Mesh Medical Device News Desk, July 18, 2018 ~ Besides transvaginal and hernia mesh, a number of other implantable medical devices for the pelvic region are also showing similar complication rates, including the implantable male sling.
Polypropylene. It is the cheap commercial plastic polymer made into hernia and pelvic mesh. Some polymer scientists will say it is not compatible with the human body and should never be fashioned into an implant meant to last a lifetime. (See 60 Minutes broadcast here).
Though not as well-known, polypropylene is also fashioned into a sling made to treat male incontinence
Male urinary incontinence, or an involuntary leakage of urine on exertion, affects an estimated 12 to 17 percent of U.S. males. The rates of this condition increase as the sphincter weakens with age or resulting from radiation therapy or prostate surgery.
The sling is based on the premise that a compromised urethral support system will require a “hammock” to support the urethra. With the male sling, the urethra is slight compressed and moved into a new position, which theoretically, overcomes the problem of urinary incontinence.
The procedure is done with a small incision in the groin on an out-patient basis. The recovery is short with perhaps a catheter overnight.
Reported rates of success with a male sling range from 9% to 100%, depending on the placement and type of mesh.
TYPES OF MALE SLINGS
The male sling was introduced to treat low-volume incontinence in the late 1990s.
American Medical Systems (AMS) of Minnetonka, Minnesota, now owned by Boston Scientific, was the leader in the medical device production with its AMS 80, an Artificial Urinary Sphincter (AUS). It reported a 79% success rate among 34 patients.
The alternative to a AUS was the AdVance male sling by American Medical Systems, a retrourethral transobturator sling or RTS, made of self- anchored polypropylene mesh arms using a transobturator placement. The I-STOP TOMS, is a transobturator male sling made of monofilament polypropylene by CL Medical of France.
The other type of male sling is the ARS or Adjustable retropubic sling and a fourth is known as a quadratic sling which has four mesh arms placed in both transobturator and prepublic manner.
The Coloplast Virtue Male Sling System uses four-armed approach to treat male incontinence (here).
To anchor the mesh, sutures in the perineum (the urogenital area) may be required. Bone anchored slings (BAS) are used in men with low-to-moderate volume of urine output.
On the other side of the equation, complications are similar to transvaginal mesh and include infection, retention, erosion, and pain.
According to a 2012 article published in Advances in Urology, male sling placement can result in urethral injury from the passage of a trocar or stainless steel tool.
The authors report the studies performed lacked any acceptable standard for reporting and defining success.
An artificial urinary sphincter (AUS) is an alternative to a mesh sling and has been around for nearly 50 years. It serves to contract the urinary sphincter until you choose to relax and open it to urinate. It is an implanted device made up of three parts- the urethral cuff, the pump and balloon. The AMS 800 is an AUS device.
In order to urinate, you squeeze the pump, which moves fluid from the urethral cuff to the balloon. That allows the urethra to open allowing the user to urinate. Then the cuff closes.
Risks include pain bleeding and infection. There may be a need to replace one or all three of the implantable devices over time.
A four-year analysis of 1,082 cases at the Mayo Clinic in Rochester, MN found nearly one-third had to undergo a secondary surgery due to device infection and erosion, device malfunction, urethral atrophy and pump or tubing complications.
THE MALE SLING COMPLICATIONS
The male sling was introduced to treat low-volume incontinence in the late 1990s.
Patients reporting on the online Inspire community say they experienced extreme scrotal pain after an Advance male sling.
Another man reports pain persisted weeks after surgery and he began to have involuntary pelvic floor muscle contractions which continued for almost four years with pain building in his pelvic floor.
The FDA issued a Class 2 device recall on the polypropylene AdVance Male Sling System in October 2014. AMS issued the voluntary recall because there was compromise to the sterile packaging of the helical needle passer components. The recall was lifted on May 28, 2015.
Dr. Daniel Elliott, a urologist at the Mayo Clinic in Minnesota, says doctors “implanted the male sling for about 1 year and in the process found so many men with chronic pain and failure that we quickly abandoned the procedure. I have found that removing the sling and placing an artificial sphincter usually resolves the pain and treats the incontinence. “
Further, Dr. Elliott writes,
With personal experience dealing with the Advance Sling, I have unfortunately found that the results and patient satisfaction with the Advance sling and the Coloplast Virtue sling are quite poor. In my practice I stopped implanting the male slings in ~2011 because of the bad side effects and failure to treat the incontinence. If fact, we found a 70% FAILURE rate with the Virtue sling. Sadly, I have had to remove more male slings then I ever implanted. I think the key for a man who is contemplating incontinence treatment with a surgeon is to ask really tough questions of the surgeon: Mainly, how many slings (or artificial sphincters) have you done and how many per year. If the number is less than ~30, then go see someone else. The next question should be what are your results? And, how do you follow your patients — meaning, does your surgeon really track his/her patients so as to be able to tell you REALLY what his/her results are. Importantly, this post is not to say that success cannot be achieved with the male slings, it’s just that you as a potential patient must choose your surgeon very carefully to insure you will have the best possible outcomes.
