The purpose of this publication is to promote visibility and transparency for an academic view of hernia surgery rather than a perspective entirely driven by the industry and its “collaborative faculty”. A view based on evidence, analyzed at arm’s length by scientists whose primary focus are facts, impartiality, sound statistics but above all integrity.
While it is becoming more difficult to distinguish what is backed, sponsored and promoted by the industry it is becoming more evident that within professional societies, privileged members of their boards are acting on their personal whims and opinions. “Collaborative faculties” who are known to cooperate with the industry are becoming indistinguishable from ordinary faculties whose aim is science on behalf of our profession. Often the issue of conflict of interest (COI) is not taken seriously (particularly in Europe where there is no obligation to declare such COI) or is simply and casually overlooked and forgotten about. Or condescendingly bandied with and simply discarded!
At an exchange on practice recommendations, I dared to suggest that there were hernias which could be done quite successfully without mesh. A younger surgeon sounded indignant and had the brass to state: “Am I practicing in the same America as Dr Bendavid?” … a certain suggestion that his training and knowledge were totally disconnected from history, evidence, reality and for all to see, heavily singed by bias.
George Farquhar, the 17th Century Irish playwright may have been right … ”Those who know the least, obey the best”!
An analysis of Faculty Disclosures in 2014 (1) at a meeting of the AHS in Las Vegas revealed a COI of 59% during which not ALL disclosures were declared. I knew personally surgeons who were remiss in not reporting one and even two COIs.
This year’s combined AHS-EHS meeting in Miami saw a declaration of COIs of 35% from speakers speaking on behalf of 256 companies! Several companies retained more than one speaker! Assuming that the AHS and EHS were equally represented and that the AHS traditionally declares 59% (1), then the declarations of COI of the Europeans ranges about 10.6%! These results are in keeping with the fact that there are no obligations nor checks of European declarations of conflict as there are in the US and Canada. Although for the purpose of public presentations, authors are expected to declare COIs, no such obligation is in place for Europeans. Or the declarations may be incomplete.
It is to be hoped that upcoming generations of surgeons will have the foresight to question their peers, their teachers and remember that the industry is only concerned with what it does best … make money first.
I would be remiss not to mention four articles which have appeared within the last 24 months and which cover sizeable patient populations.
The first such article is the publication by David Urbach and colleagues (2). A review of 235 192 groin hernias performed in Ontario: 170 192 at Ontario Hospitals and 65 127 patients (27.7%) at the Shouldice Hospital. These were recorded over a period of 14 years plus an additional 2 years for follow-up. The series was made up of patients 18-90 years of age who all had primary inguinal hernias. The age standardized risk of a hernia recurrence at the Shouldice Hospital was 1.15% while in Ontario hospitals, where mesh is de rigueur, the same risk was of the order of 4.60 to 5.63%. Within the same period of time, throughout the 14 years, the use of mesh at the Shouldice Hospital was observed to be, on average 1.38% (1.15% in males & 5.45% in females). The Shouldice Hospital did not participate in that study nor was it aware that it was taking place. All data originated from the government’s Provincial Health Care System, a publicly funded Health Insurance Plan.
It would make far more sense logically, mathematically, financially and statistically given the risks of chronic post herniorrhaphy pain syndrome quoted by the EHS-Herniasurge (International Guidelines for adult hernias) as 12% … and 21% by Porero et al (3) that ALL hernias be performed by pure tissue repair and reserve mesh for recurrences!
The second article came from the same Urbach & Baxter group at the University of Toronto, a year later. As if sorry that they reported such a fine classic first publication on hernias, they repeated the study with 109 106 patients and covered a period of 9 years and 8 months with an additional 16 months follow-up. Distribution: 73.2% open with mesh, 14.3% open without mesh and 12.5% laparoscopic. The 5 year cumulative risk of recurrence was 1.7% in open with mesh, 3.2% open without mesh and 3% in the laparoscopic group!
What these investigators failed to mention, and no one would have known other than one interested in pure tissue repairs and keeping an eye on such publications, is that within the same time period, 61 331 operations were performed at the Shouldice Hospital but were expunged from the data obtained from the government source. When contacted, Dr Baxter expressed the feeling that the “Shouldice results” were “not generalizable”. Had the Shouldice cohort been included, the risk of recurrence would have been : ”open without mesh … 1.5%”! The implication being that a simple pure tissue repair is “too complex” for the average general surgeon to perform. A frequent complaint by younger surgeons. An operation which follows the old adage of “see one, do one, teach one”. It seems a lot simpler (!?) to learn a laparoscopic repair which requires 600 or more cases before becoming a considered expert.
