The safety assessment of tampons: illustration of a comprehensive approach for four different products
IntroductionWe illustrate a comprehensive tampon safety assessment approach that assures products can be used safely. Material biocompatibility, vaginal mucosa assessment, vaginal microbiome evaluation, and in vitro assessment of potential risk of staphylococcal toxic shock syndrome expressed throug...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-06-01
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| Series: | Frontiers in Reproductive Health |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/frph.2023.1167868/full |
| _version_ | 1797799479276994560 |
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| author | Anne E. Hochwalt Joan M. Abbinante-Nissen Lisa C. Bohman Anne M. Hattersley Ping Hu Jan L. Streicher-Scott Amber G. Teufel Kara E. Woeller |
| author_facet | Anne E. Hochwalt Joan M. Abbinante-Nissen Lisa C. Bohman Anne M. Hattersley Ping Hu Jan L. Streicher-Scott Amber G. Teufel Kara E. Woeller |
| author_sort | Anne E. Hochwalt |
| collection | DOAJ |
| description | IntroductionWe illustrate a comprehensive tampon safety assessment approach that assures products can be used safely. Material biocompatibility, vaginal mucosa assessment, vaginal microbiome evaluation, and in vitro assessment of potential risk of staphylococcal toxic shock syndrome expressed through growth of Staphylococcus aureus (S. aureus) and production of TSST-1 are the four essential portions of the approach. Post-marketing surveillance informs of possible health effects that warrant follow up. The approach meets or exceeds US and international regulatory guidance and is described through the example of four tampon products.Methods/ResultsEach product is comprised mostly of large molecular weight components (cotton, rayon, polymers) that cannot pass the vaginal mucosa, are widely used across the industry, and replete with a vast body of safety data and a long history of safe use in the category. Quantitative risk assessment of all small molecular weight components assured a sufficient margin of safety supporting their use. Vaginal mucosa assessment confirmed that pressure points, rough edges and/or sharp contact points were absent. A randomized cross-over clinical trial (ClinicalTrials.gov Identifier: NCT03478371) revealed favorable comfort ratings, and few complaints of irritation, burning, stinging, or discomfort upon insertion, wear, and removal. Adverse events were few, mild in severity, self-limited and resolved without treatment. Vaginal microbiota assessment in vitro presented no adverse effect on microbial growth. Culture-independent microbiome analyses from vaginal swab samples obtained during the clinical trial showed no differences attributable to tampon usage, but instead due to statistically significant subject-to-subject variability. Growth of S. aureus and TSST-1 toxin production in the presence of any of the four products in vitro were statistically significantly reduced when compared to medium control alone.DiscussionThe data from the four elements of the comprehensive safety assessment approach illustrated herein confirm that tampons evaluated using this system can be used safely for menstrual protection. A post-marketing surveillance system that monitors and responds to in-market experiences indicated in-use tolerability of the product among consumers, thus confirming the conclusions of the pre-marketing safety assessment. |
| first_indexed | 2024-03-13T04:20:31Z |
| format | Article |
| id | doaj.art-328ff30238e941149ce03bee0c7e7d39 |
| institution | Directory Open Access Journal |
| issn | 2673-3153 |
| language | English |
| last_indexed | 2024-03-13T04:20:31Z |
| publishDate | 2023-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Reproductive Health |
