Bladder Sling Recall

by Steve Fields on November 14th, 2011

Vaginal mesh is used to treat a common condition called pelvic organ prolapse (POP). Even though a growing number of women are reporting complications following mesh surgery, there has been no FDA bladder sling recall covering all surgical mesh products used in POP or SUI repairs. In women, the pelvic organs drop from their normal positions when the muscles and ligaments that support them weaken. When these organs fall, they bulge against the vaginal wall. In the case of uterine prolapse, the uterus falls into the vaginal canal. Surgical mesh can be implanted transvaginally to help return the slipped organs to their normal positions. Unfortunately, several serious pelvic mesh complications have been reported.

Mesh has been implanted vaginally for treating pelvic organ prolapse since the 1990s. However, it wasn’t until the early 2000s that mesh kits were created specifically for the purpose of vaginal implantation. Many of the problems reported by women stem from the use of these kits. Two kit manufacturers are currently facing hundreds of transvaginal mesh lawsuit claims due to mesh complications. We’ll describe some of these issues below.

Pelvic Mesh Erosion Into The Vagina

The Food and Drug Administration reported in July 2011 that mesh erosion into the vaginal wall was the most common complication reported. Sometimes called “extrusion” or “exposure,” this issue can cause severe pain, and even discomfort for the woman’s sexual partners. Some newer mesh designs use a lighter material than that used in kits designed years ago. The lighter material is believed to result in a lower erosion rate, though there is insufficient data available to support this claim.

In cases where the device erodes into the vaginal wall, its repair is seldom an option. The device must be surgically removed. Unfortunately, as detailed in a safety communication issued by the FDA in 2011, removal is not always possible, even after multiple surgeries.

Mesh Erosion Into The Bladder

In rare cases, transvaginal mesh can erode into the wall of the bladder. This is a problem that occurs when the device is installed to treat stress urinary incontinence (SUI), which is is often accompanied by a cystocele (prolapsed bladder). Extrusion of the device into the bladder can cause severe pain in the lower abdomen as well as urinary tract infections and blood in the patient’s urine. Occasionally, a fistula may form between the bladder and vagina, allowing seepage of urine from the former into the latter. Left untreated, the patient may also experience rectal pain.

As with erosion into the vaginal wall, the ideal solution is to surgically remove the defective mesh, after which the bladder and vagina are repaired. Accomplishing both goals is sometimes possible through the vagina, but more commonly done with traditional (i.e. invasive) abdominal surgery. The surgeon should have a high level of experience and skill to minimize the likelihood of errors.

Pain During Sexual Intercourse

A common pelvic mesh complication is pain during intercourse (dyspareunia). This can occur when the device erodes through the vaginal wall, or through the wall of the bladder. The FDA reports that the device has also been known to contract, a circumstance that can produce pain during sex. A woman’s sexual partner may experience discomfort and irritation if the mesh erodes completely through the vaginal wall.

Pain during intercourse stemming from mesh extrusion, is only resolvable by removing the device, or at least the portion that has eroded through the wall. As already noted, complete removal may not be possible. Removing a portion helps, but does not preclude further erosion of the remaining part of the device.

Ancillary Side Effects Of Mesh Erosion

The bladder sling mesh complications described above can produce an assortment of other symptoms. Women have reported experiencing recurring infections, pain in the lower back, vaginal bleeding and drainage, and even a recurrence of POP. Many of these side effects can be expected to persist until the faulty device is removed.

Bladder Sling Lawsuits
Vaginal placement of mesh for POP and SUI is a relatively popular procedure. Bloomberg News reports that 75,000 women opted for the operation in 2010. If you underwent transvaginal placement of pelvic mesh, and have suffered vaginal bleeding, infection, pain, and other side effects, you may be eligible to file a claim for compensation. Contact a bladder sling lawsuits lawyer to discuss your case and any bladder sling recall news and litigation develops.


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