American Senator Rand Paul to have Shouldice surgery in Canada

[Chaunce1234]

Given that insurance and billing departments are experts at tracking down patients for the financial side of things without harming patient privacy, maybe they could attach a patient outcome survey to the bills that are sent out? That seems like an easy place to start and it would be better than nothing.

As for Senator Rand Paul, it’d be nice if some reporter spent 15-20 minutes reviewing this website and a handful of major studies demonstrating the risks/benefits associated with mesh and non-mesh hernia repair methods, and ask him some meaningful questions about his decision to go to Shouldice, and also why he didn’t bother going to an expert hernia surgeon here in the USA too. He is a medical doctor, so surely he has seen the risk data and outcome studies regarding chronic pain, recurrence, different surgical approaches etc. It’d be interesting. If he sees some particular benefit to the Shouldice approach, then perhaps he should be advocating for those particular benefits for his constituents and the rest of the country too, given his position of power.

[Good intentions]

quote DrEarle:

The problem with anonymous surveys is there is no connection to what the patient had done.

If the surgeon or clinic that performed the repair sends the survey the connection is clear. The personal information can be stripped when compiling the results.

[Good intentions]

There’s no reason that an individual surgeon can’t survey their own patients. I received a short questionnaire recently from the surgeon’s clinic that implanted the mesh in me. It was poorly formed and seemed to be mostly for the purpose of allowing the clinic to say that they track outcomes. But they did send it to me and I did fill it out and return it.

Taking the approach that things are too big and complicated to deal with feeds right in to what the device makers want. Passive agents for their products, “experts” that will use their products in unsuspecting patients under the guise of “informed” consent, and defend their usage. Even against clear evidence quantifying the chronic pain that is caused in 10 – 20% of patients who’ve received mesh implants. It seems unconscionable to continue to promote and use these products, knowing that there are people being seriously harmed by them, without, at least, trying to understand what causes the problems. It’s indefensible.

That is my basic reason for responding. Please don’t defend, or promote, these products with blanket statements unless you can explain why they are better than the pure tissue repairs, in all aspects, not just recurrence rates or the speed to get back to work. The surgeons blindly defending them are obstructing progress. Keep using them if you have to but please don’t get in the way of improving this terrible situation. Let progress happen.

[UhOh!]

quote DrEarle:

The problem with anonymous surveys is there is no connection to what the patient had done. There are also rules about this with regards to human subjects research. there are also rules however with regards to quality improvement, which are generally exempt from HIPAA, but because of a general misunderstanding of this, rarely used if even possible. A single/integrated medical record is the answer to accurate outcomes data for hernia repair, and indeed all of health care. “Medicare for all” is doomed to fail. Current payment system doesn’t have accurate outcomes data.

Not sure what Rand Paul is worried about. Seems like there is some sort of agenda there. I don’t know what, but something doesn’t quite add up.

I’m still curious, why wouldn’t you get good, or at least better, data by treating recurrence and chronic post-repair pain as separate conditions, allowing doctors to report their occurrence as they would any other condition?

Regarding Sen. Paul, here’s a purely speculative hypothesis: It seems that most of the initial negative mesh publicity, and resulting lawsuits, stem from vaginal mesh (as I understand it, a similar product, used in a different way). Prior to entering politics, his father was also a physician, an old-school OBGYN, if I recall. Perhaps he developed, and instilled in his son, an aversion to mesh based on his practice in that area?

Again, entirely speculative, and not based on any knowledge or facts other than both father and son being doctors and the types of medicine they practiced.

[DrEarle]

The problem with anonymous surveys is there is no connection to what the patient had done. There are also rules about this with regards to human subjects research. there are also rules however with regards to quality improvement, which are generally exempt from HIPAA, but because of a general misunderstanding of this, rarely used if even possible. A single/integrated medical record is the answer to accurate outcomes data for hernia repair, and indeed all of health care. “Medicare for all” is doomed to fail. Current payment system doesn’t have accurate outcomes data.

Not sure what Rand Paul is worried about. Seems like there is some sort of agenda there. I don’t know what, but something doesn’t quite add up.

[Chaunce1234]

Why is it not possible to simply mail patients a survey at 6 months, 1 year, 3 years, etc for follow up? The surveys could be anonymized if there is some privacy concern about patient data.

Personally I’m still surprised that a US Senator with access to the best health care available in the USA is going out of there way to avoid the ‘gold standard’ mesh repairs offered in the USA to seek out a Shouldice repair in Canada. That’s a very specific decision to make. What’s he worried about?

