Atlanta Center for Laparoscopic Urogynecology
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Graft use in Vaginal Prolapse Surgery
Anterior Elevate
Over the past few decades there has been growing interest and investigation in graft use for surgical correction of prolapse and incontinence. The initial work stems from the general surgery literature, where they realized many years ago that abdominal hernia repairs had much higher cure rates when a graft was used to repair the hernia. This only makes common sense, and we have recently seen more and more data supporting graft use in pelvic floor prolapse surgery. With traditional repairs (ie not using grafts to augment our repairs) we are relying on repairs in which we are suturing weak tissue to weak tissue, under tension (which goes against all basic surgical principals!). It’s no wonder that we have poor cure rates! Today, very few abdominal wall hernias are repaired without a graft and we are now seeing similar trends in prolapse surgery. We have known for many years that abdominal sacralcolpopexy has the highest cure rate for vault prolapse, and that most likely is because a graft is used and we are not relying on the patients own tissue to hold up. As stated above and in our posterior repair section, we began using grafts back in 1998 and have done much of the research and initial work in the field of graft use for rectocele repairs. We have seen a substantial increase in cure rates (>90% compared to 60% with traditional repairs) and much better anatomic outcomes . There has been work done for several years in placement of anterior vaginal wall grafts for cystoceles, however the difficulty has been in finding a minimally invasive approach to attach the grafts up higher in the vagina to the sidewall and to have a good strong attachment point and obtain anatomic restoration. Recently in a Cochrane review of the literature (comprehensive scientific review of the literature), Maher et al concluded that mesh use in the anterior compartment is associated with a higher cure rate and its use is substantiated by the literature. We feel that grafts should be considered in patients that have had previous failured operations, older patients with poor tissue or patients with large defects or severe prolapse. Up until recently, these techniques were very invasive and fraught with high complication rates such as bleeding, bladder and/or nerve injury, graft rejection, and poor anatomic outcomes.
Transobturator Approach- The initial step to less invasive
In the early 2000’s, the transobturator space was initially described for the safe placement of slings to treat stress urinary incontinence. Dr Moore and Miklos were two of the first surgeons in the United States to utilize this technique and bring this new technology to the US. They have also been involved with the largest study in the world (Dr Moore was one of the principal investigators for the worldwide study and was he Principal/Lead US Investigator directing centers such as Harvard and Cleveland Clinic in the study…Click here for link of recent paper reviewing results-sling paper ) studying this space for the treatment of stress incontinence and have found it to be a much safer, less invasive approach than other approaches to date, with excellent cure rates for SUI. Dr Moore traveled to Copenhagen and Montreal (2005) where he presented the results of those studies and he and Dr Miklos’ research, which showed cure rates in the range of 90% for the TOT sling. The TOT sling has rapidly become one of the most common forms of treatment for stress incontinence in the world. Since then there have been many studies reporting the benefits of the TOT sling for SUI.
In Dr Moore’s and Miklos’ initial travels to France and Italy, where they operated with the developers of these techniques for stress incontinence (ie Dargent, Mellier, Courtieau, Cosson,Von Theobold and others) they also observed their work in utilizing this same space to pass needles through it, to be able to attach an anterior wall graft up high on the pelvic sidewalls in a very time efficient and minimally invasive approach to treat cystoceles. At the same time, the Australians (who developed Posterior IVS system for vault prolapse), specifically Professor AJ Rane, were also investigating this same space as a potential space to be able to reach a point on the white line up near the ischial spine to have a strong attachment point for an anterior wall graft for cystocele repair. Modifications of some of these techniques have been made to make the approach easier and safer since that point in time.
