Chamber and committees

Shouldice Hospital submission dated 10 January 2022

PE1865/XXX: Suspend all surgical mesh and fixation devices

Thank you for the opportunity to participate in this very important initiative. As you know Shouldice Hospital has been a steadfast supporter of our natural tissue hernia repair for over 76 years. Few know that we were a pioneer in the investigation of using Surgical Mesh back in the 1980’s, and we choose not to pursue its use unless it was absolutely necessary to do so. To this day we use mesh in less than 2% of all our cases and our surgical outcomes remain the gold-standard in abdominal wall hernia repair.

As requested, here are our views on the questions posed in your letter of November 24, 2021. For context, Shouldice Hospital specializes exclusively on abdominal wall hernia repair and our responses should be interpreted based on that surgical focus. This means that the responses given may not be relevant, or fair, to other surgical procedures where Surgical Mesh may have a different risk profile.

For the record the following responses are a compilation of answers from Shouldice surgeons, including Dr. E. B. Shouldice:

What types of surgery natural tissue repair is best suited to? (hereafter “Tissue Repair”)

Generally speaking, where the body’s natural tissue is strong enough to support the surgical repair, it should always be used. This is in lieu of introducing a “foreign body” (Surgical Mesh) that may cause unwanted, and needless, post-operative complications.

Specific to abdominal wall hernia repair, it is important to understand that this comprises “Groin” hernias (Inguinal and Femoral) and “Ventral” hernias (Incisional, Epigastric and Umbilical).

Tissue Repair should be the first choice for all primary Inguinal hernias, most recurrent Inguinal hernias, most Femoral hernias, most Epigastric and Umbilical hernias, and small Incisional hernias. Where the underlying patient tissue is poor or minimal, Surgical Mesh may be necessary in some Femoral and large Incisional hernia repairs. Even then it should be used as a last resort, not a default.

At Shouldice Hospital all Surgeons are trained to do a Tissue Repair as their first choice.

What are the benefits of using natural tissue repair versus mesh devices?

Surgical Mesh was introduced into hernia surgery in the 1980’s to reduce the number of recurrent hernias, and over the next two decades it became the default method of hernia surgery. Five decades later, if one reviews the literature, the recurrence rate for inguinal hernia repair (over 85% of most hernia surgery) has not improved. Compounding this failure, the use of Surgical Mesh has resulted in a staggering increase in post-operative complications that were not generally seen prior to its introduction.

Consider the following:

Hernia Recurrence – there is a plethora of published papers on hernia recurrence rates, many of which are unreliable given poor patient follow up and an unrealistic definition of “recurrence”. Some define a recurrence as a hernia that reappears within 2 years, and we believe that is self serving as a hernia repair should last a life-time.

Even within acceptable research the rate of recurrence is wide ranging, from 5% to over 15% in most Hospitals. Within this range it is generally accepted that the recurrence rate has not declined with the introduction of Surgical Mesh (cited on page 9 of the “Trends of Inguinal Hernia Repairs Performed In the United States”. This paper covers a massive sample size and includes three nationally recognized institutions that concluded:

“The proportion of inguinal hernia repairs performed in the United States has remained relatively constant from 2005 to 2015. Based of these larger evaluations of recurrent hernia surgery, the current surgical literature on IHR is skewed and overly optimistic.”

Further to this, Shouldice’s recurrence rate for Inguinal Hernia Repair rate is less than 2%. This is a life- time rate, as we have the luxury of having the largest single, updated database of hernia patients in the world. To validate this, see the “Recurrence of Inguinal Hernias Repaired in a Large Hernia Surgical Specialty Hospital and General Hospitals in Ontario, Canada.”

This paper was entirely independent (in fact we never knew it was being published) and includes a large patient population, over a long period of time, when Surgical Mesh was being introduced as the default repair. It is fair to say that of the surgeries done in these public hospitals well over 95% were done using Surgical Mesh.

It concludes “Inguinal hernia repair at Shouldice Hospital was associated with a significantly lower risk for recurrence than repair at a general hospital”.

It is reasonable to conclude that hernia recurrence has not improved with the advent of mesh. You will note later, the importance of specialization through comparing our results to Ontario General Hospitals, where General Surgeons, who are all competent, do not typically specialize in hernia surgery.

Post-Operative Complications:

Prior to the introduction of Surgical Mesh there was virtually no mention of post-operative pain after hernia surgery in any medical literature. Now, chronic and debilitating pain, along with other severe complications, associated with mesh use such as mesh shrinkage, mesh migration, and related nerve entrapment, are rampant.

Again, studies vary on the incidence of these significant mesh related complications, however the paper “Pure Tissue Repairs: A Timely and Critical Revival” produces a reasonable summary of these issues and concludes:

“If we are to believe our colleagues, our registries, our guidelines as well as giant studies of The Mayo Clinic and the University of Toronto, we would be looking at a mesh complication rate of dysejaculation of 3.1%, of sexual pain of 10.9%, a recurrence rate of 10% and a rate of chronic post-inguinal herniorrhaphy pain of 13%! A combined minimal rate of 37%! These are minimum values presented in their publications.”

Using information from the Shouldice Hospital’s data bank our post-operative complication rates are around 2% for chronic pain, 0.37% for other issues including seroma, cellulitis, and hematoma, and 0.57% for wound infections.

Costs to the Healthcare System and Post-Operative Mesh Removal:

To date, and to the best of our knowledge, there are no published studies quantifying the cost of mesh related recurrence surgery, or treating the complications associated with its use. The costs of using Surgical Mesh can range widely, but include simple discomfort, visits to emergency rooms and pain clinics, additional surgery to redo the failed hernia repair, the high cost and significant risks of mesh removal surgery, to documented cases of suicide where the pain, caused by mesh’s entrapment of nerves and adherence to organs, becomes intolerable.

