In 2008, the FDA issued a warning to healthcare practitioners regarding dangers and serious complications associated with the surgical placement of transvaginal mesh for repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The FDA issued its warning after receiving more than 1,000 reports from nine surgical mesh manufacturers over the course of three years. By 2010, reports increased to nearly 3,000, and they continue to rise. The FDA continues to track these reports, and it regularly releases updates and recommendations for public safety.
Our personal injury lawyers offer legal services to women in the Milwaukee area who have been injured as a result of a transvaginal mesh or bladder sling procedure. We assist women with personal injury, medical, and pharmaceutical claims to secure representation for their transvaginal mesh lawsuits. As a part of a team of lawyers involved with multi-district litigation of medical and product liability cases, we help injured parties who have experienced complications and a decrease in quality of life as a result of a POP or SUI procedure to understand their legal rights and options.
Dangers Associated with Transvaginal Surgical Mesh
Surgical mesh has been in use since the 1950s as a way to repair hernias. In 1996, the FDA approved its use for POP, and in 2002, it was cleared for use in SUI. The mesh is made from a synthetic polypropylene, and it is placed inside the pelvis for POP or sub-urethral to support the urethra. Product names include Gynecare Prolift Anterior Pelvic Floor Repair System, Avaulta Plus BioSynthetic Support System, Gynecare TVT Secur, Align TO Trans-Obturator Urethral Support System. Manufacturers include Johnson & Johnson, its subsidiary Ethicon, and C.R. Bard.
POP occurs when there is weakening of the internal structures that support the pelvic organs, such as the bladder, uterus, and bowel. The support structures stretch, and organs can drop from their normal position and bulge, or prolapse, from the pelvic floor into the vaginal wall resulting in pelvic discomfort, disruption of sexual, urinary, or bowel functions, and an overall reduction in quality of life. SUI is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise. Traditional urogynecologic procedures are recommended, such as reconstructive surgery using the patient’s own tissue for repair, as such procedures do not have the same risks associated with them.
Reported complications that arise as a result of the insertion of surgical mesh to repair POP and SUI include:
- Erosion (exposure or protrusion of surgical mesh through the vaginal tissue or epithelium)
- Organ perforation
- Urinary problems (including incontinence)
- Need for additional surgeries or hospitalization to treat complications or remove the mesh
- Dyspareunia (discomfort during sexual intercourse)
- Recurrent prolapse
- Neuro-muscular problems
- Vaginal scarring / shrinkage
- Emotional problems
- Mesh contraction (shrinkage)
Treatment of these complications includes:
- IV therapy
- Blood transfusions
- Drainage of hematomas or abscesses
- Removal of the mesh
- Additional surgical procedures
Our Milwaukee transvaginal mesh lawyers are dedicated to helping women who have suffered as a result of a surgical mesh procedure to understand their legal rights and to procure assertive legal representation that zealously advocates for those rights.