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Jessica Smagacz
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Recent FDA Health Notification–Serious Complications Associated With Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence

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FDA recently released a health notification concerning surgical mesh for pelvic organ prolapsed and stress urinary incontinence. This notification is important for those who are thinking about or are having this procedure done.

There are serious complications that may occur when surgical mesh is used in the treatment of pelvic organ prolapse and stress urinary incontinence. FDA has received over 1,000 reports from nine surgical mesh manufacturers over the three past years dealing with complications associated with the surgical mesh devises used to repair pelvic organ prolapse and stress urinary incontinence.

FDA reported the most frequent complications included infections, pain, erosion through the vagina, and urinary problems. Erosion of the mesh and scarring of the vagina, in some cases, led to discomfort and pain.

In these cases, some of the patients needed additional surgery to remove the mesh that eroded into the vagina. FDA also reported other complications: injuries to nearby organs (bowel and bladder or blood vessels).

What is pelvic organ prolapse?

A pelvic organ prolapse occurs when a pelvic organ drops from its normal spot in your lower belly and pushes against the walls of your vagina.

What is stress urinary incontinence?

Stress urinary incontinence is when you involuntarily lose urine that can occur during physical activity.

If you are thinking about having an operation for a pelvic organ prolapse or stress urinary incontinence, you should consider asking your surgeon FDA’s recommended questions.