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Regular Member

Date Joined Nov 2009
Total Posts : 134
   Posted 12/28/2009 9:42 PM (GMT -6)   
Does anyone have any information regarding the number Coloplast Virtue implanted during 2009, or the total of Coloplast Virtue male slings implanted to date? I do not know if any Coloplast Virtue slings were implanted prior to 2009 so the answer to both questions may be the same.

I have emailed this question to Coloplast and they refused to supply this information claiming it was proprietary information. I have read where Coloplast solicited for 120 individuals to take part in Clinical Trials for Coloplast Virtue slings, which would result in free Virtue sling implants to volunteers that agreed to the terms of these Clinical Trials.

It is public information that 14 injurious Adverse Events were reported in FDA /MAUDE reports involving Coloplast’s Virtue sling implants in 2009. But it is impossible to calculate the ratio of injuries vs. the total number of Virtue implants unless their 2009 implant numbers are known. For example, if there were a total number of 280 Virtue implants in 2009, their reported ratio of injuries per implants, as shown in the MAUDE reports, would be 20:1

I ask American Medical System basically the same question and learned there have been more than 18,500 AdVance slings implanted since the AdVance sling was introduced in the fall of 2006. Doing a bit of estimating, if 5,000 AdVance slings were implanted in 2007, 6,000 in 2008 and 7,500 in 2009, that would account for approximately the total number of AdVance male sling implants to date.

Now, using a conservative number of 7,0000 AdVance implants for 2009 and dividing this number by the 7 injurious Adverse Event MAUDE reports for American Medical System’s AdVance male slings in 2009, one can calculate that the ratio of reported injurious reports compared to the estimated total number if AdVance implants is approximately 1000:1

Taking these calculations one step further, by dividing the estimated Coloplast Virtue ratio into the AMS AdVance ratio, it appears that Coloplast Virtue sling implants pose approximately 50 times the risk of reported implant injuries when compared to AMS’s AdVance sling. It would be helpful to receive actual 2009 implant numbers from Coloplast to learn if this estimate needs to be adjusted up or down.

I firmly believe that cancer survivors are entitled to the most accurate and useful information possible, including benefits and risk, as we make life saving and/or extending decisions that are so difficult to make.

The above information is of special interest to me because I might be the only person to date that had an injurious Virtue male sling removed and replaced with an AMS AdVance sling. The intolerable pain from the Virtue sling is beginning to fade and for the first time in ten (10) years, I am 100% dry!

Happy Holidays to all,


Regular Member

Date Joined Oct 2009
Total Posts : 419
   Posted 1/5/2010 8:24 PM (GMT -6)   
Glad to hear that you are doing well following the surgery to remove the Virtue and replace it with AdVance. I was going to call you but decided to wait until after the holidays.
I am still facing a decision about which sling to have done on January 29th. I contacted Dr. Nitti at NYU who was one of the inventors of Virtue. He was very candid that it was still unproven and very little data available. However, I have been in contact with ronjon who I met on this forum and he had Virtue installed by Dr. Nitti about four weeks ago and is doing great. Dr. Nitti made a slight change to the procedure by adding a "stitch" and he feels this will help the results a great deal. I am asking my Dr. at U of Mich. to contact Dr. Nitti to get his latest recommendations.
Do you have any new information as to why you had all of the pain with your Virtue? What was the potential cause of the problems? Was there something unusual about your RP surgery or anatomy that added to the problem?
I also tried to contact Coloplast and was not able to get any information.
64  year old male in excellent physical condition.
No serious illness of any kind.
PSA jumped from 3 to 8 in one year between annual physicals.
Biopsy/pathology confirmed postate cancer.
pt2b NO Mx with a Gleason score 3+3=6.
DaVinci prostatectomy, Robotic surgery July 23, 2008.
Tumor type: Acinar
size 5.5 cm x 5.7 cm weight: 77 gm.
Largest tumor nodule: 1.3 cm
All surgical margins were negative.
Seminal vesicles uninvolved by tumor.
Urinary incontinence incurred immediately followin surgery. Dry at nights but no control during day. Tried drugs imipremine and detrol but no help and caused side effects so stopped them.
Unable to obtail erection from beginning. Viagra and Cialis were used in low dose but caused headache so discontinued. Using pump for erection effectively with rubber clamp.Very loving relationship with wife and we are both fine with this situation as it is.
Underwent physical therapy and kegal exercises with no results for incontinence.
Uideo fluoroscopic urodynamics and cystourethroscopy testing in Oct. 2009. Resulted in recommendation for surgery to insert InVance Male Sling System for incontinence cure. Alternative is new sling called Virtue by Coloplast. Planning this surgery for January 2010.

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