FDA Reports Safety Concerns over Transvaginal Surgical Mesh

The U.S. Food and Drug Administration has issued new warnings regarding the use of transvaginal surgical mesh to treat pelvic organ prolapse. The agency’s warnings are targeted at the placement of the mesh, citing that its use may actually carry greater risk than other surgical options, without any evidence of greater benefit.

The number of adverse events associated with use of the mesh have increased over the past few years. In fact, approximately 1,500 reports were filed between the years 2008 and 2010, five times as many as those reported between 2005 and 2007.

The agency warned specifically that surgical mesh, when placed transvaginally, has been linked to negative side effects such as, erosion of the vaginal tissue, pain, infection, bleeding, pain during intercourse, organ perforation from surgical tools and urinary problems.

The FDA first issued its warning against the product back in 2008 and is now asking surgeons to consider all other treatment options in order to ensure their patients are fully informed of the potential complications associated with use of surgical mesh.

Alarmingly, in 2010, more than 100,000 pelvic organ prolapse repairs from surgical mesh were reported, approximately 75,000 of which were transvaginal procedures. The FDA is stressing that doctors should understand that pelvic organ prolapse can often be treated without the use of surgical mesh. The use of mesh implants are permanent and may put patients at future risk of additional complications and surgeries.

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