Transvaginal mesh (also known as vaginal mesh) is a medical implant that treats incontinence and organ prolapse. Unfortunately, it has been linked to severe side effects — including erosion into the vagina, perforation of internal organs, nerve damage, scarring, disfigurement, and chronic pain. Many of these conditions require revision surgery. Unfortunately, even with multiple surgeries, some complications may be permanent.
Do I Have a Transvaginal Mesh Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been diagnosed with complications of transvaginal mesh, you should contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit, and we can help.
Transvaginal Mesh: An Overview
Surgical mesh products have been used in abdominal hernia repair since the 1950s. After they were proven effective, surgeons began experimenting in the 1990s with transvaginal mesh products to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
The first surgical mesh material was FDA approved for SUI in 1996 — and the FDA cleared the first surgical mesh product specific for POP repair in 2002. Over the last decade, transvaginal mesh has become very popular. In 2010 alone, 75,000 women underwent POP repairs that used transvaginal mesh products. An additional 208,000 underwent transvaginal mesh repair procedures of SUI, the FDA reports.
Problems With Transvaginal Mesh
Unfortunately, the FDA has also identified at least 3,979 reports of injury, death and malfunction associated with transvaginal mesh products, including 2,874 within the past 3 years (January 1, 2008 – December 31, 2010). There were 1,503 reports of injury or malfunction linked to POP repairs and 1,371 linked to SUI repairs. Seven deaths were associated with POP repairs — three of them were determined to be directly related to mesh placement procedures. The most-frequently reported complication is erosion, which occurs when the body rejects the inserted mesh, causing the mesh to protrude through the vaginal wall.
Symptoms of Transvaginal Mesh Complications
- Organ perforation
- Need for revision surgery
- Vaginal discharge
- Pelvic pain
- Vaginal pain
- Dyspareunia (pain during sexual intercourse)
- Inability to engage in sexual intercourse
- Recurring prolapse or incontinence
- New onset of urinary incontinence
- Vaginal scarring, shortening
- And more
FDA Safety Warnings for Vaginal Mesh
In 2008, the FDA first warned transvaginal mesh products have been linked to higher risks of post-operative complication. While the FDA said the complications were rare, they advised they had received over 1,000 reports. The most common complication was erosion, where the synthetic mesh is rejected by the body and begins to protrude through the vaginal wall. The FDA said complications could decrease a patient’s quality of life and lead to dyspareunia, or pain occurring during sexual intercourse.
In July 2011, the FDA released another Safety Communication. The updated version amended a previous statement; the FDA notified patients and healthcare professionals that complications associated with transvaginal mesh procedures were not rare, as previously believed. Additionally, a review of scientific evidence lead the FDA to conclude that transvaginal mesh procedures offered no benefit over traditional non-mesh procedures and may even place patients at a greater risk.
What is Transvaginal Mesh Made From?
Mesh is divided into four categories by the FDA:
- non-absorbable synthetic mesh (make of polypropylene or polyester)
- absorbable synthetic
- biological (bovine or porcine sources)
- composite (combination of the other three materials).
When mesh products were first used in transvaginal procedures, mesh used in hernia repairs were cut to fit the organ being supported. More recently, however, transvaginal mesh “kits” have been developed. These kits feature pre-shaped mesh and the accessory tools needed for transvaginal implant of the mesh.
What is Pelvic Organ Prolapse?
Pelvic organ prolapse occurs when the pelvic organs begin to bulge (or prolapse), as a result of weakening tissues around the organs. Most often, the pelvic organs (bladder, uterus, bowel, rectum and top of the vagina) begin to sag into the vaginal wall. This can create pain and discomfort for some women. More than one organ may prolapse at one time and they may prolapse past the vaginal opening. Symptoms associated with POP include constipation, difficulty urinating or defecating, vaginal lump, and/or problems with sexual intercourse.
Most commonly, POP occurs after pregnancy or childbirth, but it can occur in women who have never had children. Several factors may contribute to POP including smoking, menopause, obesity, family history, pelvic trauma, previous surgeries, multiple vaginal deliveries, diabetes and connective tissue disorders. Anywhere between 30-50 percent of women will experience POP during their lifetime. Yet, only 2 percent will develop symptoms. Most symptoms may be treated through exercise or vaginal inserts known as pessaries. However, some cases are severe enough to warrant surgery.
What is Stress Urinary Incontinence?
Stress urinary incontinence is an uncontrollable release of the bladder that occurs during physical activity. Anywhere between 20-40 percent of women are affected by it. Sneezing, coughing, laughing or physical exercise causes a leakage of urine to occur. SUI surgery is conducted by placing a “sling” underneath the urethra for support, in order to prevent urinary loss.
Transvaginal Mesh Manufacturers
There are no vaginal mesh class action lawsuits for people with severe injuries. However, the following manufacturers of vaginal mesh are currently facing 60,000+ lawsuits in a federal Multi-District Litigation (MDL):
- 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
Do I Have a Transvaginal Mesh Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas vaginal mesh lawsuit review or you may also call us directly by dialing (866) 879-3040.