American Medical Systems (AMS), a subsidiary of Endo International PLC, has agreed to settle about 360 vaginal mesh lawsuits. The settlement value has not been disclosed, but AMS has said that it would use $830 million for settlement funds. Transvaginal mesh is used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. Serious complications are so common that the U.S. Food and Drug Administration (FDA) has required medical device makers to reclassify the mesh as a high risk device.
Transvaginal Mesh
Transvaginal mesh is also referred to as vaginal mesh and bladder sling. It is used to support the pelvic organs in women with SUI and POP. In transvaginal mesh surgery the mesh is inserted through an incision in the vaginal wall.
SUI and POP can be surgically corrected without using transvaginal mesh. The transvaginal mesh procedure is less invasive and faster than tradition surgery to correct SUI and POP, but the risk of complications is very high.
SUI is a condition in which the muscles that support the bladder and urethra are weak, allowing small amount of urine leak out during physical activity. The “physical activity” can be simple as laughing coughing or sneezing.
POP is a condition in which the pelvic organs, such as the bladder, uterus, or bowel, drop or bulge into the vagina as a result of weakening or stretching of the tissues that hold the organs in place. About half of all women over 50 develop POP. It is most often caused by childbirth or hysterectomy.
Transvaginal Mesh Injuries
Transvaginal mesh injuries are rarely fatal, but they can destroy a woman’s quality of life and cause severe chronic pain. Women who experience transvaginal mesh complications require revision surgery, and even after multiple surgeries the injuries may not be reversed. Transvaginal mesh injuries can include:
- Mesh erosion through the vaginal wall
- Fistulas connecting the vaginal to the bladder, colon, or rectum
- Persistent discharge
- Persistent odor
- Infections
- Bleeding
- Urinary problems
- Granuloma formation
- Recurrence of POP or SUI
- Vaginal scarring
- Vaginal shortening due to mesh shrinkage
- Severe and persistent pelvic pain
- Pain during intercourse (dyspareunia)
- Inability to have intercourse
- Bladder, bowel, or blood vessel perforation during surgery
Surgery to remove defective vaginal mesh is not always successful. Women who experience complications can suffer life-long debilitating pain. For many there is no medical procedure that can relive their suffering, and in addition to the pain and other injuries, it is not uncommon for POP or SUI to come back when defective mesh is used.
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