1 / FDA Consumer Health Infor mat ion / U. S. Food and Dr ug Adminis t r at ion JULY 2010

Consumer Health Information

www.fda.gov/consumer

FDA Cautions Against 

Using Unapproved IUDs 

 F

ederal health 

officials are 

warning medical 

practitioners around 

the country not to use 

unapproved intrauterine 

devices (IUDs). 

In a July 22 letter, the Food 

and Drug Administration 

(FDA) reminds health professionals that using unapproved 

IUDs raises concerns about 

effectiveness and safety—as 

well as the potential for fraud 

and counterfeiting. 

“Federal law requires that 

IUD/IUSs (intrauterine systems) be F DA-approved 

prior to marketing. This 

law is designed to protect 

patients from products that 

are unsafe and ineffective,” 

Theresa Toigo, FDA’s liaison 

with health professionals, 

says in the letter. “The recent 

issue with patients in Rhode 

Island unknowingly receiving 

imported, unapproved IUD/

IUSs highlights the unacceptable risk patients may be 

exposed to when a product’s 

identity, purity, source, handling, and storage cannot be 

verified.”

Still, patients can use their 

FDA-approved IUDs with confidence, Toigo says.

FDA experts say women who 

received unapproved IUDs 
2 / FDA Consumer Health Infor mat ion / U. S. Food and Dr ug Adminis t r at ion JULY 2010

Consumer Health Information

www.fda.gov/consumer

Federal law requires that IUDs be FDAapproved prior to marketing. This law is 

designed to protect patients from products 

that are unsafe and ineffective.

Find this and other Consumer 

Updates at www.fda.gov/

ForConsumers/ConsumerUpdates

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subscriptions at www.fda.gov/

consumer/consumerenews.html

from practitioners in Rhode Island, 

Massachusetts, and Kentucky could 

be at an increased risk for unwanted 

pregnancy. 

The small, T-shaped devices—

often made of flexible plastic or 

copper wire—are inserted into a 

woman’s uterus to prevent pregnancy. Some IUDs also deliver small 

amounts of hormone as added protection from pregnancy. 

FDA says women should not try 

to remove IUDs by themselves. The 

agency is advising women who think 

they may have an unapproved IUD 

to use another form of birth control—such as condoms, birth control 

pills, or the patch—and contact their 

health care professional. Women 

may want to ask: 

• What advantages are there for 

keeping my IUD in?

• Should I think about having my 

IUD removed? 

• If I keep my IUD in, how long 

should I use another form of 

birth control? 

• If I want my IUD removed, can I 

get a new, FDA-approved one? 

• I don’t want to use condoms. 

Will other birth control products, 

such as the pill, patch, or ring, be 

equally effective? 

• Will this affect my ability to get 

pregnant in the future?

• What should I do if I think I’m 

pregnant?

Nationwide Problem

What started out as a Rhode Island 

investigation has spread beyond the 

state’s borders. The FDA is aware of 

the use of these unapproved products in several states and is continuing to investigate.

FDA says doctors, nurses, midwives—and possibly patients 

themselves—might buy unapprove d produc t s f rom wh at 

appear to be Canadian or other 

foreign websites in a bid to save 

money. Purchasing medical products from websites that are outside of the U.S. may be illegal and 

may increase the risk of receiving 

a potentially harmful product, 

since many websites sell products 

that are not FDA-approved and 

could be manufactured in other 

countries.

“Unapproved products bring 

a lot of unk now ns into t he 

equation,” says FDA compliance 

officer Kathleen Anderson. “An 

Internet ad may claim to sell IUDs 

made in Canada, but there’s no 

way to be sure. They might have 

been made anywhere in the world 

and in unsanitary or undesirable 

conditions.” 

Advice for Consumers 

FDA investigators routinely 

monitor the Internet for the sale 

of unapproved drugs and devices 

in an effort to protect the public, 

but the rapidly growing number of 

websites trafficking in fraudulent 

medical products means consumers must remain alert.

Experts advise consumers to 

learn how to buy health-related 

products safely over the Internet. 

Legitimate Internet pharmacies 

are licensed by the appropriate 

state board of pharmacy and follow laws and regulations of the 

state where they operate. 

Legitimate Internet pharmacies 

will also display a seal from the 

National Association of Boards of 

Pharmacy—known as VIPPS seal or 

Verified Internet Pharmacy Practice 

Sites. VIPPS pharmacies are listed 

at vipps.nabp.net/verify.asp.

FDA is also asking the public to 

report information about the distribution of unapproved IUDs. To contact the agency’s criminal investigators visit www.fda.gov/oci.