Need to know if I should file a complaint

[sonick]

Greetings,

Some of you may have seen me around other portions of the site, but I'm dropping in because I have what I believe to be a potential complaint regarding interstim/pain stipulating any further treatment. Wouldn't even write me a script for a pelvic floor retrainer, the obvious source in my case. I just got sent out of the last pcp in my town's office DURING a flare, which I thought would actually be perfect to witness, as I'd "only" been at 3-5 for the other appts. Due to the fact I didn't want an interstim (after displaying all of the negative quotes(anonymous) from here), I was sent hobbling out of their office almost unable to drive, and having just gone through withdrawl from 60mg/day norco yanked cold turkey (6 months).

Not wanting a pity party here, as I like other IC'ers usually don't because we are tough or made tough by the plight. I'm looking for opinions on whether i should file a compaint about the combination of interstim certified urologist' AND pain doctor forcing weeks of interstim consults before being issued ANY relief. I can MAYBE understand without acute pain before, just an apperance of discomfort (conditioned), but today's acute presentation now drives me to want to file a complaint for wasting all of my paid (and unpaid) leave and weeks of agony on consults regarding a use that is not even approved for interstim.

The interstim is approved for use of general pain "in the trunk", but this is obviously superceded by the direct INTERNAL agitation of the hemmorages. I suppose an accused doctor would argue solely the PFD concern and apply the general trunk pain definition to the operating guidelines, but these guys had WEEKS to research the simplest of IC mechanisms.

I am barely able to type this, and I'm now headed back to bed as I seem to be able to deal with the flare best when I'm not sitting erect. As you can see it's 4AM central, and I havent' slept a lick.

I'm single, have been working professionaly doing enterprise network design for 2 of the largest private IP networks in the world for almost ten years, have no friends left due to the limitations (niceties, but that's about it), have a mortgage, car payment, all that stuff, parents are thousands of miles away - can't really ask them for help, and I'm about to lose it all due to simple lack of pain control while I try and work the biofeedback angle. What does someone with a tri-level home do when he's kicked out on the street with an entire house-full of possessions i would assume just strewn across the lawn, intractable pain, and nowhere to go ? It's so futile it's almost comical at this point, but I'll still fight, I don't know what else to do but fight. Pity and fatalism don't produce ANYTHING.

So, whattya think, should I talk to my lawyer about negligence in treatment, and especially the weeks spent going back and forth based on an unapproved use of the interstim ?

I can't believe it, but I actually feel like I've done something wrong now when I told the doc he was a jerk. I honestly feel, even with KNOWLEDGE of the situation, I honestly feel that I am somehow wrong for seeking thorough and prompt treatment of my pain.

Thanks for opinions about whether I should, or if it's even possible to file grievances about the non-approved application of interstim via the obvious fact IC pain is not "general trunk pain".

Appreciate all input..... not sure how to solve the pending career end coming within the month.
Keep on fighting I guess.....

Thanks,
Jayson

[sonick]

Here are all the FDA approvals regarding interstim use in pain....... I just really don't think IC pain that is easily revealed to originate most if not all of the direct and radiating pain, from the hemmorages as they exist where the bladder lining broke down. Sorry if this is so long it's annoying, just wanted to get it out there. Off to lay down, bad bad day and just plain worn out.

Excessive text ahead, beware:

