Recommendation of the AHS Practice Advisory Committee
The Following has been, as last discussed within the committee, the recommendations by the AHS Practice Advisory Committee. I was expelled by this committee because I accidentally included a non-member of the panel of 25 surgeons in one of my replies! Still, whether intentional as thought by the lead member Yuri Novitsky or not, I do not recall agreeing to or signing a document which imposed any sort of confidentiality or secrecy. My constant criticism at excluding pure tissue repairs by the committee in their recommendations (which were finally included, en passant, and if it has not been removed since) reflects the inflexibility and inadequate knowledge by this lead member of the effectiveness of pure tissue repairs at a time when CPIP has become a most feared complication of mesh repairs.
Novitsky keeps insisting that this advisory is NOT meant to be a “guideline” but an “advisory”. What is the difference was never clear when you speak with the apparent full backing of the Americas Hernia Society. Quite confusing but can be understood only if one agrees with Upton Sinclair (19681878) that: “It is difficult to get a man to understand something when his income depends on not understanding it”! All comments in bold are mine.
Hernias are highly prevalent throughout the world. Over the years various surgical techniques have been employed to deal with them, and these techniques have evolved with greater understanding (?). The main aim of these techniques has been to provide an effective, safe, and durable treatment of hernias. The use of mesh reinforcement has been shown to be very effective in reducing recurrences (not true for the majority of cases if one knows Pure Tissue Repairs and as proven by the Mayo study and D. Urbach)(1,2,3). Surgeons have utilized all various meshes, synthetic, biologic and bio-absorbable meshes, as an adjunct to improve results of surgical repairs. In fact, millions of patients have had successful hernia repairs with mesh (but millions -at least 120 000 cases a year in the US alone-also have had life altering complications such as chronic pain due to erosion of nerves, vas deferens, bladder etc…. if one is to believe the stats of the EHS International Guidelines on the incidence of 12% of CPIP. The use of tissue-based “non-mesh” techniques has largely been associated with disappointing long-term ventral hernia repairs (here you mean incisional repairs, not ventral repairs. Possibly, so far, the only true statement but then again incisional hernias only make up 5% of all abdominal wall hernias and are never included in stats when the discussion is about groin repairs. Ventral hernias such as umbilical, epigastric, hypogastric -rare- should be excluded as well). However, there are surgeons and centers that employ non-mesh tissue-based repairs for inguinal hernia repair, and have demonstrated efficacy in these procedures. (knowing the incidence of chronic pain complications to be, conservatively 12% (range 3%-75%), why should pure tissue repairs not be offered as a choice to patients when recurrences are not as high?)
As with all surgical implants, the use of mesh to reinforce hernia repair has potential advantages and disadvantages. The vast majority of patients who undergo mesh repairs do so without complications (if a patient feels that 12%, and increasing, is not significant a risk), and after initial recovery are able to perform daily activities without any new limitations. However, there are potential issues with mesh placement, like any other implantable device (Some other implangtable devices may fail in a higher percentage than 12%!). Patients may have to deal with complications including infections, adhesions, erosions, chronic pain and other complications (the sound of these complications already would make one balk!). These complications may be due to surgical technique (rarely), the materials utilized (always), patient anatomy and physiology(never), or a combination of factors. It is also important to recognize these complications are not only unique to surgeries that utilize mesh. They may occur with tissue-based repairs (erosions and pain are never recorded in pure tissue repairs! Lloyd Nyhus, Joseph Ponka, Brendan Devlin, EB Shouldice -all accomplished older authors have confirmed it in their own publications prior to the arrival of mesh. Only collaborative surgeons report such pains with pure tissue repairs), or other procedures where devices are implanted (true, the aim is to avoid devices whenever possible.). In addition, mesh is also used in non-hernia operations, such as pelvic surgery (here complications have been worst for urinary tract incontinence and bladder suspensions). It is important to note and differentiate that the complications that arise in those procedures do not necessarily apply to hernia surgery (but that is because different organs are involved! It is well documented that mesh has eroded through the urinary bladder, the urethra, the vaginal wall, Fallopian tubes, colon. The real problem lies with polypropylene).
