Recent FDA Safety Warning Sent Out Against Bladder Slings

Since the 1990s the bladder sling has been the most common surgical device used to treat stress urinary incontinence (SUI), which primarily occurs in women. SUI is explained as the accidental loss of urine which can be triggered by physical activities such as laughing and sneezing, it is uncommon in men.The reason for this, experts say, is because the urethra, which is the tube that carries urine out of the body, is usually a lot smaller in women (2 inches) than men (10 inches). Other conditions that may also contribute to SUI can be the stresses of child birth, pregnancy, and even ageing.When the bladder sling operation goes successful the patient’s life also gets better

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On the market there are several different types of bladder slings available to patients.The following are the more commonly used ones:

• Tension-free vaginal tape (TVT) sling: This outpatient procedure uses a polypropylene mesh tape for the sling under the urethra that is held in place by the patient’s body rather than stitches.

• Transobturator tape (TOT or TVT-O) sling: This tension-free surgery is less invasive than TVT because there is no need to blindly pass a large needle through the retropubic space when inserting the mesh tape. It was invented in France and brought to the United States in 2002.

• Mini-sling: The Mini Sling further improves the previous two procedures by eliminating the need for incisions in both the stomach and groin. Instead of groin and abdominal incisions, a metallic inserter and vaginal incisions are used. This type of procedure was just recently invented in 2006.

Usually these devices are generally safe in patients, however bladder slings have been known to cause some serious side effects. Earlier in 2008, the United States Food and Drug Administration (FDA) issued a public safety warning caused by the growing number of concerns about complications associated bladder slings and especially devices which insert mesh transvaginally. The warning states that “The FDA is alerting healthcare professionals about rare but serious complications associated with the surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence. The mesh is usually placed transvaginally using minimally invasive techniques.” Also said in the warning that the main reason for it’s issuance was to “Inform patients about the potential for serious complications and their effect on quality of life, including scarring and pain during sexual intercourse. Patients should also be informed that implantation of surgical mesh is permanent, and that some complications associated with the mesh may require additional surgery that may or may not correct the problem.”

Bladder slings still remain a popular choice for treatment for conditions such as SUI, however there has been an increasing amount of complaints by patients who have suffered serious side effects from the devices. It is best to talk to a doctor before using bladder slings for condition.

URL References:

accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=928