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Darren Tobin
Darren Tobin
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Mesh Problems Leads to FDA Warning

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Many women who have experienced complications following transvaginal mesh surgery have suffered as a result of a bad product being surgically placed inside of their bodies.

There have been a recent number of complications reported with vaginal surgeries that use mesh to repair pelvic organ prolapse. The United States Food and Drug Administration (FDA) has recently reevaluated vaginal mesh implants because of the increasingly number of reported problems. The FDA recently issued a second warning (within three years) regarding the safety of these trasvaginal mesh implants.

The FDA’s latest advisory opinion states that erosions occur in about ten percent of women who undergo vaginal prolapse repairs using mesh. FDA noted that in some cases, the material involved can be easily removed; however, in other cases, human internal tissue has grown around and inside the mesh, which requires numerous follow up medical interventions and surgeries. Of special concern are procedures that involve inserting mesh through the vagina to help hold up a woman’s sagging bladder, bowel, uterus, intestines or rectum.

Included in FDA’s announcement was that the use of mesh to repair pelvic organ prolapse in vaginal surgeries is no more effective than any other options.

Up to 50% of the women who have these surgical mesh implant sugeries can experience some type of pelvic prolapse during their lifetime. Pelvic prolapse occurs when the bladder or other organs begin slipping out of place. Pelvic prolapse may occur after a child is born, a woman goes through menopause or has a hysterectomy. Sadly, many women who have undergone this type of surgery were never told that the mesh used in their surgery could break through or scar their bodies.

Each year, approximately 75,000 women have a vaginal mesh placement surgery. Complications which result from the surgery can include urinary tract infections, erosions, pain during intercourse, bleeding, and back pain.

The main manufacturers of these vaginal mesh implants include Johnson & Johnson; Boston Scientific; C.R. Bard; and American Medical Systems.

Johnson & Johnson has manufactured the following vaginal mesh products:

  • Ethicon® TVT
  • Gynecare® TVT
  • Gynecare® Prosima
  • Gynecare® Prolift
  • Gynemesh® PS

Boston Scientific has manufactured the following vaginal mesh products:

  • Advantage™ Sling System
  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System
  • Arise®
  • Pinnacle®
  • Lynx®
  • Solyx®

C.R. Bard has manufactured the following vaginal mesh products:

  • Avaulta Plus™ BioSynthetic Support
  • Avaulta Solo™ Synthetic Support
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh

American Medical Systems has manufactured the following vaginal mesh products:

  • SPARC®
  • BioArc®
  • MiniArc®
  • Elevate®
  • Monarc®
  • Perigree®
  • In-Fast®
  • Apogee®