P840001/S058
12/14/01
Real-Time
Model 7427V Synergy Versitrel Dual Channel Implantable Pulse Generator
Medtronic, Inc.
Minneapolis, MN
55421
Approval for the Model 7427V Synergy Versitrel Dual Channel Implantable Pulse Generator and is indicated as an aid in the management of chronic, intractable pain of the trunk or limbs.
------------------------------------
P840001/S045
6/13/00
Real-Time
Model 7421 Itrel®, 7424 Itrel® II, 7425 Itrel® III and Model 7427 Synergy™ Implantable Pulse Generators
Medtronic Neurological
Minneapolis, MN
55421
Approval for expansion of the Indications for Use for the Model 7421 Itrel®, 7424 Itrel® II, 7425 Itrel® III and Model 7427 Synergy™ devices. These devices are indicated "as an aid in the management of chronic intractable pain of the trunk and limbs, including chronic and intractable unilateral or bilateral pain associated with the following: failed back syndrome or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome, post-laminectomy pain, multiple back operations, unsuccessful disc surgery, and degenerative disc disease (DDD)/herniated disc pain refractory to conservative and surgical interventions."
-------------------------------------
P840001/S045
6/13/00
Real-Time
Model 7421 Itrel®, 7424 Itrel® II, 7425 Itrel® III and Model 7427 Synergy™ Implantable Pulse Generators
Medtronic Neurological
Minneapolis, MN
55421
Approval for expansion of the Indications for Use for the Model 7421 Itrel®, 7424 Itrel® II, 7425 Itrel® III and Model 7427 Synergy™ devices. These devices are indicated "as an aid in the management of chronic intractable pain of the trunk and limbs, including chronic and intractable unilateral or bilateral pain associated with the following: failed back syndrome or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome, post-laminectomy pain, multiple back operations, unsuccessful disc surgery, and degenerative disc disease (DDD)/herniated disc pain refractory to conservative and surgical interventions."
--------------------------------------
P840001/S064
9/26/02
180-Day
Itrel®3, Synergy™ and Synergy Versitrel™ Neurostimulators
Medtronic, Inc.
Minneapolis, MN
55421
Approval for the Model 3890 Pisces Z Quad™ Lead, Model 3891 Pisces Z Quad Compact™ Lead, Model 3892 Pisces Z Quad Plus™ Lead and Model 3550-22 and 3550-23 lead revision kits. The devices are indicated as an aid in the management of chronic, intractable Pain of the trunk or limbs.
---------------------------------------
P010032/S003
9/18/02
Real-Time
Genesis Neurostimulation (IPG) System
Advanced Neuromodulation Systems, Inc.
Plano, TX
75024
Approval for the Model 3811 PainDoc Computerized Support System, Version 2.01 for use with the Genesis Model 3850 Patient Programmer which are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
-------------------------------------
P840001/S047
2/21/01
180-Day
Model 7421 Itrel®, 7424 Itrel® II, 7425 Itrel® III and Model 7427 Synergy™ Spinal Cord Stimulation Systems
Medtronic Neurological
Minneapolis, MN
55421
Approval for expansion of the Indications for Use of the Medtronic Model 7421 Itrel, 7424 Itrel II, 7425 Itrel III and Model 7427 Synergy Spinal Cord Stimulation Systems. These devices are now indicated "as an aid in the management of chronic intractable pain of the trunk or limbs, including unilateral or bilateral pain associated with the following: failed back syndrome or low back syndrome of failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, post-laminectomy pain, multiple back operations, unsuccessful disc surgery, degenerative disc disease (DDD)/herniated disc pain refractory to conservative and surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, complex regional pain syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia"
-----------------------------------
P010032
11/21/01
Genesis Neurostimulation (IPG) System
Advanced Neuromodulation Systems, Inc.
Plano, TX
75024
Approval for the Genesis Neurostimulation (IPG) System. The System includes the following components: the Model 3608 pulse generator, the Model 3850 patient programmer, the Model 1232 programming wand and the Model 1210 patient magnet. The device is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
------------------------------------
P840001/S052
8/3/01
180-Day
Model 7421 Itrel®, 7424 Itrel® II, 7425 Itrel® III and Model 7427 Synergy™ Implantable Pulse Generators
Medtronic, Inc.
Minneapolis, MN
55421
Approval for a change in the indications for use from "…chronic intractable pain of the trunk or limbs…" to "…chronic intractable pain of the trunk and/or limbs…". The indication statement has been revised to state "The Medtronic [trade name] System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back syndrome or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, post-laminectomy pain, multiple back operations, unsuccessful disc surgery, degenerative disc disease (DDD)/herniated disc pain refractory to conservative and surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, complex regional pain syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia."
------------------------------------
P840001/S052
8/3/01
180-Day
Model 7421 Itrel®, 7424 Itrel® II, 7425 Itrel® III and Model 7427 Synergy™ Implantable Pulse Generators
Medtronic, Inc.
Minneapolis, MN
55421
Approval for a change in the indications for use from "…chronic intractable pain of the trunk or limbs…" to "…chronic intractable pain of the trunk and/or limbs…". The indication statement has been revised to state "The Medtronic [trade name] System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back syndrome or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, post-laminectomy pain, multiple back operations, unsuccessful disc surgery, degenerative disc disease (DDD)/herniated disc pain refractory to conservative and surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, complex regional pain syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia."
---------------------------------

