Toxic Shock Syndrome and Vaginal Contraceptive Rings
Very rare cases of toxic shock syndrome (TSS) have been reported in NuvaRing users, but no causal relationship has been established between the contraceptive vaginal ring and TSS. 1
Evidence from FDA Drug Labeling
The NuvaRing FDA label explicitly addresses this concern in its precautions section:
- Cases of TSS have been associated with tampons and certain barrier contraceptives, with very rare cases reported by NuvaRing users 1
- In some reported cases, women were concurrently using tampons, making attribution difficult 1
- No causal relationship between NuvaRing use and TSS has been established 1
- If a patient exhibits signs or symptoms of TSS, the diagnosis should not be excluded and appropriate medical evaluation and treatment should be initiated 1
Clinical Context from Guidelines
The major guidelines addressing contraceptive vaginal rings (Pediatrics 2014, CDC Medical Eligibility Criteria 2010) do not list TSS as a significant risk or contraindication for vaginal ring use 2, 3, 4. These guidelines extensively discuss:
- Adverse effects including vaginal discharge, discomfort, and device expulsion 2, 3
- Venous thromboembolism risk comparable to combined oral contraceptives 5
- Common side effects such as headaches, nausea, and breakthrough bleeding 2, 3
TSS is notably absent from the list of clinically significant concerns in guideline recommendations, suggesting the risk is negligible in clinical practice 2, 3, 4.
Research Evidence
Recent comprehensive reviews of vaginal contraceptive rings do not identify TSS as a notable adverse event:
- A 2023 review discussing both ENG/EE and SA/EE rings lists serious adverse reactions including venous thromboembolism, psychiatric events, and hypersensitivity—but does not mention TSS 6
- A 2013 systematic review of vaginal health in contraceptive ring users found no evidence of increased infection risk or vaginal ecosystem disruption 7
- Multiple clinical trials and real-world studies spanning thousands of women-years of exposure do not report TSS as an observed complication 8, 9, 10
Historical Context
One older study from 1986 examined TSS risk factors and found a negative association between oral contraceptives and TSS (rate ratio 0.49), suggesting hormonal contraception may actually be protective 11. While this study did not specifically examine vaginal rings, it provides context that combined hormonal contraceptives do not appear to increase TSS risk.
Clinical Implications
The absolute risk of TSS with vaginal contraceptive ring use appears to be extremely low—comparable to background population risk. The FDA label's inclusion of TSS reflects regulatory thoroughness in documenting all reported adverse events, not an established causal association 1.
Clinicians should be aware that:
- Concurrent tampon use was present in some reported cases, potentially representing a confounding factor 1
- TSS remains primarily associated with tampon use and certain barrier contraceptives, not hormonal contraceptive devices 1
- Standard TSS warning signs (fever, rash, hypotension, multi-organ involvement) warrant immediate evaluation regardless of contraceptive method 1