Transvaginal Mesh Terminology and Timeline

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Anterior Repair – performed to correct cystocele and generally involves creating an opening in the layers between the vagina and bladder and placing sutures to reinforce the tissues.

Cystocele – condition in which the fibrous wall between a woman’s bladder and vagina (pubocervical fascia) is torn. There are varying grades: grade 1- mild and when the bladder droops only a short way into vagina, grade 2- bladder sinks far enough to reach the opening of the vagina, grade 2- bladder bulges through opening of the vagina

Enterocele (small bowel prolapse) – occurs when the intestine bulges into the vagina. Enterocele can occur from the front, back or top.

Erosion – the destruction or degradation of tissue by inflammation, irritation or ulceration.

Pelvic Floor – the pelvic floor is a group of muscles that forms a sling or hammock across the opening of the woman’s pelvis and keep all the pelvic organs in place.

Pelvic Organ Prolapse – condition in which muscles (see above can be between bladder and vagina or rectum) stretches and weakened pelvic muscles cause bladder and urethra to fall from their normal position pushing against vaginal wall.

Posterior repair – performed to correct rectocele and generally involves creating an opening in the vagina and tissue layers under the skin and is reinforced with strong sutures to prevent bulging.

Procidentia (uterine prolapse) – occurs when muscles and ligaments are weakened and the woman still has a uterus, the uterus can descend into vagina.

Rectocele – condition in which fibrous wall separating the rectum from the vagina becomes weakened. A small rectocele may not cause any symptoms. However, a large rectocele can cause a noticeable bulge in the vaginal opening.

Stress Urinary Incontinence – weakened pelvic muscles allow urethra to involuntary leak urine

Transvaginal Mesh – 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”).

Urinary Tract Infection (“UTI”) – an infection of one or more of the structures of the urinary system, e.g. urethra, ureter or bladder.

Vaginal Sling – the sling often made of polypropylene creates a hammock to prevent the urethra from involuntarily leaking urine.

Vaginal Vault Prolapse – occurs when the upper portion of the vagina (apex) falls towards the vaginal opening. This may cause the walls of the vagina to weaken. Commonly occurs after a hysterectomy.


OBGYNs begin using mesh for pelvic organ prolapse.


OBGYNs begin using mesh for stress urinary incontinence.


FDA approves Boston Scientifc ProtenGen device by 510k route. The evidence presented by Boston Scientific was based on a 3 month rat study.


Johnson & Johnson introducest TVT sling for stress urinary incontinence and the FDA approves it as substantially similar to Boston Scientific's ProteGen.


Boston Scientific recalls ProteGen stating that it did not meet the "company's standard of performance."


FDA issues a Public Health Notification stating that these are serious complications associated with the use of transvaginal mesh based on reports from 2005 - 2007.

  • FDA's MAUDE datebase reports 2,874 adverse events. 1,503 were for pelvic organ prolapse and 1,371 were for stress urinary incontinence.
  • FDA releases an alert regarding the safety risks associated with vaginal mesh and POP repair may pose risks to patients.
  • FDA Advisory panel states that mesh used for POP should be changes from moderate risk to high risk and additional studies must be conducted.
  • The Judicial Panel on Multidistrict Litigation (MDL) consolidates the cases before Judge Joseph R. Goodwin in Southern District of West Virginia.
  • Johnson & Johnson stops selling Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift +M products
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