[UhOh!]

quote DrEarle:

Actually, even getting data from billing databases using ICD and CPT codes is very difficult. And it’s impossible to get good data. A single.integrated medical record would allow us to get good, real world data. I respectfully disagree with the notion that medical device manufacturers dictate surgical procedures. That is generally the last thing in a surgeon’s mind when seeing a patient. And mesh choices are often dictated by hospital administrators, without, and even ignoring surgeon input. I have seen this first hand. Finally, the sutures are made out of material very similar to mesh, and I have seen plenty long term problems from suture repair in my career. Not as many as mesh, but that’s because the numbers for suture repair are lower. If 90% of groin hernias were repaired with permanent sutures, we would certainly see more problems from this. Some technique related, some anatomic related, some infection related, some related to foreign body reaction to the suture material, and some related to recurrence. And that is exactly why we need long term outcome data. By the way, I know a surgeon that had their inguinal hernia repaired at Shouldice, and ultimately had a good long term outcome, but the experience there was terrible, and there has never been a follow-up survey or contact of any kind from Shouldice. I am not advocating for or against Shouldice Clinic, but anyone claiming near perfection simply is not telling the truth. From their website: “Our 99% lifetime success rate for repairing primary inguinal hernias sets the gold standard.” This type of statement is no better than a mesh company saying the same thing about mesh repair. Nobody is perfect, but we could all be honest.

By the way, this is a very good discussion, and I appreciate you all taking the time to respond.

To clarify, my thinking about new ICD codes (or some other method of recognizing and recording this as a separate condition) was that it would allow any physicians who treat patients suffering to report numbers in an attempt to quantify the size of the problem without patients having to return to their original surgeon or respond to any survey.

And I did not mean to imply that surgeons were in the pocket of device makers, far from it. However, we know that the industry will attempt to wield whatever influence it can, and, to your point, I think hospital and insurance administrators may be more “impressionable” (unlike doctors, they aren’t the ultimate fiduciary).

[DrEarle]

Actually, even getting data from billing databases using ICD and CPT codes is very difficult. And it’s impossible to get good data. A single.integrated medical record would allow us to get good, real world data. I respectfully disagree with the notion that medical device manufacturers dictate surgical procedures. That is generally the last thing in a surgeon’s mind when seeing a patient. And mesh choices are often dictated by hospital administrators, without, and even ignoring surgeon input. I have seen this first hand. Finally, the sutures are made out of material very similar to mesh, and I have seen plenty long term problems from suture repair in my career. Not as many as mesh, but that’s because the numbers for suture repair are lower. If 90% of groin hernias were repaired with permanent sutures, we would certainly see more problems from this. Some technique related, some anatomic related, some infection related, some related to foreign body reaction to the suture material, and some related to recurrence. And that is exactly why we need long term outcome data. By the way, I know a surgeon that had their inguinal hernia repaired at Shouldice, and ultimately had a good long term outcome, but the experience there was terrible, and there has never been a follow-up survey or contact of any kind from Shouldice. I am not advocating for or against Shouldice Clinic, but anyone claiming near perfection simply is not telling the truth. From their website: “Our 99% lifetime success rate for repairing primary inguinal hernias sets the gold standard.” This type of statement is no better than a mesh company saying the same thing about mesh repair. Nobody is perfect, but we could all be honest.

By the way, this is a very good discussion, and I appreciate you all taking the time to respond.

[UhOh!]

quote DrEarle:

Good intentions – Excellent comment regarding outcomes data. You stated there are “few metrics, despite close to one million surgeries per year”. Hernia repair, like health care in general, is complex. Not complicated, but complex. Therefore, by definition we cannot control it, but we can manage it. But we can only manage it if we have real world feedback (data) from the output of the system, in this case hernia repair outcomes. Only then can we get some really smart people to analyze the data, and gradually improve our application of hernia repair methods to those most likely to benefit. This can be accomplished. However, we need a single medical record (not single payer) to do it. The PPACA required electronic records, but inadvertently created a multi-billion dollar industry who’s own interests are well above those of the public. Not only would this allow continuous practice improvement, it would allow the type of post-market surveillance of hernia mesh (along with all other devices and drugs) we so desperately need.

My question has always been: Why is follow-up data from the repairing surgeon necessary to quantify this “pretty well” (if not perfectly)?

Let’s assume two things are true enough to impact results: That people unhappy with the outcome of surgery will often go to another doctor to correct the problem, and surgeons (like all of us!) are biased towards the success of their methods and will have alternate explanations for the pain some experience.

Given this, and the difficulty of follow-ups even absent these factors, why not track all post-surgical complications (pain, recurrence) in hernia repair patients as its own, separate condition? A few new ICD codes would help classify the different complications, but now you have a way of tracking results, even when someone goes to another doctor and the original treating physician is unaware.

