AMS Sued Over Transvaginal Mesh ComplicationsJul 14, 2011
American Medical Systems (AMS), the manufacturer of Perigee, Apogee and Elevate surgical mesh products used in transvaginal pelvic organ prolapse (POP) surgery, has been named in a lawsuit alleging one of its transvaginal mesh implants caused a Texas woman to suffer serious complications.
AMS is just one of several companies that have been named in transvaginal mesh lawsuits over the past several years. According to a report from Newsinferno.com, litigation involving C.R. Bard’s Avaulta mesh was consolidated as part of a multidistrict litigation for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia last October. Last year, settlements were reached in a number of Mentor ObTape vaginal mesh lawsuits. At least two other transvaginal mesh lawsuits are pending against AMS in Delaware.
According to her lawsuit, Laura Jones had transvaginal mesh implanted in 2009 during POP surgery. Not long after the procedure, Jones began experiencing prolonged unexplained pain and urinary complications. Apparently, the device had eroded, shrunk, and partially extruded into her vagina. Jones was forced to undergo additional surgical procedures to have the device removed. Her lawsuit alleges that AMS failed to warn the public about the inherent risks of vaginal mesh side effect.
Unfortunately, Jones is not alone in suffering these types of transvaginal mesh complications. According to a notice issued by the U.S. Food & Drug Administration (FDA) yesterday, more than 2,800 women have suffered from mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems as a result of transvaginal mesh. Yesterday's notice was an update to another the FDA had issued in October 2008, when it said it had received 1,000 reports of such complications.
According to the FDA, 1,503 of the new reports were associated with POP repairs and 1,371 were associated with procedures to repair stress urinary incontinence. The agency noted that the number of adverse event reports associated with POP procedures was five times as many as the FDA received from 2005 to 2007. The FDA said its safety review also found that 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half of them require additional surgeries to remove the mesh.
In a change from its 2008 position, the FDA said complications following POP surgery that involved transvaginal mesh are not rare. It also cautioned doctors that it was not clear that POP repair involving transvaginal mesh was better than traditional non-mesh procedures, and may actually expose patients to greater risk of complications.