For many women with stress urinary incontinence and pelvic organ prolapse, doing nothing is not an option.
Treatment Options
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, inability to engage in sexual activity, 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.
The most significant, well-known risks of pelvic surgeries such as these are bleeding, pelvic pain, painful sexual intercourse, organ damage, and nerve damage. For stress urinary incontinence, the Burch colposuspension used to be the golden standard prior to the midurethral tapes such as TVT™. This was an abdominal procedure which was effective – but with significant morbidity.
The surgery was also known to lead to variable outcomes depending on the surgeons’ level of expertise. And surgical options for many types of both prolapse and stress urinary incontinence have high failure rates. For prolapse, up to 30-50%; for stress urinary incontinence, up to 25 to greater than 50% at five to fifteen years from surgery.
It was these inadequacies and the invasiveness of existing treatments that led to development of transvaginal pelvic mesh devices.
All surgical pelvic floor procedures –with and without mesh –come with the risk of developing complications, including pelvic pain and pain with intercourse. For patients, it is critical that both the benefits and risks of surgery are discussed between a patient and their doctor.
Product History
Our pelvic meshes are made of knitted PROLENE® Polypropylene. Prolene Polypropylene has been used safely in the body since the 1960s, and has been the subject of extensive testing. Ethicon’s mesh was developed and manufactured specifically for use as implantable medical devices. The mesh materials in Ethicon products have a long clinical history of safe use in the body.
In 1997, the tension-free vaginal tape (TVT™) was introduced, in which a knitted Prolene® Mesh Tape is positioned in a minimally-invasive, tension-free manner under the mid-urethra, as opposed to the bladder neck.
In January 1998, the FDA cleared TVT™ as a treatment for stress urinary incontinence.
Ethicon first received regulatory approval to market its TVT™ Device in Europe in 1997.
Transvaginal mesh products were utilized as materials in the surgical treatment of pelvic organ prolapse as early as the late 1990s to address the high levels of recurrence rates associated with traditional repairs using the patient’s own tissue and to provide a less invasive surgical approach than open abdominal repairs.
In 2000, the idea of creating kits similar to the transvaginal mesh kits for stress urinary incontinence emerged, and Ethicon launched PROLIFT®, its first mesh kit for pelvic organ prolapse, in 2005.
TVT™ was included on the Australian Register of Therapeutic Goods (ARTG) under the current regulatory regime in January 2004.
In Europe, PROLIFT® was CE marked in March 2005, and PROLIFT+M® was CE marked in November 2008.
"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." - FDA, 20115
In 2012, Ethicon determined that, although the products remain good treatment options for women, it would stop commercialization of the TVT SECUR™ System and the transvaginal products, GYNECARE PROLIFT™ Pelvic Floor Repair System, GYNECARE PROLIFT+M Pelvic Floor Repair System, GYNECARE PROSIMA* Pelvic Floor Repair System to treat pelvic organ prolapse.
In April 2018 in Australia and New Zealand, the labelling of the Gynecare TVT devices was revised to meet regulatory requirements of the regulatory bodies in Australia and New Zealand.
Commitment to Research
Our TVT™ Products are the most studied mesh devices for stress urinary incontinence on the market today. Since we launched the TVT Device in 1997, more than 100 randomized trials (highest level of evidence) have been conducted and support that the product can perform safely and effectively.
The mesh used in GYNECARE PROLIFT® was studied in over 700 patients before the kit was launched. Numerous clinical studies, including randomized controlled trials have been conducted since. Those studies showed that with the right patients and the proper surgical technique, the procedure not only worked, it also had a low rate of significant post-op complications.
After our medical devices are on the market, we closely monitor the clinical performance of these devices, irrespective of their device classification.
We continuously review sources of information about safety, including adverse event reports, post-market studies and published clinical studies. We take appropriate action based on that data.
In addition to the rigorous testing required by regulatory bodies, we've gone a step further to evaluate safety and efficacy by conducting and publishing our own clinical studies and providing funding or support to studies initiated by surgeons.