POP / SUI

The use of implantable mesh is often the preferred option to treat certain female pelvic conditions. Implantable mesh is considered by many to be the gold standard for treating stress urinary incontinence (SUI), and it is an important treatment option for some women suffering from pelvic organ prolapse (POP).

Pelvic Organ Prolapse

Pelvic Organ Prolapse (POP) is a serious medical condition that affects millions of women. POP occurs when the supportive muscles and tissues of the pelvis become weak, which causes the organs inside the pelvis to “drop” from their natural positions. POP is often linked to vaginal delivery and strain during childbirth. Surgery to remove your uterus (hysterectomy) can sometimes leave other organs in the pelvis with less support. POP can be made worse by anything that puts pressure on the pelvis, such as obesity, chronic cough, and constipation. Older women are more likely to have POP. It also tends to be hereditary.

Approximately 50% of woman who have given birth have some degree of POP. In fact, by age 80, more than one out of every ten women will have undergone surgery for prolapse.1

GYNECARE PROLIFT® PELVIC FLOOR REPAIR SYSTEM

GYNECARE PROLIFT® was developed by doctors seeking an improved pelvic floor repair surgery. Prior to the availability of pelvic mesh products, other surgical options, including procedures using native tissues, had unacceptably high rates of recurrence. Compared to these other surgical options, GYNECARE PROLIFT® provided a more durable repair.

Stress Urinary Incontinence

Stress urinary incontinence (SUI) is a common, treatable condition where an involuntary release of urine can occur from coughing, sneezing, laughing, or other effort or exertion. SUI is one of the most common types of urinary incontinence among women.

SUI occurs when weakened muscles below the urethra do not provide the necessary support for the urethra. Sudden movements from the diaphragm put stress on the bladder, causing the urethra to lose its seal and allowing urine to leak out. Factors that can lead to SUI include: childbirth, age, tissue disorders, acute injury, consitipation, frequent heavy lifting, estrogen deficiency or menopause, and obesity.

Studies show different rates, but it is suggested that 30% to 40% of women are afflicted with some type of urinary incontinence, and some of these will ultimately need surgical repair.2

The American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction issued a position statement in 2014 saying: “The polypropylene midurethral sling has helped millions of women with SUI regain control of their lives by undergoing a simple outpatient procedure that allows them to return to daily life very quickly. With its acknowledged safety and efficacy it has created an environment for a much larger number of women to have access to treatment.”3

Following a 2011 U.S. Food and Drug Administration (FDA) Advisory Committee meeting, the FDA stated: “The safety and effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one-year. Longer follow-up data is available in the literature, but there are fewer of these long-term studies compared to studies with one-year follow-up.”4

GYNECARE TVT™ Family of Products

Ethicon GYNECARE TVT™ is designed to provide support to the mid-urethra. Surgeons place a piece of flexible, permanent mesh underneath the urethra. The body then naturally incorporates the mesh into the surrounding tissue to provide support when pressures are placed upon the urethra to prevent urine leakage.

GYNECARE TVT™ Tension-free Support for Incontinence has demonstrated proven results for effectively treating stress urinary incontinence. GYNECARE TVT™ Tension-free Support for Incontinence is supported by numerous clinical studies, more than any other sling on the market.

More than 2 million patients have been treated worldwide with GYNECARE TVT™ Tension-free Support for Incontinence.

1Olsen A, Smith V, Bergstrom J, et al. Epidemiology of Surgically Managed Pelvic Organ Prolapse and Urinary Incontinence, Obstetrics & Gynecology 1997:501-506
2http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1476070/
3http://www.augs.org/d/do/2535
4http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345219.htm