t interfere with circulating hormone levels.
Real, Unsponsored Paragard User Review
One of the most popular YouTube reviews of Paragard comes from a creator named Mikayla Greenwood who shares her experience after one year of Paragard use. She documents the procedure and explains the pros and cons of the device:
FDA Warning Letter
In February of 2021, the FDA issued a warning letter to Paragard, alleging the company was running advertisements without disclosing any risk or safety information about their product.
Specifically, the letter called Paragard’s ads “false and misleading” because they presented “efficacy claims” without communicating any “risk information associated with its use.”
This doesn’t change the efficacy or safety of the Paragard device, but it is an ethical red flag in our opinion that the manufacturer appears to have been so brazen in their advertising.
We always recommend that patients refer to the FDA label when considering a medication or medical device rather than the brand's website which can sway opinion with marketing. The FDA label is just data on the safety and efficacy of the device. Here is a link to the FDA label for Paragard.
Why Has Paragard Been Sued?
Paragard has been the subject of various lawsuits, mostly related to its risk of breaking while inside of a woman and potentially causing serious injury.
DrugWatch reports at the time of updating this article that there is an active lawsuit against Paragard regarding health effects from device breakage, and anyone affected can use the above-linked resource to see if they're eligible to file a claim.
This YouTube video from a law firm claims that over 700 individual lawsuits against Paragard were recently consolidated into a class-action lawsuit:
Paragard vs. Mirena
Mirena is another contraceptive IUD so patients are often curious about which is more effective. There have been comparative studies on the two devices published in medical journals.
A meta-study published in the Contraception journal analyzed data from over 60,000 women using either Paragard or Mirena.
Mirena was found to be significantly more effective for preventing pregnancy. Women using Paragard were more than 5x as likely to become pregnant compared to women using Mirena.
Another comparative study examined the effectiveness of Paragard and Mirena for emergency contraception, which refers to the use of contraceptive methods to prevent pregnancy after unprotected sex. The two devices were found to be equally effective.
Overall we would recommend that patients focused on reducing the chance of pregnancy as much as possible speak with their doctor about Mirena rather than Paragard.
Real Paragard Patient Reviews
Paragard has been reviewed over 1,000 times on Drugs.com, which is a website that allows prescription medication and device users to publish personal reviews and ratings.
The device has an average user rating of 5.7 out of 10.
The top positive review is written by a user named "Dee" who claims that the device is effective and beyond mild side effects has no downsides:
"I have had the Paragard for 6 months now, my periods are back to normal after the first 4 months and I never feel it inside. I had light periods before insertion & they are still light after. I’m very happy with mine, try for yourself before letting these reviews scare you."
The top negative review comes from a user named "KCoop" who claims to have experienced a host of serious side effects:
"I was experiencing copper toxicity and wonky hormonal shifts. Symptoms: ovarian cysts (very expensive appointment to confirm through sonogram), cystic acne, liver started to struggle (vitamin blood test proof), easily got sick, body pains, dizziness, panic attack, trouble sleeping, DAILY diarrhea (not even docs or my mom could figure this out). After dramatically changing my diet to cater to reducing cysts and cystic acne, no dice. I was still in incurable pain at random (ibuprofen, magnesium, cbd, hot pad all did not work)."