In patients with postoperative symptoms that are not clearly caused by a mesh, removal of mesh may not improve the symptoms and in fact may worsen their condition (this is a dated statement and comes from surgeons who are afraid to remove a mesh which has become so cemented to tissues or from surgeons who have no experience in mesh removal. Results are beginning to appear confirming that the majority of patients do improve; those whose pain is worse are likely the ones in whom the mesh could not be entirely removed, especially if it has been inserted laparoscopically and adherent to major structures. The procedure may be tedious and even dangerous). Importantly, to date, there is no convincing evidence that mesh placement can cause an autoimmune or allergic reaction or any other systemic response, and therefore elective removal of mesh in asymptomatic patients is not advisable (agree that any asymptomatic patient should not be subjected to mesh removal as we do not know who will develop complications or when. Complications may occur up to 24 years (my experience) after the fact. The issue of autoimmune disease has not been convincingly confirmed but a few publications so far have already put the industry on the defensive and at least three recent articles have appeared from industry sponsored authors to deny that possibility.)
The issue of autoimmune.
Overall, the Americas Hernia Society (AHS) fully supports utilization of appropriately selected mesh reinforcement for a vast majority of both inguinal and ventral hernias,(where is the proof of such a blanket statement? My friends and colleagues, nor I, members of the AHS were never consulted that we recall) especially when prevention of hernia recurrence is of significant concern (we all know now, that recurrence is not a significant concern, CPIP is. All patients of whom I am aware would prefer a recurrence to CPIP). We emphasize the need for thorough knowledge and understanding of mesh options in order to select the most appropriate implant material for a given patient and planned repair technique (this is a moot point! Polypropylene is polypropylene, its weight, the pore size, the associated coating of the mesh have no bearing on the eventual outcome in terms of pain. Only If there is inadequate tensile strength to the mesh, will it fracture as has been seen with Physiomesh®). The AHS strongly encourages a thorough informed consent discussion be conducted prior to the use of mesh in order to familiarize patients with the aforementioned advantages, disadvantages, as well as potential risks and complications of mesh-based repairs. We will continue to assess new data regarding mesh materials to help guide hernia surgeons in making the safest and most appropriate mesh choices for their patients. (This is a hypocritical statement because if a patient wishes a mesh-free repair who is going to do it in the US where literally no one is familiar with these operations? I am constantly getting calls by US patients who cannot find a surgeon to perform such mesh free operations in the groin. Except for femoral hernias and some recurrences, mesh can be dispensed with in the hands of a competent surgeon, mostoften. It would be more logical, given the evidence from David Urbach, the HerniaMed registry, the Shouldice Hospital, the Mayo Clinic, the HerniaMed data analysis and the authors of 20 years ago that pure tissue repairs are viable in the vast majority of cases. How many surgeons would put a favorable spin on pure tissue repairs?? This “Mesh Advisory for Practice Advisory Committee” is a case in point in terms of incrusted bias! Most disconcerting however is the fact that today’s publications have been proven, in the majority of cases to be unreliable. See the text of:”COI, collusion, corruption” within The Hernia Letter).
- Brittany L. Murphy, Daniel S. Ubl, Jianying Zhang, Elizabeth B. Habermann, David R. Farley and Keith Paley, Rochester, MN, and Mansfield, MA. Trends of inguinal hernia repairs performed for recurrence in the United States. Surgery 2017. DOI: https://doi.org/10.1016/j.surg.2017.08.001
- Kockerling F, Koch A, Adolf D et al. Has Shouldice Repair in a Selected Group of Patientswith Inguinal Hernia, Comparable Results to Lichtenstein, TEPand TAPP Techniques? https://doi.org/10.1007/s00268-017-4433-5. World J. Surg. 2018. https://doi.org/10.1007/s00268-017-4433-5
- Kockerling F, Koch A, Adolf D et al. Has Shouldice Repair in a Selected Group of Patientswith Inguinal Hernia, Comparable Results to Lichtenstein, TEPand TAPP Techniques? https://doi.org/10.1007/s00268-017-4433-5. World J. Surg. 2018. https://doi.org/10.1007/s00268-017-4433-5
Hernia Surgery as a Post-truth Discipline
Post-truth politics is a current trend, which appeals to emotions and is largely disconnected from the true facts and details of an issue at hand, oblivious to any rebuttals or criticisms. As a result, Post-truth has spawned a new tendency… Populism, a means of expression by a disgruntled audience and the ordinary man towards the apodictic attitude of the privileged committees and panjandrums.
