One more miserable week to go with the Coloplast Virtue sling.

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male_sling_problems
Regular Member


Date Joined Nov 2009
Total Posts : 134
   Posted 12/9/2009 10:16 PM (GMT -6)   
I was implanted with a Coloplast Virtue male sling nearly five months ago. It has been the most miserable five months of my live. The pain has been continuous and intolerable. I am scheduled for surgery at The Cleveland Clinic next Thursday. While most people dread surgery, this will be my early Christmas present to myself.

I have read where this sling is undergoing FDA sanctioned Clinic Trials in part to learn if it is safe, if it can be tolerated and if it works. Although I was never informed about the Coloplast Virtue sling, prior to surgery, and never gave consent to have a Coloplast Virtue sling implanted in my body, it is still three strikes and you are OUT!

It was injurious to me, it has been 100% intolerable 24/7, and my incontinence has worsened with this device. Therefore it is coming out. My new surgeon told me that only part of the mesh can be removed and the remainder will remain my body permanently so I will never be totally free of this hellish experience.

I have also been told (or warned) by new surgeon that long-term pain, following surgery, is to be expected. Any relief following partial removal of mesh will be most welcome. I am hoping my status will change from alive to living again in the future.

I am not sharing my story to discourage anyone from exploring or scheduling sling surgery but will offer the following suggestions:

Make certain your doctor explains ALL options and procedures related to your condition in detail. Ask your doctor if he has any monetary association with any of the device manufactures whose device he is suggesting for your implant. Determine if you are comfortable, with this association, if your doctor has a monetary relationship with the proposed device's manufacture. Ask your doctor if he is involved with any clinical trials related to the device he is recommending for your implant. I am not implying that there associations are wrong but they should be fully disclosed to the patient.

Happy holidays to all,

John

Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 12/10/2009 9:21 AM (GMT -6)   
John,

Yours is a terrible story to have to read, but so glad you posted it. Let it serve as a warning to anyone else considering using that device. So sorry you are having to go through so much pain and agony associated with it. Perhaps after it is removed, you can recover to a better degree then you are at presently.

Please keep us posted of this unpleasant part of your journey, and my best to you.


David in SC
Age: 57, 56 dx, PSA: 7/07 5.8, 7/08 12.3, 9/08 14.5, 10/08 16.3
3rd Biopsy: 9/08 - 7/7 Positive, 40-90% Cancer, Gleason 4+3
Open RP: 11/08, Rht nerves saved, 4 days in hospt, on catheters for 63 days, 5th one out 1/09
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos margin
Incontinence:  1 Month     ED:  Non issue at any point post surgery
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Latest: 7/9 met 2 rad. oncl, 7/9 cath #6 - blockage, 8/9 2nd corr surgery, 8/9 cath #7 out  38 days, 9/9 - met 3rd rad. oncl., mapped  9/9, 10/1 - 3rd corr. surgery - SP cath/hard dialation, 10/5 - began IMRT SRT - 39 sess/72 gys ,cath #8 33 days, Cath #9 in 35 days, 12/7/9 - Cath #10 in place


male_sling_problems
Regular Member


Date Joined Nov 2009
Total Posts : 134
   Posted 12/10/2009 10:06 AM (GMT -6)   
Hello David,

There will be no "winners" in this situation except possible preventing someone in the future from falling into the same trap.

It is extremely regrettable to survive a very aggressive form of cancer only to be put into a situation like this by medical professionals.

My ordeal started with my annual PSA checkup with no complaints about my 1-2 pad per day incontinence. It all went downhill from there.

