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Shapiro & Appleton

FDA Warning-Complications With Trans-Vaginal Placement of Surgical Mesh for Pelvic Organ Prolapse or Stress Urinary Incontinence in Women

The United States food and drug administration has issued a new warning relating to complications arising from placement of surgical mesh through incisions made in the wall of the vagina. These surgical/medical mesh devices are placed trans-vaginally.

According to the FDA, " the most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence."  FDA goes on to explain:

 In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.

 Apparently, the FDA has received over 1000 complaints relating to surgical match, when sewn, partially through the vaginal wall. Because of the under reporting in general, it is likely that there are more serious complications that have gone unreported so the estimated complication level is a conservative statistic.  For further information, check the FDA warning above or contact our office if you have a potential claim arising from this issue. Our number is 1-800-752-0042 and an analysis of your potential case is free.


We have several Injuryboard blog posts that are focused on surgical errors along with a new consumer report detailing the top 5 surgical mistakes (take advantage of the free download here).

 

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