The third paper originates from the Mayo Clinic (4) which decided to seek out the facts with reference to the surgeons’ love relationship with mesh. The sources of the data were a) the Premier data base of the ACS (317 636 patients). A slight drop was recorded in surgery for recurrences from 11.4% to 10.5% in 2010 however, it remained constant for women with an insignificant increase from 6.5% to 6.7%. A far cry from many publications (including the Guidelines) which have claimed a lower rate of recurrences b) The National Surgical Quality Improvement database (180 512 patients). A change in incidence of surgery for recurrences from 10.5% to 11.2% (2005-2014) (P = .12) for men and 6.2% to 7.1% (2005-2014, P = .12) in women. c) Within the Mayo Institution (9216 patients (2005-2014, P = .12) there was no change in recurrence rate for either males (10.5% -11.2%) or females (6.2% to 7.1%). Such results do not confirm the vaunted and hackneyed claims of the mesh promoters nor their industrial backers that mesh has reduced the incidence of recurrences!
The fourth and eminent paper which originated from Herniamed, the highly respected data base of the German Hernia Society and the largest in the world, presents us with a propensity score matching analysis of homogeneous groups of Shouldice vs Lichtenstein (2115/2608); Shouldice vs TEP (2225/2606); Shouldice vs TAPP (2400/2606). “The most important characteristics of the Shouldice patient collective were younger patients with a mean age of 40 years, a large proportion of women of 30%, a mean BMI value of 24 and a proportion of defect sizes up to 3 cm of over 85%”. In these cohorts of patients there were no differences in results!
Within a relatively short span of time, we have been able to gather nearly a million patients (922 341) who, statistically, will be far more easily convincing that any RCT with small unreliable numbers, with questionable methodology and which made Professor John Ioannidis (of Stanford University) state that :”There is increasing concern that in modern research, false findings are the majority or even the vast majority of published research claims”! (7).
Antitheses of Evidence Based Medicine (EBM) abound everywhere and few can be as egregious as a study published in HERNIA involving 44 male patients with bilateral inguinal hernias, treated with mesh, followed for 6 months and which concluded that “mesh is not a factor in infertility” (8). Considering that such evidence is only present after 4 to 10 years (9), one cannot but be convinced that non-scientific, non-Hippocratic interests or patent commercial interests had to be assuaged.
It is to be hoped that surgeons will look more closely at larger studies, especially when supplied by the larger data bases of the world. Small series are too often subject to the vagaries of inadequate statistical analyses often undermined by inadequate numbers and methodologies.
- Bendavid. Hernia Societies – A Blessing or a Curse? Who is running them? Ethical Surgeons or the Industry? International Journal of Clinical Medicine.2014,5, 766-769.
- Malik A, Bell CM, Stukel TA, Urbach DR. Recurrence of inguinal hernias in a lare surgical specialty hospital and general hospitals in Ontario, Canada. Can. J. Surgery, Vol 59 No1 February 2016.
- Porrero JL, Bonachia O, Lopez-Buenadicha A, Sanjuanbenito A, Sanchez-Cabezudo C (2005) Repair of primary inguinal hernia: Lichtenstein versus Shouldice techniques. Prospective random- ized study of pain and hospital costs. Cir Esp 2:75–78
- Ramjit KR, Urbach DR, Stukel TA, Fu L, Baxter NN. Reoperation for inguinal hernia recurrence in Ontario: A Population Based Study. JACS, Vol 223 Number 4 (Supplement) 1, October 2016
- Murphy B, UblDS,ZhangJ,Habermann EB, Farley DR, Paley K. Trends of inguinal hernia repairs performed for recurrene in the United States. SURGERY.
- Köckerling F, Koch A, Adolph D, Keller t, Lorenz R, Fortelny RH, Schug-Pass. Has Shouldice Repair in a Selected Group of Patients with Inguinal Hernia Comparable Comparable Results to Lichtenstein, TEP and TAPP Techniques? World J Surg.
- Ioannidis John. Why most published result findings are false. PLoS Medicine 2005; 2(8):e124.doi10.1371/journal.pmed0020124. (10/19/2010).last accessed.
- Roos M, Clevers GJ, Verleisdonk EJ et al. Bilateral endoscopic totally extraperitoneal (TEP) inguinal hernia repair does not impair male fertility. HERNIA (2017)21:887-894.
- Iakovlev V, Koch A, Petersen et al. A Pathology of Mesh and Time. Dysejaculation, Sexual Pain, and Orchialgia resulting from Polypropylene Mesh Erosion into the Spermatic Cord. Annals of Surgery, Volume 267, Number 3, March 2018.