Catherine C. Davis
Kenneth W. Miller2
Julie A. Peterson- 1Department of Medical Microbiology and Immunology, School of Medicine, Creighton University, Omaha, NE, United States
- 2Margoshes-Miller Consulting, LLC, Liberty, OH, United States
- 3Department of Physical Therapy, School of Pharmacy and Health Professions, Creighton University, Omaha, NE, United States
Editorial on the Research Topic
Female urogenital devices used during their lifetime—managing menstruation including pelvic health
Introduction
Safety, efficacy, and regulatory oversight is essential for medical devices used by women to help them manage physiological changes throughout their lifespan. For perspective, the global female population (2021) almost equaled males and half of those are of reproductive age (1). As the global population increases in age, the world has more women (2). Thus, the articles contained in this Research Topic cover devices that can increase from decades of monthly use to literally decades of daily use.
Safety assessments are interdisciplinary processes that integrates chemical and physical hazard understanding with estimated consumer exposure to determine the potential risk associated with product use. This multi-step, tiered, iterative approach has been described by credible organizations such as the United States National Academy of Sciences and the World Health Organization. Often first tier safety assessment utilizes default, conservative assumptions, where subsequent assessment uses refined assumptions derived from generation of additional data (e.g., analytical measurement). In addition to evaluation of chemical risk, unique hazards specific to the product, such as physical and microbiological hazards, should be evaluated to assure the products are safe when used as intended.
Before a medical device is available in U.S. commerce, a manufacturer must submit required data to the US Food and Drug Administration (FDA) for review. The FDA is the oldest consumer protection governmental agency that is charged with protecting health of its citizens through regulating medical and radiation-emitting devices which enter commerce. The Center for Device and Radiological Health (CDRH) regulates medical devices, which include many female internal and external urogenital devices such as tampons, menstrual cups (MCs), pessaries designed to mitigate uterine prolapse, as well as external adult incontinence products. Pollard discusses the process that this agency uses for the risk-based review process. As Pollard points out “every medical device is classified according to its specific risks to health, from low to high, and each classification level establishes a set of controls from which FDA chooses.” Manufacturers must submit to the FDA a detailed risk assessment of the device components, the design, and test results for review and comment before urogenital devices are introduced into commerce. Depending on any unique design, technology, indications, and performance characteristics of a given product, FDA may request additional information (3).
Zou et al. 2023, examined the MAUDE (Manufacturer and User Facility Device Experience) reports during a 10 month timeframe and focused on safety reports related to the Essure (Bayer) device. To note, on December 31, 2018, Bayer stopped selling and distributing the device (4). Several safety issues related to the device were noted. Like with other obstetrics and gynecology devices, pain and bleeding were the most common adverse events noted (5–7) Based on the research results, the authors recommended that “the quality of adverse event reports need[ed] to be improved to minimize the bias from incomplete and subjective data. More health professionals need to fill out voluntary report forms, such as using the MedWatch (8) system, to provide more safety information about medical devices.” Per their website, “the FDA remains committed to collecting long-term safety information in women who have received the device. This includes ensuring that Bayer continues to meet its mandated post market study obligations for Essure beyond 2019.” (4)
Tampons are medical devices that provide a convenient and effective form of menstrual protection. Assessing tampons to assure their safe use dates back as far as the 1940s (8–10). Hochwalt et al., outlines the four elements of the comprehensive safety assessment approach used to evaluate and confirm that Tampax™ (Procter & Gamble, Cincinnati, OH) tampons can be used safely for menstrual protection. The steps in premarket safety assessment are outlined, as well as a post-marketing surveillance system that monitors and can respond to in-market experiences, indicated in-use tolerability among consumers.
Other reusable, environmentally friendly catamenial devices are used to manage menstrual periods such as MCs (11, 12). Friberg et al., reports on a study designed to determine if Staphylococcus aureus biofilms formed on MCs using a new in vitro system designed to mimic the vaginal environment most closely occurring during menstruation. For decades, Lactobacillus species have been regarded as beneficial to the human vaginal econiche by preventing the invasion and overgrowth of pathogens. Previous studies have used a monoculture of S. aureus for in vitro analyses. The results reported in this dual-species assay was conducted over 12 h (labeled wear time for MCs) and is unique in that it included one of the vaginal keystone species of lactobacilli which is known to help keep potential pathogens from overgrowth. During the time period tested, few bacteria adhered to the MC and no biofilm formed. Current washing and care of the product was also reviewed by modeling in-between uses through an additional in vitro test system.
