The original “rebuttal” (of 2500 words) as suggested by the invited guest-editor was rejected by Drs Miserez, Fitzgibbons and Montgomery, Editors. The following is the version which was shortened to 1011 words and still rejected by the same editors of HERNIA.
The release of the proposed “International Guidelines for Groin Hernia Management in Adults” will no doubt instigate a gamut of responses. The document will be a testament to a considerable effort on the part of the steering and working committees but, regrettably, the outcome falls far too short of the exegesis which it purports to be.
In response to this attempt at an “International Guidelines”, the Boston Consensus Group was formed which expressed a deep concern about the methods leading up to the conclusions and how these translated into recommendations. This group gathered in Boston at the behest of Josef Fischer, emeritus professor and chair of surgery at Harvard. There were ten people involved and an additional nine who were not listed, nor were they actually present because of their delicate positions within the AHS, EHS and the steering/working committees of the said guidelines! These unlisted members did register objections to aspects of the guidelines to the steering committee and were rebuffed without further consideration by the leadership of HerniaSurge. We must respect the wish of these unlisted members to remain incognito as it is not anyone’s aim to create a state of subversion within the sister societies. The situation whereby members of societies seek anonymity reflects upon an unsavory political nature which these societies have evolved into and promulgated.
Because of the limitations of space and time we will simply list the major objections to the HerniaSurge recommendations which the Boston Consensus Group felt were academically pertinent and significant. The following grievances must be looked at constructively and not as a gratuitous attempt to disconcert or confuse those members who labored at it.
- The EHS-HerniaSurge does not have a data base to corroborate any recommendations. As famed pharmacologist and teacher, Mark Nickerson once stated … ”If it cannot be measured, I am not interested”!
- The search for publications which use RCTs and Metanalyses may be dubious retrospectively. Many of the articles did not have the statistical power for the intended conclusions. Ioannidis, Barbour and Steen have warned us about the unreliability, fabrications and retractions of articles which have become instruments of lobbies. (1,2,3). Most reliable instead would have been Random Registered Trials (Registered Clinical Trials) and Propensity Score Matching which would depend on the availability of a very large data base. Consistency and transparency of a clearly defined, pre-specified primary outcome would improve by accuracy by 10-60% (4).
- The elimination of pure tissue repairs is a blot which tarnishes the history of hernia surgery. Only twenty years ago, such names as Stoppa, Nyhus, Shouldice, Schumpelick, Flament, Berliner etc. reported recurrence rates of less than 1-2%! Pure tissue would have been an ideal recommendation whenever meshes are removed because of a chronic pain syndrome! Where is the wisdom of removing a mesh and replacing with another albeit lighter mesh?!
- A major objection to the Guidelines is the recommendation of mesh, laparoscopically for all women! This recommendation would never be accepted by many surgeons. It is a recommendation which, in the eyes of five national hernia societies which expressed themselves in Cancun at the annual AHS meeting, has stripped much of the credibility in the Guidelines. Certainly, such a recommendation is far from being compatible with the findings of the Shouldice Hospital and the data base Herniamed, both bodies having each 400 000 case histories in their records.
- It is safe to say that the issue of mesh being used on everyone aged 18 years and older has been most controversial and has been generously rejected by everyone but the members of the steering and working committees of the EHS-HerniaSurge. Mesh complications become more evident with time and we have recorded complications as late as 20 years later. The Shouldice Hospital as well as Herniamed easily confirm this serious objection on each of our part.
- The experience of a surgeon is a major contributory factor in many surgical endeavours. Is it wise to eliminate it altogether to impose a Guideline which does not have approval of an immensely knowledgeable surgical public?
- It must be clarified unconditionally that Guidelines are not immutable laws. The appearance of a recommendation may be translated as a commandment by licensing bodies and may put (as it has already been in Nevada) many surgeons at risk unless the individual surgeon toes the mesh line! That would be unfortunate.
- The most worrisome aspect of the Guidelines is that it exonerates all manufacturers of meshes and devices from any fault, wrongdoing, inadequate research and testing before marketing, responsibility, or any obligation towards surgeons and patients. The industry would hide behind a security screen and claim (as they already have) that mesh is safe, does not degrade so that any problems lie with the incompetence of the surgeon! These are well hackneyed tactics which have been used in court proceedings. Another court defense by the industry is the fact that the industry only supplies what the surgeons are demanding!
It is our hope that HerniaSurge will lend an ear in the hope of reconsidering many of the ill-conceived recommendations. The evidence is there, it is available, let us include it!
- Ioannidis John. Why most published research findings are false. PLoS Medicine 2005; 2(8):e124. doi10.1371/journal.pmed.0020124. (10/19/2010).
- Barbour, V et al. An Unbiased Scientific Record Should Be Everyone’s Agenda. PLoS Medicine. 2009;6(2). doi: 10.1371/journal.pmed. 1000038.http://wwwncbi.nlm.nih.gov/pmc/articles/PMC2646782 (last accessed 10/19/2010).
- Steen, R. Grant. Retractions in the scientific literature: Do authors Deliberately commit Research fraud? Medical Ethics: Nov 15-2010:doi:10.1136/jme.2010.038125.
- Christopher W. Jones, Lukas G. Keil, Lukas G. Keil, et al. Comparison of registered and published outcomes in randomized controlled trials: a systematic review. BMC Medicine201513:282. DOI: 1186/s12916-015-0520-3.
- Jones CW, Keil Lo, Holland WC, Caughey MC, Platts-Mills TF. Comparison of registered and published outcomes in randomized controlled trials: a systematic review. BMC Med, 2015 Nov 18; 13:282.