In a parallel course, hernia surgery has taken on a profile, which can be rightly called Post-truth science. As in politics, HerniaSurge and the European Hernia Society (since it is one of the “generous sponsors” of HerniaSurge), have been promoting the “International Guidelines for Groin Hernia Management” agenda of polypropylene mesh for every patient with a groin hernia (1, 2). The emotional component is the call for the elimination of the recurrence, once the bane of inguinal hernia repairs. The aspiration for its vaunted aim is the imposition of mesh for every patient. The error of the “Guidelines” is to have considered the surgical community to be a naïve, unsophisticated public unable to think for itself! It would be apt at this time to recall Ayn Rand’s admonition that “an error made on your own is safer than ten truths accepted on faith!”
As evidenced last year at the meetings of the American and European Hernia Societies (Cancun and Vienna respectively), the methodology came under severe criticism from many circles. The use of meta-analysis of randomized controlled trials was not considered accurate enough for such a drastic departure from established, classical norms of practice in surgery. Not when we have two major data bases, each with close to 400 000 cases in their data bank, namely: Herniamed, the well managed registry of the German Hernia Society (the GHS and largest member by far of the European Hernia Society) and the Shouldice Hospital in Canada which has specialized in hernia surgery for the last 73 years.
More sophisticated tools for research have been: blinded randomized controlled trials, propensity score matching but most effective has been the use of data banks into which thousands of cases are entered by serious surgeons intent on discovering meaningful evidence. Neither does the European Hernia Society nor HerniaSurge have such a tool. The GHS and Shouldice Hospital do, as do Norway, Sweden and Denmark through their national registries.
Regrettably, while registries have served a good purpose for the mining of data, some interpretations have been less than objective and reminiscent of a Potemkin exercise.
The major drawback of meta-analysis is that conceptually, it uses a statistical approach to combine multiple studies in an effort to increase power over individual studies. The sensitive aspect of these meta-analyses is to find articles whose methodology and calculations are reliable when the studies are being set up, not after the fact. One such an example is the study by Eklund et al. where one surgeon has influenced the whole result as well as the meta-analysis.
Low recurrence rate after laparoscopic (TEP) and open (Lichtenstein) inguinal hernia repair: a randomized, multicenter trial with 5-year follow-up.
Eklund AS1, Montgomery AK, Rasmussen IC, Sandbue RP, Bergkvist LA, Rudberg CR.)
(Ann Surg. 2009 Jan;249(1):33-8. doi: 10.1097/SLA.0b013e31819255d0.
Of the 50 surgeons who made up the steering and working committees of the HerniaSurge and who designed the guidelines, only one surgeon was listed as a “statistical expert!” without any qualification of that status.
Most disconcerting over the last ten years have been pronouncements by eminent colleagues who have questioned the quality of scientific publications but above all their trustworthiness. How can we ignore prominent epidemiologists who warn that “Randomized Controlled Trials are frequently contaminated by design flaws, ethical lapses, bias, conflicts of interests, suppressed data, political agendas and outright fraud. In 2010, it was revealed that the United States leads the world in retracted journal articles and its scientists were cited as the most prone to engage in deliberate fraud” (3) [Steen R. Grant-2010]. Professor Ioannidis from Stanford declared that “there is increasing concern that in modern research, false findings are the majority or even the vast majority of published research claims.” (4) [Ioannidis John, 2005]. Or yet, from Barbour: “Journals may increasingly become close to works of fiction, telling stories dictated by various lobbyists than works of science (5) [Barbour V & al, 2009].