Dr. DS Elliott
In other words, lack of experience and a complete lack of following up with patients, leaves the success of new, experimental procedures an unknown quantity. That situation parallels the experimental procedure of implanting a permanent transvaginal sling.
THE INSPIRE COMMUNITY
Many complications are reported to an online group, the Inspire community (here).
I’ve been having extreme scotal sac pain after An Advanced male sling was put in. I’ve posted before and saw where there are some older post, some over 90 days old. I was wondering if anybody has experienced the same thing. I finally got an appointment with a new Urologist and want to get his opinions on whether the sling needs to come out, to be done over (by him, not my original urologist) or what. It’s been over 5 months now that the sling was put in and I don’t know what else could be causing the pain. Any discussion would be appreciated.
Had mine placed in February 2010 and within weeks, with pain still present from surgery, I started having involuntary pelvic floor muscle contraction. These continued for almost 4 years with pain building in my pelvic floor area and in and around the scrotum to a point by the end of every day I was at about a 6-7 on the 1-10 pain scale, with it feeling like a vice tightening all day long. Had 18 physical therapy sessions and bought a biofeedback machine to try and relax these muscles, while also improving my Kegals, because the sling did not fully stop leaking. Also as the time went on with these muscles worn out by the end of the day, my leaking was about 50% worse since it was placed. My physical therapist found 2 knots on either side of my scrotum, which were always very sore and I could not sit on a bicycle seat because of these. As found I do scar easily on the inside and scarring and inflammation was building around the slings mesh ends over this time, with my PT and me unable to massage it away. I therefore went back to the surgeon who placed it, who wanted to remove the whole thing an place an artificial sphincter. Knowing this would entail two major surgeries with possible more complications and more internal scarring, I talked her into just removing the sling ends to start with. This she did this last December 2013. The results were a 50% improvement in both pain and contractions and I can now ride a bike again. I did have a slight increase in leaking though, but with continued Kegals with the biofeedback machine and further healing I am slowing getting back to what I had, which it tolerable.
I would suggest looking to see if you have similar knots and if they are causing the pain. Once the mesh is in place it could become hard to remove the whole sling with your own tissue growing into it and then of course the artificial sphincter is still needed.
had the AMS installed in June, 2010. I’ve had no problems following the surgery. Since I had radiation therapy before the AMS the predicted success rate was about half that for those without radiation therapy. Used 1-2 pads per day before AMS and now .5 – 1 pad per day. Wish the surgery had resulted in less leakage but other than that, no complaints. Surgery was performed at the Cleveland Clinic.
Although different guys have different experiences, I found the procedure and recovery simple. In at 7:00 AM, out at noon. Just took Tylenol and did normal activities the following day, but slower and no lifting over 5 pounds for 6 weeks. This was difficult to remember, as I was pretty much feeling normal by day 3 or 4.
My surgeon has done hundreds of these, and I attribute my easy recovery mainly to this, and that he is really good at it. I know 5 or 6 other guys who have had this procedure, with similar recovery results, a few of them having somewhat more discomfort than I did, but nothing severe. My doc says my experience was pretty much as he expected based on his many, many sling patients.
Finding a surgeon who has done at least a couple of hundred and does a few a week is, I think, the key. There is a fair amount of skill involved in using the trocar needles to place the sling.
Responding to the online comments, Dr. Daniel Elliott writes:
“It is interesting to see all these posts on pain following male sling. My experience mirror what everyone is posting. At Mayo we only implanted the male sling for about 1 year and in the process found so many men with chronic pain and failure that we quickly abandoned the procedure. I have found that removing the sling and placing an artificial sphincter usually resolves the pain and treats the incontinence. Thank you to everyone for describing so well your experience with pain. Obviously, not everyone has a bad outcome following sling placement but everyone (including doctors) needs to be very aware of this potential complication.
Dr. DS Elliott
Cleveland Clinic on Male Sling Procedure
60 Minutes, May 13, 2018, 100,000 Women, (print version)
AMS 800 Instructions for Use (here)