AMS 700® MS 3-Piece Inflatable Penile Prosthesis

Overview

AMS 700® MS 3-Piece Inflatable Penile Prosthesis

The AMS 700 Series provides a more natural appearing erection and greater flaccidity than two-piece or malleable implants. These advanced, three-part prostheses are inflatable implants available in a variety of models and sizes for a custom fit. Each consists of a reservoir implanted in the abdomen, a pump placed in the scrotum and a pair of cylinders implanted in the penis. The entire device is totally concealed in the body.

The gold standard for innovative penile implant technology, the AMS 700 Series now features InhibiZone™ Antibiotic Surface Treatment and a special wear-reducing Parylene micro coating that increases the reliability and durability of the cylinders.

The AMS 700 is ideal for a man with good mental and physical dexterity who wants a more natural looking erection—and a more natural flaccid state—than one- or two-piece implants can provide.

Advantages

  • Acts and feels more like a natural erection than 1- or 2-piece implants
  • Expands the girth of the penis
  • More firm and full than 1- or 2-piece implants
  • Feels softer and more flaccid when deflated than 1- or 2-piece implants
  • Totally concealed within the body

Disadvantages

  • Requires some manual dexterity
  • Possibility of leakage or malfunction
  • Possibility of unintentional erections

Placement & Function

The inflatable silicone elastomer cylinders of the AMS 700 TM Series prostheses are implanted within the corporal bodies of the penis from the ischial tuberosity (the crus) to the mid-glans. The pump is implanted in the scrotum and the reservoir is implanted in the abdominal cavity.

  1. To inflate the device, the patient squeezes the pump bulb several times. The pump can be stabilized with one hand while the other is repeatedly squeezing the bulb. The Tactile Pump is designed for single-handed operation, so it can be stabilized and used with just one hand.
  2. Squeezing the pump bulb multiple times causes the saline solution to move from the reservoir, through the tubing and into the cylinders. This creates full rigidity for erection as the cylinders are inflated.
  3. To deflate the device, the patient presses and holds the release valve portion of the pump.
  4. Activating the release valve transfers the saline solution back into the reservoir, making the penis flaccid. Full fluid transfer results in complete flaccidity.

Procedure

The implantation process for the AMS 700 Series involves pre-operative preparation, surgery and post-operative care. The surgical procedure usually lasts from 30 minutes to two hours, with the length of the hospital stay depending on the condition of the patient.

The surgical approach presented here is the transverse scrotal or penoscrotal approach. The name refers to the transverse incision across the high portion of the scrotum made during the procedure. The AMS 700 Series penile prosthesis also can be implanted with an "infrapubic" approach, using a vertical incision into the pelvic cavity above the penis.

The AMS 700 surgical procedure follows these steps.

Caution: This information is for general educational purposes only. Refer to the Operating Room Manual and procedure videos for more detailed instructions on this surgical procedure.

Step 1: Make the Incision

Make a 2-3 cm transverse incision through the subcutaneous tissues of the median raphe of the high scrotum.

Step 2: Dissect and Retract

Dissect down through the Dartos fascia and Buck's fascia to expose the white, shiny tunicae albuginea. If using the SKW Retractor System, stabilize the incision and place the retractor hooks at 1, 5, 7 and 11.

Step 3: Make Corporotomy and Dilate

Make a small, 1.5 cm incision into the proximal corporal cavernosum tissue. Dilate first the distal corpus cavernosum and then the proximal cavernosum to create a space for inserting the penile cylinders. Make sure to go all the way to the glans. Some surgeons use the Metzenbaum or curved Mayo scissors on the first pass. Continue to dilate from 8-12 or 13 mm with sequentially larger Hegar or Brooks dilators or AMS Cavernotome tools. Repeat on the adjacent corpus cavernosum.

Step 4: Measure

Using the Furlow Insertion Tool, the AMS Measuring Tool or the AMS Proximal Tool, measure the length of each corpus, taking the proximal measurement first and then the distal. Stretch the penis slightly while measuring. Measure from the stay suture, insuring that the whole corporotomy is measured.

