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A new call for a registry
I just came across a new paper describing the need for improved monitoring of mesh device results. It’s interesting but I still see a fear of disclosing the bad devices and/or their makers. They describe a “successful” effort to get a change in a mesh device Indications For Use (IFU). But don’t name the manufacturer or the device. Apparently the AHSQC was involved. But what good is the AHSQC to the patient if the data is hidden? It seems to be for the device makers and the surgeons. Better than nothing but in the age of “informed consent” how can it not be rational to make the data transparent?
The change was in the advice to the surgeons, the Indications For Use. But the patient is left out of the loop. The surgeon can still use in the wrong way.
Anyway, it looks like progress. Could move much faster though.
Excerpt:
“Recently, the Americas Hernia Society Quality Collaborative (AHSQC) was able to affect a change in the IFU for a broadly marketed hernia mesh device after several surgeons raised concerns of central mesh fractures, resulting in unexpected hernia recurrences. ……
Subsequently, the manufacturer issued a medical device correction, citing hernia-specific details: ….
The medical device correction advised against the usage of the device in the context of a specific type of hernia repair. ”
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5 Replies
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I just noticed also the word “catastrophic”. It seems like all of these programs that seem in the right direction, are qualified downward to less impactful, ill-defined efforts. The solution is so simple, but everyone is avoiding it. Afraid of what it will show, I assume.
Really, why is a catastrophe necessary?
“The AHSQC plans to develop a questionnaire that is valid for addressing long-term catastrophic mesh related complications.”
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@jnomesh
“But the patient is left out of the loop. The surgeon can still use in the wrong way.”
Follow the money.“Seems a little concerning that from what you posted the concern seems to be around recurrence?”
Agree looks like there is a fixation on recurrence, and an avoidance of a discussion on chronic pain. Maybe partly because a recurrence can be physically identified, and requires a medical intervention — whereas chronic pain is invisible, and at can be passed off to pain management. Discussions of the latter would also lead to a reduction in surgeries surely. Hmm. -
Looks somewhat promising and I Haven’t had a chance to read yet but seems a little concerning that from what you posted the concern seems to be around recurrence?
Hopefully it takes into account pain, migration, Mashoma and other factors and not simply recurrence.@good intentions
I’m gonna post a research paper that someone in another forum posted. It seems a dense read but very interesting and something you might want to dig in to.
Will post it under a separate topic/post but here it is:https://etda.libraries.psu.edu/files/final_submissions/11854
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“Patient reported outcome (PRO)
The AHSQC plans to develop a questionnaire that is valid for addressing long-term catastrophic mesh related complications. ”Maybe the questionnaire is done? @drtowfigh
I don’t see it on the web page.
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Here is more from one of the references. The patient, I assume, is still in the dark. It’s not an open database, as far as I can tell.
http://mdepinet.org/crn-community-practice/
http://mdepinet.org/core-abdominal-health-crn/
“Patient reported outcome (PRO)
The AHSQC plans to develop a questionnaire that is valid for addressing long-term catastrophic mesh related complications. The plan is to decouple the assessment of highly impactful patient events (that patients are very likely to recall) from a clinical visit with a provider to enhance the efficiency of surveillance.In this effort, the CRN prioritizes the evaluation of outcomes such as readmission, reoperation, surgical site infection, and mesh-related complications, developing PROs sensitive to long-term, low rate, serious complications after hernia repair, and developing a common set of core variables in concert with international partners.”
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