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Transvaginal Mesh Failures Result in a Warning by the FDA

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. While originally developed to treat and repair hernias, manufacturers of surgical mesh actively marketed their product to surgeons as appropriate for the treatment pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Unfortunately, while the product can be appropriate for repair of hernias due to the mesh remaining static, serious complications have resulted when it’s used in the female reproductive system, a highly dynamic area. In this application, the surgical mesh is commonly referred to as "transvaginal mesh".  

FDA Transvaginal Mesh Reports & Updates

On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI. In noting serious complications associated with transvaginal mesh, the FDA listed the most frequent complications reported to the FDA were mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems.

In July 2011, the FDA issued an update report and press announcement, which was followed recently by a January 2012 update, noting:

  1. serious complications associated with surgical mesh for transvaginal repair of POP are not rare; and
  2. it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh. 

Many of of the transvaginal mesh complications require additional intervention, including medical or surgical treatment and hospitalization. In some cases, even multiple surgeries won't resolve complications. Also, such complications associated with the use of surgical mesh for POP repair haven't been linked to a single brand of mesh. This along with the fact that in most cases POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications presents a clear argument that transvaginal mesh may be unsafe and unnecessary in virtually all circumstances.

If you’ve suffered complications or side effects from transvaginal mesh, call Whitfield Bryson & Mason LLP today to see if we can help.