[Good intentions]

I miswrote above, about the surgeon who said the problem was too big to quantify. It was not an Australian surgeon it was Dr. Voeller of the University of Tennessee. He is also of the opinion that most meshes are the same. He is teaching these opinions, I assume, at the UT Medical School.

https://www.herniatalk.com/9650-to-mesh-or-not-to-mesh-that-is-the-question-dr-bendavid-vs-dr-voeller

“It is most certainly higher, but we will never know the truth in a country with a population of more than 300 million like the United States, since long-term follow-up is impossible.”

I still can’t believe that a professor, at any school in any profession, would say that because the numbers are so large nothing can be learned from them. It’s incredible. This type of thinking is very damaging.

[Good intentions]

quote DrEarle:

Good intentions – Excellent comment regarding outcomes data. You stated there are “few metrics, despite close to one million surgeries per year”. Hernia repair, like health care in general, is complex. Not complicated, but complex. Therefore, by definition we cannot control it, but we can manage it. But we can only manage it if we have real world feedback (data) from the output of the system, in this case hernia repair outcomes. Only then can we get some really smart people to analyze the data, and gradually improve our application of hernia repair methods to those most likely to benefit. This can be accomplished. However, we need a single medical record (not single payer) to do it. The PPACA required electronic records, but inadvertently created a multi-billion dollar industry who’s own interests are well above those of the public. Not only would this allow continuous practice improvement, it would allow the type of post-market surveillance of hernia mesh (along with all other devices and drugs) we so desperately need.

Thank you for the response Dr. Earle. It is much more constructive than attacking the Shouldice hospital. I posted a link to an Australian surgeon’s comments, who had a similar view – “the problem is too big too handle, it’s hopeless”. But, of course, the individual physicians can easily track their own results, using surveys. The Shouldice hospital does.

As long as surgeons keep repeating the vague generalizations about successful use of mesh implantation for hernia repair, avoiding the chronic pain issue, the drive to find the truth will be weakened. That was my point in responding to the article you posted. She is just repeating something that she read on a medical device maker’s web site or from her training from the device maker. She is supporting, on her blog, what she does, without actually knowing if it’s true. She’s advertising for mesh. I just posted a link about Ethicon and their usage of their “Registry” data to make unverifiable claims about their mesh products. The device makers will sell sell sell as long as people keep buying their stories.

That is the real battle. Against the medical device makers’ propaganda. They have no reason at all, besides moral reasons, to discover if their products are better or worse than simple suturing techniques. If sutures are better, considering both recurrence and chronic pain, they don’t sell as much mesh. It’s really that simple. They have no reason to disturb the growth of the 5-6 billion dollar market. They don’t want to know the truth.

But the individual surgeon does. Because they took up their profession for the good of humanity and have taken the Hippocratic oath to confirm this. But many have been duped or coerced by the device makers. It’s “do things the device maker way or life will be very difficult”. They have co-opted the profession for their own benefit. It’s the great failure of the unregulated free market economic model we use. Business concerns are controlling the health care professions.

Good luck and please stay engaged in this issue. The truth is easy to see for those who want to see it.

[kevin-pa]

I think it should be noted that Senator Bernie Sanders had hernia repair back in 2016. I believe it was at Georgetown University hospital in DC. Must have been laparoscopic, because he was back in the campaign trail just days later. Not sure of the type of hernia or how his recovery has been.

[DrEarle]

Good intentions – Excellent comment regarding outcomes data. You stated there are “few metrics, despite close to one million surgeries per year”. Hernia repair, like health care in general, is complex. Not complicated, but complex. Therefore, by definition we cannot control it, but we can manage it. But we can only manage it if we have real world feedback (data) from the output of the system, in this case hernia repair outcomes. Only then can we get some really smart people to analyze the data, and gradually improve our application of hernia repair methods to those most likely to benefit. This can be accomplished. However, we need a single medical record (not single payer) to do it. The PPACA required electronic records, but inadvertently created a multi-billion dollar industry who’s own interests are well above those of the public. Not only would this allow continuous practice improvement, it would allow the type of post-market surveillance of hernia mesh (along with all other devices and drugs) we so desperately need.

[Good intentions]

Notice that she does not give her name on the blog. But it is linked indirectly. It would be interesting to know how her hernia repairs are doing. She said that she had two. That is the main problem with the industry today. It’s all internet stories, with few metrics, despite close to one million surgeries per year.

Here’s the quote. The blog post was May 2015. So it’s been at least three years. It sounds like a lap procedure. Notice the focus on the scar.

