Tuesday, May 28, 2013

How Do You Prove Your Transvaginal Mesh is Failing?

Knowing how transvaginal mesh is constructed can help women implanted with the mesh to understand how it can potentially fail and how that failure can be documented. Polypropylene was first developed in the 1950’s and is made from petroleum. Polypropylene can be molded or extruded and fibers, suture material and mesh are constructed from the material. In its most basic form, polypropylene is fishing line, made from petroleum resin, heated and extruded into long rolls of fiber which are then placed on knitting machines and woven into mesh materials.

 

Generally, the companies who manufacture transvaginal mesh buy long rolls of fiber from the chemical company and weave it into the form they choose to include in mesh kits. Chemical companies who manufacture the fiber added a medical caution many years ago stating there should be no permanent medical application into the human body or permanent contact with internal body fluids or tissues. Despite that warning, some companies found ways to contract around such a problem by offering the chemical company indemnity in return for the ability to use the resin in any application they chose.

 

When transvaginal mesh is constructed from the rolls of fiber, a thermal process is used in order to melt the fiber and allow weaving. It is believed that this melting process can further cause the mesh to degrade. In other words, synthetic mesh suffers continual degradation beginning with the thermal knitting during manufacture, in the package on the shelf and finally inside the human body. If you go back to the original construction, think about fishing line: every spring, after storing a fishing pole and line through the winter months, most fishermen replace the line under the theory that it has degraded and could potentially “snap.” Yet the transvaginal mesh used in surgical POP and SUI surgeries has potentially been sitting on the shelf for many years then is subjected to further degradation through the thermal process.

 

So, women who have suffered such serious medical issues as chronic pain, discomfort, irritation, inflammation, infection, painful sexual intercourse and nerve injury obviously are aware their transvaginal mesh has failed, but may not know how to prove that fact. One primary way to show failure of a mesh product is to have the explant examined by experts following surgical mesh removal. The mesh can be examined under scanning electron microscopy or Fourier Transform Infrared Spectroscopy (FTIR) in order to analyze and determine whether degradation is present.   

 

Considering there is at least a 15-18% erosion rate among women implanted with mesh products, there is no specific protocol for removal of the product and women are given no information regarding what to do should the mesh fail, it is clear significant problems exist regarding the failure of transvaginal mesh.

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