Transvaginal Mesh (TVM)

Transvaginal Mesh (TVM)

Women who have had pelvic organ prolapse (POP), or other abdominal surgery for weakened or damaged internal tissue, and received an implant of a product called transvaginal mesh (TVM) are reporting serious and potentially fatal injuries caused by the mesh.

There have also been deaths according to news reports.

The U.S. Food and Drug Administration (FDA) issued an initial safety alert in 2008, and followed up in 2011 with a stronger warning, saying “this update is to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”

Nearly a half million women per year since 2000 have had surgery involving transvaginal mesh.

Have you had a transvaginal mesh implant that prolapsed, ruptured, become loose and/or required additional surgery? 

Contact our attorneys for a no cost, no obligation consultation to learn your legal options. Call 215-557-0099 or fill out this inquiry form to learn more.

 

According to the FDA 30-50% of women will experience pelvic organ prolapse in their lifetime, with 2% developing symptoms.  Organs involved can include: the bladder, uterus, rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel. The woman may also have the mesh surgically implanted to treat urinary incontinence as well.

The surgical mesh material may fail, or may break off and disintegrate cutting into delicate tissue in the abdomen. This is potentially very painful for which corrective surgery is difficult. Women could be left with insufficient support of their internal organs and experience extreme side effects.

Lawsuits underway

Lawsuits are currently underway on behalf of women who claim they have suffered injury or serious side effects from transvaginal mesh. They allege the devices were defective in design, prone to erosion and breakage, that the manufacturers knew of the device’s potential for injury and side effects and failed to fully warn both doctors and patients of the risk.

Manufacturers of TVM

  • C. R. Bard Medical
  • Boston Scientific
  • Coloplast
  • Endo International/American Medical Systems (AMS)
  • J&J/Ethicon

Links

Surgical Mesh: No Testing, Consumer Reports, May 2012, 2nd report

UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication, July 2011

Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence: FDA Public Health Notification, October 2008

Olmesartan Medoxomil: Label Changes To Include Intestinal Problems (Sprue-Like Enteropathy), FDA Drug Safety Communication  2013

Severe Spruelike Enteropathy Associated With Olmesartan, The Mayo Clinic, August 2012