The U.S. Food & Drug Administration (FDA) has said that it has received over 1,000 reports of adverse side effects concerning transvaginal surgical mesh devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). But, what are these devices, who makes them, why are they dangerous and most importantly – what should you do if you've been injured? Here are answers to those questions...

What are surgical mesh devices?

Surgical mesh devices are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

Who makes them?

There are nine manufacturers who make these devices. Below are the names of the manufacturers, their product names and the number of MAUDE* reports received by the FDA:

Manufacturer	Product names	Number of MAUDE* reports
American Medical Systems	SPARC	65
Bard	Pelvicol, Pelvisoft	64, 1
Boston Scientific Scimed	Prefyx PPS, Obtryx Curved Single, Obtryx Mesh Sling, Advantage Sling System, Prefyx System Mid U, Mesh Sling System	23, 1, 62, 29, 23, 78
Caldera	T-Sling	2
Ethicon	Gynemesh PS (K013718) a/k/a/ Prolift Pelvic Floor, Prolene Polypropylene Mesh	123, 72
Gynecare	Secur, Tension Free Vaginal Tape	1, 4
Johnson & Johnson – Switzerland	K974098	495
Mentor	ObTape (K031767)	236
Sofradim	Uretex TO, Avaulta Biosynthetic, Uretex Pubovaginal Sling/support kit, Bard Posterior Biosynthetic Support System, Pelvetex Polypropylene Mesh	64, 0, 27, 3, 0

*MAUDE (Manufacturer and User Facility Device Experience) data represents reports of adverse events involving medical devices received by the FDA.

Why are they dangerous?

According to a October 2008 FDA warning sent to healthcare professionals, complications while using the devices included:

• erosion through vaginal epithelium;
• infection;
• pain;
• urinary problems;
• recurrence of prolapse and/or incontinence and bowel, bladder and blood vessel perforation during insertion.

The FDA also reported that vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia (pain during intercourse). It warned healthcare professionals to be:

• vigilant for potential adverse events from the mesh, especially erosion and infection, and
• inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.

Treating the various complications can include surgical procedures to remove the mesh, IV therapy, blood transfusions and drainage of hematomas or abscesses.

What should you do if you've been injured?

As more and more women are reporting injuries due to the use of surgical mesh devices and the FDA continues to research the issue, an increasing number of lawsuits against the manufacturers are being filed. If you've been injured due to a surgical mesh device, contact an experienced attorney whose practice focuses in this area of the law to discuss your situation and evaluate your options. You may be entitled to compensation.