Bailey & Galyen, Attorneys at Law

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Surgical Mesh Recalls

Texas Attorneys for Surgical Mesh Injury

 
On July 13, 2011, the FDA warned physicians and patients of complications that could occur with the use of surgical mesh Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) surgeries performed on women. The surgical mesh is inserted through an incision made in the wall of the vagina, and these complications can have serious consequences.
 
POP is a condition where a woman's muscles holding her pelvic organs in place weaken or become stretched to where the organ drops or "prolapses" from its normal position and pushes against the walls of the vagina. SUI is simply the leakage of urine from the bladder during moments of physical stress.
 
These complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels, multiple surgeries and other complications such as infection, chronic pain, and bowel and bladder problems.
 
These FDA's warning made it clear that these complications are not rare, and more importantly, that "… it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risks."
 
The FDA became concerned when it reviewed the published scientific literature from 1996 – 2011 to evaluate surgical mesh's safety and effectiveness. That review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA stated in its warning that the literature review revealed:
  • 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.

If you or a loved one had surgical mesh implanted for Pelvic Organ Prolapse (POP) or Stress Urinary incontinence (SUI), you may be entitled to compensation for your injuries. The lawyers at Bailey & Galyen can help.

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