International guidelines for groin hernia management: Do they have a vested interest?

Abstract

International HerniaSurge guidelines have standardized groin hernia management, yet uncertainty persists regarding the optimal repair technique because available evidence remains heterogeneous, surgeon-dependent, and frequently influenced by patient selection and expertise. Concerns over industry sponsorship, conflicts of interest, and selective reporting raise questions about the impartiality of existing recommendations. Current evidence suggests that no single technique consistently demonstrates superiority in long-term recurrence, chronic pain, or patient satisfaction across all clinical settings. Therefore, individualized treatment based on patient characteristics, surgeon proficiency, and shared decision-making remains appropriate. Future international guidelines should be developed by independent multidisciplinary panels free from industry funding, with mandatory conflict-of-interest disclosure, transparent Grading of Recommendations Assessment, Development and Evaluation-based evidence synthesis, public consultation, external peer review, publication of complete evidence tables, inclusion of patient representatives, and regular independent updates. Comparative trials should emphasize long-term patient-centred outcomes, decision regret, quality of life, chronic pain, mesh-related complications, cost-effectiveness, and recurrence rather than procedural preference alone.

Key Words: Inguinal hernia; Hernia repair; Clinical practice guidelines; Conflict of interest; Industry funding; Evidence-based medicine

Core Tip: Current HerniaSurge guidelines provide a structured approach to groin hernia management, but concerns remain regarding industry influence, conflicts of interest, and the absence of definitive evidence supporting one superior repair technique. Greater transparency, independent evidence appraisal, and individualized surgeon-patient decision-making are essential for optimizing outcomes and maintaining trust.

INTRODUCTION

The HerniaSurge guidelines were developed by 50 international surgeons in 2018 to identify the “best inguinal hernia repair” through a structured, evidence-based process that promotes rigorous, unbiased literature evaluation and sets recommendations and guidelines for groin hernia management[1]. Laparo-endoscopic repair is a minimally invasive surgical approach that combines the techniques of laparoscopy (operating through small abdominal incisions) and endoscopy (using a flexible tube with a camera inserted through natural body openings). While the 2018 HerniaSurge guidelines established mesh-based repair (especially laparo-endoscopic repair where expertise exists) as the standard for groin hernia management, the 2023 update largely confirmed those principles but added stronger evidence for tailored patient-specific treatment, management of chronic postoperative pain, and selective use of non-mesh repairs[2]. The fact remains that, despite these guidelines, there is still insufficient high-quality evidence to determine the best groin hernia repair, with conflicting reports from meta-analyses. The incidence of medicolegal cases involving mesh-related complications is never reported[3].

INDUSTRY VERSUS THE EXPERIENCE OF THE SURGEON

The most likely reason for such fragile, conflicting, and controversial HerniaSurge guidelines may be that they had conflicts of interest in the form of industry funding, personal sponsorship, financial or professional relationships with manufacturers of hernia-related devices and surgical products, in addition to the vested interest of the various hernia societies[4]. All these guidelines seem frugal and unscientific, as the majority of randomized trials on groin hernia repair depend heavily on the surgeon’s expertise and the patient’s preference for the technique, rather than strictly taking into account postoperative pain, seroma, mesh-related complications, and the recurrence rate. Thus, setting guidelines seems irrelevant when modern inguinal hernia treatment has become an individualised practice[5].

The role of the hernia industry in promoting costly minimally invasive surgery with advanced mesh and surgical instruments under general anaesthesia, with a prolonged learning curve, over a reasonably simple open hernia repair under local anaesthesia without any ultimate long-term difference in postoperative pain or recurrence rate is something really mysterious. Most of the randomised controlled trials comparing open, laparoscopic, and robotic-assisted groin hernia repair have a uniform conclusion as “all techniques are safe and effective in qualified hands”[6].

The basic question is - if the choice of surgery is based on the preference of the patient and the surgical expertise of the surgeon for groin hernia repair, what is the need then for International HerniaSurge guidelines? These guidelines will always promote the hernia industry, as the Editor of a Hernia journal queried, “Are we somehow wrong to be ‘taking advantage’ of financial aid in order to constantly improve the science we produce?”[7]. Robert Bendavid was blunt when he commented in 2014, “It is sad in retrospect, that we, as naive surgeons, have created the American Hernia Society only to become the promoters, the wholesalers, the middlemen, the distributors, and if truth be said, the peddlers of a 2 billion dollars industry which projects to be a 6 billion dollars behemoth within the next ten years. Our courts have been doing much more to extract the truth from these giant multinationals than their scientific researchers and collaborative faculties”[8].

