Friday, March 2, 2012

Transvaginal Mesh Discussions: Problems and Warnings

Problems Caused by Transvaginal Mesh Implants
Once the mesh is implanted in the body, it can move around leading to potentially serious injuries in the form of nearby organ punctures or frayed edges of the mesh eating into surrounding tissues. Some women have become septic as a result of the mesh implant, such severe infections, when not treated immediately, can lead to death in some cases. Other common complaints regarding the transvaginal mesh implants include extremely painful intercourse, scarring in the areas surrounding the mesh implant, a recurrence of the original pelvic organ prolapse, and chronic urinary infections and problems.

It is estimated that erosion of the transvaginal mesh implant into surrounding organs and tissues occurs in about 10 percent of all women who have undergone vaginal prolapsed repairs using mesh. In some cases the mesh material can be removed during another surgical procedure, however in some cases tissue may have grown in and around the mesh leading to multiple surgeries or interventions. Many women are not fully informed about alternatives to mesh implants, nor are they informed about the possible risks of transvaginal mesh implants.

Has There Been a Recall of Transvaginal Mesh Implants?
There are currently many, many manufacturers of transvaginal mesh, however the majority of the negative reports regarding the mesh center around the following mesh brand-names along with the manufacturer. Gynecare, Gynemesh and Ethico are Johnson and Johnson products, Avaulta, Pelvicol and Pelvisoft are manufactured by C.R. Bard, The Advantage Sling, Obtryx, Perfyx and Pinnacle are made by Boston Scientific, and Spar, Miniarc, Monarc, Apogee, Perigee and Elevate are made by American Medical Systems. It appears that the use of surgical mesh to treat pelvic organ prolapse or SUI may never have been sufficiently tested; after gynecologists began using mesh in their surgical applications in the 90’s the FDA approved the mesh under a 510(k) clearance “loophole,” meaning the mesh was approved without proper testing and clinical trials.

The pelvic transvaginal mesh types currently bringing so much concern are very similar to the ProtoGen mesh which was recalled over a decade ago. In October of 2008 a Public Health Notification was issued by the FDA cautioning physicians about potential health issues resulting from the implantation of transvaginal mesh. At this point the FDA had received hundreds of reports of negative health issues from use of the transvaginal mesh implant. It was not until July of 2011, however, that the FDA issued an updated safety warning which indicated serious complications could arise from the use of transvaginal mesh implants, and that those complications were “not rare.”

The FDA further stated that repairs done with transvaginal mesh rather than the more traditional surgery which did not use mesh had not been shown to significantly improve the results of the surgery or the quality of life in the patient. FDA studies show that over ten percent of all women who undergo transvaginal pelvic organ prolapse repair will experience erosion of the mesh into surrounding tissues or organs within the twelve-month period following surgery. This statistic is considered significant among such surgical implants. The FDA revealed in January of this year that they are considering a recommendation that mesh used in the repair of prolapse of pelvic organs undergo a reclassification from a Class 2 to a Class 3 which would cause manufacturer’s safety requirements to be much stricter.

The FDA also ordered the manufacturers of the transvaginal mesh to conduct new trials and studies to more fully assess mesh safety and the risk of complications. While some consumer organizations have demanded the FDA recall the mesh implants and ban any further promotion of transvaginal mesh, other well-recognized medical organizations have yet to reach a definitive conclusion about discontinuing the use of the mesh implants. While the FDA acknowledges the dangers of the mesh they have not issues a recall and it is highly doubtful that the manufacturers of the transvaginal mesh will issue a voluntary recall. The current FDA warning applies only to transvaginally placed mesh and does not include abdominally-placed mesh or mesh

Author: Sullo & Sullo Attorneys

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