| spelling | doaj.art-328ff30238e941149ce03bee0c7e7d392023-06-20T10:24:38ZengFrontiers Media S.A.Frontiers in Reproductive Health2673-31532023-06-01510.3389/frph.2023.11678681167868The safety assessment of tampons: illustration of a comprehensive approach for four different productsAnne E. Hochwalt0Joan M. Abbinante-Nissen1Lisa C. Bohman2Anne M. Hattersley3Ping Hu4Jan L. Streicher-Scott5Amber G. Teufel6Kara E. Woeller7RWTS, LLC, West Chester, OH, United StatesBaby, Feminine and Family Care, Global Product Stewardship, The Procter & Gamble Company, Cincinnati, OH, United StatesData Modeling and Sciences, The Procter & Gamble Company, Mason, OH, United StatesGlobal Safety Surveillance and Analysis, The Procter & Gamble Company, Mason, OH, United StatesCorporate Biosciences, The Procter & Gamble Company, Mason, OH, United StatesBaby, Feminine and Family Care Clinical Sciences, The Procter & Gamble Company, Cincinnati, OH, United StatesBaby, Feminine and Family Care Microbiology, The Procter & Gamble Company, Cincinnati, OH, United StatesBaby, Feminine and Family Care, Global Product Stewardship, The Procter & Gamble Company, Cincinnati, OH, United StatesIntroductionWe illustrate a comprehensive tampon safety assessment approach that assures products can be used safely. Material biocompatibility, vaginal mucosa assessment, vaginal microbiome evaluation, and in vitro assessment of potential risk of staphylococcal toxic shock syndrome expressed through growth of Staphylococcus aureus (S. aureus) and production of TSST-1 are the four essential portions of the approach. Post-marketing surveillance informs of possible health effects that warrant follow up. The approach meets or exceeds US and international regulatory guidance and is described through the example of four tampon products.Methods/ResultsEach product is comprised mostly of large molecular weight components (cotton, rayon, polymers) that cannot pass the vaginal mucosa, are widely used across the industry, and replete with a vast body of safety data and a long history of safe use in the category. Quantitative risk assessment of all small molecular weight components assured a sufficient margin of safety supporting their use. Vaginal mucosa assessment confirmed that pressure points, rough edges and/or sharp contact points were absent. A randomized cross-over clinical trial (ClinicalTrials.gov Identifier: NCT03478371) revealed favorable comfort ratings, and few complaints of irritation, burning, stinging, or discomfort upon insertion, wear, and removal. Adverse events were few, mild in severity, self-limited and resolved without treatment. Vaginal microbiota assessment in vitro presented no adverse effect on microbial growth. Culture-independent microbiome analyses from vaginal swab samples obtained during the clinical trial showed no differences attributable to tampon usage, but instead due to statistically significant subject-to-subject variability. Growth of S. aureus and TSST-1 toxin production in the presence of any of the four products in vitro were statistically significantly reduced when compared to medium control alone.DiscussionThe data from the four elements of the comprehensive safety assessment approach illustrated herein confirm that tampons evaluated using this system can be used safely for menstrual protection. A post-marketing surveillance system that monitors and responds to in-market experiences indicated in-use tolerability of the product among consumers, thus confirming the conclusions of the pre-marketing safety assessment.https://www.frontiersin.org/articles/10.3389/frph.2023.1167868/fulltamponsafety assessmentbiocompatibilityvaginal mucosavaginal microbiomestaphylococcal toxic shock syndrome |
| spellingShingle | Anne E. Hochwalt Joan M. Abbinante-Nissen Lisa C. Bohman Anne M. Hattersley Ping Hu Jan L. Streicher-Scott Amber G. Teufel Kara E. Woeller The safety assessment of tampons: illustration of a comprehensive approach for four different products Frontiers in Reproductive Health tampon safety assessment biocompatibility vaginal mucosa vaginal microbiome staphylococcal toxic shock syndrome |
| title | The safety assessment of tampons: illustration of a comprehensive approach for four different products |
| title_full | The safety assessment of tampons: illustration of a comprehensive approach for four different products |
| title_fullStr | The safety assessment of tampons: illustration of a comprehensive approach for four different products |
| title_full_unstemmed | The safety assessment of tampons: illustration of a comprehensive approach for four different products |
| title_short | The safety assessment of tampons: illustration of a comprehensive approach for four different products |
| title_sort | safety assessment of tampons illustration of a comprehensive approach for four different products |
| topic | tampon safety assessment biocompatibility vaginal mucosa vaginal microbiome staphylococcal toxic shock syndrome |
| url | https://www.frontiersin.org/articles/10.3389/frph.2023.1167868/full |
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