After evaluating the procedure in Europe and completing many cadaver studies, Dr Moore was the first US surgeon to utilize the Perigee system (the first Transobturator system released in the US) to place an anterior wall graft for repair of cystocele in 2004. Since that point in time, he has also become the lead investigator in the United States clinical trial of the Perigee and presented (in conjunction with Dr Miklos) one of the first papers and videos in the world on the procedure at the International Urogynecology Meeting in Copenhagen in 2005. Since that time Dr Moore has presented all across the globe the Perigee procedure and has demonstrated and taught the procedure via live surgery in countries such as Russia, Finland, Sweden, Greece, Turkey, Spain, Italy, and Chile. He has become known worldwide for his work in this field and recently was asked to chair a workshop at the International Urogynecology Association Mtg in Italy with Prof Michelle Cosson from France on “Minimizing complications with Vaginal Mesh Repairs”. Dr Moore has worked with other world wide leaders to help develop this product in the United States and is directing other centers such as Harvard, Cleveland Clinic and others in the current US study that is following patients for 5 years. The results of the studies have been very good with cure rates in the range of 90% and minimal complications have occurred in their studies. Other similar procedures were developed by different companies such as Prolift (Gynecare, Ethicon, NJ), Avaulta (Bard Urology, GA) that had slightly different methods of placement and mesh composition that was also slightly different, that may have affected complication rates (in a negative way) however the thought process of passing needles through the obturator space to get the graft in place to support the bladder was very similar.
The original Perigee procedure. Needles are passed through the groins to get the mesh into position.
Despite the improved outcomes seen with the vaginal mesh procedures in certain patients, risks are know to still occur. Complications such as pain with intercourse, mesh complications (extrusions, infection, fistulas, vaginal pain, leg pain, pelvic pain, etc) have all been reported and has caused some concern regarding the procedures. Dr Moore and Miklos feel that many of these complications have occurred secondary to inexperienced surgeons completing the procedures and/or the procedures being completed in the wrong patients. Dr Moore just published a comprehensive review of vaginal mesh procedures in the Scientific World Journal (click here for download of the paper) in which he and Dr Miklos reviewed all of the published data on mesh use in vaginal surgery and associated complications. In the paper all studies to date (2009) on results are summarized (including Perigee and Prolift studies) and also recommendations given to other surgeons on how to minimize the risks of complications. The bottom line is that: used properly by properly trained and experienced surgeons, with proper patient selection, graft use vaginally does seem to be beneficial and is supported by the literature. However, it is always the goal to continue to look for improvements in procedures to minimize and reduce the risk of any surgical procedure, including vaginal mesh use.
Limitations / Deficits of Current Vaginal Mesh Kits
Superior Needle Pass
Inferior / Apical Needle PassThe Perigee and Prolift procedures involve passing needles through the groins and obturator spaces blindly to help get the mesh into place. Mesh arms are pulled through the pelvic sidewall muscles to hold the graft into place. If these arms are too tight or heal under too much tension, this can pull on the pelvic muscles and cause pain in the vagina or pelvis and/or can cause pain with intercourse. If this occurs, it can typically be treated either conservatively or with a surgical release of the tension. However, if needles do not have to be passed through the groins/obturator space then risks such as bleeding or injury to the bladder may be reduced or eliminated. Likewise, if an attachment point for the mesh can be found to minimize risk of tension or pain, and/or to get better apical support then of course this should be pursued.
Perigee mesh in position under bladder. Note the mesh arms that are attached and go through the pelvic sidwall muscles up near the ischial spines. If these arms are placed too tight, or heal too tight, tension on the muscles can cause pain. Additionally, note that the bladder is supported, however the top or apex of the vagina is not supported by the Perigee procedure.
Another limitation of the Perigee (as well as Prolift, Avaulta, etc) is that the procedure only supports the bladder and is not designed to get apical or vault support at the same time. If the patient had vault prolapse, then a separate procedure would have to be done to support the vault, which many times would involve having to open up the posterior compartment, even if the patient did not have a rectocele. It is also thought that many recurrent cystoceles or failures occur because the vaginal vault was not supported at the same time (ie even in patients that may not have had vault prolapse) and that concomitant vault support at time of cystocele repair will help reduce failures (see vaginal vault section).