Doctor and patientTransvaginal Mesh (TVM) is generally used in surgical procedures that treat Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). POP occurs when the tissue holding pelvic organs becomes weak or stretched. SUI is a leakage of urine during moments of physical activity such as laughing, coughing or sneezing which increase pressure on the bladder.

The FDA has issued multiple public safety warnings about the use of transvaginal mesh. The first came in October 2008 when the agency alerted consumers to the more than 1,000 reports of adverse effects associated with the medical devices when they were used to treat POP and SUI. During a three-year period, the most common complications reported were erosion of the device and organ perforations. Surgeons were advised to use caution with the implants and to explain all the risk factors – including permanent body changes – which patients could suffer.

The FDA updated its warning in July 2011, focusing specifically on TVM use in POP procedures. The agency changed its stance, saying that complications are not rare and that it was not clear that TVM procedures are more effective than traditional methods of treating POP. The FDA continued evaluating the use of surgical mesh in SUI repairs. Six months later, on January 4, 2012, the FDA issued this update: “Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.” In April 2014, the FDA announced that it aims to re-classify transvaginal mesh from “moderate risk” to “high risk” and increase regulation of the devices.

The FDA has received thousands of reports of complications, and more than 80,000 women have turned to legal action to hold the makers of these products accountable. Juries have already found in favor of the patients that suffered from these surgeries.

Complications

Several complications are associated with Transvaginal Mesh, including life-altering issues such as:

  • Bleeding
  • Pain
  • Infections
  • Urinary problems
  • Scaring
  • Painful sexual intercourse

Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

Contact Us Today

If you or someone you know has had Transvaginal Mesh surgery and is suffering from pain, infection, urinary issues, bladder or bowel problems, the time to act is now. You could be eligible for significant cash compensation. Lawsuits have already been filed and some victims have received their settlements. It’s not too late.

We are conveniently located in several locations in the states of New York and Vermont to ensure you have legal representation close to you. We have offices in: Albany, NY, Saratoga, NY, Schenectady, NY, Plattsburgh, NY, Utica, NY, Buffalo, NY, New York City, NY, White Plains, NY, Rochester, NY – as well as Manchester, VT and Burlington, VT.

Call us today for a free consultation and learn your rights. Call 1800LAW1010 (1-800-529-1010) and take the first steps toward getting the justice you deserve.