Continuing Problems with Coloplast Virtue sling

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male_sling_problems
Regular Member


Date Joined Nov 2009
Total Posts : 134
   Posted 6/27/2010 5:03 PM (GMT -6)   
July 14th will make one year since I was implanted with a Coloplast Virtue male sling. It was a bait and switch situation. The urologist described the tried and proven Advance sling by American Medical Systems in great detail to me, and then implanted a Virtue sling by Coloplast, which I knew absolutely nothing about. Additionally, no mention was made to me that this sling had just begun Clinical Trials for suitability in a human being at any time by my urologist.

Since the day of this surgery, almost one year ago, my life has been transformed into what can best be described as a “living hell”. I have been thrust into constant pain and suffering. For the first five months the pain was absolutely intolerable. I could not stand straight, could not walk correctly, could not tolerate sitting and suffered severe scrotal pain, even when laying flat in my bed. The mesh of the lower arms of the Virtue QUADRATIC sling, which were wrapped around my pubic rami (lower pelvic bones), caused raised areas on the lower pressure bearing areas of my pelvic bones.

This raised area creates the same pain and discomfort that one would experience when sitting on the “tongue” of a tongue and groove board placed on edge. Strong narcotic drugs did little to lesson the pain. In addition to continuous intolerable pain, my incontinence increased from 1-2 pads per day to 4-6 pads per day with the Coloplast Virtue sling.

Last December I was fortunate to have the Coloplast Virtue sling surgically removed in a 3 ½ hour operation at The Cleveland Clinic. Near the completion of this surgery an AdVance sling by American Medical Systems was implanted. The advance sling has been fantastic. I am now 100% dry for the first time in ten years.

I wish that was the end of my ordeal but unfortunately the pain caused by the Coloplast Virtue sling continues. My scrotal skin remains EXTREMELY sore to touch. Even soft underwear causes pain. Toweling dry, following a shower, requires great caution or the pain will be severe. I am beginning to suspect the scrotal nerve damage, caused by the Coloplast Virtue sling will be permanent. There is only one quarter sized area, of my scrotal skin, that I can touch and that is because this area remains numb almost one year after the Coloplast Virtue sling was implanted.

The urology reconstruction specialist that removed the Coloplast Virtue sling and implanted the AdVance sling by American Medical Systems told be he would remove as much of the Virtue sling as possible but the mesh wrapped around my lower pelvic bones was implanted “too deep” in my pelvis for him to remove.

Since the sensation of sitting on the “tongue” of a tongue and groove board daily is becoming increasingly painful to the point of being intolerable, I plan to schedule an appointment with a pelvic reconstruction specialist at The Cleveland Clinic to learn if it is possible cut my lower pelvic area open on both sides and scrape or cut these high spots off my bones. I do not look forward to a third painful surgery regarding my sling ordeal but I do not want to live my life in constant pain if it can be avoided.

I only wish that my urologist had implanted the AdVance type sling that I had consented to during the original surgery and spared me all of this agony.

This posting is not intended to discourage anyone from considering sling surgery for incontinence. Just ask a lot of questions and make certain your doctor will follow your instructions (consent) regarding which device to implant.

I will post a follow up after meeting with the orthopedic surgeons at The Cleveland Clinic.

Best wishes,

John

Post Edited (male_sling_problems) : 6/28/2010 6:07:03 AM (GMT-6)


Worried Guy
Veteran Member


Date Joined Jul 2009
Total Posts : 3742
   Posted 6/27/2010 8:48 PM (GMT -6)   
John,
Thanks for letting us know about your horrible experience with the Coloplast. I am also concerned that the surgeon did a "bait and switch". It is up to you of course, but if it were me I would mention the surgeon's name and where you had the procedure. That is valuable information as well.

I hope you are on the road to recovery.
I am about 6 months behind you and appreciate the signposts left by guys like you who are blazing the trail.
Thanks,
Jeff
Married 34 years, DX Age 56. First routine PSA test on April 8, 09: 17.8. Start 2 weeks of Cipro to rule out protatitis. May '09 PSA: 22.6, 3 weeks later: PSA: 23.2.
Biopsy 6/10/09: 7/12 scores positive, 20%-70%, Gleason 3+4=7, 3+3=6. Bone and C/T scans neg.
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.
Extraprostatic extension present; Perineural invasion: present, extensive.
No Malignancy in Seminal Vesicle, vasa deferentia, lymph nodes 0/13
Prostate mass 56 grams. Pathologic Stage: pT3aN0MX
Post Surgery Status:
Potency - 12/11 5 months, Still no activity, zip. Using pump daily since 11/11. No effect with 20 mg of Cialis or 100 mg of Viagra. Shots next See Uro 1/22/10 Trimix #1. Try 0.08- 25%, 0.12-25%, 2/26/10 try 0.16 First Success! 90%.
Incontinence - 8/20 4 full pads per day
.. 9/7 3-4 full pads per day. Try controlling fluids.
12/11/09 5 months: 3 pads per day, 400-450ml/day
02/26/10 7 months: 3 pads but leak is now 320 ml (5 day avg.)
03/22/10 8 months: 3 pads per day, 280 ml/day (5 day avg.) PT says all muscles are tight and working properly. There must be another issue. Uro mtg 4/23.
5/22/10 10 months: 2 pads per day, 190 ml/day Scope on June 15 Short sphincter
Post Surgery PSA - 9/3 6 weeks - 0.05; 10/13 3 months - 0.04, 1/14 6 months - 0.05, 4/14 9 months - 0.04 and <0.01 with ECLIA.


Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25393
   Posted 6/27/2010 9:03 PM (GMT -6)   
John,

Your story is hard to read without really cringing from the living hell that you have and are still going through. I am not one that usually encourages legal action, but it would sound like you could have an easy case of malpractice big time on your hands. That was an absolutely terrible doctor to swtich on you without your consent, and then leave you in such a state of horror.

May things improve for you, some how, soon, real soon. No one should have to go through that level of pain for so long. Bless you for your endurance.

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, no problem post SRT
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, next one:  July
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 - 11/27 IMRT SRT 39 sess/72 gys ,cath #8 33 days, Cath #9 35 days, 12/7 - Cath #10 43 days, 1/19 - Corr Surgery #4,  Caths #11 and #12  same time, 2/8-Cath #11 out - 21 days, 3/2- Cath #12 out - 41 days, 3/2- Corr Surgery #5, 3/6 Cath #13 out - 4 days, Cath #14- 27 days, Cath #15 - 26 days, Cath #16 - 31 days, 5/24 put in Cath #17


NY-Sooner
Regular Member


Date Joined Sep 2009
Total Posts : 464
   Posted 6/28/2010 7:00 AM (GMT -6)   
I hope you took legal action against your first uro, at least to pay for all your reconstructive surgery and all the pain and suffering you are going through.
 
Age 56, Biopsy 6/2007 - PSA 4.5, 2 of 12 with  <5% cancer Gleason 6
Surgery 9/2007 Strong Memorial,  Rochester  NY with Dr. Jean Joseph (1300 plus surgeries)
 Path - Negative margins, cancer in 20% examined tissue, Gleason 6
 Post Op - No ED issues, full erections without drugs,  used 5-7 pads a day for 3 months. Now dry except for stress leaks now and then.
 All post op psa's <.04


male_sling_problems
Regular Member


Date Joined Nov 2009
Total Posts : 134
   Posted 6/28/2010 7:52 AM (GMT -6)   
Hello Jeff, David and Sooner,

Thanks for your support. I plan to post more details as my Coloplast sling fiasco unfolds.

In the mean time, my bad experience with the Coloplast Virtue sling does not appear to be unique.

Others have emailed me with horror stories of their own. I exchanged several emails with a person from Quebec whom best described himself as "alive" but "not living" due to intolerable pain several months following his implant of the Virtue sling.

There have also been many posting by "Tallman" on this HealingWell site. Although his surgeon, Dr. Notti of New York, a co-inventor of the Coloplast sling recommend an artificial sphincter valve, Tallman chose to blaze the trail for others and was implanted with the Coloplast Virtue sling.

Although his initial posting indicated limited success, in a fairly short time his incontinence returned to its former state. This means perhaps the most to be gained from his suffering and approximately $50,000 in expenses was to educate others regarding the uncertainty of new devices. I think we all owe Tallman a big debt of gratitude for so caringly sharing his ongoing experience with us.

A recent search of FDA's MAUDE Adverse Event website reviels continuing problems with this device. Thirty three adverse events have been reported to date. I will paste a listing of this report. For those interested in more details, you can Google the MAUDE website, search out the Virtue sling or any other sling of interest to you. Once your listing of choice appears, you can "click" on each report for details requiring the intervention.


33 records meeting your search criteria returned - Brand Name: virtue Report Date From: 01/01/2009 Report Date To: 06/28/2010
New Search
Help | Download Files | More about MAUDE
Manufacturer Brand Name Date Report Received
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 05/20/2010
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 02/08/2010
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 02/08/2010
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 01/07/2010
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 12/29/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 12/07/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 12/07/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 12/01/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 12/01/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 12/01/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 12/01/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 12/01/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 09/14/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 09/14/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 09/08/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 09/03/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 09/03/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 09/03/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 09/01/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 08/28/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 08/28/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 08/20/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 08/20/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 08/20/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 08/19/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 08/19/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 07/21/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 07/21/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 06/30/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 06/02/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 06/02/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 04/06/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 04/01/2009

I think it is extremely important for those dealing with the effects of cancer to share their experiences with each without regard to where the chips might fall. Fortunately we live in a country where we can benefit from these honest discussions.

Best wishes,

John

male_sling_problems
Regular Member


Date Joined Nov 2009
Total Posts : 134
   Posted 6/28/2010 8:47 AM (GMT -6)   
I forgot to mention that for those desiring a better understanding of how a Coloplast Virtue sling can cause pain when sitting originating from "raised areas" on the lower pelvic bones, you can Google: ORLive & Coloplast

After a choice of videos appear, "click" on SPOTLIGHT Virtue Male Incontinence Sling.