A study concluded that 76.5% of industry-funded trials reported a positive outcome (odds ratio = 5.32; confidence interval: 2.60-10.88; P < 0.001) as compared to only 38.0% in non-industry-funded trials in general and abdominal surgery, and the industry-funded trials more often reported a positive outcome without statistical justification, thereby concluding that industry funding of surgical trials leads to exaggerated positive reporting of outcomes[9]. In a study on pelvic mesh, it was seen that financial involvement of industry in mesh research is extensive, often undeclared, and may shape the quality of conclusions drawn, resulting in overstated benefits and overuse of pelvic mesh in clinical practice, as in 60% of studies, the authors have not declared the payments received from the industry[10]. In the ventral hernia literature, 70% of articles have a conflict of interest, which increases the chances that an article will cast a favorable impression on the company paying the authors by 200%[11].

The most important factor that has not received a clear mandate in the HerniaSurge guidelines is cost. The direct operative costs for laparo-endoscopic inguinal hernia repair are higher. The difference decreases when the total community costs are considered, and the surgeon has sufficient experience, but the guidelines do not recommend open hernia procedure boldly till that happens.

There are several designated “Hernia Centre(s) of Excellence” in the world charging huge fees for training surgeons, but none are clear about the best technique they want young surgeons to learn and excel at, an area where the HerniaSurge guidelines are silent[12]. Bendavid[8] predicted a decade ago, “The intended purpose of hernia societies is being lost. Originally, they were meant to be a venue for the dissemination of basic science and knowledge sharing of research by experienced surgeons with the ultimate aim of improving a patient’s lot. Instead, they have become venues and brokerage houses where the plastics industry may advertise and sell products that have barely been tested or about which the truth was never entirely revealed”[8]. Industry funding may likely lead to less transparent clinical results, and in such a scenario, any groin HerniaSurge guidelines are meaningless and industry-friendly[13].

International hernia guidelines should be developed transparently by an independent, multidisciplinary panel funded solely by academic societies, governments, or non-profit organizations, without industry sponsorship. All members should publicly disclose financial and non-financial conflicts of interest, with chairs and the majority of voting members remaining conflict-free. Recommendations should be based on independent systematic reviews using Grading of Recommendations Assessment, Development and Evaluation methodology, with predefined protocols, open voting, and external peer review[14]. Patient representatives, methodologists, and surgeons from diverse healthcare settings should participate. Public consultation, publication of evidence tables, and regular updates will enhance transparency, credibility, global applicability, and trust.

Although several systematic reviews have reported lower recurrence rates after mesh repair, this finding should not be interpreted as evidence of overall superiority. The absolute reduction in recurrence is modest; modern non-mesh techniques such as expert-performed Shouldice repair were underrepresented in many meta-analyses, and long-term mesh-related complications are often inadequately assessed. Furthermore, recent meta-analyses have shown that technical modifications of mesh repair (e.g., fixation vs non-fixation) do not significantly influence recurrence, highlighting that surgical expertise and patient selection may be more important determinants of outcome than mesh implantation itself. Therefore, the assertion that mesh-based repair is unequivocally superior is not fully supported by the totality of contemporary evidence[15].

All types of hernia repair should be promoted in an academic conference or in a centre of excellence, and the surgeon be allowed to decide their preferred choice of repair as the clear-cut, hard-core level 1 evidence for the best groin hernia technique is still elusive (Table 1). The incidence of decision regret of the patient, regardless of the technique, after groin hernia repair is 10% at present, and this needs to come down in the future[16].

Table 1 Strengths and limitations of each technique in inguinal hernia.

Technique	Major strengths	Major limitations
Open repair	Lowest cost; can be performed under local anaesthesia; short operative time; universally available; excellent long-term outcomes	Slightly greater early postoperative pain and slower recovery
Laparoscopic repair	Less postoperative pain; earlier return to work; preferred for bilateral and recurrent hernias	Requires general anaesthesia; steeper learning curve
Robotic repair	Improved ergonomics and dexterity; excellent visualization; easier intracorporeal suturing	Highest cost; longer operative time; limited availability; no proven superiority in major clinical outcomes

CONCLUSION

The vested interest concerns with HerniaSurge guidelines were due to the majority of panel members being surgeons whose careers focused on mesh and minimally invasive hernia surgery. Industry funding was accepted for the guideline process. Most panel members had declared financial relationships with mesh manufacturers. Non-mesh procedures (Shouldice and other tissue repairs) received comparatively less emphasis despite continuing evidence supporting their use in selected patients. Long-term mesh-related complications and patient-reported outcomes were less extensively represented than recurrence outcomes.

Current HerniaSurge guidelines provide a useful framework for groin hernia management but remain limited by ongoing uncertainty regarding the optimal repair technique and concerns about industry influence. As outcomes are heavily dependent on surgeon expertise and patient-specific factors, a universal recommendation may be unrealistic. Future guideline development should prioritize transparency, independent evidence review, and exclusion of biased data wherever possible. Until stronger evidence emerges, individualized decision-making remains the cornerstone of modern hernia surgery.