Transvaginal mesh is a medical device that is used to treat incontinence and organ prolapse in women. Unfortunately, thousands of women have been seriously injured when their implant eroded into their vagina, perforated organs, caused chronic pain, or required revision surgery.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting transvaginal mesh induced injury cases in all 50 states. If you or somebody you know has been injured by transvaginal mesh, you should contact our firm immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Vaginal Mesh: An Overview
Vaginal mesh is one option used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). In 1996, the FDA cleared the first surgical mesh product for use in SUI procedures. And in 2002, it cleared the first for POP procedures.
When used in transvaginal POP repair, mesh is inserted through small stitches made in the vaginal wall (also known as “transvaginal”) to reinforce the weakened vaginal wall and support bulging organs. For SUI repair, the mesh is used as a sling to support the urethra.
In 2010, the FDA reports approximately 300,000 women underwent surgical procedures in the United States to repair POP — 260,000 underwent SUI repair procedures. One out three POP surgeries used mesh, and 75% of the mesh POP procedures were done transvaginally. For SUI surgeries, 80% were done with transvaginal mesh.
Problems With Transvaginal Mesh
Unfortunately, in 2008 and again in July of 2011, the FDA warned of the possible adverse side effects of surgically implanted transvaginal mesh. To date, the FDA has received over 3,874 reports of injury, death and malfunction occurring after transvaginal mesh procedures.
The most common complications included erosion of mesh through the vagina (also known as exposure, extrusion or protrusion), pain, dyspareunia, infection, urinary problems, bleeding, and organ perforation. There were additional reports of recurring prolapse or incontinence, neuro-muscular problems, vaginal scarring or shrinkage, and emotional problems. Some of these symptoms required hospitalization and additional revision surgery, sometimes even to remove the mesh.
Side Effects of Transvaginal Mesh
- Erosion through the vagina
- Organ perforation (bowel, bladder and blood vessel)
- Need for revision surgery
- Infection
- Bleeding
- Severe pelvic of vaginal pain
- Painful sexual intercourse (dyspareunia)
- Inability to engage in sexual intercourse
- Recurring prolapse or incontinence
- Neuro-muscular problems
- Vaginal scarring
- Mesh contraction
- Vaginal shortening/shrinking
What is Transvaginal Mesh Made From?
Mesh materials can be divided into four general categories:
- Non-absorbable synthetic (polypropylene or polyester)
- Absorbable synthetic
- Biological (acellular collagen derived from bovine or porcine sources)
- Composite (combination of any of the previous three categories)
Most meshes used in transvaginal surgeries are composed of non-absorbable synthetic polypropylene.
What is Pelvic Organ Prolapse (POP)?
Pelvic organ prolapse occurs when the tissue surrounding pelvic organs becomes weakened or stretched, often from childbirth. While it is commonly associated with pregnancy, it can occur even if a woman has never had children. It causes organs (including the bladder, uterus, bowel, rectum and top of the vagina) to bulge into the vagina. More than one organ may prolapse at once and they may prolapse past the vaginal opening.
Anywhere between 30-50 percent of women will experience POP during their lifetime, but only 2 percent will develop symptoms. Most cases can be treated through exercise or vaginal inserts called pessaries. However, women have an 11 percent lifetime incidence of having POP or SUI surgically repaired. Surgical repair may be done abdominally or transvaginally.
What is Stress Urinary Incontinence (SUI)?
Stress urinary incontinence affects anywhere between 20-40 percent of women. It is characterized by a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing or exercise. It can be treated through exercise or surgery, either done abdominally or transvaginally. When treated transvaginally, a synthetic sling is placed under the urethra to prevent urinary loss during physical activity.
Synthetic Mesh Manufacturers
In 2008, the FDA stated nine manufacturers were mentioned in the reports of post-surgical transvaginal mesh complications. The majority of adverse events have been noted among products made by:
- C.R. Bard, MDL No. 2187
- American Medical Systems, MDL No. 2325
- Boston Scientific, MDL No. 2326
- Johnson & Johnson, Ethicon, MDL No. 2327
- Coloplast Corp, MDL No. 2387
- Cook Medical, MDL No. 2440
- Mentor Corp. ObTape Transobturator Sling, MDL No. 2004
FDA Warnings for Vaginal Mesh
October 20, 2008 — On this date, the FDA released a Public Health Notification, warning patients and doctors of over 1,000 reports of complications associated with transvaginal placement of surgical mesh in repair of POP and SUI.
At the time, the FDA stated that the complications were reported in rare cases. The most commonly reported side effect was erosion through the vaginal wall, but other complications included pain, urinary problems, recurrence, organ perforation and vaginal scarring. The FDA reported that cases of vaginal scarring and erosion caused a decrease in patient quality of life and pain, including dyspareunia.
July 13, 2011 — The FDA updated its 2008 Public Health Notification with a Safety Communication. The FDA reported that complications were not rare, contrary the the FDA’s previous statement. Additionally, the complications may be life-altering.
On top of the 1,000 reports of complications received prior to its 2008 notification, the FDA received an additional 2,874 reports of injury, death and malfunction. 1,503 were associated with POP repairs, while 1,371 were associated with SUI repairs. There were also seven deaths linked to POP repairs. Three of the deaths were directly associated with mesh placement procedures. It appeared post-operative medical complications led to the other four.
Additionally, the FDA reported patients who received a transvaginal mesh procedure were at greater risk of complications over patients who received traditional non-mesh procedures. Synthetic mesh vaginal procedures introduced risks not present in other non-mesh surgeries. The FDA also suggested transvaginal POP repair does not appear to provide any benefit compared to traditional surgeries without mesh — it does not improve quality of life.
Do I Have a Transvaginal Mesh Lawsuit?
The Schmidt Firm, PLLC is currently accepting transvaginal mesh induced injury cases in all 50 states. If you or somebody you know has been injured by transvaginal mesh, you should contact our firm immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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