[jd]

I HAVE THE INTERSTIM. THE FDA HAS NOT APPROVED THE INTERSTIM IMPLANT FOR PAIN, IT IS ONLY APPROVED FOR URGE/FREQUENCY/INCONTINENCE!!! EVEN MY UROS MEDTRONICS REP SAYS THAT IT IS NOT APPROVED FOR PAIN. MY IMPLANT WORKS GREAT AND I AM ONE OF THE FEW WHO DO GET HELP FROM THE IMPLANT FOR IC PAIN. BUT AGAIN IT IS NOT APPROVED FOR PAIN!!! IF I WERE YOU I WOULD SEEK ANOTHER UROLOGIST.

grouphug

JANE

[jd]

ANOTHER THOUGHT:

MY INTERSTIM MODEL NUMBER IS 3023.

THAT DOES NOT MATCH ANY THAT YOU LISTED. MEDTRONICS DOES HAVE SOME OTHER IMPLANTS THAT MIGHT JUST BE FOR PAIN.

JANE

[ICNDonna]

A complaint to the physicians' licensing bureau in your state is one option.

I don't know what the laws are in your state regarding treatment of pain, but in some states people have been successful in suits against doctors for refusing to treat pain.

In the meantime, I do suggest you find another doctor.

Sending an encouraging hug,
Donna

[sonick]

jane, donna, thank you so very much for the replies.
I'm still up, haha, trying to find a clearing house for medical papers so I can become a subject matter expert on the bladder and pelvic floor. Well, need a doctor to write a script for the specific retrainer that I can log my muscle activities 24 hours per day to a computer; without a script I can't buy one. I do a lot of data trending, and once that dang data makes it to the computer, I WILL FIND SOMETHING RELEVANT to my case, or to everyone. If I lose my job, I'm dedicating my life to 1) IC and 2) a home-user hardware firewall prototype (failsafe and lilliputian size) I'm certain will prop me up.... so I can then study IC full-time.

If everyone on this board were to submit daily activities to every possible degree we could think of, then plug those into a central database, coupled with the critical y-axis of EMG Retrainer IR output.... I could almost surely shape data to locate or support some extremely important trends, that have not been found. I'm not aware of anyone doing this type of research.... I think it takes the hunger of a scientist WITH IC and nerdy enough to hone millions of runs and trends to find out *** is going on in there.

Sigh. Donna, this was my third (and last) pain doc in this town. I've also been to a doc in Chicago that was willing to treat, but needed to do an epidural to check an on/off pain switch by pushing on the bladder, but have no good way to reliably report to a hospital 2 hours away for a procedure the hospital security WILL NOT let me leave alone after. Jerk. My friends have either given up because my case got so bad over the last year, or they are undependable. BTW, it turns out this epidural was to serve more of an academic purpose than treatment/diagnosis focus, and I have the proof. He doesn't answer calls anymore (after a civil presentation). He at least took care of me for a month to find another doc, which was the RIGHT thing to do if he required academic tests that are extremely dangerous, just to get treated longer term. Um, no.
I'm in the middle of Illinois, it's pretty conservative (not that that's good or bad, unless your a pundit Color me Independent, but that does mean intense scrutiny on these meds in this area for sure..... and I look very much like the guy you would NOT give it to. I don't LOOK like someone who wears his heart on his sleeve and speaks overtly about his condition, and articulately (when not flaring anyway, then it's grunting), I look like... a kid. But I'm 30. If they spent an hour with me they would have time to articulate back and forth to see where I am, but they just come in, face drops, listen unintently and suggest whichever is the most invasive first.

