Transvaginal Mesh Hemorrhage

One of the complications of implanting surgical mesh vaginally is bleeding. This could result from the procedure itself, the material used, or the inappropriate use of surgical instruments. The U.S. Food and Drug Administration (FDA) concluded in a July 13, 2011 report that using an abdominal approach to surgery resulted in fewer complications than using a transvaginal approach.

The FDA also reported that transvaginal apical or posterior repair with mesh does not appear to provide any added benefit compared to traditional surgery without mesh.

Complications of Hemorrhage

Blood loss is one of the major complications of hemorrhage. If bleeding does not stop, the surgeon needs to find the source of the bleeding and stop it. Sometimes, blood transfusions are required. Anemia is another complication of hemorrhage.

Safety of Transvaginal Placed Surgical Mesh

Because of concerns among surgeons about the safety of doing a transvaginal procedure using vaginal mesh to repair pelvic organ prolapse (POP), the FDA reviewed the relevant scientific literature published between January 1996 and April 2011.

The FDA listed a number of primary safety concerns with transvaginally placed surgical mesh for POP repair:

  • Patients who have POP mesh repair face mesh-related complications that patients having traditional surgery without mesh do not face.
  • Adverse events associated with transvaginally placed mesh can be life-altering for some women. Complications, such as pain, might continue even with removal of the mesh. Sometimes not all the mesh can be removed.
  • Mesh-associated complications are NOT rare. The most common mesh-related complication experienced by patients undergoing transvaginal POP mesh repair is vaginal mesh erosion. Data from 110 studies that included 11,785 women, showed that about 10 percent of women undergoing the procedure experienced mesh erosion within 12 months of surgery.
  • Mesh contraction, which causes vaginal shortening, tightening and/or vaginal pain in association with transvaginal POP repair with mesh is being increasingly reported in the literature.
  • New onset stress urinary incontinence is reported to occur more often after using mesh for anterior repair compared to traditional anterior repair that doesn't use mesh.
  • Abdominal POP surgery using mesh seems to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh. The median rate of vaginal erosion was four percent within 23 months of surgery.

In addition to reviewing the literature for safety, the FDA also reviewed how effective transvaginal POP repair with mesh compared to traditional non-mesh repair. The agency reported that there is no evidence that using transvaginal mesh is more beneficial than doing surgery without it.

The FDA summarized its key findings by saying, "Based on evaluation of adverse event reports and assessment of the scientific literature, the FDA had NOT seen conclusive evidence that using transvaginally placed mesh in POP repair improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risk."

Have You Experienced Hemorrhage?

If you've suffered as a result of complications caused by vaginal mesh, you might qualify for financial compensation. To schedule a free and private initial consultation with an experienced transvaginal mesh hemorrhage lawyer, please contact us today.

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