Dear Patient Advocates: Seeking Feedback
02/26/2018 at 4:55 am #11195
I have put together a Patient Advocacy Forum, bringing surgeons, patient advocates, and the FDA together to talk amongst themselves. The goal is to initiate dialogue about hernia repairs, mesh, chronic pain, and other issues that are of interest to these groups and what can be done to improve patient outcomes, satisfaction, etc. This is the first of its kind to address this topic head-on, with key stakeholders at the table and face-to-face. As a pilot attempt, the group is kept small and is closed. I am hoping this will grow into larger townhalls and spearhead major innovations and changes in how we practice hernia repairs.
1. Please post questions or suggestions you feel should be addressed, covered, brought up.
2. Please private message me if you would like to function as a patient advocate and participate in this forum. I can provide you with details at that time.
There are so many amazing people on this forum, so well versed in all the issues and minutia. I would love to have one of you represent.
Thank you in advance!
02/26/2018 at 6:33 am #15666
This is exciting Dr. Towfigh. I hope that some good comes from it.
One question I would like to pose, that I’ve also recently posted about, is the extent of the role of the FDA in approving new devices. Of course, mesh is defined as a medical device. Do the medical device makers supply the approval data, or does the FDA do actual product testing? If the FDA does testing, where can the results be found? If the device makers supply the data, how can they be held to account if their data does not match reality? And where can their data be found?
A second question would be – how is adverse event data collected? Who supplies it, and who collects and tabulates it? For example, if I, as a patient, complain to my surgeon that I have a problem with my mesh implant, how far along the path to removal do I have to go before it gets recognized as an adverse event? Is the first complaint the trigger, or does some actual physical action have to take place? Do the doctors and surgeons trust the adverse event reporting function of the FDA? Do they have a professional obligation to report what their patients tell them?
There are many stories about patients who can’t find relief from what they feel are bad mesh reactions, but it’s not clear if the FDA knows about these patients.
I look forward to seeing this effort progress. It might be that small changes could have big effects. But without good information nobody knows what to act on.
02/26/2018 at 6:46 pm #15671tesskParticipant
I think this is great news. I certainly might be interested. I’ll p.m. you if I can remember how. LOL. Thanks, tessk
03/01/2018 at 4:22 am #15686Chaunce1234Member
This is a great idea, please reach out to patients who specifically have had complications relating to hernia surgery, and patients who have had complications with mesh products.
A few general thoughts/topics/suggestions for discussion:
– Chronic pain mitigation and reduction should be the highest priority for groin hernia repair, particularly given its impact on life, and the current opioid hysteria. People would not need pain killers if they were not in pain in the first place.
– Medical schools should routinely teach non-mesh repairs along with mesh repair, and hernia surgeons should be confidently competent in both repair types, knowing when to use what for each individual patient
– Mesh should be made so that it is easy to identify on any MRI, CT, ultrasound
– Mesh should be made so that it is relatively easy to remove if necessary
– The concepts of hidden hernia and sports hernia / inguinal disruption should be well understood by surgeons, as well as proper diagnostics and proper treatment
– For groin and/or pelvic pain, a clear diagnostic protocol should be established, which would be particularly helpful for the cases that do not have an obvious presentation or cause, and something that routinely pops up on these web forums
– Research and investigate cellular printing of muscle and tissue replacement using the patients own cells, Wake Forest Institute for Regenerative Medicine is working on this so perhaps adapt those concepts specifically for hernia repair
03/01/2018 at 10:37 pm #15690JnomeshParticipant
This is a great idea Dr. Towfigh as there is definitely a subset of population that has and is suffering from mesh issues which is now the gold standard.
i agree a lot with Chaunce123 and his many suggestions. My mesh was folded inside of me and for 5 years I suffered but was told by surgeons, scans and tests that everything was fine so:
1) there definitely needs to be a way for mesh problems to show up more easily on scans-so if something is fundamentally wrong it can be identified.
2) in the meantime ither surgeons and radiologists need to be trained by those who can read cat scans or MRI’s to see the mesh and if it is doing what it is supposed to do (folded, migrated) in my opinion this training should be mandatory before a surgeon is allowed to use mesh
3) all hernia surgeons should be trained on how to successfully remove mesh or be armed with the names of the experts that do remove mesh so if a patient is suffering they aren’t simply whisked off to pain management as the surgeon wiped his hands clean of the patient.
3) there absolutely needs to be a specialty hospital like the Shouldice Hospital in Toronto locates here in the U.S that specializes in non mesh repairs as an alternative to mesh.