I'll seek the medication treatment, but that's only to enable the retrainer IR or something similar and setting up the entity to cull daily data from sufferers; the infrastructure and databases/queries/shaping/access are already setup and ready to go. Just need a script for the device which all the pain docs say go to a uro, and the uro won't beacuse he wants to do interstim. Anyway, I'll buy it cash and have a damn doc in the box sign it if I have to. So if anyone is interested in such a project of precise tracking with a 3rd dimension of 24x7 pelvic data logs, contact me at [email protected] . Guess I'll start calling more uros (on my third, prior wanted nerve blocks) and see if the doc in the box will treat pain (yeah right). I have some tramadol so the "I want to slam my head in a door" apex of pain can be demi dulled, but this won't hold long.

Hmm, sorry if off topic and long, I'm very tired and finally un-anxious enough to go to bed. Sorry if there are typos or run-on sentences.

Keep fighting yall, I guess I'll hit the interstates within a 35-mile limit to find a doc.. if that doesn't pan, big trouble ahead. :\

Goodnite my fellow tough-as-nails-yet-still-open-and-embracing friends,
J

[tigger_gal]

I have the interstim and my uro made sure I knew it was not for pain... I suggest yuo seek a new uro as he is steering you in a wrong direction. You can go to www.interstim.com for info and you can look up info in www.fda.gov
Brat

[sonick]

Howdy Howdy, thanks for the info Brat. I love that nickname BTW, I always picture you huffing and kicking your legs when you post. Not in a bad way, in an endearing way. Forgive me, I visualize by nickname without being able to see faces

Well as far as the fda stuff goes, I THINK my above post covered every single possible FDA approval for Interstim of any make and model for pain. "Trunk pain" is part of approved use as seen above, but I deeply feel that since the pain obviously is most severe from the hemmorages INSIDE The bladder, that does NOT qualify as trunk...... and I blame my pain mgmt. doc for either a) not learning the basics of the disease and origin of pain and b) not asking my urologist about whether it qualifies as trunk pain. This is my third urologist by the way..... The first just up and left town on me, not that he was that great but I am very thankful for his prompt diagnosis; the second wouldn't shut up about BCG no matter what else was going on.... BCG BCG BCG he was like a broken record. The third uro is the one that should have known the interstim does not apply to IC as the interior surface is NOT trunk pain.

Anyhow, time to hit the interstate, there are 3 cities within 35 miles and pain clinics in each of them. At least one has to have half a brain. As important as the short term relief is the biofeedback wireless logging I spoke of above to finally identify and eliminate this condition. I don't have anymore time to give to this condition and noone seems to be researching anything but drugs drugs and more drugs. No more drugs, PFD is my angle.

I digress, contact me if interested in contributing to the metrics to input into a 3d map of symptoms. I even had a harebrained idea to chip in on one of these EMG retrainer IR's, would have to buy our own probes for hygenic reasons, then ship the controller person to person 3 weeks at a time.... everyone vowing to log all data metrics to a central server unless they hurt so bad they can't move. Then cull it all together and fix this BS by plotting all of the dimensions of the disease. I don't foresee a clearcut cure through pharmacological research, and don't plan on waiting around for that.

Probably not a feasible idea regarding the group effort, as the device require a prescription. Another hurdle, what a shock. I will for sure share what I find myself though. More later.