Step 5: Select Cylinder Size

Choose the proper cylinder size based on the measurements.

Step 6: Safety Check

Before proceeding with the implant, complete two safety checks. First, place a dilator in each corpora to check depth and evenness. This check exposes cross-over perforation and assures full corporal body dilation. Secondly, irrigate the corpora with antibiotic solution to make sure no solution comes out around the catheter.

Step 7: Insert Cylinders

Use the Furlow Insertion Tool and Keith Needle to introduce cylinders into the corpora cavernosa. Hold the four strands of suture material against the insertion tool. Insert the Furlow Insertion Tool into the distal portion of the corporal body so the front tip is palpable beneath the glans. Push the inner obturator to advance the needle through the glans. Pull needle through glans and remove from suture. The sutures now extend through the glans, allowing the surgeon to pull the cylinder into place. Repeat for the other cylinder. Close the corporotomy.

Step 8: Complete Inflate/Deflate Test

Flush cylinder tubing. Attach the 60 cc syringe filled with 55 cc of filling solution to each cylinder. Inflate cylinders to evaluate erection quality. Deflate to evaluate flaccidity.

Step 9: Implant Reservoir and Back Pressure Test

Create a defect in the transversalis fascia through the external inguinal ring. This defect provides access to the prevesical space. Implant the reservoir in the prevesical space. After implantation, fill the reservoir with the appropriate amount of filling solution. After the reservoir has been filled, perform a back-pressure test by checking to see that there is no flow of filling solution back into the syringe barrel when the thumb is removed from the syringe's plunger. If solution flows back into the syringe, the reservoir pocket may need to be enlarged or fluid needs to be removed from the system.

Step 10: Implant Pump

Use blunt dissection to form a pocket in the most dependent portion of the scrotum. Insert the pump into the scrotal pocket. Apply Allis or Babcock clamps to pump tubing through scrotal skin to hold pump in place.

Step 11: Complete Surrogate Reservoir Test

Before connecting tubing between the pump and reservoir, perform surrogate reservoir test. CAUTION: To avoid damaging the pump, don't inject the fluid into the reservoir line of the pump using a syringe. Prepare a syringe containing 55 cc of filling solution. Attach the 15-gauge blunt needle to the syringe. Flush the pump tubing with 22-gauge blunt needle on 10 cc syringe. Connect syringe with 15-gauge needle to tubing while holding syringe upright (acting as a reservoir). Unclamp the hemostat from the pump tubing. Squeeze the pump several times to inflate the cylinders and make the penis erect. Confirm that the cosmetic result is satisfactory. Note: The patient's penis should not buckle or bend and it should be rigid. Deflate the cylinders by pressing the pump's deflate mechanism. Note: The penis should be totally flaccid. All of the fluid should be stored in the reservoir during postoperative healing in order to limit the amount of fibrosis around the reservoir. Excessive fibrosis could result in the inability to completely deflate the cylinders. Reclamp the pump tubing with the tubing covered hemostat. Remove the 15-gauge needle and syringe.

Step 12: Connect Tubing and Final Inflate/Deflate Test

Connect the component tubing using AMS Suture-Tie Connectors or AMS Quick Connect Sutureless Window Connectors, after the cylinder, reservoir and pump are implanted. After all the components are connected, inflate the prosthesis to check the quality of the erection and deflate to evaluate flaccidity.

Step 13: Close and Apply Dressing

Close the incision and completely deflate the prosthesis. Apply a wound dressing.

Post-Operative Care

Immediately post-op, consultants may partially inflate the cylinders for the first 24 hours to aid in hemostasis. Then, after 24 hours, the dressing is removed and the cylinders must be completely deflated.

Partial inflation also is used with patients who have bleeding that needs to be controlled with slight tamponade of the inflated cylinder. The device, however, must be deflated within five days. For other patients, the device may be totally deflated for the entire post-operative period of four to six weeks, to aid in the formation of a fibrous sheath around a full reservoir.

