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Biocompatible
Mesh Optimizes the Treatment
of Pelvic Organ Prolapse |
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More Biocompatible
Mesh Optimizes the Treatment of
Pelvic Organ Prolapse
Story by Caroline Helwick
Interview by Charles Bankhead
ECCC (November 18, 2009)—Advances in material science is resulting in better transvaginal mesh kits for the treatment of pelvic organ prolapse, according to an Ethicon booth presentation by Vincent Lucente, MD, MBA, Medical Director of the Institute for Female Pelvic Medicine and Reconstructive Surgery and Chief of Gynecology at St. Luke’s Hospital, Allentown, Pennsylvania.
“We are outliving our bodies, and we cannot rely on suture repairs of endogenous tissue,” he noted. Based on feedback from surgeons, industry has developed more “biocompatible” mesh to improve long-term outcomes. And enhanced biocompatibility means elasticity and flexibility, stress resistance, improved bi-directionality, large pore size, decreased mesh density, tissue integration, minimal foreign body response, and improved handling characteristics.
“The mesh should resist contraction. We want some resistance upon insertion but we can’t have it wrinkling or folding, as this increases the erosion rate. We want to minimize the foreign body response, which reduces the inflammation that triggers fibrosis. And with vaginal penetration, we want inward movement,” Dr. Lucente told those who attended his presentation.
“But the outcome we focus on most is patient comfort and sexual health, especially in younger women,” he said. Dr. Lucente said he chooses an approach that offers the best results in this area and has found that the Gynecare Prolift+M system satisfies these conditions, and early outcomes data are very positive. Interim 3-month clinical data from a multicenter study of 125 patients, for which he was an investigator, show an overall success rate of 92.3%, stringently defined as POP-Q stage 1 or less in the treated compartment. “Most outcome studies use stage 2 to define success. We held ourselves to a higher bar for anatomical success.”
There have been no de-novo cases of dyspareunia; with the standard procedure, the rate of new-onset dyspareunia is 3.4%. Furthermore, 75% of patients who were sexually active at baseline actually experienced a resolution of the dyspareunia, he said.
The system is a blend of prolene (polypropylene) suture and monocryl (poliglecaprone 25) suture material. For anatomic restoration, the Prolift+M uses the Prolift delivery system with the cannula, allows for mesh adjustability after closure of the incision, and incorporates a mesh with resistance to wrinkling and folding. For functional restoration, it features large pores that minimize scar plate formation “bridging fibrosis,” partially absorbable mesh with good longitudinal elasticity and strong lateral support, and mesh shrinkage that results in 46% less mesh at 84 days, he said.
“Women have a lot less awareness of this mesh,” he observed, adding that on follow-up examination it can even be difficult for the surgeon to determine where it was placed.
The monocryl suture material improves intra-operative handling and diminishes the foreign body response, compared with the pure polypropylene mesh. The monocryl is also responsible for less mesh palpability and improved tissue in-growth. This material yields a greater distance between pores, which guards against bridging fibrosis. The large-pore mesh enables a compliant, flexible scar tissue that mimics the mobility of natural tissues, he said.
New materials have increased biocompatibility with the vagina, i.e. they have mechanical properties that are similar to those of vaginal tissue. Experimental studies have shown that lightweight biomaterial (with reduced polypropylene content) matches the physiologic distensibility of natural tissue more closely (Cobb et al. Presentation at the 38th Annual Meeting of the Association for Academic Surgery. Houston, Texas, Nov. 11-13, 2004). And they have shown that large pore size enhances vascular host tissue response and helps form densely vascularized granulation tissue (Laschke et al. J Biomed Mater Res A. 2005;74:696-794). “Angiogenesis and vascularization will bring oxygen and nutrients to vital tissues for years to come, which will enhance in-growth and prevent exposure,” he explained.
Additionally, new meshes are less “uniform” within the vagina and provide directionality that improves flexibility, he added. In particular, the Prolift+M’s mesh offers 200 mg/cm of longitudinal flexibility post-absorption, “which is, dramatically, ten times more than other meshes,” he told listeners. “You can feel this when you examine the patient. It is striking. This is the best innovation I have seen in 20 years,” Dr. Lucente concluded. “Properly executed, compared to the standard of care the delta is enormous.”
Thomas Ebersole, MD, one of the conference attendees who practices in West Reading, Pennsylvania, commented after the presentation that the new materials are improving outcomes for his patients. “The mesh is replacing sutures that we were putting into worn-out tissues in the body. The mesh sits in the tissue plane and grows in healthy,” he said. “Having a better product for this is very important.” (Dr. Lucente has served as a consultant and received research support from Ethicon, Inc.)
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