Pelvic organ prolapse 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. This causes a bulge in the vaginal wall, which in the worst cases extends outside of the vaginal opening. Pelvic organ prolapse is often linked to vaginal delivery and strain during childbirth. Pelvic organ prolapse can be made worse by anything that puts prolonged pressure on the pelvis, such as obesity, chronic cough, and constipation. Older women are more likely to have this condition. It also tends to be hereditary.
Stress urinary incontinence occurs when weakened muscles below the urethra do not provide the necessary support for the urethra. Sudden movements from the diaphragm, like laughing or coughing, put stress on the bladder, causing the urethra to lose its seal and allow urine to leak out. Factors that can lead to stress urinary incontinence include: childbirth, age, tissue disorders, acute injury, constipation, frequent heavy lifting, estrogen deficiency or menopause, and obesity.
For many women with bothersome stress urinary incontinence and pelvic organ prolapse, doing nothing is not an option. There are limited treatment options for women suffering from pelvic organ prolapse or stress urinary incontinence, some surgical and some nonsurgical. Women typically decide to undergo surgery after trying more conservative options without success. Patients with either condition should discuss treatment options with their doctor including whether or not surgery is right for them.
Ethicon devices are among the most studied products for these conditions. Ethicon conducted and published clinical studies to evaluate safety and efficacy, even though there were no regulatory requirements mandating the studies.
Over 700 patients were studied with the mesh used in GYNECARE PROLIFT® before PROLIFT was launched as a treatment option for pelvic organ prolapse, and numerous clinical studies, including randomized controlled trials (RCTs), involving PROLIFT have been conducted since launch. Those studies demonstrated that PROLIFT was efficacious and had a positive benefit-to-risk profile and an acceptable rate of post-operative complications when used with appropriate patient selection and proper surgical technique.
Further, over 100 independent studies, involving thousands of women, corroborated PROLIFT’s safety and efficacy. The results from these studies have been subjected to rigorous review by experts and have been published in some of the most prestigious medical journals in the field.
Ethicon’s mid-urethral sling TVT™ Devices are the most studied stress urinary incontinence treatment as recognized by medical societies, the recent 2015 Cochrane Review and numerous systematic reviews and meta-analyses. There are also numerous longer term studies on these devices. More than 100 RCTs involving TVT products have been conducted since the initial launch of TVT in 1997.
Both the benefits and risks of surgery should be discussed between the doctor and patient.
In 2012, Ethicon determined that, although the products were safe and effective options for women, it would stop commercialization of the transvaginal pelvic mesh products. This decision was reached after considering the commercial viability of these products in a competitive and declining U.S. market, the complexities of the FDA clinical study requirements, the availability of other available treatment options for women, and the significant adverse publicity being driven by the litigious environment in the U.S.
The following products were discontinued: GYNECARE PROSIMA™ Pelvic Floor Repair System, GYNECARE PROLIFT® Pelvic Floor Repair System, GYNECARE PROLIFT + M® Pelvic Floor Repair System and the GYNECARE TVT SECUR™ System. In addition, the indication for GYNECARE GYNEMESH® PS was revised to provide for only abdominal placement of the mesh to treat prolapse."
There are a limited number of treatment options for women suffering from these conditions. Physicians typically offer mesh devices as an option to women who have tried more conservative options without long-term success.
Non-surgical treatment options include Kegel exercises to strengthen the pelvic floor, and pessaries, balloon-like devices inserted through the vagina to hold organs in place. Not only are these treatment options often ineffective, but pessaries also carry risks of complications such as bleeding, vaginal discharge, discomfort, erosion and open sores in the vaginal wall.
Surgical options include everything from colporrhaphy (native tissue repair), which involves suturing the patient’s weakened tissue, to reconstruction of the pelvic floor or suturing the vagina closed altogether, to open abdominal surgery to suspend the vagina or uterus from the sacrum using mesh or biologic grafts.
You may have recently seen attorney advertising around the topic of pelvic mesh. Attorney advertising, rather than scientific findings, has come to define this issue and deterred some women from getting treatment that they need to improve their quality of life and, in some cases, has resulted in women having unnecessary surgeries.