Transvaginal mesh is a medical device used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. It was initially seen as an improvement over traditional surgery to treat the conditions, because the procedure to place it is minimally invasive and requires a smaller incision. Over time it was discovered that serious transvaginal mesh complications were not uncommon and they can be irreversible.
What is Transvaginal Mesh?
Transvaginal mesh is surgical mesh that is inserted in a woman’s body, transvaginally, to treat SUI and POP. It is sometimes referred to as a bladder sling. The mesh is used to support internal organs when the pelvic floor has become weak as a result of childbirth, obesity or another cause.
In transvaginal placement, the mesh is inserted through an incision in the vaginal wall. The mesh can be placed abdominally instead. The transvaginal procedure was thought to be an improvement because it is less invasive.
Pelvic Floor Disorders
SUI is a condition in which the muscles that support the bladder or urethra are weak, causing women to experience urine leakage, sometimes from very minor activity such as sneezing or laughing. In POP, the tissues that hold the pelvic organs in place are weak or stretched, allowing one or more of the organs, such as the bladder or small bowel, to protrude into the vagina.
Both conditions can sometimes be treated with surgery that does not involve any surgical mesh.
Transvaginal Mesh Injuries
Transvaginal mesh complications can include:
- Erosion of the mesh into the vagina
- Vaginal scarring
- Vaginal shrinkage, due to scar tissue
- Infection
- Bleeding
- Pelvic pain
- Vaginal fistulas
- Organ perforation
- Severe pain during intercourse
- Neuromuscular problems
- Emotional problems
- Recurrence of POP or SUI
Treatment for transvaginal mesh complications includes surgery to remove the mesh, often multiple surgeries. However, it is not always possible to completely remove the mesh because it is designed to be permanent and, over time it becomes integrated with the body’s tissues. Transvaginal mesh injuries can be permanent. The longer the mesh is in place, the more difficult it is to remove.
The FDA and Transvaginal Mesh
In 2008, the U.S. Food and Drug Administration (FDA) said that transvaginal mesh complications were rare. In 2011, it revised its stance, stating that complications were not rare. Later that year it convened and advisory panel to gather recommendations on transvaginal mesh for POP.
In 2012, the FDA issued post market study orders to numerous manufacturers of transvaginal mesh for POP and SUI repair. And in January 2016, the agency gave manufacturers of existing transvaginal mesh for POP 30 months submit a premarket approval (PMA) to address safety concerns.
If you have concerns about transvaginal mesh or believe you have been harmed, call us toll-free at 800-DRUG-411 (800-378-4411) or email us. We will help you find answers to your questions and we can help you find an attorney who represents victims injured by transvaginal mesh.