Transvaginal mesh is one of the most popular options for surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), used in 75% of surgeries to treat POP, and in 80% of SUI repair surgeries in 2010. However, a growing body of research has suggested that the implantation of transvaginal mesh may pose a significant danger to patients, possibly putting them at risk for serious side effects, including surgical mesh infection and erosion of surgical mesh into the vaginal tissue. In fact, the FDA recently indicated that transvaginal placement of surgical mesh for POP or SUI repair may carry more risks than other surgical options, without any evidence of greater benefit. If you received a transvaginal mesh implant to correct POP or SUI, and have since suffered from one or more major side effects, contact an experienced transvaginal mesh attorney today to discuss your legal options.
Both pelvic organ prolapse and stress urinary incontinence are common in women who have had multiple pregnancies, had exceedingly long pushing phases of labor, or who have undergone a hysterectomy, in which the tissues and muscles in the pelvic area become weakened or damaged. Because both POP and SUI can cause severe discomfort and may significantly diminish a patient’s quality of life, many women opt for surgical repair of these conditions, which most often includes transvaginal placement of surgical mesh. Unfortunately, new information suggests that transvaginal mesh may no longer be considered a safe treatment option for some women, due to the risk of serious transvaginal mesh side effects. Some possible surgical and nonsurgical alternatives to potentially risky TVM procedures for POP or SUI repair include the following:
October 2008 – A Public Health Safety Notification from the FDA suggests that complications from vaginal mesh used for the repair of POP are rare.
July 2011 – The FDA issues an update on serious side effects associated with transvaginal mesh, indicating that has received 4,000 reports of adverse events associated with transvaginal mesh in the previous six years. The agency also updates it previous statement, warning that TVM complications are, in fact, not rare.
September 2011 – An advisory committee for the FDA meets to discuss the safety and effectiveness of transvaginal mesh products.
January 2012 – Based on recommendations from its advisory panel, the FDA orders the makers of transvaginal mesh products to conduct post-market studies on the safety of surgical mesh devices.
February 2012 – The FDA issues 95 post-market study orders to 34 manufacturers of vaginal mesh devices for POP repair, and 14 orders to seven manufacturers of vaginal mesh devices for SUI repair.
April 2012 – Federal regulators report that women who have had transvaginal mesh implanted to support their reproductive organs may be at a greater risk of bleeding, pain and infection than women who have undergone traditional surgery with stitches.
March 2013 – The FDA makes changes to its web page to include updated information about adverse events possibly associated with transvaginal mesh for POP and SUI repair.
May 2014 – The FDA submits two proposed orders to reclassify vaginal mesh as a Class III device, which means the products would require stringent premarket testing prior to widespread distribution.
August 2008 – Retracted mesh resulting in vaginal pain occurred in 11.7% of patients who underwent transvaginal mesh procedures, according to a large retrospective multicenter cohort study published in the Journal of Obstetrics and Gynaecology Research.
February 2009 – The rate of revision surgery to correct complications, as well as the total reoperation rate, is highest for vaginal mesh kits compared to native tissue and abdominal repairs, according to research published in the medical journal Obstetrics and Gynecology.
May 2009 – The Journal of Minimally Invasive Gynecology publishes a study finding that transvaginal mesh erosion rates range from 7% to 20%.
July 2009 – A study published in the American Journal of Obstetrics and Gynecology finds that 18% of women who underwent transvaginal mesh procedures developed pelvic muscle dysfunction and pain, with one-quarter of these women experiencing continued symptoms after six months of therapy.
April 2010 – A report published in the Cochrane Database of Systematic Reviews evaluates 3,773 participants in 40 trials of different surgical procedures for pelvic organ prolapse, and shows that there is a higher rate of side effects from vaginal mesh compared to native tissue repairs, including a 10% rate of mesh erosion complications.
April 2010 – Research published in Ultrasound in Obstetrics & Gynecology indicates that 9.3% of patients experienced severe mesh contraction or shrinkage, defined as a decrease of more than 50% of the size of the vaginal mesh, at three months after the mesh device was implanted.
May 2011 – A five-year follow-up in a cohort of 85 women following transvaginal mesh surgery, published in the journal Female Pelvic Medicine & Reconstructive Surgery, finds the overall rate of vaginal mesh exposure to be 18.8%, with 56% of patients requiring surgery for partial mesh excision.
February 2013 – A study conducted by researchers from the University of North Carolina (UNC), and published in the International Urogynecology Journal suggests that using transvaginal mesh versus native tissue for POP repair is tied to a five-year increased risk of revision surgery.
March 2013 – A study conducted by researchers from the Mayo Clinic, and published in Current Bladder Dysfunction Reports, indicates that traditional native tissue repair is the best procedure for most women undergoing vaginal pelvic organ prolapse repair, compared to vaginal mesh-augmented repair of POP.
More and more women across the country are coming forward with horror stories about painful and debilitating transvaginal mesh complications, and to date, tens of thousands of lawsuits have been brought against the makers of vaginal mesh devices, like Bard Avaulta mesh, over life-altering side effects. All of the transvaginal mesh lawsuits involve similar allegations that the makers of surgical mesh products:
The side effects potentially linked to transvaginal mesh are severe and may cause permanent injuries that require long-term medical care. If you or a loved one has suffered from a transvaginal mesh side effect, legal help is available. Contact an experienced surgical mesh attorney to discuss the benefits of filing a surgical mesh lawsuit against the manufacturing company responsible for producing the medical device. The main goal of surgical mesh lawsuits is to help injured victims seek financial compensation for their injuries, the medical cost of treating their injuries, and the pain and suffering endured by victims and their families. By hiring an experienced transvaginal mesh lawyer to represent your case, you can protect your legal rights and seek fair and timely reimbursement for your losses.