FDA Alert - Vaginal Mesh

On July 13th 2011, the FDA issued a safety communication regarding 'Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse'.

In other words, serious complications have been linked to the use of vaginal mesh or transvaginal mesh.  As discussed previously, this vaginal mesh is an implant used to strengthen vaginal tissue that can weaken due to childbirth, hernias, etc.  According to the FDA, the purpose of their "serious concerns" are specific to pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  


The most common complication that was reported for these vaginal mesh implants was an erosion of the device through the vagina, also known as a protrusion.  The vast majority of these reports came between 2008 and 2010.


Some of the most important revelations from the FDAs investigation (taken directly from the FDAs website) are as follows:

• Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
• Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
• There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
• While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.

 Patients that experienced either mesh erosion or mesh contraction reported severe pelvic pain and/or discomfort.

If you have had a vaginal mesh implant and have suffered from any discomfort, it is important that you contact your physician immediately.  There are surgical steps that can be taken to repair this damage and/or reduce the pain or discomfort.  If you are interested in legal remedies from such complications, it would be best to speak with a vaginal mesh lawyer.

If you have not had a mesh implant but are considering doing so, please be aware of the alternatives (such as biologic grafts) as well as asking your physician the appropriate questions (recommended by the FDA):

• Are you planning to use mesh in my surgery?
• Why do you think I am a good candidate for surgical mesh?
• Why is surgical mesh being chosen for my repair?
• What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
• What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
• Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
• If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
• What can I expect to feel after surgery and for how long?
• Which specific side effects should I report to you after the surgery?
• What if the mesh surgery doesn’t correct my problem?
• If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
• If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
• If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?