For women experiencing Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI), placement of transvaginal surgical mesh was intended to help reinforce the weakened vaginal or urethral walls. Ideally, the permanently implanted surgical mesh would repair POP and/or treat urinary incontinence.
In 2008 the United States Food and Drug Administration (FDA) noticed that the number of ‘adverse events’ reported in the previous 3 years was “over 1,000.” The Adverse Event Reporting System of the FDA is a database for voluntarily (and in the case of a manufacturer receiving an adverse event report, mandatorily) reported information regarding safety concerns and medication errors. In this case, the reports, most specifically, included the erosion of the mesh through the vagina. Reports of pain, infection, bleeding, pain during sexual intercourse, as well as organ perforation and urinary problems, were also among the most frequently reported problems.
Unfortunately, the FDA’s 2011 summer update indicated that such serious complications are “NOT RARE.” Just as troubling, the FDA stated that it is “not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” This is worrisome and even scary for tens of thousands of women who went through the trying ordeal of placement of ‘permanent’ mesh with the thought they would be resolving POP. Study of published scientific literature indicates that the erosion of the mesh through the vagina is the most common mesh-related complication from transvaginal surgical mesh for POP repair. To repair the damages caused by such erosion can take multiple surgeries, with no guarantee of success.
If you have had transvaginal mesh implanted and suffer from any of the symptoms, including but not limited to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse, urinary problems, neuro-muscular problems, pain, infection, bleeding, vaginal scarring/shrinkage, and/or emotional problems, please contact our attorneys at The Levensten Law Firm, P.C. Please call or email to speak with one of our understanding, knowledgeable and caring male or female attorneys for a free case evaluation. Your conversation will be kept confidential, regardless of whether you do choose to pursue your potential case, but we urge you to contact us as soon as possible because any claim you may have is governed by the Statue of Limitations in your state, which sets deadlines for the filing of your lawsuit.