Most recently, in the Journal of the American College of Surgeons… “there is a substantial discordance between self reported Conflict of Interest (COI) in published manuscripts as compared with those in the CMS Open Payments database” (6); this fact was clearly aimed at “Published Hernia Researchers” in the title of the article! (7). More recently, the same journal (JACS: Vol 226, No 3, March 2018) reiterated the message that “70% of articles have a COI. Self-reporting of COI is discordant in 63% of articles. Twenty five percent of relevant COI are not disclosed. Having a COI increases the chances that an article will cast a favorable impression on the company paying the authors, by 200 %”! (8)
While these findings corroborate with the US failure, namely by the US members on the committees of the “Guidelines”, to declare their COI, the same could not be done with Europeans who do not have a comparable, legal, government organism to check for extraneous income from the industry. In short, unless Europeans come forward to declare their COI, there is no likelihood to verify that status!
No less an authority than Carl Heneghan of the Oxford Evidence Based Medicine chimes in with: “... manifesto for better health care”; in his editorial, Pr. Heneghan states about clinicians and patients: “…but with the questionable integrity of much of today’s evidence, the lack of research answering questions that matter to patients, and the lack of evidence to inform shared decision, how are they expected to do this?” (9). Indeed, HOW?
With all these warnings, the HerniaSurge did not hesitate to issue “Guidelines” which:
- Recommends mesh for all patients beyond the age of 18, the age of adulthood in most countries.
- Recommends that all women with groin hernias be done laparoscopically with mesh regardless of the nature of the original hernia. Women generally have 65% of indirect hernias, according to our own statistics, and need nothing more than a resection or reduction of the sac! Femoral hernias account for 27% and may well require mesh.
- Pure tissue repairs are no longer recommended unless absolutely unavoidable and to be offered after the advantages of mesh are explained to unsuspecting patients.
- The issue of chronic post-herniorrhaphy pain is not given due coverage considering that it has become the most common and the most severe complication of hernia surgery. More so than recurrences.
- The accuracy for COI could not be independently confirmed for most of the steering and working committee members. Europeans are under no such obligation. But where it could be, as in 5 cases from the US, which included an external reviewer, all failed to declare their COI. In summary, 34 surgeons received grants for the purpose of working on the “Guidelines” only while another 17 surgeons had “Conflicts of Interest, not related to the present work”! In short 51 declarations and not one with a bona fide COI!! Strange indeed!
Drastic departures from pure tissue repairs have been creeping over the last 20 years, surreptitiously without real reason or impartial evidence. Bassini who is widely recognized as the father of modern hernia surgery reported a series of 262 patients from 1883-1889, at a time when antibiotics were unavailable and anaesthesia less than ideal following which he had 7 recurrences for an incidence of 2.67% (10)! Less than 20 years ago, the Shouldice repair was considered a gold standard and a bench mark against which all new operations were to be compared and whose recurrences were recorded between 0.5%-2.6% as registered or reported by eminent players such as Wantz, Flament, Devlin, Moran, Shouldice (11) V.Schumpelick (12, 13) Lloyd M. Nyhus (14) and Josef Fischer (15).
Notwithstanding this lengthy introduction, two papers emanating from the University of Toronto have shaken the statistical evidence of the last twenty years, simply based on the massive sizes of the studies (16, 17). No need for meta-analysis here to gather significant statistical power.
In both of these studies (16, 17), the data of all patients operated on, in Ontario, were examined through the registry of the Government of Ontario, which is available to the statistical department of the University of Toronto. The statistical analysis was made possible because the Government of Ontario is the sole payer of all surgical procedures in the province of Ontario.
The first study (16) covered a population of 235 192 patients, followed- up over a period of 14 years (1993-2007) and an additional two years for the purpose of follow-up. The Shouldice Hospital performed 65 148 operations or 27.7% of all groins hernias in Ontario, a province with a population of 13.6 million. The patients included were 18-90 years of age, all hernias were primary groin hernias. No emergencies were included. Taken into consideration were gender, hospital volume of hernia surgery, income, rural population and high co-morbidities. While the Shouldice Hospital was a unique entity, the other hospitals in Ontario were stratified according to the number of cases of surgery carried out and made up 4 distinct groups based on volume of surgery performed. The Shouldice Hospital was never contacted during this research. In fact, the number of operations carried out at the Shouldice was 81 937, a higher number than had been reported in the study since the databank of the government does not include out of province or out of country patients who came to Shouldice Hospital.