Peace
J

[tcbc1989]

I am so sorry that you were misled in thinking that the Interstim was an answer to pain.....I was told...FIRST THING!!! that it is not for pain, but for my retention problem, which may, and I said MAY help indirectly with my discomfort.....I have had fairly good results with my retention problem with my Interstim.... I hope you find peace and comfort with any further choices you make. Good Luck. Tina C. from Florida... hi

[mbrogier]

Why don't you call Medtronic and report the doctor...and call the FDA as well. Your insurance company won't even pay for the interstim because the doctor's office can't put down that your diagnosis is IC. They'll have to put down frequency/urgency to extract payment. I hope you find a decent doctor. It sounds to me like your present doctor needs to be sued. You deserve treatment even if you decline a recommended course of action. Medicine isn't a dictatorship.

[sonick]

mbrogier thank you so much for backing me up on this. I have been through so much in the last 3 months I have to slap myself to keep from agreeing with what OTHERS tell me I am! I am not even kidding.... after hearing the same thing so many times I start to doubt myself without even realizing it. I am going to do as you recommend, and report this to Medtronics tomorrow; at least anecdotally to see what they lean towards doing about it, if anything. Thanks again!!
Still fighting for my rights,
Jayson

[Dixiefireball]

I know how you feel being cut off i was on norco 10.325 a 120 pain pills a mth and all of a sudden i got cut off because the uro that put me on them said i had no infection. I had been on norcos for 2 1/2 years. needless to say i was off of them for a week and since i'm one of those odd ic pat. i have lots of uti. and after my urine test came back they seen i had an infection and he called me in 30 10.5 lortabs. please let me know what you do.

[tigger_gal]

I hope you get this resolved. I think the pain stimulater by medtronic is ans.... my model # for interstim is 3031A, which is not listed either.
Brat

[sonick]

First off, dixiefireball I went to empathize with you right now, I know exactly what you've been/going through. My life's objective is now to cure conditions of IC patients, and the disease itself.
I sincerely feel that's why I have the disease, to gain the perspective needed to fuel vigorous comfort and cure factors. I literally wish I could personally help you out, right this second, despite what I'm also going through. We do NOT deserve this!!!!!!!!! It takes ALL my strength to maintain composure while witnessing and enduring this medication CHAOS. I will pray for your comfort. Drop me a line anytime.

Now, the Interstim thing. I called Medtronics today, spoke with a couple people, and the employee physicians were NOT happy about the device being forced upon me like this. Medtronic articulates themselves, clearly, that they do NOT have a current approved offering for "IC PAIN". They offer bladder control as we all know, and also have approved use in trunk and limb pain.... but they specifically cite UNAPPROVED FOR IC PAIN repeatedly during conversation. This is a caveat that is in all interstim certification classes, the doctors SHOULD KNOW THIS. Then, they ask about the doctors that forced this needless hardship upon me; names, numbers, background, etc...... and I CHOKED. I envisioned these doctors getting reprimanded, and their families and other patients suffering as a result of my actions of turning them in to Medtronics. I was literally scared for this man, who had shown me NO basic compassion or respect. Medtronic was very understanding and wanted me to contact them if I changed my mind. I have placed a call into the doctor one last time to see if he'll cede the inappropriateness of his recommendation, regardless of whether it was to avoid opioid therapy, or just plain ignorance of Interstitial Cystitis. My warm fuzzy side (which is dominant) tells me it is just ignorance, in which case I don't think I can bring myself to report him... even though he still won't treat me.
I don't even know if i can report him if he blows me off.... I just have a real problem with messing with a person's livelihood.... even though they're doing it to me!!!! It's no wonder I find myself so alone philisophically in this greed-driven world. Try finding a compassionate capitalist, I'm the only one I know of!!!!

Caught between a moral rock and a hard place here, not sure what to do. Holding off reporting his name for now.

Let there be no doubt that Medtronics does not have ANY device currently approved for use in IC PAIN. That's 100% certain, straight from the horse's mouth.

Sheesh, I just want a humane existence, not a moral debacle!!! Awaiting contact from the doctor himself...... Feel free to opine regarding my next steps!

Jayson

[tigger_gal]

hello sonic,
I am so glad that you called medtronic's and clearafied what you needed to know.. about the dr thing... I think I may have choked too.. good luck my friend
Brat