The Ritchie Centre, Monash Institute of Medical Research-Prince Henry's Institute, Clayton, Victoria, Australia.
Commonwealth Scientific and Industrial Research Organisation Manufacturing Flagship, Clayton, Victoria, Australia.
Am J Obstet Gynecol. 2016 Feb;214(2):260.e1-260.e8. doi: 10.1016/j.ajog.2015.08.071. Epub 2015 Sep 5.
Pelvic organ prolapse (POP) is a multifactorial disease that manifests as the herniation of the pelvic organs into the vagina. Surgical methods for prolapse repair involve the use of a synthetic polypropylene mesh. The use of this mesh has led to significantly higher anatomical success rates compared with native tissue repairs, and therefore, despite recent warnings by the Food and Drug Administration regarding the use of vaginal mesh, the number of POP mesh surgeries has increased over the last few years. However, mesh implantation is associated with higher postsurgery complications, including pain and erosion, with higher consecutive rates of reoperation when placed vaginally. Little is known on how the mechanical properties of the implanted mesh itself change in vivo. It is assumed that the mechanical properties of these meshes remain unchanged, with any differences in mechanical properties of the formed mesh-tissue complex attributed to the attached tissue alone. It is likely that any changes in mesh mechanical properties that do occur in vivo will have an impact on the biomechanical properties of the formed mesh-tissue complex.
The objective of the study was to assess changes in the multiaxial mechanical properties of synthetic clinical prolapse meshes implanted abdominally for up to 90 days, using a rat model. Another objective of the study was to assess the biomechanical properties of the formed mesh-tissue complex following implantation.
Three nondegradable polypropylene clinical synthetic mesh types for prolapse repair (Gynemesh PS, Polyform Lite, and Restorelle) and a partially degradable polypropylene/polyglecaprone mesh (UltraPro) were mechanically assessed before and after implantation (n = 5/ mesh type) in Sprague Dawley rats for 30 (Gynemesh PS, Polyform Lite, and Restorelle) and 90 (UltraPro and Polyform Lite) days. Stiffness and permanent extension following cyclic loading, and breaking load, of the preimplanted mesh types, explanted mesh-tissue complexes, and explanted meshes were assessed using a multi-axial (ball-burst) method.
The 4 clinical meshes varied from each other in weight, thickness, porosity, and pore size and showed significant differences in stiffness and breaking load before implantation. Following 30 days of implantation, the mechanical properties of some mesh types altered, with significant decreases in mesh stiffness and breaking load, and increased permanent extension. After 90 days these changes were more obvious, with significant decreases in stiffness and breaking load and increased permanent extension. Similar biomechanical properties of formed mesh-tissue complexes were observed for mesh types of different preimplant stiffness and structure after 90 days implantation.
This is the first study to report on intrinsic changes in the mechanical properties of implanted meshes and how these changes have an impact on the estimated tissue contribution of the formed mesh-tissue complex. Decreased mesh stiffness, strength, and increased permanent extension following 90 days of implantation increase the biomechanical contribution of the attached tissue of the formed mesh-tissue complex more than previously thought. This needs to be considered when using meshes for prolapse repair.
盆腔器官脱垂(POP)是一种多因素疾病,表现为盆腔器官向阴道突出。脱垂修复的手术方法涉及使用合成聚丙烯网。与天然组织修复相比,使用这种网显著提高了解剖成功率,因此,尽管美国食品和药物管理局最近对阴道网的使用发出警告,但过去几年中 POP 网手术的数量有所增加。然而,网植入物与更高的术后并发症相关,包括疼痛和侵蚀,阴道内放置时再次手术的连续率更高。对于植入物本身的机械性能在体内如何变化知之甚少。假设这些网的机械性能保持不变,形成的网-组织复合物的任何机械性能差异仅归因于附着的组织。很可能在体内发生的任何网机械性能变化都会对形成的网-组织复合物的生物力学性能产生影响。
本研究的目的是使用大鼠模型评估腹部植入的三种合成临床脱垂网的多轴向机械性能变化,研究时间长达 90 天。本研究的另一个目的是评估植入后形成的网-组织复合物的生物力学特性。
在 Sprague Dawley 大鼠中,对三种不可降解的聚丙烯临床合成脱垂修复网(Gynemesh PS、Polyform Lite 和 Restorelle)和一种部分可降解的聚丙烯/聚己内酯网(UltraPro)进行机械评估(n=5/网类型),植入时间为 30 天(Gynemesh PS、Polyform Lite 和 Restorelle)和 90 天(UltraPro 和 Polyform Lite)。使用多轴(球爆裂)方法评估植入前、植入后的网-组织复合物和植入后的网的循环载荷后的刚度和永久伸长率以及断裂载荷。
四种临床网在重量、厚度、孔隙率和孔径方面彼此不同,并且在植入前的刚度和断裂载荷方面显示出显著差异。植入 30 天后,一些网类型的机械性能发生改变,网的刚度和断裂载荷显著降低,永久伸长率增加。90 天后,这些变化更加明显,刚度和断裂载荷显著降低,永久伸长率增加。90 天后植入后,不同植入前刚度和结构的网类型形成的网-组织复合物具有相似的生物力学特性。
这是第一项报告植入网机械性能内在变化以及这些变化如何影响形成的网-组织复合物中估计的组织贡献的研究。90 天后植入后网刚度、强度降低,永久伸长率增加,使形成的网-组织复合物中附着组织的生物力学贡献超过了之前的预期。在使用网进行脱垂修复时需要考虑这一点。