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Coloplast Virtue FDA incident reports

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Posted 11/12/2009 1:22 AM (GMT 0)
I was implanted with a Coloplast Virtue male sling approximately 4 months ago. The pain has been intolerable since the time of my surgery. I am learning others are also suffering from this same device. My Coloplast sling will be surgically removed in the near future at The Cleveland Clinic. I hope to have an AdVance sling implanted during this surgery if my condition permits.

For more information regarding FDA /MAUDE Coloplast Virtue incident reports, copy and paste the following:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm?start_search=1&searchyear=&productcode=&productproblem=&devicename=&knumber=K&pmanumber=P&manufacturer=coloplast&brandname=virtue&eventtype=&reportdatefrom=01%2F01%2F2008&reportdateto=11%2F30%2F2009&pagenum=10&key_count=0

I would appreciate hearing from others that are suffering ongoing pain or other complications from the Coloplast Virtue male sling. My email is: [email protected]
Posted 11/13/2009 5:28 PM (GMT 0)
Make sure your urologist also explains the pro's and con's of the Advance sling (as well as providing experience on his/her experience with the device). There have also been reports for this device of (perineal) pain and discomfort as well as obstruction requiring suprapubic catheters for up to 3 months.
Posted 11/14/2009 3:44 AM (GMT 0)
Hello Utrecht

Thanks for the reply.

I have learned several things from my recent ordeal. This includes making CERTAIN which device your doctor is planning to implant at the time of your surgery. In my case, one device was described to me in great detail, and to my horror, an entirely different device was implanted in my body. Secondly, know the history of the device that you are favoring for implant. Thirdly, know how many procedures your surgeon has performed, with this device, and how many failures have occurred in this total. And lastly, learn if your surgeon has any manufacture ties, such as FDA Clinical Trial Investigator, or Sub Investigator, to the device he is promoting as your best choice for a successful outcome.. Make certain his first obligation is to you, his patient, and not a device manufacture.

The above guidelines would have prevented the necessity of my upcoming surgery to have a Coloplast Virtue male sling surgically dug out of my body.

I will have it replaced with an AdVance sling. The AdVance has a three year history with an 85% success rating. My surgery will be at The Cleveland Clinic. My surgeon will be Dr. Kenneth Angermeier. He and Dr. Kurt McCammon, Sentara Hospital, Norfolk, Va are two of the most experienced sling doctors in the USA. They both promote American Medical System's Advance sling. I firmly believe this surgery will put an end to my intolerable pain.
Posted 11/15/2009 4:04 AM (GMT 0)
Hello Utrecht

Thanks for the reply.

I have learned several things from my recent ordeal. This includes making CERTAIN which device your doctor is planning to implant at the time of your surgery. In my case, one device was described to me in great detail, and to my horror, an entirely different device was implanted in my body. Secondly, know the history of the device that you are favoring for implant. Thirdly, know how many procedures your surgeon has performed, with this device, and how many failures have occurred in this total. And lastly, learn if your surgeon has any manufacture's ties, such as FDA Clinical Trial Investigator, or Sub Investigator, to the device he is promoting as your best choice for a successful outcome.. Make certain his first obligation is to you, his patient, and not a device manufacture.

The above guidelines would have prevented the necessity of my upcoming surgery to have a Coloplast Virtue male sling surgically dug out of my body.

I will have it replaced with an AdVance sling. The AdVance has a three year history with an 85% success rating. My surgery will be at The Cleveland Clinic. My surgeon will be Dr. Kenneth Angermeier. He and Dr. Kurt McCammon, Sentara Hospital, Norfolk, Va are two of the most experienced sling doctors in the USA. They both promote American Medical System's Advance sling. I firmly believe this surgery will put an end to my intolerable pain.

Post Edited (male_sling_problems) : 11/14/2009 9:10:35 PM (GMT-7)

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