Beginning in October 2008 the FDA began to warn doctors and patients about the increased risk presented by the use of synthetic mesh to treat POP (pelvic organ prolapse) and Stress Urinary Incontinence compared to repairs not involving mesh.  In recent years this mesh has often been implanted using the less invasive transvaginal procedure.  From 2005 through 2010 more than 4,000 women have reported mesh complications to the FDA and the numbers continue to grow daily.

Symptoms of Pelvic Mesh Failure:

  • Continued or Recurring Urinary Incontinence
  • Recurring Pelvic Organ Prolapse
  • Hardening of Mesh
  • Injury to nearby organs
  • Mesh Erosion
  • Mesh Exposure
  • Sexual difficulty after surgery
  • Vaginal Pain
  • Bowel, Bladder
  • Blood vessel perforation
  • Mesh Removal Surgery
  • Pelvic Reconstructive Surgery

Pelvic Surgical Mesh is manufactured by a number of companies under a variety of brand names:

  • Johnson & Johnson / Ethicon, Inc./ Gynecare
  • R. Bard / Davol, Inc
  • American Medical Systems
  • Boston Scientific
  • Mentor Corp

A West Virginia jury awarded a woman $2 million on August 15 in the first federal trial regarding vaginal mesh injuries. The defendant, C.R. Bard Inc., still faces thousands of other claims over its Avaulta line of transvaginal mesh (TVM). Ethicon (Johnson & Johnson), Endo Health Solutions (American Medical Systems, Inc.), Mentor Worldwide LLC, Coloplast, and Boston Scientific face similar claims.[1]

On October 20, 2008, the FDA issued a Public Health Notification regarding serious complications associated with the use of TVM in repairing pelvic organ prolapse (POP) and stress urinary incontinence (SUI). On July 13, 2011, the FDA published an update on its 2008 warning:

The FDA issued this update to inform consumers that serious complications associated with surgical mesh for transvaginal repair of POP are not rare . . . Furthermore, 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 a greater risk.

Thousands of adverse events have been reported to the FDA regarding TVM, the most common of which include: pain, infection, bleeding, mesh erosion through the vagina, pain during intercourse, urinary problems, and organ perforation. Other complications include: recurrent prolapse, neuromuscular problems, vaginal scarring, vaginal shrinkage, and emotional distress.

In a report entitled, “Urogynecologic Surgical Mesh,” the FDA expressed particular concern over the additional intervention necessitated by some of the TVM complications. For example, vaginal mesh erosion (also called exposure, extrusion, or protrusion) “can require multiple surgeries to repair and may result in continued sequelae (e.g., pain) even after mesh removal.”

[1] The affected products include: Johnson & Johnson’s Gynemesh, Prolene Mesh, Prolift, Prolift M, Secur, TVT, TVT-O, and TVT-S; C.R. Bard’s Avaulta Solo Synthetic, Faslata Allograft, Avaulta Biosynthetic, Avaulta Plus Biosynthetic, Alyte Y-Mesh Graft, Bard Plevisoft, and Accellular Collagen Biomesh; American Medical Systems’ Apogee, Perogee, Elevate, Sparc, Triangle Gelatin-Sealed Transvaginal Mesh Sling, AMS Large Pore Polypropylene Mesh, Intemesh Silicone-Coated Sling & Surgical Mesh with Inhibizone, and AMS Triangle Silicone-Coated Sling & Surgical Mesh; Boston Scientific’s Pinnacle, Obtryx, Prefyx, Boston Scientific Surgical Mesh, Surgical Mesh Polymeric, and Trelex Mesh; Mentor Worldwide’s OB Tape and Mentor NovaSilk Mesh; Coloplast’s Novasilk Synthetic Flat Mesh, Restorelle Smartmesh, Exair Mesh, Aris Transobturator (TOT) Sling, Minitape Sling, Omnisure Sling, Supris Suprapubic Sling, and T-Sling with Centrasorb.