Wishing you Happy Holidays,

John

Worried Guy
Veteran Member


Date Joined Jul 2009
Total Posts : 3732
   Posted 12/10/2009 3:13 PM (GMT -6)   
John,
Thank you for all your postings. You will never know how many guys you have saved by spreading the word.
I, for one, will take note if/when it is decided I need surgical help to stem the flow.
I hope your early Christmas present to yourself helps you join the "living".
Good Luck,
Jeff
You make my 3 pads per day problem seem small.
DX Age 56. First routine PSA test on April 8th: 17.8.
May PSA: 22.6, 3 weeks later: PSA: 23.2.
Biopsy 6/10/09: 7/12 scores positive, Gleason 6=3+3. Bone scan and C/T scan negative.
RP DaVinci -7/21/2009 @ Univ of Roch Medical Center
Left nerve gone, right partial spared.
Catheter removed - 7/31/2009 Pathology report received:
Gleason 3+4=7 Tumor size: 2.5 x 1.8 cm location: both lobes and apex. No Malignancy in Seminal Vesicle, vasa deferentia, lymph nodes 0/13
Extraprostatic extension present; Perineural invasion: present, extensive
Prostate mass 56 grams. Pathologic Stage: pT3aN0MX
Post Surgery Status:
Potency - 10/31 3 months, Still no activity, nada, zip
Incontinence - 8/20 4 full pads per day
. 9/7 3-4 full pads per day (I'm going to try cutting down on fluids. Bad idea. I know.)
9/27 2 months: Still 3 pads per day.
11/14 4 month: Still 3 pads per day. 420ml/day, 91 um leak. At this rate I'll be fine in 2012.
Post Surgery PSA - 9/3 6 weeks- 0.05, 10/13 3 months- 0.04 undetectable.


Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 12/10/2009 3:44 PM (GMT -6)   
John, i fully agree with Jeff above. Your experience, though a terrible and painful one, will be read and studied by who knows how many other people passing through here. If you spare even one man from doing the same thing and going through what you did, you can feel real good about that.

Still rooting for you when you get on the other side of this.

David in SC
Age: 57, 56 dx, PSA: 7/07 5.8, 7/08 12.3, 9/08 14.5, 10/08 16.3
3rd Biopsy: 9/08 - 7/7 Positive, 40-90% Cancer, Gleason 4+3
Open RP: 11/08, Rht nerves saved, 4 days in hospt, on catheters for 63 days, 5th one out 1/09
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos margin
Incontinence:  1 Month     ED:  Non issue at any point post surgery
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Latest: 7/9 met 2 rad. oncl, 7/9 cath #6 - blockage, 8/9 2nd corr surgery, 8/9 cath #7 out  38 days, 9/9 - met 3rd rad. oncl., mapped  9/9, 10/1 - 3rd corr. surgery - SP cath/hard dialation, 10/5 - began IMRT SRT - 39 sess/72 gys ,cath #8 33 days, Cath #9 in 35 days, 12/7/9 - Cath #10 in place


male_sling_problems
Regular Member


Date Joined Nov 2009
Total Posts : 134
   Posted 12/10/2009 4:13 PM (GMT -6)   
Hello Jeff & David,

Thanks for the replies. I often wonder how many men are "suffering in silence" since being implanted with this device. Privacy laws makes it basically impossible to learn of other's experiences including their sufferings. I know of others that are waiting for the outcome of my surgery, next week, to decide if they should schedule "removal" surgery too.

I do not understand how this device received its pre-market 510(k) clearance without some kind of a substantial study being submitted to the FDA. Coloplast told the FDA, in their 510(k) application, that their four (4) armed (Quadratic) mesh sling device, with a scrotal platform, is "substantially equivalent" to American Medical System's simple AdVance mesh sling. To me, that is a HUGE stretch of one's imagination.

It also appears to me that, if a company can obtain a 510(k) pre-marking clearance this way, they can market a permanently implantable device with minimal or possible in some instances, no testing.

I believe congress is working on legislation to close these dreadful loopholes. Hopefully the sooner the better to prevent future preventable injuries and unnecessary suffering.


