Florida Woman Says Transvaginal Mesh Complications Ruined Her LifeMay 29, 2012 | Parker Waichman LLP
Women around the country continue to report horror stories associated with the implantation of transvaginal mesh devices. Most recently, a woman Florida told the Sun-Sentinel that transvaginal mesh she received in 2007 during surgery to repair stress urinary incontinence has "ruined" her life.
Since her surgery, Susana Franklin has had to undergo four additional procedures to remove eroding pieces of transvaginal mesh from her body. Franklin also told the Sun-Sentinel that she is afraid that transvaginal mesh complications have put her marriage at risk, as she is no longer able to be intimate with her husband. Franklin is now so anxious and demoralized that she's on tranquilizers.
Recently, a doctor told her she will never be free of pain and will never be completely rid of the mesh that has become permanently embedded in her tissue. Franklin has now joined hundreds of women around the country who have filed lawsuits over transvaginal mesh injuries and complications.
"If you put it on a scale of 1 to 10, [my original problem] was a 10. Now it's over 100. My quality of life will never be the same," Franklin said. "I don't want anyone else to have to go through this. If I can share what I've gone through, people would think twice before getting this procedure that may not be necessary."
The transvaginal mesh Franklin received was manufactured by American Medical Systems. However, other manufacturers, including Boston Scientific, C.R. Bard and Johnson & Johnson, have been named in similar lawsuits. Such lawsuits allege transvaginal mesh caused various complications, including vaginal erosion, infection, extrusion, perforation, chronic pain and abscess.
More than 75,000 women a year have transvaginal mesh devices implanted to treat stress urinary incontinence and pelvic organ prolapse. The U.S. Food & Drug Administration (FDA) has been conducting a safety review of transvaginal mesh since 2008, and has received nearly 3,000 adverse event reports from women who’ve been injured by transvaginal mesh devices. This has prompted a Congressional inquiry in which lawmakers have required the 33 makers of transvaginal mesh devices to conduct full post-market safety studies on their products. Last year, the FDA updated its stance on transvaginal mesh devices and determined that it’s uncertain whether women are experiencing any clinical benefit from these devices. It also ruled that injuries caused by transvaginal mesh devices were not “uncommon” as it had previously determined.