Transvaginal mesh and slings were created to help patients suffering from pelvic organ prolapse and stress urinary incontinence. Originally, surgeries for stress urinary incontinence or pelvic organ prolapse were performed abdominally by placing sutures above the bladder neck to prevent incontinence or sutures under the vaginal skin to prevent prolapse. These surgeries were widely successful in the 1970s and 1980s. However, given concerns regarding the invasive nature of the surgeries and recovery time for abdominal surgeries, manufacturers began to market the use of mesh and slings during vaginal surgery. For a more complete timeline of events, please visit the vaginal mesh timeline page.
began to market their mesh and sling products for vaginal surgery by hosting cadaver workshops. During these workshops, doctors would practice implanting the mesh and slings in cadavers. Generally, the workshops would take place over one day and gynecologist and urologist attendees would begin to implant the mesh and slings in patients over the next couple of months.
Patients began to experience terribly painful symptoms including pelvic pain, pain during intercourse (dyspareunia), urinary tract infections, vaginal bleeding and urinary retention. These symptoms were associated with mesh complications including mesh erosion, mesh exposure, mesh shrinkage/contraction and mesh migration. In many instances, patients have undergone removal surgeries to attempt to repair these conditions.
The FDA has asked mesh manufacturers including Ethicon (J&J subsidiary), C.R. Bard and AMS to conduct three years of trials on the safety and effectiveness of their products.
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In June 2012, Johnson & Johnson’s Ethicon division announced that it would stop selling four types of mesh implants, GynecareTVTSecur™ System, GynecareProsima™ Pelvic Floor Repair System, GynecareProlift™ Pelvic Floor Repair System, and GynecareProlift+M™ Pelvic Floor Repair System, used to treat stress urinary incontinence. The company claimed that it was removing the products “in light of changing market dynamics, and is not related to safety or efficacy.” However, the timing is very coincidental in light of the FDA’s demand that the manufacturers test these products and monitor adverse event reports.
Similarly in July 2012, C.R. Bard stopped selling the AvaultaPlus Biosynthetic Support System. This was revealed after a $5.5 million verdict was obtained for a Plaintiff in California against C.R. Bard based on the AvaultaPlus Biosynthetic Support System.
Vaginal Mesh and Sling products remain a large portion of manufacturers’ profits and it has been reported that manufacturers have sold approximately $175 million worth of pelvic organ prolapse mesh and another $295 million for stress urinary incontinence in 2010.
For more information regarding transvaginal mesh lawsuits, please contact an experienced attorney at Pierce | Skrabanek. Our attorneys have handled medical device and pharmaceutical cases and are available for a free consultation. All cases are handled on a contingency basis meaning we don’t get paid until we win.
Transvaginal mesh is a type of woven surgical mesh, generally made of polypropylene, inserted through the vagina for treatment of stress urinary incontinence (“SUI”) or Pelvic Organ Prolapse (“POP”)
Transvaginal mesh is used to treat stress urinary incontinence (“SUI”) which is a condition involving weakened pelvic muscles that cause the urethra to involuntarily leak urine. Transvaginal mesh is also used to treat pelvic organ prolapse (“POP”) which is a condition in which the muscles stretch and weakened pelvic muscles cause the bladder and urethra to fall from their normal position pushing against the vaginal wall.
The most frequent complications with Transvaginal mesh include erosion, organ perforation, infection, dyspareunia, pelvic pain and recurrent prolapse and incontinence.
In some of the more severe cases, the treatments for complications such as erosion and organ perforation can include surgical removal of the mesh, trimming of the mesh and antibiotic treatment for the infections. If you have experienced pelvic pain, dyspareunia, infections or vaginal bleeding, it is important that you see your doctor and discuss treatment options. Your doctor might recommend a vaginal ultrasound or physical examination to determine the severity of your complication.