Sullo & Sullo - Product Defect Blog

How Dangerous is Your Transvaginal Mesh or Bladder Sling?

May 24

Friday, May 24, 2013  RssIcon

Transvaginal mesh has come under fire because of the many risks it exposes women to and, in fact, the current stance of the FDA is there is no evidence that pelvic organ prolapse repair using mesh is more effective than no-mesh repair. The FDA additionally stated that using transvaginal mesh can expose patients to greater risks. If you are a recipient of transvaginal mesh used in the repair of pelvic organ prolapse and have experienced significant health issues, you may wonder just how dangerous your mesh or bladder sling really is. Those women who have suffered significant mesh erosion, the formation of adhesions, extrusion, fistula formation, infection or sepsis, vaginal shortening, nerve injury or scar formation which results in mesh contraction may be forced to undergo revision surgery.


The synthetic mesh which was supposed to fix pelvic organ prolapse can damage internal organs, requiring that the faulty mesh be removed. These women could be considered to be in the “worse off” group, primarily because there is no specific protocol or procedure for removal of the mesh product. In many cases the surgeon is unable to fully remove the mesh product, meaning many women have been forced to undergo multiple surgeries. From 2008 to 2010 the FDA received almost 3,000 reports of mesh-related complications. Although not all of these 3,000 patients required mesh revision surgery, some of them underwent three or more surgical procedures in an effort to completely remove the mesh.


A second group of women who underwent POP mesh surgery are having the same adverse effects from their transvaginal mesh yet while they need to have the mesh removed, they may not be able to afford subsequent surgeries. The process to remove the mesh and recover is time-consuming, requiring significant amounts of time away from work. Removing the mesh is also painful and requires an extremely skilled surgeon to remove the pieces of fine mesh which may have already fused with tissues and organs nearby.  Eighty-seven percent of women who were forced to undergo revision surgery stated they would not have had the original mesh surgery if they had been fully informed of the risks involved. This second group of women who may not be able or willing to undergo revision surgery (or surgeries) will suffer serious health consequences from the implant which may worsen as time passes.


Women who were implanted with mesh to correct stress urinary incontinence may not suffer adverse effects to the same degree as those who were implanted with mesh to correct pelvic organ prolapse, however the surgical procedure to remove the device can still be extremely traumatic. Prior to surgical intervention, some gynecologists may use alternative procedures to alleviate mesh-erosion symptoms including estrogen-cream treatment and office excision. Assuming the symptoms are not severe and the woman is not sexually active, the doctor may choose to observe symptoms at three-month intervals to ensure they have not worsened rather than subject the patient to revision surgery.


The estrogen cream is believed to plump the surrounding tissues, absorbing the eroded mesh however there is little evidence to suggest this is a viable option for most women. The last group of women are those who have suffered adverse health effects following a mesh implantation for stress urinary incontinence but whose symptoms are not severe enough to warrant surgical revision. Despite the harm done, the expected case value of a lawsuit against the manufacturer is considered to be much lower than those women who were forced to undergo revision surgery. 

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