Vaginal Mesh Lawsuit
Last July 2011, the United States Food and Drug Administration (FDA) issued a safety communication that cautioned healthcare providers and patients about the potential risks associated with the involvement of vaginal mesh in operations that seek to fix Pelvic Organ Prolapse (POP) and Urinary Incontinence (UI).
Moreover, in October 2008, the FDA sent out a warning about the severity of the transvaginal placement’s complications and side effects, with regard to implanting a surgical mesh in the vaginal area.
After a number of studies, the FDA released another warning to physicians and patients about probable complications brought by vaginal mesh surgeries, including vaginal bleeding and infection, mesh erosion in the vaginal area, organ punctures, physical and sexual pain, and urinary difficulties.
Additional reports cite chronic prolapse, tissue deformation, pelvic pain, rectal problems, vaginal scarring and shrinkage, and emotional problems. Oftentimes, complications call for eventual hospitalization and surgeries.
In recent years, numerous women filed many vaginal mesh lawsuits because of mesh displacement and surgical complications.
Vaginal Mesh Lawsuit Overview
As vaginal mesh lawsuits are filed, the FDA promptly took an action as to determining the root cause of the surgical problems.
Primarily, the FDA warned doctors against using vaginal mesh products that were reported to be defective and infected. Moreover, the FDA advised doctors to obtain training in vaginal mesh placement in order to avoid further complications.
However, the FDA has considered a second look at the case of vaginal mesh lawsuits. The agency aims to release a premarket approval process for surgical mesh products, as well as reclassifying the mesh devices from a medium-risk category to a high-risk category.
The companies involved in most lawsuits include C.R. Bard, Inc. (Bard Avaulta), American Medical Systems, Ethicon TVT Gynecare, Faslata, Tyco, Uretex, Mentor, Johnson & Johnson, Sparc, and Boston Scientific, amongst many others.
The complications from the aforementioned manufacturers’ defective products have decreased the quality of life that its patients once had. Mesh cannot be completely removed since it is permanently placed on the vaginal area, which allows tissues to grow into it.
Vaginal Mesh Lawsuit Services
If you or someone you care for, like a loved one or a friend, is a victim or has problems due to surgical mesh complications, contact us toll free at 1.888.835.8055 or fill out our online form here. The attorneys at Milstein Adelman will provide you with a confidential and free case evaluation.
