Medical-Grade Materials in Menstrual Cups: Biodegradation, Safety, and Allergic Reaction


Authors : Sujan Surya D.; Pavan Kumar Chikkavalli Muddanna; Prem; Mudigere Gowda Sanjay; Kavya K. M.; Asfiya Siddiqha; Mahendra Kumar Betur Jayappa; Amrutha Thoobinakere Devarajegowda

Volume/Issue : Volume 11 - 2026, Issue 2 - February


Google Scholar : https://tinyurl.com/2m6b7ayc

Scribd : https://tinyurl.com/yhbywkze

DOI : https://doi.org/10.38124/ijisrt/26feb627

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.


Abstract : Menstrual cups have become popular as a greener option compared to disposable menstrual products. The safety and biocompatibility of medical-grade materials employed in these products e.g., medical-grade silicone, thermoplastic elastomers (TPEs), natural rubber continue to be of main concern. This paper assesses the potential for biodegradation, safety profile, and risk of allergic reaction of these materials, especially against international medical standards (e.g., ISO, FDA, EU regulations). Whereas medical-grade silicone reflects excellent stability, low toxicity, and limited allergenicity, TPEs and natural rubber are associated with increased risks through chemical additives and protein residues, respectively. Accelerated aging and in vitro cytotoxicity experiments indicate that silicone-based cups show excellent long-term safety. Rare instances of hypersensitivity reactions do, however, indicate the necessity of better material standardization and allergen marking. This review highlights the necessity of strict material testing for safeguarding users' safety while pressing for continued research in biodegradable options without sacrificing biocompatibility.

Keywords : Medical-Gradesilicone;Thermoplastic Elastomers (TPE);Natural Rubber Latex;Biodegradable Polymers;Medical Device Materials;Biocompatibility;Cytotoxicity;Vaginal Microbiome;Biofilm Formation;Latex Hypersensitivity; Syndrome;Allergic Contact Dermatitis;Toxic Shock Syndrome.

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Menstrual cups have become popular as a greener option compared to disposable menstrual products. The safety and biocompatibility of medical-grade materials employed in these products e.g., medical-grade silicone, thermoplastic elastomers (TPEs), natural rubber continue to be of main concern. This paper assesses the potential for biodegradation, safety profile, and risk of allergic reaction of these materials, especially against international medical standards (e.g., ISO, FDA, EU regulations). Whereas medical-grade silicone reflects excellent stability, low toxicity, and limited allergenicity, TPEs and natural rubber are associated with increased risks through chemical additives and protein residues, respectively. Accelerated aging and in vitro cytotoxicity experiments indicate that silicone-based cups show excellent long-term safety. Rare instances of hypersensitivity reactions do, however, indicate the necessity of better material standardization and allergen marking. This review highlights the necessity of strict material testing for safeguarding users' safety while pressing for continued research in biodegradable options without sacrificing biocompatibility.

Keywords : Medical-Gradesilicone;Thermoplastic Elastomers (TPE);Natural Rubber Latex;Biodegradable Polymers;Medical Device Materials;Biocompatibility;Cytotoxicity;Vaginal Microbiome;Biofilm Formation;Latex Hypersensitivity; Syndrome;Allergic Contact Dermatitis;Toxic Shock Syndrome.

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