You should see an animation clearly showing the invasiveness of the Virtue sling including the procedure of "wrapping" polypropylene mesh around the lower bones of the pelvis aka pubic rami.

By comparison, the AdVance sling by American Medical Systems is a thin mesh "U" shaped support that only extends upward from the urethra. No part of the AdVance sling is wrapped around the lower pelvic bones, thus no risk of lower pubic rami pain due to its design.

Best wishes,

John

Worried Guy
Veteran Member


Date Joined Jul 2009
Total Posts : 3742
   Posted 6/28/2010 3:18 PM (GMT -6)   
John,
I have watched yours and Tallman's Coloplast Virtue journey to hell and will avoid that sling like the plague.

Guys, take note and keep your eyes open for a surreptitious name change. (Like Blackwater changing to Xe, it's just changing the color of the lipstick. Don't be fooled.)

Jeff (the leaking one - and looking for a solution)
Married 34 years, DX Age 56. First routine PSA test on April 8, 09: 17.8. Start 2 weeks of Cipro to rule out protatitis. May '09 PSA: 22.6, 3 weeks later: PSA: 23.2.
Biopsy 6/10/09: 7/12 scores positive, 20%-70%, Gleason 3+4=7, 3+3=6. Bone and C/T scans neg.
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.
Extraprostatic extension present; Perineural invasion: present, extensive.
No Malignancy in Seminal Vesicle, vasa deferentia, lymph nodes 0/13
Prostate mass 56 grams. Pathologic Stage: pT3aN0MX
Post Surgery Status:
Potency - 12/11 5 months, Still no activity, zip. Using pump daily since 11/11. No effect with 20 mg of Cialis or 100 mg of Viagra. Shots next See Uro 1/22/10 Trimix #1. Try 0.08- 25%, 0.12-25%, 2/26/10 try 0.16 First Success! 90%.
Incontinence - 8/20 4 full pads per day
.. 9/7 3-4 full pads per day. Try controlling fluids.
12/11/09 5 months: 3 pads per day, 400-450ml/day
02/26/10 7 months: 3 pads but leak is now 320 ml (5 day avg.)
03/22/10 8 months: 3 pads per day, 280 ml/day (5 day avg.) PT says all muscles are tight and working properly. There must be another issue. Uro mtg 4/23.
5/22/10 10 months: 2 pads per day, 190 ml/day Scope on June 15 Short sphincter
Post Surgery PSA - 9/3 6 weeks - 0.05; 10/13 3 months - 0.04, 1/14 6 months - 0.05, 4/14 9 months - 0.04 and <0.01 with ECLIA.


Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25393
   Posted 6/28/2010 3:46 PM (GMT -6)   
John, just thought of this, and I know its a long shot, but have you talked to a good radiation oncologist about having the affected area treated with a few zaps of radiation? They use radiation for pain control for other purposes, perhaps in your case too?
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, no problem post SRT
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, next one:  July
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 - 11/27 IMRT SRT 39 sess/72 gys ,cath #8 33 days, Cath #9 35 days, 12/7 - Cath #10 43 days, 1/19 - Corr Surgery #4,  Caths #11 and #12  same time, 2/8-Cath #11 out - 21 days, 3/2- Cath #12 out - 41 days, 3/2- Corr Surgery #5, 3/6 Cath #13 out - 4 days, Cath #14- 27 days, Cath #15 - 26 days, Cath #16 - 31 days, 5/24 put in Cath #17


male_sling_problems
Regular Member


Date Joined Nov 2009
Total Posts : 134
   Posted 6/28/2010 3:54 PM (GMT -6)   
Hello Jeff,

What I have posted on HellingWell's site is a "sanitized" or "abbreviated" accounting of the facts. The rest-of-the-story, my story, becomes much more disgusting. Since events are still unfolding, I will keep it brief for now.

My biggest fear is that individuals that could benefit from sling surgery will be scared off by bad experiences like Tallman's and mine. That should not be the case. Just use experienced doctors with a good history combined with a good sling with good history and everything should be fine.

It is important not to be timid and ask a lot of meaningful questions. Remember, it is your life and health at stake.

Best wishes,

John

Worried Guy
Veteran Member


Date Joined Jul 2009
Total Posts : 3742
   Posted 6/28/2010 4:26 PM (GMT -6)   
John,
Good luck. May Shapiro & Shapiro, Santini & Santini, or Dewey, Cheetum, & Howe be in your court.
Jeff
Keep us informed

male_sling_problems
Regular Member


Date Joined Nov 2009
Total Posts : 134
   Posted 6/28/2010 10:37 PM (GMT -6)   
Hello Purgatory,

Thanks for the long shot idea. I want to meet with an orthopedic surgeon first and learn if he can cut, scrape or somehow remove the polypropylene mesh that remains wrapped around my lower pelvic bones aka pubic rami.

My hope is that once the raised areas are eliminated perhaps the pain and discomfort will diminish.

For now, it feels like I am sitting on two golf balls placed about 6 inches apart on my chair. By the end of the day it feels like my entire bottom side is on fire. I do not know how the Coloplast thought anyone could tolerate this device.

Best wishes,

John
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