Paz Etcheverry, MS, PhD

March 2024

What exactly is toxic shock syndrome, and why does the Food and Drug Administration (FDA) enforce a warning on tampon packaging? 

Toxic shock syndrome, or TSS, is an acute illness predominantly caused by the toxin-producing bacteria Staphylococcus aureus.^[6]TSS is characterized by fever, chills, body rashes, vomiting, diarrhea, muscle aches, and low blood pressure. It is a very serious illness that can lead to multiple organ damage (including of the liver, kidneys, and heart) and death.^{[1] [3]} 

TSS is primarily associated with the use of tampons, especially the super- and higher-absorbency types.^[2] However, keeping a tampon inside the vagina for a long time can lead to TSS regardless of the tampon type. 

The incidence of TSS related to menstruation, also known in the literature as menstrual TSS or mTSS, currently ranges between 1 to 3 per 100,000 in the US.^{[1] [6]}This represents a considerable decline from the 1980s, when the incidence rate was between 2 to 16 cases per 100,000 menstruating women. This decline is mainly attributed to the implementation of consumer education and to the introduction of labeling requirements by the FDA.^{[7] [8]} As per regulatory requirements, the FDA mandates that all tampon packages include the following warning: “Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information”.^[9] 

For mTSS to occur, two essential factors are necessary: 

1. the presence of S. aureus in the vagina
2. the lack of antibodies to neutralize toxic shock syndrome toxin-1 (TSST-1) produced by the bacteria^[10]

Among the women who use tampons, 1 to 5 percent have TSST-1-producing S. aureus in their vaginas and 10 to 20 percent have no protective antibodies against TSST-1.^[1]In addition to the above two factors, scientists believe that tampons introduce oxygen, which creates a more aerobic environment in the vagina, which is favored by S. aureus.^[10] The rapid removal of tampons may also cause small vaginal tears, which could lead to infections.^[5] 

To reduce the risk of mTSS, women should avoid wearing the same tampon for more than 8 hours, refrain from wearing tampons overnight, change the tampon preferably every 4 hours, and unwrap the tampon from its packaging only when ready to use it. Additionally, women should use tampons with the lowest absorbency for their flow and switch from tampons to pads every other day, especially when the menstrual flow is the heaviest. Compared to regular- and light-absorbency tampons, super and higher-absorbency types are larger in size. This increased size could potentially lead to abrasion and irritation in the vagina, making it easier for TSST-1 to enter the body. Furthermore, it is important to opt for all-cotton tampons, as opposed to tampons with rayon/cotton blends, as they may be less irritating.^[5] 

Treatment of mTSS usually involves intravenous fluids and antibiotics such as penicillinase-resistant penicillin, cephalosporin, or vancomycin along with either clindamycin or linezolid.^[3] 

While mTSS has been associated with tampon use, wearing menstrual cups, cervical caps, diaphragms, pessaries, and natural sea-sponges increases the risk of the illness.^{[4] [6]} TSS may also occur in non-menstrual settings such as in soft tissue infections, post-surgical infections, burns, nasal packing—gauze or sponge-like materials placed inside the nasal cavity—, and dialysis catheters.^[6] 

If any signs of TSS arise, such as sudden high fever, rash, and low blood pressure, seeking prompt medical attention is of utmost importance. Overall, balancing menstrual practices with awareness and caution is key to minimizing potential risks associated with tampon use.

References 

[1] Billon, A., Gustin, M. P., Tristan, A., Bénet, T., Berthiller, J., Gustave, C. A., Vanhems, P., & Lina, G. (2020). Association of characteristics of tampon use with menstrual toxic shock syndrome in France. EClinicalMedicine, 21, 100308. https://doi.org/10.1016/j.eclinm.2020.100308

[2] Bobel, C., Winkler, I.T., Fahs, B., et al., editors (2020). The Palgrave Handbook of Critical Menstruation Studies [Internet]. Singapore: Palgrave Macmillan. https://www.ncbi.nlm.nih.gov/books/NBK565605

[3] Gottlieb, M., Long, B., & Koyfman, A. (2018). The Evaluation and Management of Toxic Shock Syndrome in the Emergency Department: A Review of the Literature. The Journal of Emergency Medicine, 54(6), 807–814. https://doi.org/10.1016/j.jemermed.2017.12.048 

[4] Hochwalt, A. E., Abbinante-Nissen, J. M., Bohman, L. C., Hattersley, A. M., Hu, P., Streicher-Scott, J. L., Teufel, A. G., & Woeller, K. E. (2023). The safety assessment of tampons: illustration of a comprehensive approach for four different products. Frontiers in Reproductive Health, 5, 1167868. https://doi.org/10.3389/frph.2023.1167868 

[5] Nicole, W. (2014). A question for women’s health: chemicals in feminine hygiene products and personal lubricants. Environmental Health Perspectives, 122(3), A70–A75. https://doi.org/10.1289/ehp.122-A70 

[6] Ross, A., & Shoff, H.W. Toxic Shock Syndrome. [Updated 2023 Aug 7]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459345/ 

[7] Roy, P., Sahni, A. K., & Kumar, A. (2015). A fatal case of staphylococcal toxic shock syndrome. Medical Journal, Armed Forces India, 71(Suppl 1), S107–S110. https://doi.org/10.1016/j.mjafi.2013.05.012 

[8] U.S. Food and Drug Administration (2005, July). Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) – Guidance for Industry and FDA Staff. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/menstrual-tampons and-pads-information-premarket-notification-submissions-510ks-guidance-industry#1 

[9] U.S. Food and Drug Administration (2023, October). CFR – Code of Federal Regulations Title 21. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=801.430 

[10] Vostral, S. (2017). Toxic shock syndrome, tampons and laboratory standard-setting. CMAJ: Canadian Medical Association Journal = Journal de l’Association Medicale Canadienne, 189(20), E726–E728. https://doi.org/10.1503/cmaj.161479