Friday, June 1, 2012

Transvaginal Mesh Litigation Issues: Part Three: Problems Associated With Polypropylene

This article is the third part in a discussion regarding the current multidistrict litigation against the manufacturers of vaginal mesh. Literally thousands of women have suffered serious complications after receiving vaginal mesh implants in the treatment of pelvic organ prolapse and stress urinary incontinence. Many of these complications are difficult, if not impossible, to cure, and in rare cases the implants have resulted in death due to infection and erosion. A large number of women who have received mesh implants have been forced to undergo multiple surgeries in order to have the mesh removed entirely or the sharp edges trimmed.

The current lawsuits claim the mesh manufacturers were well aware of the risks posed to women yet ignored those risks in the quest for huge profits. Before artificial mesh was manufactured surgeons stitched to a woman’s natural tissues to remedy POP and SUI. In most cases using natural tissue was effective and brought none of the complications inherent in implanting polypropylene mesh into the body through the vaginal canal. A primary reason mesh manufacturers allowed safety concerns to go by the wayside probably lies in the fact that a pelvic organ prolapse kit which costs less than $100 to manufacture sells to hospitals for over $2,000.

Is Polypropylene Harmless?

Defendants in this case claim polypropylene is an inert substance which, when permanently implanted in the body, causes no adverse reactions, yet article after article shows polypropylene is not an inert substance. The defendants also claim polypropylene is both non-carcinogenic as well as non-inflammatory however the lawyers working with the MDL mesh claims have a completely different story to tell. Polypropylene is well-known to degrade in the body plus the manner in which the vaginal mesh is inserted into the body can make it become stiff and roll. Anatomical distinctions affect the polypropylene and the body sees the mesh as a foreign intruder. The mesh hardens, and the manner in which the pelvis moves around the vaginal mesh implant leads to what is known as a “cheese grater effect”. Even though newer developments have led to lightweight, large pore polypropylene meshes which adjust more readily, permitting proper tissue integration, there are still complications arising from the mesh.

Defendants further claim polypropylene meshes provide stability and elasticity and that no lasting degradation has been reported. They add that polypropylene mesh is not as likely to cause infection and in some cases can remain in place even when an infection occurs. Defendants admit that their mesh product—like most any material placed in the body—may provoke a “mild” chronic foreign body reaction but maintain the safety and efficacy of the product. In truth, synthetic mesh severely taxes the body’s inflammatory response and polypropylene has also been shown to leach nonylphenol—an endocrine disruptor with an estrogen effect—into the body. Despite the risks, polypropylene mesh has become the standard in POP and SUI surgical procedures with proponents point to the fact that biologic mesh is more expensive and that surgeons require greater skills and training to use biologic mesh. Part four of the transvaginal mesh litigation article series will discuss the potential timing issues surrounding a mesh implant lawsuit.

Author: Sullo & Sullo Attorneys

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