Colporrhaphy, the repair of pelvic organ prolapse by folding the native tissue or anchoring them to surrounding lcoations is the traditional surgical procedure for women suffering this medical condition. The use of synthetic mesh material in the repair of POP is an alternative to colporrhaphy as detailed in a June, 2012 article in Current Urology Reports Journal. This article details outcomes and complications when synthetic mesh is used and reports the FDA findings on the subject as well.
Women who have delivered one or more babies vaginally, women who have undergone surgical procedures and women who have been through menopause or are over 60 are all at a higher risk of pelvic organ prolapse. Pelvic organ prolapse occurs when the connective tissues—made up primarily of the proteins elastin and collagen—begin to lose their elasticity. These muscles hold the bladder, uterus, vagina and uretha in place, therefore when the muscles and tissues break down, these organs can move downward. When the defect is anterior, it is classified as a cystocele, when it is posterior it is classified as a rectocele and when the defect is apical it is classified as an enterocele.
Approximately 17% of colporrhaphy surgeries will require further surgical intervention however the use of grafts can lessen those numbers. A further advantage to using grafts is that surgeons can repair multiple sites during the operation. Biologic grafts fall into three categories: autografts use tissue from the same individual, allografts use tissue from another human and xenografts use non-human organism tissue. Biologic grafts tend to be more expensive, they are not as readily available as synthetic mesh and there is a higher risk of the transmission of disease.
Synthetic grafts are also classified into four categories with the most widely used being Type 1 mesh which is macroporous, monofilament polypropylene. The larger pore size of this synthetic mesh allows better tissue growth and has been shown to result in lower infection rates than the microporous mesh types. Type 1 mesh is marketed under such brand names as Marlex™, Pelvitex™, Gynemesh™, Atrium™ and Prolene™. Type 1 mesh has seen the highest success rates, nevertheless the mesh can lead to defense cell responses which in turn can cause granulomas to form. Anterior POP repairs show mesh augmentation reduced the rate of recurrence, but the complication rate was higher. When mesh was used in apical repairs the rates were similar to anterior repairs however in posterior repairs there was no significant difference in recurrence or complications as compared to colporrhaphy procedures.
An erosion and extrusion rate between five and nineteen percent was observed when synthetic mesh kits are used in pelvic organ prolapse surgery. Complications were divided between those which were immediate (caused by the physician) short-term erosion or bleeding and long-term complications which included painful sexual intercourse, chronic pelvic pain and mesh extrusion. Colporrhaphy surgical procedures, according to the journal article, appeared to result in fewer incidences of stress incontinence as compared to surgical mesh use although painful sexual relations was roughly equal in both groups. It was noted that Type 1 polypropylene mesh—the most commonly used type of synthetic mesh—could sometimes retract as much as 66%, leading to shortening and narrowing of the vagina.
A notice issued in 2006 by the French Health Authorities noted more research was necessary in the use of synthetic mesh for pelvic organ prolapse surgery. Two years later the FDA issued a notification offering suggestions that physicians be trained specially in the use of mesh for pelvic organ prolapse and that mesh should be used only after the surgeon had carefully weighed all other alternatives. The FDA instructed physicians to clearly inform patients of all potential complications and to advise them that mesh implantation is considered permanent. In 2011 the FDA issued an update to the 2008 notification, stating complications from the use of surgical mesh were "not rare." The FDA stated at this time that it was uncertain whether there were any benefits to be seen when surgical mesh was used over more traditional surgical procedures. This particular article, however, concluded the view of the FDA was biased and that further research was needed.
Women who have delivered one or more babies vaginally, women who have undergone surgical procedures and women who have been through menopause or are over 60 are all at a higher risk of pelvic organ prolapse. Pelvic organ prolapse occurs when the connective tissues—made up primarily of the proteins elastin and collagen—begin to lose their elasticity. These muscles hold the bladder, uterus, vagina and uretha in place, therefore when the muscles and tissues break down, these organs can move downward. When the defect is anterior, it is classified as a cystocele, when it is posterior it is classified as a rectocele and when the defect is apical it is classified as an enterocele.
Approximately 17% of colporrhaphy surgeries will require further surgical intervention however the use of grafts can lessen those numbers. A further advantage to using grafts is that surgeons can repair multiple sites during the operation. Biologic grafts fall into three categories: autografts use tissue from the same individual, allografts use tissue from another human and xenografts use non-human organism tissue. Biologic grafts tend to be more expensive, they are not as readily available as synthetic mesh and there is a higher risk of the transmission of disease.
Synthetic grafts are also classified into four categories with the most widely used being Type 1 mesh which is macroporous, monofilament polypropylene. The larger pore size of this synthetic mesh allows better tissue growth and has been shown to result in lower infection rates than the microporous mesh types. Type 1 mesh is marketed under such brand names as Marlex™, Pelvitex™, Gynemesh™, Atrium™ and Prolene™. Type 1 mesh has seen the highest success rates, nevertheless the mesh can lead to defense cell responses which in turn can cause granulomas to form. Anterior POP repairs show mesh augmentation reduced the rate of recurrence, but the complication rate was higher. When mesh was used in apical repairs the rates were similar to anterior repairs however in posterior repairs there was no significant difference in recurrence or complications as compared to colporrhaphy procedures.
An erosion and extrusion rate between five and nineteen percent was observed when synthetic mesh kits are used in pelvic organ prolapse surgery. Complications were divided between those which were immediate (caused by the physician) short-term erosion or bleeding and long-term complications which included painful sexual intercourse, chronic pelvic pain and mesh extrusion. Colporrhaphy surgical procedures, according to the journal article, appeared to result in fewer incidences of stress incontinence as compared to surgical mesh use although painful sexual relations was roughly equal in both groups. It was noted that Type 1 polypropylene mesh—the most commonly used type of synthetic mesh—could sometimes retract as much as 66%, leading to shortening and narrowing of the vagina.
A notice issued in 2006 by the French Health Authorities noted more research was necessary in the use of synthetic mesh for pelvic organ prolapse surgery. Two years later the FDA issued a notification offering suggestions that physicians be trained specially in the use of mesh for pelvic organ prolapse and that mesh should be used only after the surgeon had carefully weighed all other alternatives. The FDA instructed physicians to clearly inform patients of all potential complications and to advise them that mesh implantation is considered permanent. In 2011 the FDA issued an update to the 2008 notification, stating complications from the use of surgical mesh were "not rare." The FDA stated at this time that it was uncertain whether there were any benefits to be seen when surgical mesh was used over more traditional surgical procedures. This particular article, however, concluded the view of the FDA was biased and that further research was needed.
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