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Posted 10/19/2012 3:00 PM (GMT -5)
Guys,
This was in Medical Design Technology today. The plaintiff is a member of this forum and has helped many of us considering sling surgery. He has been having problems with his surgery and warning us for years.
(I will let him mention his screen name if he wishes.)
Congratulations, John. You have made a difference. You're my hero!

Jeff
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A subset of the article is attached:
"Federal judge denies Coloplast's motion to dismiss a personal injury lawsuit filed over the Virtue ventral urethral elevation sling.

Coloplast (CPH:COLO B) can't dodge a personal injury lawsuit filed in a Colorado federal court over its Virtue urethral sling, but the majority of the counts and moves for legal fees and punitive damages were stricken from the case.

John Lautzenhiser sued Coloplast in July 2011, 2 years after he was implanted with a Virtue sling to treat his stress urinary incontinence. Lautzenhiser's SUI worsened and the device had to be explanted, leaving him with "permanent and substantial physical pain, loss of ability to perform sexually, lost wages and impairment of ability to earn wages, lengthy delay in prognosis and corrective action, and shortening of life expectancy," according to court documents.
Posted 10/20/2012 2:11 PM (GMT -5)
Guys,
Here's another article that summarizes it very well.

Good summary of the situation.

"The victim claims that he received the device without his consent or knowledge. He had given consent to a well-proven sling, not this one. Five months following implantation of the Virtue Sling, and months of continued, intolerable pain, as well as continued incontinence, a reconstructive surgeon removed a portion of the Virtue sling mesh and implanted an Advance Sling in the operating room.

Following this corrective surgery, the victim sued Coloplast in a 10-count complaint, alleging that the device should not have been used on him to treat his incontinence and that the company failed to warn him and his doctors of the risks associated with the mesh products.

Several months prior to his surgery, the FDA issued a warning regarding complications of mesh devices used in the treatment of female incontinence, specifically a kit manufactured by Mentor Corp., using the same material used in the Virtue device. Mentor Corp. sold its surgical, urological, clinical and consumer healthcare business to Coloplast in 2006."

We're rooting for you!

Jeff
Posted 10/20/2012 2:14 PM (GMT -5)
Shudders

Very very stupid move on the companys part

Yes we are rooting for him!
Posted 10/20/2012 2:35 PM (GMT -5)
I hope he's suing the doctor and hospital as well. After what he went through, John deserves a substantial settlement.
Posted 10/20/2012 2:43 PM (GMT -5)
His description of the excruciating pain and the sharp credit card like edge pushing against his perineum from the inside still gives me shivers.
How bad does it have to be to willingly go back to a surgeon to have the sling ground out? I can't imagine!

Jeff Happy with my AdVance sling
Posted 10/20/2012 2:50 PM (GMT -5)
Yep, things that nightmares are made of. I remember him looking here for others who suffered the same fate. I don't know if he found any, it may have been just specific to that one doctor who installed the wrong one, seems like I remember something about the sales rep. being in the operating room, so that may have been why it got switched....In any case, hope be wins that big time.
Posted 10/20/2012 9:01 PM (GMT -5)
To those that have offered unwavering support for nearly three years, I am very grateful.

I cannot imagine anyone, suffering from a botched medical procedure, enjoying the necessity of a lawsuit. Regrettably, at times, it becomes the only logical recourse.

Although, through no choice of my own, I appear to be on the forefront of botched male sling litigation.

I have talked with other men who have described their suffering as nearly identical to mine, One of these men had a portion of his Virtue sling removed last month due to long term intolerable suffering while his incontinence remained unabated. He was implanted with an AUS and healing as well as can be expected following a wicked explantation surgery.

Additionally, I recently talked with a 77 year old gentleman near Atlanta that told me he has suffered intolerable pain since his Virtue sling implant last January. He is scheduled for explant surgery as soon as his health permits. He also has heart problems which limits travel options for his explantation surgery.

I have talked with others who have, and continue, to suffer a similar fate.