The results showed that the 4 groups of hospitals had “a risk of recurrence rate of 5.10, 5.44, 4.52 and 4.50, while at the Shouldice Hospital, the risk was 1.08, after adjustments for the effect of age, sex, comorbidity and income level (adjusted hazard ratio 0.21, 95% CI 0.19-0.23, p<0.001)”.
While the percentage of pure tissue repairs was not pointed out in this first publication, the said rate was extrapolated from the subsequent paper. It pointed out that the 4 groups making up the general hospitals in Ontario used mesh in 85.7% of all cases.
At the Shouldice Hospital, out of 81 937 patients, mesh was used on 1196 cases or 1.46% of all patients and yielding the 1.1% risk of recurrence reported in this largest ever series!
The second publication was also co-authored by David Urbach with Nancy Baxter as the senior author. Although the paper has not been published yet, it was presented at the American College of Surgeons Scientific Forum Abstracts (2016 Clinical Congress). The review covered “109,106 adult patients undergoing primary inguinal hernia repairs (73.2% open with mesh, 14.3% open without mesh, 12.5% laparoscopic with a 5.6 years median follow-up. The 5-year cumulative risk of recurrent inguinal hernia was 1.7% in the open with mesh, 3.2% in the open without mesh and 3% in the laparoscopic group…. hazard ratio 1.88, 95% CI1.61-2.20 and 1.53, 95% CI 1.33-1.77, respectively, p<0.001 both comparisons”.
In the latter study, all figures for inguinal repairs without mesh seemed too low since we knew that the Shouldice repairs during the same period numbered 61,331 operations. Dr. Nancy Baxter, the lead author, was contacted and she confirmed the fact that the “Shouldice Hospital operations were excluded from the study”. The reason… “the results of the Shouldice Hospital were not generalizable." This, despite the fact that the Shouldice Hospital did in fact perform 79.72% of all primary inguinal hernia repairs without mesh in Ontario or 36% of all primary inguinal hernias repairs in Ontario during that specific study period.
A simple extrapolation, which would have included the Shouldice results, would have revealed a general risk of recurrence for pure tissue repairs of 1.46% for all pure tissue repairs done in Ontario had the Shouldice results been included! In that same period, in the second study above, the use of mesh was observed in 73.2% in the large cohort of 109,106 patients while at the Shouldice Hospital, mesh was used in 1082 patients out of 61,331 or on average: 1.76%!!
It has often been said that the Shouldice operation is difficult to perform, that a Lichtenstein responds to the principle of tension free repair and is much easier. Schumpelick has demonstrated that a Shouldice repair does not mean added tension (10) and it is well known that muscles adapt to new tensions and movements and develop according to the activities of that muscle, as any body builder will attest. Besides, replacing a weak transversalis fascia with striated muscle is tantamount to a muscle rotation well known to plastic surgeons. Nevertheless, while the pleonastic “tension free repair” was an effective marketing plug, it has not been confirmed by the larger and largest set of data by Urbach and then Urbach and Baxter.
An aspect of mesh repair which must not be overlooked is the new syndrome of “chronic post-herniorrhaphy pain” which has become the commonest complication of inguinal hernia repair, with an accepted average incidence of 12-15% (16, 17) and higher. The pain can be severe enough to effect drastic changes in lifestyle and require mesh removal. Other complications have been dysejaculation (19, 20), which has increased eightyfold, from 0.04% to 3.1%. An additional 10.9%n of patients report groin and testicular pain during sexual activity (19). Further complications have been stiffness of mesh felt as an irritation beneath the skin, erosion into adjacent tissues, migration of mesh and devices, infections.
What has been a revelation from surgeons is that a pure tissue repair is difficult to perform! Nowadays, the majority of surgeons have never seen one much less performed one. Chronic post-herniorrhaphy pain and other serious complications are imposing new norms and already, surgeons are re-developing an interest in pure tissue repairs, at last. We are now dealing with a public, which has become emancipated thanks to the internet, is savvy and one that knows what it wants in a way of hernia repair.
