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 intrauterine device (IUD), and while commonly-prescribed, it 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's manufacturer been sued and received an FDA warning letter?
In this article we’ll answer all of these questions and more, as we review studies on Paragard to determine if it's effective at reducing pregnancy, and to compare its effectiveness to other birth control methods.
We'll also discuss the risk of side effects, share Paragard patient reviews, and explain some of the legal and regulatory challenges its manufacturer has faced (to give our take on whether or not patients should be concerned).
Does Paragard Prevent Pregnancy?
Paragard was initially approved by the FDA in 1984.
When the device was launched in the US 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 2017 medical review 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 six years.
The per-year failure rate decreases annually, meaning that 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, which is unsurprising given that it's approved by the FDA for that indication.
Paragard vs. Other Contraceptives
Barrier methods such as condoms are described in research studies as having different failure rates for typical and “perfect” use, because theoretical perfect use of a product doesn’t reflect real-world risks such as breakage or the occasional choice to have sex without a condom, which can increase 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 on another birth control medication, long-term, internal birth control devices like Paragard 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.
Does Paragard Cause Side Effects?
A medical review on 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.
The FDA data on Paragard indicates that perforation (tearing) of the uterine wall or cervix occurs 0.2% of the time upon insertion.
This is a significantly more severe side effect than the others reported, and lactating (breastfeeding) women should speak with their doctor about this risk, because it appears to be increased when a woman is lactating.
Some women express concern over the risk of pelvic inflammatory disease (PID) with use of IUDs, however this risk is very low (under 0.5%), and returns to baseline after the first 20 days of using the device, according to a 2019 medical review on the safety of IUDs.
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.
YouTuber Tries Paragard
One of the most popular reviews of Paragard comes from a YouTube creator named Mikayla Greenwood who shared her experience after one year of Paragard use:
FDA Warns Paragard
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 includes data on the safety and efficacy of the device. Here is a link to the FDA label for Paragard.
Why Was Paragard 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.
Patients Review Paragard
Drugs.com is a website that allows prescription medication patients to rate and review the drugs they're taking.
We cannot verify the accuracy or authenticity of any reviews on this site.
At the time of updating this article, Paragard has been reviewed over 1,000 times on Drugs.com, and has an average patient rating of 5.8 out of 10.
A top positive review is written by a user named "Dee" who gave Paragard a 10/10 rating:
"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."
A top negative review comes from a user named "KCoop" who gave Paragard a 1/10 rating:
"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)."