Unfortunately, HIPPA (privacy laws) makes it very difficult to learn just how widespread the suffering is from this device.

The FDA's MAUDE Reports offer some insight but I strongly suspect under reporting of adverse events regarding male implants gone wrong.

For now, it appears to me that HealingWell.com is the best clearing house for this vital information.

Thanks to all,

John

aka male_sling_problems

Post Edited (male_sling_problems) : 10/21/2012 6:27:48 AM (GMT-6)

Posted 10/21/2012 2:30 AM (GMT -5)
John - "GO GET EM" - and good luck to you....
Posted 10/21/2012 7:02 AM (GMT -5)
Those of us that have been around a while do remember when this happened. It was a wake up call for many of the guys fighting the leaky problem.

Best of luck John. I think the biggest offender was the Dr. Go get em guy!

Cajun Jeff
Posted 10/21/2012 8:48 AM (GMT -5)
I see that, although the judge refused to dismiss four of 10 charges against Coloplast, he denied John's claim for attorney fees and punitive damages.

The law is an ass.
Posted 10/22/2012 10:17 PM (GMT -5)
Like many others, I have noticed in the last year or so an increasing number of lawyers and law firms soliciting on TV for women that have been injured by pelvic mesh.

Ironically, I was talking with a 77 year old gentleman a short time ago and he was explaining to me how much he was suffering due to a Virtue sling implant last January. He told me his suffering was so great that he was in the process of scheduling surgery to have the sling explanted.

Without being asked, he told me he had called one of the law firms advertising on TV to represent those that had been injured by pelvic mesh. Somewhat to his surprise, he was told that they were only interested in representing females that had suffered injuries from pelvic mesh, not men.

Perhaps with my litigation being so widely publicized on the Internet by others, it will become easier for men to find the representation they deserve when they have been injured by pelvic mesh.

Best wishes,

John

aka male_sling_problems
Posted 10/25/2012 6:13 PM (GMT -5)
The 77 year old gentleman that I mentioned twice earlier in this string called yesterday to tell me he was finally able to have the majority of his Virtue sling mesh removed after suffering intolerable pain since its implantation last January.

He had told me earlier that his incontinence worsened following his implant last January. What I found fascinating was; he told me his incontinence has significantly improved since partial removal of his Virtue sling last month. He declined an AUS replacement implant for fear of future interventions.

Coloplast has recently launched a European Study (aka clinical trials) for their Virtue sling seeking 120 volunteers. For their safety, I hope the volunteers receive adequate warnings of potential risk, thus enabling them to make truly informed decisions.

Best wishes,

John
Posted 10/28/2012 5:20 PM (GMT -5)
Wow John, glad to see you are getting some closure. As you know, I also had a Virtue sling implanted. While it did nothing to help my incontinence I did not have the pain complications that you had. When I had my AUS AMS800 implanted my surgeon said she could not even see the Virtue sling. So, it is still in there and I pray it does not come back to cause me the same issues you have had.

Good luck as you wrap up this terrible chapter in your live.

 

Posted 10/29/2012 9:50 PM (GMT -5)
Hello tallguy,

Good news that you are getting along so well.

I think you were lucky with your Virtue sling implant. Although you mentioned it did not help with your incontinence, at least you are not suffering long term pain.

Besides myself, I know of three others whose long term pain was so great that they elected to have as much of the Virtue sling mesh removed as possible.

This is a brutal procedure but one has to do what one has to due when the continuous pain becomes unbearable.

I hope journeys such as yours and mine enable those considering treatment for incontinence to realize all procedures have risk and failures and some devices apparently have more risk and failures than others.

You finally achieved your goal of dryness with an AUS and I finally achieved my goal of dryness with an AdVance sling. I am happy for both of us that we did not give up on our goals of dryness based on the failures of the Virtue sling.

Best wishes,

John

Post Edited (male_sling_problems) : 10/29/2012 8:56:20 PM (GMT-6)

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