Urinary incontinence (UI) is the accidental loss of urine. According to the National Association for Continence, over 25 million adult Americans experience temporary or chronic urinary incontinence (13). UI can occur at any age, but it is more common among women over 50. Krause et al., focused on the European Union Medical Device Regulations (EU MDRs) and described how the work completed for adult incontinence (AI) products meets the requirements of these regulations. A robust safety assessment process described Quality Assurance measures and safety surveillance efforts necessary to augment the overall approach and provide a strong weight of evidence support for the safety of these AI products.
UI is not a condition unique to Americans. Omeke and Azuka detail the impact of UI on women in Africa. The issue of availability of products as well as the cultural impacts of UI on women in Africa is described and provides a needed reminder that the need for urogenital devices is a global one and requires devices that incorporate the unique needs of women in other geographies.
Conclusions
The six articles included in this Research Topic highlight how different approaches and resources have shaped and informed our understanding of urogenital devices used during a woman's lifetime. They offer a unique resource to those wishing to learn more about the consumer need, safety, and regulatory review of the devices.
Author contributions
CD: Writing – original draft, Writing – review & editing. KM: Writing – original draft, Writing – review & editing. JP: Writing – review & editing.
Conflict of interest
CD and KM are retired employees of The Procter & Gamble Company. KM is currently Principal Consultant and co-owner of Margoshes-Miller Consulting, LLC.
The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
References
1. UN Women Facts and Figures: Economic Empowerment. Available at: https://www.unwomen.org/en/what-we-do/economic-empowerment/facts-and-figures (Downloaded August 23, 2023).
2. Carey IW, Hackett C. 2022 Global population skews male, but UN projects parity between sexes by 2050. Pew Research Center. (2022). Available at: https://www.pewresearch.org/short-reads/2022/08/31/global-population-skews-male-but-un-projects-parity-between-sexes-by-2050/ (Downloaded August 23, 2023).
3. Schlievert PM, Davis CC. Device-associated menstrual toxic shock syndrome. Clin Microbiol Rev. (2020) 33(3):e00032–19. doi: 10.1128/CMR.00032-19
4. U.S. Food and Drug Administration. Essure Permanent Birth Control. Available at: https://www.fda.gov/medical-devices/implants-and-prosthetics/essure-permanent-birth-control (Downloaded August 23, 2023).
5. Ahluwalia J, Avram MM, Ortiz AE. Lasers and energy-based devices marketed for vaginal rejuvenation: a cross-sectional analysis of the MAUDE database. Lasers Surg Med. (2019) 51(8):671–7. doi: 10.1002/lsm.23084
6. Correa J, Aribo C, Stuparich M, Nahas S, Cheung C, Behbehani S. Malfunction events in the US FDA MAUDE database: how does robotic gynecologic surgery compare with other specialties? J Minim Invasive Gynecol. (2022) 29(2):300–7.e1. doi: 10.1016/j.jmig.2021.08.021
7. Wallace SL, Sokol ER, Enemchukwu EA. Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. Menopause. (2021) 28(2):135–41. doi: 10.1097/GME.0000000000001661
8. U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Available at: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program (Downloaded August 23, 2023).
9. Magid MO, Geiger J. The intravaginal tampon in menstrual hygiene: clinical study. Med Rec. (1942) 155:316–23.
10. Dickinson RL. Tampons as menstrual guards. JAMA J Am Med Assoc. (1945) 128:490–4. 107–9. doi: 10.1001/jama.1945.02860240016004
11. van Eijk AM, Zulaika G, Lenchner M, Mason L, Sivakami M, Nyothach E, et al. Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis. Lancet Public Health. (2019) 4(8):e376–93. doi: 10.1016/S2468-2667(19)30111-2
12. Sica VP, Friberg MA, Teufel AG, Streicher-Scott JL, Hu P, Sauer UG, et al. Safety assessment scheme for menstrual cups and application for the evaluation of a menstrual cup comprised of medical grade silicone. EBioMedicine. (2022) 86:104339. doi: 10.1016/j.ebiom.2022.104339
13. Johns Hopkins Medicine. Urinary Incontinence in Women. Available at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/urinary-incontinence/urinary-incontinence-in-women (Downloaded November 6, 2023).
Keywords: menstrual cups, biofilms, cleaning, regulatory, adult incontinence, tampons, MAUDE, surveillance, Essure device
Citation: Davis CC, Miller KW and Peterson JA (2024) Editorial: Female urogenital devices used during their lifetime—managing menstruation including pelvic health. Front. Reprod. Health 5:1339278. doi: 10.3389/frph.2023.1339278
Received: 15 November 2023; Accepted: 5 December 2023;
Published: 4 January 2024.
Edited and Reviewed by: Pamela Stratton, National Institutes of Health (NIH), United States
© 2024 Davis, Miller and Peterson. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Catherine C. Davis catherinedavis@creighton.edu