“So one last confession. I had two hernias repaired in November last year. I got a colleague to do it, with mesh, and a general anesthetic, as day surgery, in one of our local hospitals. I went back to work in less than 48 hours and I am very happy with my scar. I would recommend this approach (and frequently do) to anyone, including my patients”

https://www.drlesleybarron.net/

[UhOh!]

quote DrEarle:

There’s always more than one side of a story. Here’s an interesting perspective of the Shouldice Clinic from a Canadian Surgeon.

https://canadianfemalesurgeon.wordpress.com/2015/05/19/the-problem-with-shouldice-or-the-most-dangerous-phrase-in-the-english-language-weve-always-done-it-this-way/

“this blog comes from my own professional opinion as a general surgeon/hernia fixer and defender of evidence based medicine and socialized healthcare, discussions with many patients who have gone or are considering going to the Shouldice clinic, going to a talk some years back given by a surgeon who worked there, and the Shouldice clinic website.”

I read through this, and the problem is that she melds three largely separate issues in ways that make it difficult to consider each individually. As I see it, she is saying:

1. Mesh is best and should be the repair of choice.

2. The problem with the Shouldice repair is the unwillingness of its namesake clinic to evolve it along with the rest of medical science.

3. Socialized medicine is better and Shouldice is cost-inefficient.

I think that the first is highly debatable, and is, indeed, debated by medical professionals far more qualified to render an opinion than I am.

The second is perhaps the most interesting and poses very important questions regardless of where one stands on mesh vs. non-mesh. It certainly seems as though there is merit to this argument, and that improvements to non-mesh surgery could be made.

The final argument is a political one, and (in my opinion) doesn’t belong in a discussion of what the “best” way to repair a hernia is. Governments and insurance companies can enter the arena on that one, but I don’t particularly want that to be the basis of physicians’ decisions on what is “best.”

[dog]

Very interesting article about the shouldice clinic.
I agree that their results are partly do to the fact that they only operate on skinny healthy people.
I do agree that keeping the patient in the hospital is wrong.
I also believe that fixing the hernia the same way every time does not offer the patient the best method for repair.
Have a good day.
Bill Brown, M.D.
510 793 2404 Office
650 703 9694 Cell

[Good intentions]

I read the article that Dr. Earle linked and can’t get past the fact that even she, the author, “chooses” to believe the story that is told over and over, despite well-documented and available evidence to the contrary. It’s not the mesh, it’s the skill of the surgeon. The cognitive bias is incredible, but understandable. It must be very hard to accept that you’ve been harming one out of six of your patients, by the inherent qualities of the material itself. Not the technique, or placement of the material. Accepting that the device makers have pulled a fast one.

Very frustrating to see well-educated people avoiding confronting a very important health issue.

“The “standard of care” now is to do hernia repairs with mesh, a plastic like substance which allows for less pain (if inserted properly), earlier return to work, and decreased recurrence rates. ”

Any problems with the Shouldice method are completely unrelated to the problems with mesh implantation. That’s where true progress in health care can be made. We should focus on mesh.

[Good intentions]

Thank you for commenting Dr. Earle. I think that the more salient point is not that he chose Shouldice, but that he did not choose one of the prevailing laparoscopic mesh repair methods from an American clinic.

Is he really choosing Shouldice or is he avoiding mesh? He is from Kentucky, why didn’t he go to the University of Kentucky’s clinic? Good political publicity, keeping it in state, advertising the capabilities of a state university.

https://ukhealthcare.uky.edu/services/hernia-program

Or he could have gone back to Duke, his alma mater.

https://surgery.duke.edu/divisions/metabolic-and-weight-loss-surgery/patient-care/general-surgery/hernias/spotlight-hernias

So, not only did he miss the opportunity to keep it in state, he even left the country. There are plenty of well-known American clinics that accept cash payment. The stated reason for going to Shouldice seems disingenuous.

[DrEarle]

There’s always more than one side of a story. Here’s an interesting perspective of the Shouldice Clinic from a Canadian Surgeon.

https://canadianfemalesurgeon.wordpress.com/2015/05/19/the-problem-with-shouldice-or-the-most-dangerous-phrase-in-the-english-language-weve-always-done-it-this-way/

“this blog comes from my own professional opinion as a general surgeon/hernia fixer and defender of evidence based medicine and socialized healthcare, discussions with many patients who have gone or are considering going to the Shouldice clinic, going to a talk some years back given by a surgeon who worked there, and the Shouldice clinic website.”

[dog]

WOW !!! Truly unbelievable ! Thank you for that post.