Recent studies as well as FDA adverse event reports have linked transvaginal mesh surgery for stress urinary incontinence and pelvic organ prolapse to high risks of complications, like mesh erosion. Medical device manufacturer Boston Scientific is one of four major companies that develops and distributes this problematic type of transvaginal mesh. One such model is called the Solyx SIS System, which is a sling made of Advantage Mesh and is used to treat stress urinary incontinence. Unfortunately, the Solyx System as well as all other transvaginal mesh product can result in serious complications that can require hospitalization and revision surgeries. In many patients, even a second surgery cannot fully fix the problem of mesh erosion, and the quality of life for the victim is permanently diminished.
The Solyx SIS System is not the only mesh device that has been developed and created by the Boston Scientific Corporation. Currently, Boston Scientific has all of the following mesh products available for the treatment of either pelvic organ prolapse, stress urinary incontinence and/or vaginal wall prolapse:
In January of 2012, the United States Food and Drug Administration is considering that transvaginal surgical mesh be reclassified from Class II to Class III when used in treatment for stress urinary incontinence and pelvic organ prolapse. This decision was based on information collected from adverse event reports of vaginal mesh complications, medical literature published on the subject, as well as the September 2011 meeting of the Obstetrics-Gynecology Devices Panel. Furthermore, the FDA has mandated postmarket studies the manufacturers of transvaginal mesh used in both SUI and POP treatment. As soon as further information is discovered regarding Boston Scientific Solyx and other devices, the FDA will make it available to the public.
Many women who suffer from mesh erosion and other bladder sling complications find themselves bombarded with medical expenses as the result of their injuries. If you have been hurt as the result of treatment with the Solyx SIS System or other type of transvaginal mesh, call the Willis Law Firm today. We may be able to help you secure financial damages in relation to your situation; currently we are looking at mesh cases nationwide. Call us today.