TVM (Transvaginal Mesh)

  • Pelvic Mesh Medical Record Review & Outsourcing Services

Transvaginal mesh is a surgical net-like implant, manufactured by various companies such as Ethicon, C.R. Bard, American Medical Systems, Boston Scientific, Coloplast, Cook Medical, Neomedic. It is used in form of a sling to treat Stress urinary incontinence (SUI) and Pelvic organ prolapse (POP) in women since the 1990s. Abdominal hernias have also been treated with a surgical mesh since the 1950s. The insertion of this mesh or a bladder sling through the vagina is known as a transvaginal mesh. The Food and Drug Administration (FDA) approved the first surgical mesh specifically designed for SUI in 1996. Later, in 2004, FDA approved the first surgical mesh specifically for use in POP.

Analysis of the market data by the manufacturers points out that as of 2010, a mesh was used in one out of three POP surgeries. Moreover, a transvaginal mesh was used in over 80% of the SUI surgeries.

Popular bladder slings are the following types:

Popular bladder slings are the following types:

  • Tension-free vaginal tape (TVT):  TVT is a polypropylene mesh tape that is placed under the urethra and the patient’s body holds it in place.

  • Transobturator tape (TOT): This is less invasive than TVT because there is no need to use a large needle when inserting it.

  • Mini-sling: Through an incision in the vagina, a mesh tape is placed with the help of a metallic inserter that safely avoids the need for any incisions in the abdomen.

Serious Alleged Injuries may include:

  • Abdominal and Pelvic Pain
  • Multiple Surgeries to repair or remove the mesh
  • Mesh Erosion
  • Recurrence of POP or SUI
  • Dyspareunia (Painful Sexual Intercourse)

FDA SAFETY WARNINGS:

Nearly 4,000 injuries were reported to the FDA between 2005 and 2010, in connection with transvaginal/pelvic mesh devices.

In 2008, the FDA issued a safety communication as it received complaints regarding the transvaginal mesh complications that patients faced during the placement of the mesh to treat SUI and POP.

In July 2011, alternative methods for POP and SUI, including conditions that may occur after childbirth and pregnancy were recommended by the FDA when it warned patients and healthcare providers of the risks associated with the use of transvaginal mesh.

Lawsuit Allegations:

The filing of more than 100,000 Transvaginal lawsuits, makes it one of the largest mass torts in history.

There are in all 7 MDLs to handle Transvaginal Mesh Litigations which are being overseen by U.S. District Judge Joseph R. Goodwin. Millions have been paid in settlements. Thousands of claims have been settled by the company, but more than half of the lawsuits are still pending.

MDL No. 2187 · MDL No. 2325 ·  MDL No. 2326 ·  MDL No. 2327 ·  MDL No. 2387 ·  MDL No. 2440 ·  MDL No. 2511

Evidences:

  • Usage of Device in operative records.
  • Product identification (Implant sticker) in the medical records.
  • Treatment provided for the injuries.
  • Proof of Injury in Medical Records.

Medical Record Review and claim validation of TVM (Transvaginal Mesh) case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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