Also, this technique is not always effective long-term, Dr. Harmanli notes. So, in the s, gynecologic and urologic surgeons began to experiment with mesh, cutting it themselves and inserting it through abdominal incisions. In the s, a minimally invasive approach—making an incision in the vagina to insert the mesh in an effort to shorten recovery time—was developed. Meanwhile, the FDA approved the first pelvic mesh for stress urinary incontinence the midurethral sling in In , the first mesh for transvaginal repair of pelvic organ prolapse was approved.
It was around that time when manufacturers began marketing kits that included surgical tools and mesh for transvaginal prolapse procedures, the first of which received FDA clearance in It is important to note that the FDA has only stopped the sale and distribution of devices containing mesh used for the transvaginal repair of pelvic organ prolapse. Two common pelvic floor surgeries that use mesh and are not affected by the FDA announcement are as follows:. Transvaginal prolapse repair is a more complicated surgery, especially compared to the straightforward sling procedures to treat urinary incontinence, Dr.
Rickey says. The complex nature of the surgery, Dr. Harmanli adds, requires specialized training. Harmanli says. There are a number of nonsurgical options that can address pelvic organ prolapse and stress incontinence, including physical therapy to strengthen the pelvic floor and devices called pessaries that are made of silicone and can be placed into the vagina to hold the organs in place.
Patients can often self-manage the pessaries, meaning that women can place and remove the pessary themselves as needed. A large number of countries have now recommended that mesh inserted vaginally for pelvic organ prolapse should only be used in special cases, for example when a prolapse is very severe or traditional surgery has failed. Mesh is usually only placed to support the wall between the vagina and bladder, as mesh placed between the rectum and vagina has not been found to be better than traditional surgery.
Some countries, like Australia and New Zealand, have gone further and restricted or discontinued the use of vaginal mesh for prolapse repair, while in the United Kingdom its use is currently suspended. When simple measures like pelvic floor exercises and lifestyle changes have failed to cure urinary incontinence, surgery may be needed.
A mid-urethral sling procedure would be considered as an option in this situation. Mid-urethral slings are placed under the middle portion of the urethra through a small 1-centimeter cut in the vaginal skin.
Within 3 to 4 weeks of sling placement, scar tissue develops around the sling and the body grows tissue through the sling. The combination of the sling and scar tissue strengthens and supports the area of weakness under the urethra to reduce or stop urine leakage.
Even if complete dryness is not achieved, the severity of leakage is almost always much less. Large scientific studies from around the world have supported the safety and efficacy of the mid-urethral sling. Urge incontinence refers to the urgent need to pass urine that results in leakage.
Some women have triggers for this, such as hearing a running tap or placing the key into the front door. Mid-urethral slings are not designed to fix urge incontinence. Treatment for this involves lifestyle changes, bladder training, and medications or Botulinum Toxin. Should I have it removed?
If you are feeling fine and have no symptoms, there is no need to do anything; you do not need to remove the mesh sling. Additionally, removal of mesh that is not causing any problems can actually lead to a return of incontinence. Recent evidence has also confirmed that there is no increased risk of cancer or autoimmune disorders with mesh sling placement and mesh does not break down, disintegrate, or degenerate in the body.
Possible complications include bleeding, injury to surrounding blood vessels or perforation making a small hole in the bladder , urinary tract infections, difficulty passing urine, and pain. Pain is usually mild and lasts a few days but for some women pain may be severe and require the removal of the sling. Pain is more common following a transobturator sling procedure and can present as groin pain, pain with walking or squatting, or a burning nerve-type pain.
Other women may experience vaginal pain or discomfort. Mesh exposure is the term used to describe when a sling that has been placed is visible at the skin surface. Mesh exposure may occur early after a mesh is placed due to a failure of a surgical incision to heal well. In some cases, the mesh exposure may not occur until a later date. Other terms you may have heard used for mesh exposure include mesh erosion or extrusion.
This is a particular problem with older mesh types that are no longer used. Newer light-weight meshes used in prolapse surgery have an exposure rate less than half that of older products. You may have no symptoms at all or may notice a vaginal discharge which could be pinkish in color. Some women may feel the mesh as a roughness in the vagina or their partner may feel the mesh during intercourse. Research has shown that older women and women suffering with diabetes, obesity, or who smoke have an increased risk of mesh exposure.
In addition, women who have had previous scarring and vaginal surgery, or who have longer surgical incisions during mesh placement, are also at increased risk. Mesh exposure following a mid-urethral sling procedure is usually easy to manage either by re-covering the exposed sling with the surrounding tissue or by trimming the exposed piece. This sort of procedure can usually be done in the office under local anesthesia.
If a mid-urethral sling needs to be trimmed it may reduce its effectiveness and the symptoms of stress incontinence could return. How is this addressed? It is important to remember that pain as a complication can occur with any pelvic surgery, whether mesh is used or not.
Usually when this occurs it is because the mesh was placed too tightly or is healing with a lot of scarring, resulting in a pulling on the muscles and nerves and causing irritation to these structures.
There is also little robust information on the success of the procedures in the long term and when carried out in the wider population. However, there are indications that complication rates could be significantly higher than those typically reported in trials — in the UK, NHS data suggests that one in 15 women later has to have their implant surgically removed. However, this was a consumer survey, carried out by the consumer advocacy group, the Health Issues Centre, rather than being a scientific study.
As the mesh became more widely used, women came forward suffering complications and class actions have been brought against manufacturers around the world. In the United States Food and Drug Administration reclassified transvaginal mesh as a high-risk device.
These include mesh exposure and erosion — when the mesh pokes through the vaginal wall or cuts through internal tissue — vaginal scarring, fistula formation, painful sex, and pelvic, back and leg pains.
Some of these complications may occur years after surgery and can be difficult to treat. And although serious complications appear to be rare, given the thousands of women who have had the implants, the numbers of women suffering adverse reactions is high.
Similar class actions involving thousands of women are also under way in the UK and US. In many of the cases, issues have been raised around informed consent. The Australian government is also holding a Senate inquiry into the use of transvaginal mesh examining any financial or other incentives provided to medical practitioners to use or promote transvaginal mesh implants, the lack of data available on how many procedures were performed, and the type and incidence of health problems women have experienced.
The next round of public hearings will be held in Sydney on 18 September. In the UK, a government report estimated the procedure was performed on about about 17, women per year suffering stress incontinence and that these numbers had remained stable for a few years. The number of vaginal mesh implants used for prolapse peaked around with 3, implants sold to hospitals, but had dropped gradually to about 2, per year, the report found. In the US, the Food and Drug Administration [FDA] issued safety warnings to doctors and consumers in about an increase in adverse event reports related to mesh.
The latest available FDA figures show approximately , women in the US undergo surgical procedures for prolapse each year and approximately , underwent surgical procedures to repair stress incontinence. There is no accurate data available to track the number of women who have had a mesh implant for the treatment of prolapse or incontinence in Australia, Higgs says.
It also makes it hard to determine complication rates related to mesh unless women are signed up to clinical trials. Brands of mesh have been pulled from the market around the world by manufacturers, and brands and types that have been studied have been replaced by newer versions that doctors have less evidence about.
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