Tampons—shown within an applicator on the left and outside of an applicator on the right—are regulated by the U.S. Food and Drug Administration as medical devices.
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If you use tampons during your period (also called a “menstrual cycle”), it’s important to know the basics for how to use them safely. Consider this important information from the U.S. Food and Drug Administration—and please share it with friends and loved ones who may use these products.
What are tampons—and what are they made of?
You may be surprised to know that the FDA regulates tampons as medical devices. Tampons are inserted into the vagina to absorb menstrual flow when people have their periods. They are cylindrical in shape and made of cotton, rayon, or a blend of the two. Tampons are either designed to be inserted using a plastic or cardboard applicator or to be directly inserted, without an applicator.
What should you know about different types of tampons? And are tampons safe?
Tampons are available in “organic” and standard varieties. Tampons are also available in “scented” and “unscented” options. But before any tampons can be sold, they must go through FDA review to determine whether they are substantially equivalent to, including as safe and effective as, a legally marketed tampon.
As part of this FDA review, manufacturers submit, among other information, the results of testing to evaluate the safety of the materials used to make tampons and applicators (if present); tampons’ absorbency, strength, and integrity; and whether tampons enhance the growth of certain harmful bacteria or alter normal bacterial growth in the vagina.
Tampons sold today are made with a chlorine-free bleaching process, which also prevents products from having dangerous levels of dioxin (a type of pollutant found in the environment).
The bottom line: The FDA views any marketed tampons that comply with FDA requirements, including FDA premarket review, to be safe and effective when used as directed.
What do consumers need to know in order to use tampons safely?
You may want to ask your health care provider if you have questions about whether tampons—or other FDA-regulated products such as menstrual pads or cups—are right for you. If you decide to use tampons, consider the following general advice.
- Follow all labeled directions. Even if you’ve used tampons before, refresh yourself on best practices, including any information on washing your hands before and after use. (Note: A tampon cannot get “lost” in your body when used as directed.)
- Only use tampons when you have your period—and only use them as directed. Tampons are not intended to be used at any other time.
- Change each tampon every 4 to 8 hours. Never wear a single tampon for more than 8 hours at a time.
- Use the lowest absorbency tampon that you need. Consider how heavy or light your period is and how often you need to change your tampon. If you can wear one tampon up to eight hours without changing it, the absorbency may be too high.
- Consider which period products are best for different activities. For example, if you need coverage for longer than 8 hours, such as when sleeping, choose a pad instead.
- Beware of pain or other unusual symptoms. Tell your health care provider if you ever have discomfort, pain, or other unusual symptoms like unusual discharge when trying to insert or wear a tampon. (Note: You shouldn’t feel a tampon when it is inserted properly.) These symptoms may mean that you need to take a break from using tampons. Symptoms such as a sudden fever (usually 102°F or more) and vomiting, diarrhea, fainting or feeling like you are going to faint when standing up, dizziness, or a rash that looks like a sunburn may be signs of toxic shock syndrome (TSS). If you have any of these symptoms during your period, remove the tampon and seek medical attention immediately. And if you have these symptoms soon after your period, seek medical attention immediately. If you ever have an allergic reaction or irritation from using tampons, stop using tampons and talk with your health care provider.
Finally, if you ever have a problem with a tampon, consider also reporting it to MedWatch, the FDA’s safety information and adverse event reporting program.
What should you know about toxic shock syndrome (TSS)?
One safety issue associated with using tampons is toxic shock syndrome, a rare disease caused by a toxic substance that is produced by certain kinds of bacteria. The toxic substance can cause organ damage (including kidney, heart, and liver failure), shock, and even death.
Rates of reported TSS cases associated with tampons have declined significantly over the past 20 years. One reason is that, as part of the premarket review, the FDA evaluates whether a tampon enhances the growth of the bacteria that causes TSS before deciding whether the product can be marketed. The FDA also believes that more informative tampon labeling, as well as educational efforts by the FDA and manufacturers, have contributed to this major reduction in TSS cases.
While TSS is rare today, the risk is higher if you:
- use more absorbent tampons than needed, or
- wear a tampon for longer than recommended.
So remember to follow the safety instructions on the tampon labeling and consider the advice outlined above.
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