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).

 

References

  1. 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
  2. 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
  3. 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

1 Comment

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