Novel, Plastic-Free Vaginal Applicator for Reduction of Environmental and Systemic Plastic Chemical Exposures That Associate With Cancers Academic Article uri icon

abstract

  • PURPOSE A cost-effective, prebiotic gel (PreBioGyn) is being developed to prevent genital cancers by reducing biological risk factors for women including vaginal infections, mucosal inflammation, and plastic contaminant exposure. PreBioGyn is packaged in a reduced-plastic system, using a Kraft-paper vaginal applicator. Vaginal mucosa has high absorption and permeability putting women at risk to contaminants in feminine-care products. Specifically, cell toxic levels of phthalates and bisphenols are found in 90% of these products with increased serum levels (e.g. 5X) occurring in some users. Short-term exposure to plastics used in these products results in over 5,000 leachable chemicals migrating into water samples. Plastic chemical burdens are amplified for women in low-resource settings, women who also have increased genital cancer risks. These studies evaluated the dosing accuracy, user acceptance, and cytotoxicity of the paper PreBioGyn applicator. METHODS (1) Dosing accuracy of the paper applicator was compared to that of plastic applicators used with existing vaginal gels (Trimosan and RepHresh; modified ISO11608-1:2014). (2) Table-top acceptability of the paper applicator was scored by 42 HPV-positive women in two locations (BWH and UPRMSC). Women were not educated about any benefits of plastic-free vaginal applicators. (3) Cytotoxicity of the paper applicator was tested (ISO 10993-1:2018, 10993-5:2009, 10993-12:2012) with 48 hr extract exposure to L929 cells. Latex glove extracts served as positive controls. RESULTS For the PreBioGyn paper applicator: (1) 90% of gel doses fell within target levels (+10%) which was significantly more accurate as compared to the two plastic applicators. (2) The proportion of women who scored the applicator in Likert responses as neutral or better (vs a negative acceptance score) was >50% for appearance, feel, and dose-preparation; and >64% for use with vaginal medications as part of a cancer prevention program. (3) No cytotoxicity or biological reactivity was seen in applicator extracts. Latex extracts resulted in severe destruction of cells. CONCLUSION The novel paper applicator was safe, effective and acceptable in these studies. Acceptability was equal to published ratings for many plastic applicators used in existing vaginal products. The reduced-plastic PreBioGyn delivery system is designed to minimize plastic contaminant exposure in the vagina and the environment, further supporting its adoption as a cancer prevention gel.

authors

  • Godoy Vitorino, Filipa
  • Clifton, Dennis
  • Fichorova, Raina
  • Feldman, Sarah
  • Romaguera, Josefina
  • Godoy-Vitorino, Filipa
  • Fremlin, Jenny
  • Ellington-Lawrence, Rayne
  • Carey, Vincent
  • Pena, Nancy
  • Diaz, Janice
  • Stokes, Erisa
  • Ellington, Joanna

publication date

  • 2024

number of pages

  • 1

start page

  • 135

end page

  • 136

volume

  • 10

issue

  • Supplement_1