A vaginal mesh lawsuit filed in the U.S. District Court, Southern District of West Virginia (Charleston) reveal 6 more vaginal mesh products that are defective in nature and could adversely affect women’s body. The lawsuit filed on September 17 2012 in the Multi District Litigation (MDL) District Court of Western Virginia reported Selena Denise as the plaintiff.

Vaginal mesh products that are under the scrutiny of FDA after this lawsuit were:

  • Prolene Mesh
  • The Prolift system
  • Gynemesh,
  • TVT
  • Prolift+M
  • Prosima system

Vaginal mesh implants that are commonly used to treat Pelvic Organ Prolepses and hernia was approved by the United Stated Food & Drug Administration in the year of 1970s and since then it had been used widely across the regions of United States to treat these diseases. In the year of 1990s, the device was also found to be effective in treating Stress Urinary Incontinence which is also known as SUI.

However, later on complaints began to come out pertaining to its high failure rate and other side effects. Some of the side effects of vaginal mesh implants that are common these days are:

  • Organ Perforation
  • Infections
  • Inflammation
  • Vaginal Mesh Erosion
  • Scarring
  • Urinary Problems
  • Fistula

Viewing the growing number of failure rates, complaints and lawsuits FDA became conscious and alert about the defect in 2008 and soon after that it released a public alert notice stating the potential adverse impacts of the device.

Trans vaginal mesh, pelvic mesh or vaginal mesh implants are surgical remedies that are used to treat Pelvic Organ Prolepses, Hernia and Stress Urinary Incontinence in women. According to various reports one of the common reasons of hernia and Pelvic Organ Prolepses is pregnancy where in, due to extra pressure exerted by the growing baby shifts pelvic organ from its original place that leads to bladder incontinence and other associated problems. These devices are designed and manufactured to repair the problem and alleviate above mentioned symptoms.

Some other complications that are associated with the implant are:

  • Bladder, bowel and blood vessel perforation during insertion
  • Abdominal pain, Vaginal Pain, leg pain or pain in the pelvic region
  • Urinary tract infection
  • Appearance of Urinary problems, like stress urinary incontinence

It s important to underline here, that, vaginal mesh implants enjoyed fast tract approval of USFDA under the FDA’s 501(k) process. The 501(k) approval process is a fast track approval system that bypasses safety testing. However, only those products are considered for fast track approval process which is substantially similar to another existing product that was previously approved. The assumption is that if a predecessor of a particular medical device is already approved the device in question becomes worthy of being approved.

Viewing the growing number of vaginal mesh implant lawsuits some vaginal mesh Multi District Litigation courts were established. The main purpose of these MDLs or Multidistrict Litigation Court is to streamline the judicial process by consolidating the cases and minimizing the judicial resources that each of these case demands.

 These MDL cases are being examined and overseen by Chief District Judge Joseph R. Goodwin of the U.S. District Court for the Western District of West Virginia.