For many surgeons, HERNIA and its editorial team will lose credibility because of a dubious and murky set of “independent” guidelines foisted on the world through HerniaSurge with no proper vetting nor transparent statistical accuracy. No diddling can be tolerated in a field of endeavor where absolute transparency, clarity and integrity are the necessary requirements for forging ahead. Why the editors so fiercely and stubbornly avoided blind peer review cannot be understood. Unless of course, there is a hidden duplicitous agenda. This possibility does not seem to have been ruled out.
No dissertation about hernias is complete without quoting Sir Astley Paston Cooper … “If you are too fond of new remedies, first you will not cure your patients; secondly, you will have no patients to cure”.
- EHS_Guidelines: Version 1: 2009.
- EHS-Guidelines: Version 2: 2016
- Steen R. Grant. Retractions in the Scientific Literature: Do authors deliberately commit research fraud? Medical Ethics published online, November 15, 2010 doi10:1136/jme.2010.038125.
- Ioannidis John. Why most published research findings are false. PLoS Medicine 2005; 2(8):e124. Doi10.1371/journal.pmed.0020124. (10/19/2010).last accessed.
- 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 10/17/2010).
- CMS Open Payments Base
- Oscar Olivaria, Julie L Holihan, Juan R. Flores-Gonzalez & al. Comparison of Self Reported Conflict of Interest among Published Hernia Researchers to the Centers of Medicare and Medicaid Services Open Payment Database. JACS, Volume 223, No4 (Supplement) 1, page: S47. October 2016.
- Deepa V. Cherla, Oscar A. Olavarria, Karla Bernardi et al. Investigation of Financial Conflict of Interest Among Published Ventral Hernia Research. JACS, Vol.226, No 3,March 2018 pp:231-233.
- Heneghan Carl. BMJ 2017;357:j2973
- Bassini E. Nuovo metodo operative per la cura dell’ernia inguinale. 1889, Prosperini, Padova Italia.
- Bendavid R, Koch A, Iakovlev V. The Shouldice repair. In: Textbook of Hernia. Editors: William W. Hope, William S. Cobb, Gina L Adrales. Table 9.5. Page 63. Springer International Publishing Switzeland 2017.
- Schumpelick V. Editorial. Does every hernia demand a mesh repair. A critical Review. HERNIA (2001) 5:5-8.
- Junge K, Peiper C, Schumpelick et al. Breaking strength and tissue elasticity after Shouldice repair. HERNIA (2003), 7: 17-20.
- Nyhus LM. Editorial. Experts point of view. Ubiquitous use of prosthetic mesh in inguinal hernia repair: the dilemma. HERNIA (2000). 4:184-186.
- Fischer, Josef. Hernia repair: why do we continue to perform mesh repair in the face of the human toll of inguinodynia. Am. J. Surg. February 8 2013.
- Atiqa Malik, Chaim M. Bell, Thérèse A. Stukel P, David R. Urbach. Recurrence of Inguinal hernias repaired in a large hernia surgical specialty hospital and general hospitals in Ontario, Canada. Can. J. Surg. Vol: 59, No1, February 2016, pp 19-25.
- Reoperation for inguinal hernia recurrence in Ontario: A Population-Based Study. Joshua K. Ramjist, David R. Urbach, Longdi Fu, Nancy N. Baxter. University of Toronto, Toronto, ON. J Amer. Coolege .Surg. Volme 223, Number 4 (Supplement ) 1, October 2016.
- Lange JFM, Meyer VM, Voropai DA & al. The role of surgical expertise with regard to chronic postoperative inguinal pain (CPIP) after Lichtenstein correction of inguinal hernia: a systematic review. HERNIA (20160 20:349-356.)
- Bischoff JM, Linderoth G, Aaswang EK, Werner MU, Kehlet H. Dysejaculation after laparoscopic inguinal herniorrhaphy. Surgical Endoscopy 2012 Apr; 26(4),: 979-83.
- V. Iakovlev 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 2017, Jan 6. PubMedd:28067674. DOI 10:10.1097/SLA.0000000000002134.