After three to six weeks, the consultant may instruct the patient to begin cycling the device for the first time. Full inflation several times daily encourages maximum pseudocapsure development and reservoir capacity.

Four to six weeks post-operatively, the patient may usually begin using the prosthesis to have intercourse.

A reference copy of the Operating Room Manual is provided below.

Operating Room Manual

Results

Some studies report the following AMS 700 satisfaction and reliability scores:

Satisfaction

  • 92% patient and 96% partner satisfaction rate 1
  • 88% would recommend procedure to someone else 2
  • 86% would undergo procedure again if necessary 2

Reliability

Some studies report:

  • 92% functional after 3 years 2
  • 86% functional after 5 years 2

1. Montorsi F, Rigatti P, Carmignani G, Corbu C, Campo B, Ordesi G, Breda G, Silvestre P, Giammusso B, Morgia G, Graziottin A. AMS three-piece inflatable implants for erectile dysfunction: a long-term multi-institutional study in 200 consecutive patients. Eur Urol Jan 2000 Jan v. 37(1)p. 50-5.

2. Carson CC, Mulcahy JJ, Govier FE. Efficacy, safety and patient satisfaction outcomes of the AMS 700CX inflatable penile prosthesis: results of a long-term multicenter study. AMS 700CX Study Group. J Urol Aug2000 v. 164(2)p.376-80.

Patient Selection

No one penile prosthesis is right for all patients experiencing ED. The AMS 700 is ideal for a man with good mental and physical dexterity who wants a natural looking erection and a more natural flaccid state than a one- or two-piece implant can provide. The AMS 700 Series products may be well suited for patients who:

  • Have adequate manual strength and dexterity to operate a mechanical device
  • May require routine endoscopic procedures
  • Are not intimidated by multi-component devices
  • Have Peyronie's disease or previous priapism (the AMS 700 CX and AMS 700 CXR can overcome these tissue problems; the AMS 700 Ultrex should not be used for these conditions)

As with all prosthetic devices, there are limitations that affect when and how the AMS 700 Series penile prostheses should be used. Limitations include:

  • A required level of manual and mental dexterity for operation
  • Potentially longer operating room implantation time, necessitated by 3-piece design
  • The inability of patients with severe abdominal scarring, such as scarring from pelvic fracture, to use any of the AMS 700 Series prostheses, because the reservoir must be implanted in the patient's abdomen.
  • The possibility of not being able to dilate the corporal bodies enough to accommodate the device in patients with extensive corporal scarring. Note: The consultant may execute a backup plan of using an AMS 700 CXR or AMS 600M non-inflatable prosthesis if that happens.
  • All prosthetics are man-made and have inherent risks of malfunction. Some patients may not be interested in any prosthesis for that reason.

Patient Profile

Anthony is a 53 year-old man with atherosclerosis. The disease was discovered after Anthony had consulted his consultant about an increasing problem of ED. After the diagnosis and an unsatisfactory trial of Viagra, Anthony tried vacuum and injection therapy as his second line of treatment. However, none of those treatments were successful in alleviating his condition.

Anthony's consultant suggested that he consider a penile prosthesis to treat his ED, since atherosclerosis requires long-term medical therapy, and the consultant felt Anthony will most likely never recover the ability to achieve a natural erection. Anthony has no abdominal scarring or compromised penile tissues, and his physical and mental condition made him a good candidate for surgery.

It was important to Anthony that he have a natural looking penile prosthesis. After reviewing all of the options, Anthony and his consultant decided that the AMS 700 CX, which provides a fully rigid and fully flaccid penis, was the logical choice. Anthony is pleased with the results. It has brought physical intimacy back into his marriage and renewed his self-confidence.


This scenario is based upon a composite of typical patient and consultant experiences, and is not reflective of any one individual's medical situation. Individual situations and results may vary.