Happy Holidays to all,

John

Post Edited (male_sling_problems) : 12/10/2009 3:18:45 PM (GMT-7)


Worried Guy
Veteran Member


Date Joined Jul 2009
Total Posts : 3732
   Posted 12/10/2009 5:09 PM (GMT -6)   
John,
Just for the record, I worked on an Emergency Ventilator for several years. We, too, showed substantial equivalence to get our 510(k) pre-market clearance and it was a lot of work. In addition to all the data and lab testing, we had to run our device in parallel with an approved device on a patient. Of course we knew it worked perfectly or else we would not have even considered the testing. The FDA official responsible for respiratory devices was a biomedical engineer, very thorough and really knew his stuff. He kew all about air flow measurement techniques, pressure, and, since this was a life support device, triple redundant controls and protection devices. It was not a walk in the park but we got it.
Clearly the sling is not considered life support so the requirements must be different.
It would be interesting to see their application.
Jeff

Post Edited (Worried Guy) : 11/29/2012 6:01:14 PM (GMT-7)


Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25380
   Posted 12/10/2009 5:35 PM (GMT -6)   
Jeff, that was a heck of an engineer's answer, lol. You must be good at what you do. I can be just as geeky if someone wanted a financial aspect and cost justification reports in my world of numbers, lol.

One thing I was wondering, John, I wonder how many or how few of these units were sold and installed. The pool of PC guys that would need the device would have to be small. Wonder if there is any way to find that out.

David in SC
Age: 57, 56 dx, PSA: 7/07 5.8, 7/08 12.3, 9/08 14.5, 10/08 16.3
3rd Biopsy: 9/08 - 7/7 Positive, 40-90% Cancer, Gleason 4+3
Open RP: 11/08, Rht nerves saved, 4 days in hospt, on catheters for 63 days, 5th one out 1/09
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos margin
Incontinence:  1 Month     ED:  Non issue at any point post surgery
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Latest: 7/9 met 2 rad. oncl, 7/9 cath #6 - blockage, 8/9 2nd corr surgery, 8/9 cath #7 out  38 days, 9/9 - met 3rd rad. oncl., mapped  9/9, 10/1 - 3rd corr. surgery - SP cath/hard dialation, 10/5 - began IMRT SRT - 39 sess/72 gys ,cath #8 33 days, Cath #9 in 35 days, 12/7/9 - Cath #10 in place


male_sling_problems
Regular Member


Date Joined Nov 2009
Total Posts : 134
   Posted 12/10/2009 5:53 PM (GMT -6)   
Hello David,

Without entering into the legal world of "discovery", I think it would be nearly impossible to obtain that information.

You can look at Coloplast's 510(k) sling applications by Googling: 510(k) K082640
and second search: 510(k) K091152

Regards,

John

male_sling_problems
Regular Member


Date Joined Nov 2009
Total Posts : 134
   Posted 12/10/2009 9:12 PM (GMT -6)   
I do have an additional comment regarding Coloplast and their new Virtue male sling.

After applying for and receiving two (2) 510(k) clearances to market their sling, they began soliciting for volunteers to participate in Clinical Trials for their Virtue sling. In their solicitation for participants for their Clinic Trials, it states that some of the trials objectives are to learn if the Virtue sling is safe, if it can be tolerated and if it is effective.

If a person knows these risk, in advance, and desires to participate in their Clinical Trial, that is their choice and informed decision.

But It seams reasonable to me that this type of testing should be completed and results compiled before a permanent implantable device is implanted in an individuals body outside of Clinical Trials.

This "pre-market clearance" before thorough testing is completed puts the public at higher risk because their doctor might fail to mention that the device is new and still undergoing Clinical Trials, therefore not disclosing the three (3) risk stated above.

Since I received no information about the Coloplast Virtue sling and therefore did not give my consent to a Coloplast Virtue implant, I think I was doomed for other reasons.

I continue to post my situation hoping others will learn from my misfortune and ask very specific questions if they are considering sling surgery. I firmly believe a well informed patient can expect and enjoy a very positive outcome.
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