AUGS Position Statement: Information and Guidance on the Adoption of Surgical Innovation and Technology in Urogynecology

ABSTRACT

The development of new technology and techniques (NTT) is an integral component of contemporary medicine. In surgery, rapidly advancing technology offers opportunities to innovate and study new approaches to help improve the quality and effectiveness of therapies. The American Urogynecologic Society is committed to the responsible implementation and use of NTT prior to the broad application of clinical care for patients, which includes not just new devices but application of new procedures. The aim of this document is to present a framework by which AUGS and its members can address future NTT development. Core areas of patient advocacy, industry partnerships, postmarket surveillance, and credentialing were identified to provide both a perspective and pathway for responsible use of NTT.

WHY THIS MATTERS

A hallmark feature of contemporary medicine is the continual emergence of innovation and the introduction of new technology and techniques (NTT), particularly in the surgical arena. Surgical innovation can provide the future tools for improved patient care; however, there are challenges to consider for the responsible adoption of NTT and its implementation in a patient-centered fashion. In urogynecology, the standards of scientific evaluation and reporting began to change in the late 1990s. The development of mesh slings for stress urinary incontinence revolutionized pelvic reconstructive surgery and ushered in the subsequent introduction of new techniques coupled with medical devices that transformed women's pelvic surgical care. This created a scenario where surgeons were presented with several potential NTTs to help care for their patients with limited data on efficacy and long-term safety. The challenge then, as it is now, is that regulatory processes for devices like the Food and Drug Administration's 510K process allow market introduction using predicate data that, at times, may be insufficient. Therefore, by exploring the areas of patient advocacy, effective and transparent relationships with industry, longitudinal postmarket surveillance, and an emphasis of proper training and credentialing, this document aims to serve as a framework for AUGS members and other stakeholders to responsibly use and approach innovation with a balance of data-driven outcomes, minimizing potential surgeon and industry bias with the goal optimizing the good of the public approach to new innovation that will optimize patients’ health.

The development of new technology and techniques (NTT)1 is an integral component of contemporary medicine. For surgery in particular, advances in care have often been closely linked to innovation or to the introduction of a novel device or procedure. Rapidly advancing technology offers surgeons’ opportunities to innovate and study new approaches to help improve the quality and effectiveness of therapies.2 Although the tempered adoption of these advances has often resulted in successful implementation and efficacious outcomes, occasionally unrestrained and/or uncoordinated adoption can lead to suboptimal outcomes and high rates of complications.3–5 The American College of Obstetricians and Gynecologists recently released a Committee Opinion6 on accessing and adopting new medical devices for care. This document comprehensively outlines the U.S. Food and Drug Administration's (FDA) regulatory process for new medical devices. It further aims to educate the obstetrician-gynecologist on the importance of assessing evidence prior to clinical use and encourages physicians to use existing reporting mechanisms for adverse events. Although governmental regulations and guidance are essential for the safe introduction of new medication and devices, the FDA does not regulate the practice of medicine. As described in American College of Obstetricians and Gynecologists’ Committee Opinion No. 801,6 it is the FDA regulatory pathway and the Manufacturer and User Facility Device Experience (MAUDE) Database that are the established course of device approval and surveillance, respectively. This top-down approach limits the ability for all collaborators and partners to participate in the full lifecycle, ranging from development to implementation to long-term surveillance. Current and evolving technology should allow for refinement of this process. The challenges facing a surgical subspecialty, such as urogynecology, are not wholly unique but there are distinctions, and the need for specific direction is more germane. There are currently no consensus guidelines that apply to urogynecologic or gynecologic surgical innovations, which have created a chasm between the regulatory aims and clinical practices. As we have moved to a more patient-centered focus with emphasis on risk reduction, clearer measures to ensure patient safety are needed. Responsibility falls on physicians, professional societies, the government, and industry to each act conscientiously and collaboratively to introduce NTT. The aim of this document is to present a framework, which AUGS members and other stakeholders could use to address future implementation of NTT.

The American Urogynecologic Society believes in the practitioner's obligation of responsible use of NTT prior to the broad application of clinical care for patients. This includes not only new devices but new procedures. When introducing NTT, surgeons should integrate evidence with clinical needs to guide decisions about whether and under what conditions it is used. We believe professional societies should be responsible for providing guidance to clinicians pertaining to NTT. Responsible use of NTT ultimately relies upon a critical evaluation by physicians regarding safety and efficacy. This evaluation can be facilitated by the guidance of professional societies. This applies not just to the initial pilot data, but also to long-term evaluation when preliminary results lead to widespread implementation in clinical practice. Fundamentally, evaluation should rely on science-based evidence, be free from industry bias or financial influences, and be ethically undertaken. The current interplay between industry, regulatory institutions, surgeons, and most importantly, patients is paramount when considering how to improve on the state of adoption of NTT. This document has assimilated these ideas and provided guidance for what to consider when implementing NTT into clinical care.

REFERENCES

1. Stefanidis D, Fanelli RD, Price R, et al, SAGES Guidelines Committee. SAGES guidelines for the introduction of new technology and techniques. Surg Endosc 2014;28(8):2257–2271. doi: 10.1007/ s00464-014-3587-6.

2. Biffl WL, Spain DA, Reitsma AM, et al, Society of University Surgeons Surgical Innovations Project Team. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons. J Am Coll Surg 2008;206(6):1204–1209. https://doi.org/10.1016/j.jamcollsurg.2008.02.011.

3. Pelvic Organ Prolapse. Interim Update: Practice Bulletin. The American College of Obstetricians and Gynecologists and the American Urogynecologic Society. Female Pelvic Medicine & Reconstructive Surgery. 2019;25:397–408. doi: 10.1097/SPV.0000000000000794

4. Richter LA, Sokol AI. Pelvic organ prolapse—vaginal and laparoscopic mesh: the evidence. Obstet Gynecol Clin North Am 2016;43:83–92. doi: 10.1016/j.ogc.2015.10.004.

5. Kowalik CR, Lakeman MME, de Kraker AT, et al. Effects of mesh-related complications in vaginal surgery on quality of life. Int Urogynecol J 2019;30:1083–1089. doi: 10.1007/s00192-018-3680-9.

6. Assessing and adopting new medical devices for obstetric and gynecologic care. ACOG Committee Opinion 801. American College of Obstetricians and Gynecologists. Obstet Gynecol 2020;135: 985–986. doi: 10.1097/AOG.0000000000003767.

(Urogynecology 2023;29:318–326)

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