The shoukdice hospitals data reports that they have a less than 1% recurrence rate and a less than 1% chronic pain. Um this fly’s in the face of what we hear from the average surgeon that Mesh reduces recurrent rates when they report that Mesh has a recurrent rate of 3% which is 3x the rate of the Shouldice Hospital-3x. The read between the lines is that A) surgeons in training get very little training in non mesh repairs and focus in mesh repairs-so ofcourse in the non mesh repairs outside of the shoukdice hospitals will have a higher rate of recurrence. It’s a self fulfilling prophecy and a horrible loop that needs to be stopped. Patients need choices and a place to go that can give them the best chance to have the best care and that isn’t the case now-it’s really Mesh or nothing.
4) all patients need to be tested to see if they have a reaction to propylene before mesh is implanted. I know the numbers of these cases maybe small but god almighty I can’t think of anything worse than sticking a plastic permanent device in someone who is allergic and has a allergic reaction or infection to the mesh and then has to be told it’s not the mesh or we can’t remove the mesh or have the mesh removed and then sutured with propylene sutures. Just cruel.
5) I think the size of the mesh used in laparoscopic hernia surgery needs to be re-explored. I get that it covers all 3 areas of groin hernia by I’ve also read that the large mesh size is also a by-product if the lapro surgery itself.
Unfortunately when something goes wrong with the mesh it can damage and devastate so many structures because of how much surface it covers
6) there needs to be a shared data base for people who have to have there mesh removed so we can develop more protocols for all of the different patient variables
7) and there needs to be more of a focus on aftercare for mesh removal. What should people be doing (PT or no PT, supplements, etc) and when to start these activities (right away, 3 months , 6 months. It’s crazy the patient has just had a piece of mesh ripped out of their body and the departing instructions can’t be “listen to your body”…”.see ya”. In my opinion there needs to be a facility in the U.S. that is geared to mesh problems from A-Z : pain management, different therapies, mesh removal and care post mesh removal.
just some thoughts
03/11/2018 at 12:22 am #15703jerseattlewaMember
CONCERNS AND IDEAS FOR INCLUSION:
1) As to the value of having someone, or some people, from the FDA in the patient advocacy group or on a panel it cannot be determined unless we know their job titles, duties and powers. The FDA has 14,824 employees. It’s likely that only a few have any real power. So, I would encourage the disclosure of their job titles, duties and powers.
2) There seems to be little consensus in the medical community as to treatment or diagnosis of the various maladies related to hernia mesh in its use or complications thereafter. Accordingly, it could in effect be a case of the blind leading the blind with any conclusions or recommendations of such a group of limited value, or flawed, working from such a base of no real consensus.
3) My third concern is that as this group is initiated by one person with their own viewpoint, opinion and preferred treatment modalities it would seem possible that there could be consciously or subconsciously some preference in selection to those of a like mind to be on this patient advocacy panel. I believe Dr. Towfigh should be given credit for initiating herniatalk and I believe she acts in good faith. It should be noted that at Dr. Towfigh’s Beverly Hills Hernia Center website it states in part: “We always choose the best mesh for each patient’s needs to minimize risk and maximize outcome. We also offer non-mesh repairs…” However, there are other doctors and patients who do not believe that mesh should be used at all. Such contradicting view point should have voice within the patient advocacy group. Accordingly, I think it would be appropriate to have representation in the patient advocacy group by those who are against using mesh such as, but not limited to persons such as: William Brown, M.D., Fresno, CA and/or Kevin Petersen, M.D., Las Vegas, and/or Shlomo Raz, M.D., Las Angeles (As to Dr. Raz he deals with mainly mesh related to prolapse, but is well familiar with mesh in any event), or other similar persons. Unless there is such representation I think the conclusions or recommendations of the patient advocacy group will lack credibility and/or will be vulnerable to criticism on that basis.
4) I believe that any conclusions or recommendations that the patient advocacy group would come up with should be sent out by email and posted for 30, 60 or 90 days for group and public comment prior to any such conclusions or recommendations being finalized and that such resultant comments be incorporated or at least attached.
5) To disclose my own viewpoint as to my opinions herein; my personal belief, as someone with hernia mesh complications, is that mesh should never be used unless it’s a matter of life or death with then no other treatment modality option available. According to the FDA’s website nearly 100 medical mesh products have been recalled and that does not count those that have been voluntarily removed. One would be hard pressed to find recall numbers like that as to a product class or group in any other industry.
