The Hernia Letter

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.

References:

  1. 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.
  2. 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.
  3. 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
  4. 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
  5. Murphy B, UblDS,ZhangJ,Habermann EB, Farley DR, Paley K. Trends of inguinal hernia repairs performed for recurrene in the United States. SURGERY.
  6. 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.
  7. Ioannidis John. Why most published result findings are false. PLoS Medicine 2005; 2(8):e124.doi10.1371/journal.pmed0020124. (10/19/2010).last accessed.
  8. 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.
  9. 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.

19 Comments

  1. Martin Kurzer on July 11, 2018 at 10:08 am

    Hello Robert,
    Good to have an independent view. Hard hitting with a lot of truth in what you say.
    I hope you are keeping well.
    Best wishes
    Martin

    • R. Bendavid MD on July 12, 2018 at 6:18 pm

      Hello Martin. Thank you for your comment. We have a duty to be transparent and integrity must be our motto. Robert.

  2. Mrs Sarah Bookham on July 13, 2018 at 12:11 pm

    Really would like to find out more about this nasty mesh. As I’ve been left horrified with what I’ve been left like

    • R. Bendavid MD on July 13, 2018 at 3:01 pm

      Please consult your family physician who should refer you to a surgeon with experience in mesh removal, should the need arise.

  3. Denise Conway on July 13, 2018 at 12:17 pm

    Very well written article tackling a major global issue. Let’s hope that change is coming!!

  4. Rebecca on July 13, 2018 at 7:47 pm

    Thank you so much for providing a counter to industry-funded narratives. Reduced rate of recurrence was the only ‘pro’ argument offered when mesh was recommended to me. Lo and behold, when my mesh was removed three years later, with a foreign body giant cell reaction diagnosed, a recurrent hernia had to be repaired. Seven years of pain and illness—likely with a lifetime of it ahead—and the one benefit of mesh hadn’t even panned out.

  5. Blair Baker on July 14, 2018 at 9:30 am

    Thank you Dr Bendavid.

  6. jacqui scott on July 21, 2018 at 6:18 pm

    Thank you Dr Bendavid i had Trans vaginal mesh implanted into me in 2006 i flew from New Zealand were i live to Dr Raz in America and got all of my mesh removed i developed an inguinal hernia it took me a full year of Dr shopping to find a surgeon here in New Zealand who would repair it the old fashioned way it was repaired last year with no mesh by using The Shouldice method of repair i have had no problems with it what so ever no pain its brilliant so thank you for all of the information that you and other surgeons like you give us about non mesh repairs

  7. Denise Schrader on July 27, 2018 at 8:02 pm

    Thank you for finally writing about this mesh, after getting Ethicon in and out in less than two weeks 5 months after it was given a 510k only 5 months before, I thought I was going to die…the moment I woke from surgery there was a burning feeling in my chest…I was told that I had a 2.5cm hole that was from a aortobifemoral bypass 8 yrs prior. I was shown a piece of rectangular cloth that looked like ‘cross-stitch’ fabric. Wasn’t told what it was but mesh.. with the prior surgeries that I have had, I had no prior effects like this afterward… I wasn’t given any information from dr that this or any other mesh would hurt me… I woke up after about 8 hour surgery, dr stating I had this incisional hole plus as he wrote in my chart I had a umbilical hernia so he kept cutting……then on the bottom of the report it stated ”was not thru abdominal wall”…I ended with a 15×20 oval, which I wasn’t shown. I woke up after 2nd surgery not burning, but not knowing what all was taken out either… He told me that ”He tried to debride the mesh but couldn’t so he took it out”….
    I was in my room and wound care came in to change my dressing. I thought it was a piece of thin foam with tape holding my chest together, I was wrong… The nurses asked floor nurses if I had had any pain meds and I heard one of the drs nurses say ” Dr wants to give it to her AFTER wound change”… They started by removing the tape, along with that came a piece of foam that was about 2” thick, started to get freaked, my dad came to the door and they started pulling out the 2nd piece of 2” foam, it felt like it had grown into my body, I grabbed the nurses arms that were holding my arms and started freaking out….someone finally said the hell with the dr I’m giving her pain meds now… I was squeezing the nurses arms so tight they needed others to help them get my hands off… the hole in my chest was the size of the mesh x 3D… the size of a Nerf Football …. every 2 days wound care would come and rip this foam out…for the next 12 weeks… each time I felt it was ripped out pieces of my body, started to smell like road kill, a deer dead on the highway smelled just like me… I went to plastic surgeon January 2011 and he did surgery to cover up what mess the other one left … cut the muscle material where it should have been cut to not let it grow out instead of look normal. He used Allomax… but the only reason I even went to him was I wasn’t going back to the other one that did this to me… the only reason I was ”fixed” was because of the mess that I was left with…I wouldn’t have had to if not for the physiomesh.

