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Transvaginal mesh is a net-like implant used to treat pelvic organ prolapse(POP) and stress urinary incontinence(SUI) in women. While surgical mesh has been used since the 1950s to repair abdominal hernias, gynecologists began using surgical mesh to treat POP and SUI in the 1990s. The first surgical mesh specifically designed for SUI was approved by the FDA in 1996. Later in 2002, FDA approved the first surgical mesh specifically for use in POP.
Transvaginal Mesh and Pelvic Organ Prolapse: Pelvic organ prolapse is a condition in which the bladder, top of the vagina, uterus, rectum or bowel has descended from its normal position. The condition is thought to be the result of weakened pelvic muscles, usually from pregnancy and childbirth. To treat pelvic organ prolapse, surgical mesh can be implanted at the time of a hysterectomy or as a separate surgery. Mesh is most commonly placed in the anterior vaginal wall to correct a bladder prolapse; the posterior vaginal wall to correct a rectal prolapse and the top of the vagina to correct a uterine prolapse. When surgical mesh is inserted through the vagina, it is referred to as transvaginal mesh.
Transvaginal Mesh and Stress Urinary Incontinence: When a bladder sling is inserted through the vagina, it is known as transvaginal mesh. Surgical mesh can also be used to create a bladder sling that is positioned under the urethra and bladder neck and anchored on the sides. The bladder sling is designed to treat stress urinary incontinence (SUI), which occurs when the bladder is stressed by an everyday activity, such as sneezing or laughing, and subsequently leaks urine. The sling keeps the urethra and bladder neck closed during normal activities, stopping the leakage.
Manufacturer market data from 2010 indicates that in 2010 approximately 300,000 women underwent surgical procedures in the United States to repair POP and approximately 260,000 underwent surgical procedures to repair SUI.
Some of the most popular bladder slings are:
- Tension-free vaginal tape (TVT): A polypropylene mesh tape is used under the urethra and is held in place by the patient's body.
- Transobturator tape (TOT): Less invasive than TVT, because there is no need to use a large needle when inserting it.
- Mini-sling: Eliminates the need for abdominal incisions. A metallic inserter and a vaginal incision are used to place the mesh tape.
Most common potential injuries or side effects associated with defective pelvic mesh products are:
- Abdominal And Pelvic Pain
- Multiple Surgeries to repair or remove mesh
- Mesh Erosion
- Reoccurrence of POP or SUI
- Dyspareunia (Painful Sexual Intercourse)
Between 2005 and 2010, nearly 4,000 injuries were reported to the FDA in connection with transvaginal/pelvic mesh devices. The FDA first alerted the people to transvaginal mesh problems when it released a safety communication in 2008 regarding the complications associated with the transvaginal placement of surgical mesh to treat POP and stress urinary incontinence (SUI). The FDA warned patients and healthcare providers in July 2011 of the risks associated with the use of transvaginal mesh and recommended they consider alternatives for treating POP and SUI; conditions that may occur after childbirth and pregnancy.
Not less than 30,000 lawsuits related to transvaginal mesh procedures are currently making their way through state and federal courts across the country, alleging serious problems with products made by: Boston Scientific, Johnson & Johnson, Ethicon, American Medical Systems, Coloplast, C.R. Bard, Mentor, etc.
Evidence to be looked for in potential cases
- Usage of transvaginal mesh in operative records.
- Product identification (implant stickers) in the medical records.
- Proof of Injury in Medical Records.
- Treatment provided for the injuries.
Medical Record Review and claim validation of TVM case should take approximately 1 hour and 30 minutes in most instances; however, this approximation may vary in cases based on the volume of records.