Transvaginal Mesh (TVM) Lawsuit
Senior partner Bill Robins is a member of the Plaintiff Steering Committee for the cases pending before the Federal Multidistrict Litigation Court sitting in the Southern District of West Virginia and overseeing transvaginal mesh cases from across the entire country. Robins Cloud attorneys have been highly active in the discovery and prosecution of transvaginal mesh cases in the MDL and in state courts. The attorneys are committed to the vigorous prosecution of these cases until the manufacturers of these products are held responsible for their actions and the clients of Robins Cloud are adequately compensated for their injuries.
Complications and injuries related to transvaginal mesh.
Transvaginal Mesh products have been identified by the FDA as having serious potential for complications and injuries when used to treat Pelvic Organ Prolapse (POP). There have further been thousands of complaints regarding certain transvaginal mesh product when used to treat Stress urinary Incontinence (SUI). Transvaginal mesh implants and related devices can result in serious injuries such as severe infection, tissue erosion and contraction, painful and unsuccessful subsequent surgeries, and a major decrease in the quality of life for those who have suffered the results of Transvaginal Mesh.
What is transvaginal mesh?
Transvaginal mesh is a permanent, synthetic, perforated mesh material that is implanted to provide a framework of tissue support in patients diagnosed with pelvic organ prolapse and/or stress urinary incontinence. Pelvic organ prolapse is a condition in which the pelvic tissues supporting the position of the bladder, urethra, cervix or rectum have become weakened. Stress urinary incontinence is a condition in which urine involuntarily leaks from the urethra as a result of physical activity such as coughing, laughing, sneezing, or even walking or running. Many people experience SUI as a result of pregnancy, childbirth or aging.
It is estimated that more than hundreds of thousands of women each year undergo surgical procedures, often receiving implants of the defective TVM products that remain on the market.
Transvaginal mesh products and manufacturers
Transvaginal Mesh products were made by several manufacturers including: Johnson & Johnson, Boston Scientific Corp., American Medical Systems, Inc., Covidien, Coloplast, Neo Medic and C. R. Bard, Inc. Many of these products have been sold on the medical device market since 1996 when Boston Scientific Corp’s ProtoGen mesh received FDA clearance as a Class II medical device. The ProtoGen mesh was pulled from the market when it was found to be associated with serious complications and injury to patients who received the implants. However, the FDA’s 510(k) Medical Device Amendment passed by Congress in 1976, allows manufacturers to sell medical devices that have never been clinically tested for safety and effectiveness if they are considered similar enough to a previously approved product known as a “predicate”. In some instances, manufacturers were able to bring their TVM products to market without clinical testing by relying on the now discontinued and discredited ProteGen product as a predicate. Unfortunately, it is estimated that more than hundreds of thousands of women each year undergo surgical procedures, often receiving implants of the defective TVM products that remain on the market.
Types of transvaginal mesh injuries.
Many patients report the following complications and injuries: mesh erosion through the vaginal and/or pelvic tissue, chronic infection, abnormal vaginal bleeding, pain during intercourse, organ perforation (including the bowel, bladder and ureter), urinary problems, recurrent prolapse, vaginal scarring, and vaginal shrinkage. Often times, these complications are so severe that additional surgeries to remove or adjust the mesh are necessary. Even when treated with additional surgeries, there is no guarantee that complications will not persist indefinitely.