Jill Stein
November 01, 2007
AMS 700 Series devices elicit high degree of patient satisfaction 

PARIS ?Early results suggest that patients like the newly modified AMS 700 series inflatable pump penis prosthesis. 

The findings are based on a six-month follow-up of 32 men diagnosed with organic erectile dysfunction who underwent implantation of an AMS 700 series penile prosthesis with the new Momentary Squeeze Pump. Findings were presented here at the Soci?t? Internationale d’Urologie 29^th Congress. 

Overall, there was a high degree of satisfaction with respect to ease of inflation and deflation of the device as documented by patient questionnaires, said principal investigator Ajay Nehra, MD, professor of urology at Mayo Clinic College of Medicine in Rochester, Minn. ?Developments in the field of biosynthetic materials have allowed physicians the use of artificial/mechanical devices to replace malfunctioning or damaged body parts and organs,? Dr. Nehra pointed out in a poster presentation. ?These devices, or prostheses, are not compatible with long-term error-free function and are limited to minimal local tissue reaction. They have replaced earlier attempts at using tissue from donor areas and even xenografts in substituting damaged organs.? 

Historically, penile prosthetic surgery did not become popular until the early ’70s with the introduction of the first inflatable penile prosthesis and paired semirigid intercorporeal sponge-filled silicone implants followed by the flexirod prosthesis.   

As for the hydraulic devices that are used today, modifications have resulted in significant improvements in overall mechanical failure rates. Recently, the FDA approved additional modifications in the AMS 700 series. Specifically, changes were made to the scrotal pump to ease deflation. In addition, angulation changes were made in the exit tubing of the penile cylinders to ease proximal and distal positioning. A new feature was added to the pump’s fluid to resist flow into the deflated cylinders caused by pressure on the fluid-filled reservoir with auto-inflation. 

Of the study participants, 29 had primary placement of the device, and three underwent explant of malfunctioning penile prosthesis and immediate re-implant of an AMS 700 MS prosthesis. There have been no cases of infection.      

Fifteen of 19 patients who completed the questionnaire six months after surgery said that they were very satisfied with the device, two re-ported being moderately satisfied, and two described themselves as somewhat dissatisfied. 

All 19 respondents agreed that it was easy to find the device for inflation of the cylinders. Eighteen patients agreed or tended to agree that it was easy to hold the pump while inflating, and 18 reported that there was a reasonable amount of force required to inflate the device. Sixteen reported that they could inflate the device with relative ease. 

Eighteen respondents felt that the force required to initiate deflation was reasonable. Nineteen reported that the amount of time required to hold the deflation button to deflate the device was reasonable, and all of them stated that the amount of time required to actually deflate the device was reasonable. Seventeen stated that the overall ease of deflating the prosthesis was either very easy or easy.

New Penile Prostheses Found Easier to Use

The fluid transfer pump is necessary for inflatable prosthesis function.   Whereas previous deflate mechanisms have used a sustained squeeze bar, the MS release systems stands for Momentary Squeeze.  Push down on a 3/16″ raise dot for 3 seconds and then the device deflates automatically.  Whereas sustained squeezing could be painful, this (momentary squeeze) is usually well accepted.        

Harold M. Reed, M.D. 

Peyronies, penile curvature affects 3% of sexually active men, and perhaps more who could care less.

Some are very creative with sexual positioning and can work around some very mind-boggling angulations.  Peyronie’s curvature which is caused by a deposition of scar tissue or plaque is also associated with erectile impairment, but not always.  For most patients there are many ways to approach Peyronie’s including medication, traction, suture plication of the larger curvature side, and insertion of a graft on the lesser involved side.

In severe cases where Peyronie’s results in severe loss of length, then many urologists would certainly consider the option of an inflatable implant, with or without insertion of graft.  As a rule of thumb, if over a 35% lysis in circumference is required to relax the tension and straighten the penis, then a graft such as Tutoplast should be employed.  Otherwise leaving an open defect may not provide enough integrity to the casing or tunica albuginea to provide sufficient axial rigidity.