    in 7 months 3 surgeries, that was back in 2010-11 and since then almost 8 yrs of pain, depression, anxiety, sleep problems ………….

  8. Hakan Kulacoglu on November 1, 2018 at 3:04 pm

    “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!”
    Very interesting!!!
    Hopefully still 65% of the speakers are independent.

    • R. Bendavid MD on November 1, 2018 at 4:27 pm

      Unfortunately, the 35% with COI are chosen to become opinion leaders by the industry, based on their prominence in societies ‘ activities or academic influence. Over the last 5 years, the industry has paid 8 billion dollars to physicians and their departments. Invariably for research that serves the purpose of the industry rather than the welfare of the patient primarily.

  9. Kieran Conlon on November 26, 2018 at 4:13 am

    I am in the UK and experiencing autoimmune issues from hernia mesh, but struggling to convince doctors here that there is a connection. What is the best research I can quote? The official view is that there is no proven link. Thank you, KC

    • R. Bendavid MD on November 26, 2018 at 4:48 am

      I am not aware of any convincing studies which connect mesh with any immunological illnesses. There is no doubt that many patients have some of the symptoms and some may even see reversal of those symptoms upon mesh removal but research is scant. A project would be of interest but would prove to be an expensive proposition. We are still looking for a potential sponsor.RB.

  10. Eryk8038 on November 30, 2018 at 10:08 am

    Dzięki wielkie za fajne porady. Nie znam się na tego typu działaniach – bardzo mi pomogliście! Niech żyje Internet 🙂
    Thanks so much for great advice. I do not know about this type of activity – you helped me a lot! Long live the Internet

  11. James Patrick Cronin on December 26, 2018 at 11:12 pm

    Dr Bendavid,

    Is there a list of doctors experienced in Pure Tissue Repair, specifically in the Dallas/ Fort Worth area?
    I have been unable to find one easily…Internet search found one doctor in California, one in Las Vegas and one in Florida.

    • R. Bendavid MD on December 27, 2018 at 12:05 am

      Mr Cronin

      I am not aware of any surgeon in the Dallas-Fort Worth area who performs pure tissue repairs. Neither in California nor in Florida. I am aware of two surgeons in Nevada (Las Vegas) and one in Ohio (Cleveland). Of course, the Shouldice hospital in Toronto has probably the most experience at a competitive cost. You can communicate your decision through my private email and I can put you in touch with each as you may want to examine your projected expenses.

  12. Darby on January 6, 2019 at 2:47 am

    Hello Doctor
    Thank you for an informative article. I had a small inguinal hernia repaired with mesh about 3 years ago and I’ve been suffering with chronic pain ever since. I’m in Ottawa Canada and desperately trying to find a surgeon in Canada to remove the mesh. Can you recommend a Canadian surgeon who can remove mesh?

    • R. Bendavid MD on January 6, 2019 at 3:15 am

      Hello Kevin

      Because there are no established standards in classifying pain, the degree of pain, the nature of the pain, the origin of the pain, results can be as varied. More importantly, surgeons are not recognizing the syndrome or are simply denying it with patients having temporary relief in pain clinics.Certainly, if one is to consult the attempt by the Herni DSurge Guidelines, one is facing a conservative incidence of 12-15%. This would mean 120 000-150 000 chronic pain problems per year in the US alone!

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