Transvaginal Mesh Injury
Midland Transvaginal Mesh Injury Lawyer
A transvaginal mesh device is a surgical mesh that has a screen-like quality, and is often made from metals or polymers consisting of non-organic chemical compounds. Transvaginal mesh can also be enhanced with bovine collagen extracted from cows. The mesh inserts are often used to reinforce soft tissue, such as the bladder, or bone in areas that are weakened. It is cut to the shape that is needed and placed in the body either through an incision in the abdomen or transvaginally.
The two most common conditions transvaginal mesh devices are used for are pelvic organ prolapsed and stress urinary incontinence.
- Pelvic organ prolapsed (POP) - a condition whereby organs, such as the rectum, bladder or uterus slip into the vaginal cavity
- Stress urinary incontinence (SUI) – a condition known as overactive bladder syndrome causing the frequent need to urinate. It is often the result of pressure placed on the bladder from fallen or prolapsed organs
Approval of Transvaginal Mesh
Between 2008 and 2010, the Food and Drug Administration (FDA) received more than 1,500 reports of injury or defect in the mesh devices. As a result, the FDA issued a public notice that the use of transvaginal mesh devices may expose patients to much greater risk, both surgically and post-surgically, and that they are not any more effective than other traditional non-mesh repair techniques available.
The FDA approved the first ever transvaginal mesh product in 1996. It was introduced by Boston Scientific and called the ProteGen® sling. The ProteGen® sling was made from a polyester material coated with bovine collagen. It was made to be implanted in the vagina through transvaginal incision and anchored to the pelvic bones, and was intended to support the bladder and the urethra. It was introduced primarily as a treatment for stress urinary incontinence, or SUI.
The ProteGen® sling was approved by the FDA through the filing of a 510(k) application, which is a process that eliminates the need for new research and safety studies and piggybacks onto previously approved devices that are substantially equivalent. Transvaginal mesh was originally used as a hernia mesh and has never actually been approved for treating incontinence.
The Boston Scientific mesh, ProteGen®, was subsequently recalled in 1999 after hundreds of complaints were received, but there are currently a number of transvaginal mesh products on the market and nine manufacturers in total. The primary manufacturers are American Medical Systems, Boston Scientific, C.R. Bard, and Johnson & Johnson, although Johnson & Johnson is the global leader in sales of transvaginal mesh devices.
Symptoms and Complications of Transvaginal Mesh Failure
Listed below are some of the symptoms or complications that have been reported as a result of using a transvaginal mesh implant. These complications and injuries can include:
- Mesh erosion through the vagina (mesh protruding out of vaginal wall)
- Vaginal Bleeding
- Vaginal Infection
- Scarring and scar tissue
- Urinary problems
- Organ perforation
- Hardening of the vaginal mesh
- Nerve damage
- Injury to nearby organs
- Severe pelvic pain
- Sexual dysfunction
- Mesh contraction and shrinkage
- Complications from surgery
- Additional surgeries to remove the mesh
- Permanent complications or disfigurement
If You Have Been Injured, We Can Help
If you have had a transvaginal mesh device implant that resulted in injury, complications, or additional surgeries, the attorneys at Zinda Law Group would like to help you. Call us today at (800) 863-5312 for your free consultation and let us help you get the care and compensation that you deserve.