Transvaginal Mesh Implants

Transvaginal mesh implants were one of many methods used to treat:

• Stress urinary incontinence
• Pelvic organ prolapse 

These conditions occur when the muscles and ligaments supporting a woman’s pelvic organs (bladder, rectum, uterus, vaginal canal and bowel) weaken.  This weakening results in stress urinary incontinence (leaking urine with sneezing, laughing, running, etc.) and organs slipping out of place.  The symptoms of these conditions include:

• Urinary incontinence
• Sensation of vaginal fullness or pressure
• Back pain
• Spotting
• Lower abdominal pain
• Bowel abnormalities

Transvaginal mesh implants were originally cleared for marketing by the FDA in 2002; however, many gynecologic surgeons believed that the use of these mesh like products to hold the prolapsed organs in place was controversial from the outset.  There were little to no studies done on transvaginal mesh implants before manufacturers began marketing them for use.  These manufacturers include

• Johnson & Johnson through their subsidiary Ethicon (Gynecare implant system)
• American Medical Systems (Elevate, Apogee, Perigee, Monarc and Sparc implant systems)
• Boston Scientific (Pinnacle and Uphold implant systems)
• Bard (Avaulta implant system)
• And others

From 2005-2010, the FDA received 3,785 reports of injuries from transvaginal mesh implants.  These injuries included:

• Mesh erosion
• Erosion of the vaginal tissue
• Infection
• Pain
• Perforation of the bowel, bladder or blood vessels
• Recurrence of stress urinary incontinence
• Recurrance of pelvic organ prolapse
• Scarring

On July 13, 2011, the FDA issued a statement that serious complications are not rare with the use of transvaginal mesh.  This statement was based on a review of literature from 1996-2011 that concluded that transvaginal mesh does not improve symptoms or quality of life more than non-mesh repair.  Not surprisingly, a 2011 study published in the Journal of Obstetrics and Gynecology stated, “Until adequate effectiveness and safety evidence is available, the use of new transvaginal mesh devices for prolapse repair should be considered experimental and restricted to use in investigative trials.”

If you or a loved one has been injured by a transvaginal mesh implant, contact Cannon & Dunphy, S.C. today for a free confidential consultation with the women on our staff. 

We are large enough to have the best available technology and resources available to pursue your case, but small enough to provide you with the individualized attention that you and your case deserve.