Releasing plaque of course restores the lesser curvature back to the length of the uninvolved greater curvature.  For men who insist on a closer approximation of their length of yesteryear, the LGX cylinder of AMS (American Medical Systems) may be considered.  The LGX, different from its Ultrex predecessor, expands more uniformly and is not considered as prone to aneurysm formation.  Using a table top model as a demonstrator, easily a 3/8″ increase in length is obtained, but the manufacturer says could be at least twice that in some applications.

Grafting as the sole remedy for Peyronie’s has yielded a disappointing successful length restoration result rate.  Only 30% of patients, despite correction of angulation have some restoration. .  Perhaps for Peyronie’s patients, we should be thinking more of implants.  For a patient to opt for an implant is an important decision, because he will forsake forever being able to have a natural erection.  Although some tumescence does occur with implants, it is never enough should the implant be removed to provide sufficient intromission.  The patient must also accept occasional replacement as part of the deal and the 2 to 8% incidence of infection (all comers having implant surgery).  However, for most with implants, happiness is being able to never have to say “I’m sorry.”

Harold M. Reed, M.D.                                                                                                                                  305-865-2000

A penile implant should be considered is a last resort for men with erectile impairment.  It may occur every time, or frequently enough that the uncertainty of a good performance becomes an anxiety provoking experience with down moderation of what needs to be done.

Sure, a penile implant is a mechanical device and while inflatables are the most commonly chosen by patients, still it is a mechanical device and as such, is not guaranteed to last forever.  The two major manufacturers, AMS and Mentor, both have warrantees that cover the implant for life.  They last on average 6 to 8 years, and just like a set of Michelin tires, could last 40,000 miles or you could have an unexpected problem a lot sooner.

That is why the implants alone today are so costly, about $8,000 plus dollars.  For a 45 to 50 year old man, conceivably 4 replacements may be needed in a lifetime.   The warrantees do not provide for surgical services, just the implant.  However, most surgeons would charge a nominal fee for an early redo.  Hospitals are usually not so inclined for self-pays.  In that we own the Reed Centre facility outright, we are perhaps the most affordable.

The satisfaction rate of patients and their partners approaches 90% and in the event of a breakdown, most rush to be up and running again.   Some of the closest and most social relationships I have had with patients has centered around their satisfaction with the implant.  As one wife stated, if I knew sex was going to be so much fun, I wouldn’t have said “no” so often.

 
Harold M. Reed, M.D.                                                                                                                                       305-865-2000

Surgical Correction of Peyronie’s Disease via Tunica Albuginea
Plication (TAP) Partial Plaque Excision with Pericardial Graft  (PEG) with Long term Follow Up

by Frederick L. Taylor, M.D.and Laurence A. Levine, M.D.

(as reported in Journal of Sexual Medicine, 2008, voume 5)

61 patients underwent TAP and 81 underwent PEG (Plaque Incision with Tutoplast Pericardial Graft).    Average followup time was 72 months and 58 month respectively.   Rigidity was reported as good or better than pre-op in 81% of TAP and only 68% in PEG patients.  82% of TAP patients and 75% of PEG patients were satisfied.

The paper is critiqued by Dr. David Ralph who points out that another way of looking at the data is 32% had worsening of erections and 21% had new onset of erectile dysfunction following surgery. 

The authors Taylor and Levine reply, there is no doubt that penile prosthesis insertion with manual molding should be recommended for any Peyronies’s patient with erectile impairment.

Some urologists lean towards this approach anyway.  Other, as do I offer patients the options and they decide.  An implant can always be installed as a fall-back procedure.

Inflatable implants have on average a 6 to 8 year survival rate before a secondary revision may be indicated.

Not emphasized but described in other recent papers is penile shortening which is to be expected with plication, but surprisingly occurs not infrequently  with release of plaque by incision or excision even if the curvature is corrected.

For your correction of Peyronies, I would recommend a phalloplasty surgeon.  Our phalloplasty before and after photos and phalloplasty images are posted along with phalloplasty cost.  Augmentation phalloplasty may be considered as an adjunctive or followup procedure.

abstract and comments by
Harold M. Reed, M.D.