Paragard is one of the most popular intrauterine devices (IUD), but it’s also been the subject of various lawsuits.
In this article we’ll review the medical research backing the Paragard device to determine if it’s a safe and effective contraceptive. We’ll also highlight some of the issues the Food and Drug Administration (FDA) and law firms have raised about the device.
The Paragard has been around for a long time; it was initially approved by the FDA in 1984.
When it was initially brought to market, it was one of the most effective contraceptive medical devices. A medical review from 1989 published in the American Journal of Gynecological Health detailed how the Paragard was the “most effective IUD to date” because it reduced pregnancy rates to 1/100 after 2 years of use.
The efficacy of the Paragard device has been well-studied since, and the device continues to be proven effective on average. A more recent medical review published in 2017 evidenced the following cumulative failure rates for the Paragard: 0.7% after 1 year, 1.3% after 4 years and 2.1% after 10 years. No pregnancies were reported after year 8 using the device.
Failures in the above-linked study were defined as unintended pregnancies.
Because the failure rates were cumulative, this proves that the risk of unintended pregnancy 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 can conclude that the Paragard is effective at significantly reducing risk of unintended pregnancy. This isn’t surprising given that the FDA requires significant clinical research before a medical device is approved.
Many women are curious about the relative efficacy of the Paragard compared with other long-term contraceptive solutions like the birth control pill.
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 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.
A 2021 meta-review published in the Sexual & Reproductive HealthCare journal compared IUDs to oral contraceptives for “emergency contraceptive” effectiveness, which means effectiveness in preventing pregnancy after unprotected sex. The IUD was found to be much more effective (0-6% pregnancy rate vs. 2.7-12% for the pill).
It’s clear from the data that Paragard is more effective at preventing pregnancy than barrier and oral methods of birth control, both for regular use and emergency use.
This is unsurprising given that the Paragard is physically implanted in the woman, and there is no risk of user failure.
Perfect use of oral contraceptives, meaning regular intake without lapses, had similar rates of effectiveness after 1 year compared with the Paragard.
Paragard Side Effects
A medical review of the side effects of various IUD 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 3.41 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. 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 medicationed IUDs or oral birth control, because it doesn’t interfere with circulating hormone levels.
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 was so brazen in their advertising.
Paragard has been the subject of various lawsuits, mostly related to its risk of breaking while inside of a woman and potentially causing her serious injury.
There don’t appear to be any active class-action lawsuits against Paragard; just individual suits.
In our opinion, while lawsuits against medical companies get a lot of media attention, this doesn’t provide any valuable information about the safety of the device.
Lawyers can choose to sue over anything, but Paragard clearly references the risks involved in using their device on their label and website, and there exists extensive clinical data that we’ve linked to in this article highlighting the statistical chance of side effects.