When you consider there are 20 million hernia surgeries done in the world each year, any reasonable estimate of these costs is astonishing considering the lack of documented benefits.

How many natural tissue surgeries are performed at Shouldice every year and what is the complication rate?

Shouldice Hospital has been in operation for over 76 years (founded in 1945 by Dr. E.E. Shouldice) and has to date performed over 407,000 abdominal wall hernia repairs. Of these repairs approximately 85% are Groin hernias, and the remainder Ventral hernias, of which the vast majority are Umbilical hernias.

The number of surgeries performed each year depends on our surgical complement, which over the past 10 years has averaged 10 full-time employed Surgeons, performing approximately 6,800 surgeries per year.

One critical factor to our success is due to specialization. Each of our Surgeons perform between 600-700 hernia surgeries per year, which is more than a typical General Surgeon would do in a lifetime. Quite simply “the more you do of anything the better you are at it”.

Our comparative recurrence and complication rates are summarized above.

What are the most commonly reported side effects?

All invasive surgery (whether “open” or “Laparoscopic”) has inherent risks, but in terms of “side effects” a huge advantage of Tissue Repair, done right, is that there are none. This is essentially because you use the body’s natural tissue as the basis for the hernia repair. This means the well known “foreign body reaction” in response to the implanted Surgical Mesh is avoided.

How many surgeries have been reported as unsuccessful and the reason why?

If we define “unsuccessful” as hernia recurrence and post-operative surgical complications and adverse symptoms, the comparative numbers between Tissue Repair and repairs using Surgical Mesh, have been summarized above.

In principle a proper Shouldice Tissue Repair (Groin) should always be successful when done correctly, however surgery is never perfect. Reasons why a Tissue Repair is unsuccessful include:

• Surgeon experience and competence – for a Tissue Repair to be successful it requires a thoughtful and complete dissection of the groin area. Most General Surgeons have a poor understanding of the complexity of the human groin because typical surgical training does not focus on this area. As a result, inexperienced Surgeons who opt to use any Tissue Repair (the Shouldice Repair is one of 2 or 3 most currently performed in the world) often do not perform the dissection or hernia repair technique correctly. As outlined, this is why Shouldice Hospital has superior surgical outcomes, not only over Surgical Mesh, but also over those other Surgeons performing any Tissue Repair. When done incorrectly the following can result;
• Recurrence of the hernia; and
• Post-operative complications such as infection (poor sterile field), pain (nerve and vas ‘deferens’ entrapment) and testicular atrophy (rarely, but can result through carelessness or from sources that remain uncertain).
• Post-operative issues such as smoking, obesity (both pre and post), diabetes, use of steroids, connective tissue disease, and wound infections.

What aftercare is required following natural tissue repair surgery?

As all Tissue Repair is done using the “Open” approach (versus “Laparoscopic”) the aftercare is simple and involves non - narcotic pain control, exercise, rehabilitation, and routine wound care. This would be comparable to when Surgical Mesh is implanted using an Open Repair (85-90% of cases), but is different than when Laparoscopy is used. In this case it is argued that there is less incisional area and resulting wound care, but there is a minimal 1–2-day issue as Tissue Repair wounds heal very quickly.

Why do you not use mesh devices in your surgery?

As outlined above we do use Surgical Mesh when it is required due to the state of the underlying tissue being unable to support the hernia defect’s repair. In our experience this is in less that 1 % of all Groin repairs and up to 5% in large Femoral and Ventral hernias (less than 2% on average).

Simply put, the virtually universal use of mesh in abdominal wall hernia repair is not supported by the facts, and in our case NO technique, even other Tissue Repairs, can match the surgical outcomes of the Shouldice Natural Tissue Repair done by an experienced Shouldice Surgeon.

Furthermore, as today’s healthcare costs are skyrocketing the use of Surgical Mesh, and a Laparoscope, contribute needlessly. Individual Surgical Meshes can range from C$35 to over CS1,000 for complex organic versions, and Laparoscopes costs well over C$100,000 per machine. Natural-tissue Repairs “may” take slightly longer in the operating room, but this cost pales in insignificance given the other negative issues with using Surgical Mesh as noted.

How long it takes for a surgeon to be trained in natural tissue repair and cost?

The duration of training depends on the experience of the Surgeon, and ranges from 3 months for an experienced Fellowship General Surgeon, to 6 to 9 months for an inexperienced General Surgeon. The cost of this is difficult to determine given variances in healthcare systems. In Canada, this is a paid position whose services are then billable to the provincial healthcare system where the dollars equal out. In our case the real cost is “soft”, where the in-person training slows down the Operating Room’s normal rhythm and throughput by 15-20%.

On a comparative basis there is little doubt that it is simpler, and quicker, to train a General Surgeon to do a Mesh based hernia repair using the Open technique. However, this comes with all the above- mentioned costs of complications and poorer surgical outcomes, therefore it should not be the reason why Surgical Mesh is used as much as it is.

Conversely, training a General Surgeon to implant Mesh Laparoscopically can take equal or more time, as instead of learning to do a Groin dissection, they must train to do the procedures mechanically. Studies have shown that it takes between 200-300 cases to become totally proficient with a laparoscope, whereas a typical Open technique will take 20-30 cases when Mesh is used, and up to 100-150 when the Open repair is done using a Tissue Repair.

Thank you again for allowing Shouldice Hospital to introduce our views on these important questions. If you require clarification on our responses, or have any follow-up questions, please contact me anytime.