There is a medical association known as: Society of American Gastrointestinal and Endoscopic Surgeons aka “SAGES”. Do a Google search using these terms: SAGES use of synthetic mesh in infected field. Do other searches on Google such as: NIH hernia mesh infection; Or; NIH hernia mesh sub-clinical infection, Or; NIH hernia mesh chronic inflammation, Or: NIH chronic inflammation sub-clinical, Or, NIH hernia mesh biofilm infection Or; NIH hernia mesh chronic pain. Note: National Institute of Health = NIH. As to sub-clinical infection alone, or as to sub-clinical chronic inflammation alone, either of these are very difficult to impossible to diagnose with any kind of testing available yet they are very real possible outcomes for those with mesh implants. And, how does a doctor differentiate either of those conditions which he or she can’t really diagnose to begin with from chronic pain which is common due to shrinkage of mesh of up to 50 percent? Good luck! Getting a solution is virtually impossible. In my personal experience, when you complain of pain or symptoms of infection or inflammation/allergy your most likely to get referred to pain management by a surgeon. All of this is reason enough to avoid mesh like a disease. Your just gambling with your health when it comes to mesh. Make no mistake, implanting mesh in humans is an experiment, a fast and dirty method that allows surgeons with marginal skills to do surgeries. Would you get new parts put in your car or computer by a tech who had no ability to remove it later if need be? Most all surgeons that repair hernias use mesh, but good luck on finding one with any experience in removing it or even willing to try. In my experience the threshold/standard is that you have to have a raging infection bursting through the skin before they will even talk about removal.
Further, surgical mesh comes with no warranty. Even a small child knows that anything of value comes with a warranty and that most items without warranty are garbage, worthless or of little value. For contrast, a pool cover made from polypropylene (one of the common materials surgical mesh is made from) can be obtained with a warranty and is typically offered. A pool tarp is exposed to wind, weather, pool chlorine, water and sun, etc. In contrast, an implanted medical mesh is exposed to and interacts with unknown numbers of proteins, enzymes, a constant flow of blood, physical pressures and no one really knows how much more. Until such time as medical device manufacturers are willing to give a 20 year, or lifetime warranty, on mesh it should be banned.
6) I suggest that the patient advocacy group should consider having or creating a clear mission statement to have focus. Personally, I would prefer to see such a mission statement to include in part a recommendation to ban surgical mesh production or use until the multi-billion dollar pharma industry decides to sell all surgical mesh with a substantial warranty like ordinary products you can buy at Walmart, Home Depot, Walgreen’s, Target, Costco, etc. Would a person buy a new computer, smartphone or car without a warranty? Would any person of ordinary reasoning buy a surgical mesh to be implanted in their body that comes with no warranty? They would or might do so only if they had no option.
03/11/2018 at 1:42 am #15704
Thanks everyone. These are all excellent points. I really appreciate your input. Let’s hope this is a successful small step forward.
12/13/2021 at 1:37 pm #30285
Hello @drtowfigh . Could you provide some follow-up on your meeting with the FDA. I know that the times have been tough, and all government agencies were seriously handicapped by the last administration (no offense to anyone’s political views, it’s just a reality), and the ongoing COVID pandmeic, but, maybe, efforts can be re-initiated? The FDA is the supposed regulatory body that would be monitoring product problems. There is little sign of their efforts in the past.
12/13/2021 at 10:11 pm #30289
FDA is seriously looking into ways they can be involved in improving hernia care. I know there were plans for them to meet with me as a followup, but it seems that may have been on hold due to pandemic, etc.
Meanwhile, The ACHQC has a close relationship with the FDA. It is the only hernia database we have in the US that is broad and follows patients prospectively. As part of their efforts, they have developed a patient advocacy arm that includes patient representatives who can help improve care.
12/14/2021 at 3:44 am #30297William BryantParticipant
Got all excited reading this then disappointed when I saw not much has happened since inception.
12/14/2021 at 5:36 pm #30309
Here is a link to the AHCQC web site and a link to the inguinal hernia Patient Reported Outcome survey form.
The results do not appear to be freely available, it has to be requested. If the news is good, why not broadcast it to the world?
12/14/2021 at 5:38 pm #30310
Here is the ACHQC youtube channel video page and a video showing how the PRO form is used.
12/15/2021 at 2:18 am #30311William BryantParticipant
Could someone with access not report the findings. Why would it he difficult to view?
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