Monday, May 21, 2012

Transvaginal Mesh and Stress Urinary Incontinence : Information and Non-Surgical Options

Continuing the discussion of stress urinary incontinence from part one of this article we will detail the non-surgical options used in the treatment of SUI as well as discuss the current differences in SUI devices and POP kits currently on the market. Stress urinary incontinence is a fairly common occurrence among women, particularly in those who have had gone through childbirth several times, who are in the midst of menopause or those who smoke, are obese, or have a genetic predisposition to SUI. While the most common solutions for cases of SUI are surgical, there are non-surgical options available.

Non-Surgical Options for SUI

The first non-surgical options fall under the category of maintenance of the disorder as they do not stop SUI symptoms, merely help manage them. Incontinence absorbents are widely sold at many stores and are specially designed to absorb urine and control any resulting odor. There are choices among these absorbent products such as reusable or disposable, but regardless of the type used, close attention must be paid to the skin in the area to avoid irritation or infection. Urethral inserts also provide control over loss of urine, odor and wetness however require a prescription from your physician. The single-use, disposable product is marketed under the brand name FemSoft and is worn when protection for leakage is necessary. This product can be used in conjunction with other non-invasive treatments.

Prior to suggesting surgical treatment most physicians will pursue other types of interventions. If a woman is overweight the physician may recommend weight loss to determine if the SUI symptoms will decrease. Studies indicate that obese women who both exercised and lost at least 10% of their body weight successfully reduced SUI leakage by 50%. Women who smoke will be counseled to quit, since cigarette smoke is well-known to cause a chronic cough, and coughing can escalate the symptoms of SUI. Pelvic floor muscle exercises, also known as Kegels, can help increase bladder control and decrease unwanted leakage however this technique requires discipline and commitment.

This level of discipline can be challenging, therefore special biofeedback devices are available to teach women the specific exercises. Small sensors are placed close to the muscles which are being monitored, giving the patient instant information regarding he muscles being used. Pelvic floor stimulation is sometimes used to help women strengthen the pelvic floor, and is based on the principle that an external stimulus causes the muscles to contract and gain strength. Duloxetine is currently the only prescription medication used in the treatment of SUI however it is not approved by the FDA for this particular use. Women undergoing menopause may suffer from a loss of estrogen which in turn contributes to SUI. Physicians may prescribe a topical form of estrogen which can improve the symptoms of SUI.

Differences in POP Kits on the Market

Since 2004, synthetic mesh has increasingly been used in the treatment of pelvic organ prolapse when surgery is warranted. Vaginal mesh kits were originally marketed to physicians as a method of improving success rates for POP repairs. Unfortunately, mesh has been found to bring its own risks, such as erosion, infection and degradation—risks which do not exist in native tissue repairs. There are a wide variety of POP kits on the market including:

1. Gynecare markets two types of POP kits sold under the brand names of Prolift and Prosima. These kits are specially designed soft mesh which is placed inside the pelvis to support the pelvic organs. A small incision is made and the physician inserts the mesh through the vagina, correcting any organs which have migrated from their normal position. The mesh is held in place by the friction which results from the strap-like arms of the mesh material, then the body’s natural tissues grow into the mesh pores. The surgery takes one to two hours and is performed under regional anesthesia.

2. Boston Scientific markets the Pinnacle and Uphold POP kits. The Pinnacle POP kit is designed to offer both Level 1 and Level 2 support. The surgeon performing the surgery will leverage the suture capturing device in order to facilitate the prolapse repair. The Pinnacle has protective sleeves which allow facilitation of mesh adjustability which allows better placement.
3.

4. AMS brands of POP kits are marketed under the brand names Apogee, Perigee and Elevate.
The Apogee is a simplified, tension-free system which implements a minimally invasive approach while restoring normal patient function. The Apogee is used in a transvaginal approach rather than open abdominal, and has pre-cut mesh grafts which can be trimmed to shape. The mesh arms have removable plastic sheaths to facilitate smooth passage and tension-free adjustments along with needle-tip connectors.

5. C.R. Bard has marketed the Avaulta System which is a permanent implant that provides stabilization of the pelvic organs and has knit arms which proved competent fixation of the mesh implant. Like the other products, the Avaulta is made of synthetic polypropylene mesh which can lead to erosion, infection and the need for further surgery.

While there are minor differences in the POP kits, they are substantially the same although the Perigee system appears to have fewer incidences of erosion among patients as compared to the others.

Differences in SUI Devices on the Market

The SUI devices which are marketed for the treatment of stress urinary incontinence include Gynecare’s tension-free vaginal tape which has been shown to work as well as the Burch colposuspension surgery to cure SUI with approximately eight in ten women judged to be cured a year following surgery, however long-term success rates are unavailable. Boston Scientific markets the Advantage, Lynx, Obtryx, Prefyx and Solyx while AMS markets the following SUI devices: In-Fast, Monarc and MiniArc. C.R. Bard offers Adjust, Align and Pelvilace while Mentor markets OBTape. As with the POP kits, these products are substantially the same with minor differences. Surgical mesh kits have evolved with the addition of new insertions tools, tissue fixation anchors, mesh materials as well as surgical techniques, yet there is still considerable concern regarding the polypropylene mesh used in most of these SUI devices.

Author: Sullo & Sullo Attorneys

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