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{"id":556166545481,"title":"Paragard Review: More Effective Than The Pill?","created_at":"2022-02-03T22:49:49-05:00","body_html":"\u003cscript type=\"application\/ld+json\"\u003e\/\/ \u003c![CDATA[\n{\n \"@context\": \"https:\/\/schema.org\",\n \"@type\": \"Article\",\n \"headline\": \"Paragard Review: More Effective Than The Pill?\",\n \"keywords\": \"paragard, paragard reviews, paragard review, paragard iud, paragard side effects, paragard lawsuit, paragard iud side effects, paragard vs mirena, paragard birth control, pargard copper iud, paragard iud lawsuit\",\n \"description\": \"Our MD and research team review medical research on the Paragard device to determine if it’s a safe and effective contraceptive. We also highlight some issues the FDA and law firms have raised about the device.\",\n \"url\": \"https:\/\/illuminatelabs.org\/blogs\/health\/paragard-review\",\n\"author\": {\n \"@type\": \"Person\",\n \"name\": \"Taylor Graber MD\",\n \"url\": \"https:\/\/illuminatelabs.org\/pages\/taylor-graber\",\n \"sameAs\": \"https:\/\/www.linkedin.com\/in\/taylor-j-graber-md-81351642\/\",\n \"jobTitle\": \"Content Partner\",\n \"knowsAbout\": \"medicine, health, anesthesiology, iv therapy, science, drugs, pharmaceutical, medical research, scientific research, medical journals, entrepreneurship, healthcare, orthopedic surgery, biomedical engineering\",\n \"alumniOf\": {\n \"@type\": \"EducationalOrganization\",\n \"name\": [\n \"University of California San Diego\",\n \"Arizona University\",\n \"University of Arizona College of Medicine\"\n ]\n },\n \"memberOf\": {\n \"@type\": \"Organization\",\n \"name\": \"Illuminate Labs\"\n }\n},\n\"contributor\": {\n \"@type\": \"Person\",\n \"name\": \"Calloway Cook\",\n \"url\": \"https:\/\/illuminatelabs.org\/pages\/calloway-cook\",\n \"sameAs\": \"https:\/\/www.linkedin.com\/in\/calloway-cook\/\",\n \"jobTitle\": \"President\",\n \"knowsAbout\": \"entrepreneurship, dietary supplements, herbal supplements, eCommerce, medical research\",\n \"alumniOf\": {\n \"@type\": \"EducationalOrganization\",\n \"name\": \"S.I. Newhouse School of Public Communications at Syracuse University\"\n },\n \"memberOf\": {\n \"@type\": \"Organization\",\n \"name\": \"Illuminate Labs\"\n }\n},\n\"editor\": {\n \"@type\": \"Person\",\n \"name\": \"DJ Mazzoni\",\n \"honorificSuffix\": [\n \"M.S.\",\n \"R.D.\",\n \"C.D.N.\",\n \"C.S.C.S.\"\n ],\n \"url\": \"https:\/\/illuminatelabs.org\/pages\/dj-mazzoni\",\n \"sameAs\": \"https:\/\/www.linkedin.com\/in\/dj-mazzoni-rd-cdn-cscs-00a33038\/\",\n \"jobTitle\": \"Medical Reviewer\",\n \"knowsAbout\": \"exercise, drugs, pharmaceutical, health, workout, strength and conditioning, nutrition, dietetics, medicine, medical research, scientific research, scientific method, healthcare, patient care, wellness\",\n \"alumniOf\": {\n \"@type\": \"EducationalOrganization\",\n \"name\": [\n \"State University of New York College Oswego\",\n \"D’Youville College\"\n ]\n },\n \"memberOf\": {\n \"@type\": \"Organization\",\n \"name\": \"Illuminate Labs\"\n }\n},\n\"image\": {\n\"@type\": \"ImageObject\",\n\"url\": \"https:\/\/cdn.shopify.com\/s\/files\/1\/0047\/1524\/9737\/files\/Paragard_Thumbnail.png?v=1643947535\",\n\"width\": \"2279\",\n\"height\": \"2279\"\n},\n\"citation\": [\n\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/018680s069s070lbl.pdf\", \n\"https:\/\/pubmed.ncbi.nlm.nih.gov\/12285000\/\",\n\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5683151\/\",\n\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7533104\/\",\n\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33799166\/\",\n\"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/abs\/10.1016\/j.ijgo.2013.02.016\",\n\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/018680s069s070lbl.pdf\",\n\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/coopersurgical-inc-613339-02122021\"\n],\n\"mentions\": [{\n \"@type\": \"Thing\",\n \"name\": \"unintended pregnancy\"\n },\n {\n \"@type\": \"Thing\",\n \"name\": \"condom\"\n },\n {\n \"@type\": \"Thing\",\n \"name\": \"birth control\"\n }\n],\n\"datePublished\": \"2022-02-08\",\n\"copyrightHolder\": {\n \"@type\": \"Organization\",\n \"name\": \"Illuminate Labs\"\n},\n\"publisher\": {\n \"@type\": \"Organization\",\n \"name\": \"Illuminate Labs\",\n \"url\": \"https:\/\/illuminatelabs.org\/\",\n \"description\": \"Illuminate Labs is the most transparent supplement company in the U.S., and is a leading publisher of research-based health information.\",\n \"knowsAbout\": \"supplements, science, nutrition, exercise, health, medication, pharmaceutical, wellness, diet, weight loss, medical research\",\n \"publishingPrinciples\": \"https:\/\/illuminatelabs.org\/pages\/editorial-guidelines\",\n \"logo\": {\n \"@type\": \"ImageObject\",\n \"url\": \"https:\/\/cdn.shopify.com\/s\/files\/1\/0047\/1524\/9737\/files\/Illuminate_Labs_Logo.png?v=1641249064\", \n \"width\": 150,\n \"height\": 150\n},\n \"foundingDate\": \"2019-01-30\",\n \"Address\": {\n \"@type\": \"PostalAddress\",\n \"streetAddress\": \"50 Union Street, Unit 9\",\n \"addressLocality\": \"Northampton\",\n \"addressRegion\": \"Massachusetts\",\n \"postalCode\": \"01060\",\n \"addressCountry\": \"US\"\n},\n \"sameAs\": [\n \"https:\/\/www.instagram.com\/illuminatelabs\",\n \"https:\/\/twitter.com\/illuminatelabs\",\n \"https:\/\/www.linkedin.com\/company\/illuminate-labs-supplements\",\n \"https:\/\/www.youtube.com\/channel\/UCpgSJAsIPb-fZ25djtTxBEA\"\n ]\n }\n}\n\/\/ ]]\u003e\u003c\/script\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003e\u003cimg src=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0047\/1524\/9737\/files\/Paragard_Review_Article_Header_Image_Optimized.png?v=1643947458\" alt=\"\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003e\u003cspan class=\"dc\"\u003eP\u003c\/span\u003earagard is one of the most popular intrauterine devices (IUD), but it’s also been the subject of various lawsuits.