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, causing a bulge in the vaginal wall, which in the worst cases, extends outside of the vaginal opening. POP is often linked to vaginal delivery and strain during childbirth. Surgery to remove the 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 or incontinence. Surgery for prolapse is performed twice as commonly as incontinence surgery, and prevalence varies widely from 6 to 18%. Surgical correction of pelvic organ prolapse (POP) is anticipated to increase 48% from 2010 to 2050 given the aging population in the United States. In fact, by age 80, more than one out of every ten women will have undergone surgery for prolapse.1, 2, 3
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 allow urine to leak out. Factors that can lead to SUI include: childbirth, age, tissue disorders, acute injury, constipation, 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.4
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.”5 This position statement was re-issued in 2016 with the support of additional organizations and confirmed again as recently as February 2018.
Following a 2011 U.S. Food and Drug Administration (FDA) Advisory Committee meeting, the FDA stated in 2013: “The safety and effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one-year." 6
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 and prevent urine leakage when pressures are placed upon the urethra.
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.
2Wu JM, Kawasaki A, Hundley AF, Dieter AA, Myers ER, Sung VW. Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050. Am. J. Obstet. Gynecol.Sep; 2011 205(3):230.e1–230.e5. [PubMed: 21600549]
3Olsen A, Smith V, Bergstrom J, et al. Epidemiology of Surgically Managed Pelvic Organ Prolapse and Urinary Incontinence, Obstetrics & Gynecology 1997:501-506