Transvaginal Mesh Implants
On July 13, 2011, the Food and Drug Administration (FDA) updated an advisory warning on transvaginal mesh implants reporting that the implants expose patients to a number of serious risks without significant proof of their effectiveness. Transvaginal mesh implants, commonly referred to as “bladder slings,” are medical devices generally used to repair pelvic organ prolapse (POP) or to support the urethra to treat stress urinary incontinence (SUI).
Also known as bladder sling implants, transvaginal mesh implants are medical devices generally used to repair pelvic organ prolapse (POP) or to support the urethra to treat stress urinary incontinence (SUI). ( What is pelvic organ prolapse and stress urinary incontinence? ) They are surgically implanted vaginally or abdominally. These devices are made of synthetic polypropylene mesh, some of which use a porcine (pig) collagen covering over the mesh.
In 2010, there were at least 100,000 women treated for pelvic organ prolapse with surgical mesh. Approximately, 75,000 of those repairs were performed transvaginally.
FDA advised of a five-fold rise in reported complications associated with the devices that can be debilitating for some women. The most commonly reported complications include:
- Erosion of the mesh into the vagina
- Mesh shrinkage
- Severe pelvic pain
- Painful sexual intercourse or inability to engage in sexual intercourse
- Vaginal discharge
- Vaginal scarring
- Mesh extrusion
- Perforations of the bladder, bowel or blood vessels
- Recurrence of Pelvic Organ Prolapse and Stress Urinary Incontinence
Click here to view the most recent FDA Safety Communication.
These complications could have been prevented if adequate warnings by the manufacturer had been provided for the defective and dangerous products. Since these devices are permanent implants, complete removal may not be possible nor may completely resolve the complications thousands of women are suffering each year. Any future surgical repairs may be more challenging and can put the patient at risk for additional complications and surgeries.
Popular brand names of mesh devices or bladder sling include:
- Johnson & Johnson
- CR Bard
- Boston Scientific
- American Medical Systems
If you or a loved one is suffering from the dangerous effects of transvaginal mesh implants or bladder sling implants, we urge you to contact our Miami product liability lawyers at Friedman Rodman Frank & Estrada, P.A. We represent cases nationwide and you can be confident in our ability to take on the manufacturers of these medical devices and hold them accountable for their defective products. We will pursue maximum compensation for you.