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eIn 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2 style=\"text-align: center;\"\u003e\u003cb\u003eMedical Research\u003c\/b\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eThe Paragard has been around for a long time; it was \u003c\/span\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/018680s069s070lbl.pdf\"\u003e\u003cspan style=\"font-weight: 400;\"\u003einitially approved\u003c\/span\u003e\u003c\/a\u003e\u003cspan style=\"font-weight: 400;\"\u003e by the FDA in 1984.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eWhen it was initially brought to market, it was one of the most effective contraceptive medical devices. A \u003c\/span\u003e\u003ca href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/12285000\/\"\u003e\u003cspan style=\"font-weight: 400;\"\u003emedical review\u003c\/span\u003e\u003c\/a\u003e\u003cspan style=\"font-weight: 400;\"\u003e 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eThe efficacy of the Paragard device has been well-studied since, and the device continues to be proven effective on average. A \u003c\/span\u003e\u003ca href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5683151\/\"\u003e\u003cspan style=\"font-weight: 400;\"\u003emore recent medical review\u003c\/span\u003e\u003c\/a\u003e\u003cspan style=\"font-weight: 400;\"\u003e 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eFailures in the above-linked study were defined as unintended pregnancies.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eBecause 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 \u003c\/span\u003e\u003ci\u003e\u003cspan style=\"font-weight: 400;\"\u003eper-year\u003c\/span\u003e\u003c\/i\u003e\u003cspan style=\"font-weight: 400;\"\u003e failure rate decreases annually, meaning for every year a woman is using the device she’s less likely to experience an unintended pregnancy.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eBased 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eMany women are curious about the relative efficacy of the Paragard compared with other long-term contraceptive solutions like the birth control pill.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2 style=\"text-align: center;\"\u003e\u003cb\u003eParagard Vs. Other Contraceptives\u003c\/b\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eBarrier 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eA \u003c\/span\u003e\u003ca href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7533104\/\"\u003e\u003cspan style=\"font-weight: 400;\"\u003erecent study\u003c\/span\u003e\u003c\/a\u003e\u003cspan style=\"font-weight: 400;\"\u003e on contraceptive efficacy found failure rates with the male condom to be 13% for typical use and 2% for perfect use.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eThe same study found failure rates with a female condom to be 21% for typical use and 5% for perfect use.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eFailure rates for hormonal contraceptives like the birth control pill were reported as less than 1% with perfect use and 7-9% with typical use.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eA 2021 \u003c\/span\u003e\u003ca href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33799166\/\"\u003e\u003cspan style=\"font-weight: 400;\"\u003emeta-review\u003c\/span\u003e\u003c\/a\u003e\u003cspan style=\"font-weight: 400;\"\u003e published in the Sexual \u0026amp; 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).\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eIt’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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eThis is unsurprising given that the Paragard is physically implanted in the woman, and there is no risk of user failure.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003ePerfect use of oral contraceptives, meaning regular intake without lapses, had similar rates of effectiveness after 1 year compared with the Paragard.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2 style=\"text-align: center;\"\u003e\u003cb\u003eParagard Side Effects\u003c\/b\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eA \u003c\/span\u003e\u003ca href=\"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/abs\/10.1016\/j.ijgo.2013.02.016\"\u003e\u003cspan style=\"font-weight: 400;\"\u003emedical review\u003c\/span\u003e\u003c\/a\u003e\u003cspan style=\"font-weight: 400;\"\u003e of the side effects of various IUD reported that side effects from Paragard use were relatively infrequent.