Pelvic floor replacement kits developed by Sofradim, are indicated for tissue reinforcement and stabilization of the pelvic floor for patients suffering from vaginal wall prolapse or stress urinary incontinence due to sagging organs. Made of knitted surgical mesh, the vaginal sling is designed to function as a mechanical support or bridging material for any fascial defects in the pelvic region. Sofradim, recently acquired by Covidien, has manufactured several transvaginal mesh slings, including:

  • Pelvetex Polypropylene Mesh Patch
  • Uretex Pubovaginal Sling
  • Uretex Pubovaginal Support Kit
  • Uretex TO
  • Uretex TO Avaulta BioSynthetic System
  • Uretex TOO2
  • Uretex TOO3

Transvaginal Mesh Products

Mesh slings inserted transvaginally were believed to be more effective in treating pelvic organ prolapse (POP) and involved a very simple surgical procedure with very little recovery time. Unlike traditional surgery that required an open surgery, Pinnacle and similar devices could be implanted through small incisions in the pelvic region. As a result, transvaginal mesh implants became increasingly popular with over 75,000 women receiving the treatments in 2011. But that same year, the FDA alerted the public of the thousands of adverse event reports related to the vaginal slings and warned that complications such as mesh erosion were not uncommon.

Design Failures

The primary cause of implant failure for transvaginal mesh patients is mesh erosion. The porous surgical mesh allows tissue to grow through the mesh and become a part of the vaginal wall or another pelvic organ. The FDA has warned, mesh erosion is not uncommon and can result in severe injuries requiring multiple revision surgeries that pose its own risks. Possible complications of transvaginal mesh devices are:

  • Mesh extrusion
  • Recurrent POP or SUI
  • Mesh contracture
  • Nerve damage
  • Scar tissue
  • Dyspareunia
  • Infection

What to do After a Transvaginal Mesh Implant

Because of the risks involved with mesh removal, women who are not suffering adverse events are advised against implant removal surgery. Instead, the FDA recommends close monitoring of the implant through annual and other routine check-ups and follow-up care. Notify your healthcare provider at the sign of any complications or symptoms of implant failure. For patients who have suffered serious injuries related to their implant, consider contacting a professional product liability lawyer to learn about your legal rights to compensation.

File a Product Liability Claim

On July 2012, a California couple was awarded $5.5 million in compensation for the severe injuries caused by a defective transvaginal mesh. If you have also suffered severe health complications after being treated with a transvaginal mesh product, contact a professional product liability lawyer immediately to protect your rights to compensation. The statute of limitations for product liability claims differs for each state; to ensure your rightful compensation will not be compromised by any time limitations, schedule a free consultation with a knowledgeable attorney today.

Leave a Reply