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eIncreased 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eThe \u003c\/span\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/018680s069s070lbl.pdf\"\u003e\u003cspan style=\"font-weight: 400;\"\u003eFDA data\u003c\/span\u003e\u003c\/a\u003e\u003cspan style=\"font-weight: 400;\"\u003e 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eBecause 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2 style=\"text-align: center;\"\u003e\u003cb\u003eFDA Warning Letter\u003c\/b\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eIn February of 2021, the FDA \u003c\/span\u003e\u003ca href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/coopersurgical-inc-613339-02122021\"\u003e\u003cspan style=\"font-weight: 400;\"\u003eissued a warning letter\u003c\/span\u003e\u003c\/a\u003e\u003cspan style=\"font-weight: 400;\"\u003e to Paragard, alleging the company was running advertisements without disclosing any risk or safety information about their product.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eSpecifically, the letter called Paragard’s ads “false and misleading” because they presented “efficacy claims” without communicating any “risk information associated with its use.”\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eThis 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2 style=\"text-align: center;\"\u003e\u003cb\u003eParagard Lawsuits\u003c\/b\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eParagard 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eThere don’t appear to be any active class-action lawsuits against Paragard; just individual suits.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eIn 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. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eLawyers 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2 style=\"text-align: center;\"\u003e\u003cb\u003eConclusion\u003c\/b\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eThe Paragard device is effective for controlling unplanned pregnancies. Based on a review of medical research it appears significantly more effective than barrier methods of contraception and oral birth control pills.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003ePerforation is a rare but significant side effect that patients should discuss with their doctor, particularly if they’re lactating. Most medical devices come with some level of risk, but the risk in this case is significantly lower than 1%.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eOne benefit of Paragard compared with hormonal IUD like Mirena is that it shouldn’t cause any hormone dysregulation. The Paragard is a copper device, and there is no biological mechanism for it to interfere with circulating hormone levels.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eWhile Paragard has been the subject of some controversy with the FDA and law firms, we find it to be a relatively low-risk and effective birth control aid that women seeking a long-term option may want to discuss with their doctor.\u003c\/span\u003e\u003c\/p\u003e","blog_id":49281925193,"author":"Calloway Cook","user_id":26601750601,"published_at":"2022-02-08T09:30:01-05:00","updated_at":"2022-02-08T09:30:01-05:00","summary_html":"We review medical research on the IUD Paragard to determine if it’s a safe and effective contraceptive. We also highlight some issues the FDA and law firms have raised about the device.","template_suffix":"","handle":"paragard-review","tags":"_related:birth-control"}

Paragard Review: More Effective Than The Pill?

Paragard Review: More Effective Than The Pill?


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Read our Editorial Guidelines to learn more about what makes our site the premier resource for online health information.
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Read our Editorial Guidelines to learn more about what makes our site the premier resource for online health information.


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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.

Medical Research

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 Lawsuits

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.

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Conclusion

The Paragard device is effective for controlling unplanned pregnancies. Based on a review of medical research it appears significantly more effective than barrier methods of contraception and oral birth control pills.

Perforation is a rare but significant side effect that patients should discuss with their doctor, particularly if they’re lactating. Most medical devices come with some level of risk, but the risk in this case is significantly lower than 1%.

One benefit of Paragard compared with hormonal IUD like Mirena is that it shouldn’t cause any hormone dysregulation. The Paragard is a copper device, and there is no biological mechanism for it to interfere with circulating hormone levels.

While Paragard has been the subject of some controversy with the FDA and law firms, we find it to be a relatively low-risk and effective birth control aid that women seeking a long-term option may want to discuss with their doctor.





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