July 13, 2013 marks two years since the release of the transvaginal mesh safety communication issued by the U.S. Food and Drug Administration (FDA) regarding transvaginal mesh products used to treat pelvic organ prolapse (POP). The safety communication has since been updated, most recently in June 2013, with new information as the FDA’s investigation into the safety of transvaginal mesh products continues.
The safety communication is intended to inform health care providers and patients about the risks of transvaginal mesh implantation, and follows a notification issued by the FDA in October 2008 about transvaginal mesh used to treat POP and stress urinary incontinence (SUI).
In the 2008 notice, the FDA communicated that the health complications reported with the use of transvaginal mesh were rare, and in the most recent safety communication from 2011, the FDA corrected that previous conclusion by stating that transvaginal mesh complications are “not rare”.
According to the FDA’s safety communication issued on July 13, 2011, most commonly reported complications with transvaginal mesh products include transvaginal mesh erosion and organ damage. In addition, patients reported to the FDA instances of pelvic area pain, bleeding, pain during intercourse, and urinary complications.
In its review of transvaginal mesh in patients with POP, the FDA concluded that treating POP with transvaginal mesh shows no significantly better patient outcome versus other treatment options.
The FDA continues to collect and review information about transvaginal mesh used to treat POP and SUI. As a national law firm representing individuals who claim to have been injured by transvaginal mesh products, Carey Danis & Lowe transvaginal mesh lawyers await the release of any new information from the FDA regarding these important women’s health issues.
Carey Danis & Lowe is currently accepting transvaginal mesh cases. In addition to a free legal evaluations of transvaginal mesh cases, Carey Danis & Lowe transvaginal mesh lawyers can assist in filing transvaginal mesh lawsuits.
Contact Carey Danis & Lowe today by calling 800.721.2519 or by submitting a personal injury claim form.References: Defective Medical Device litigation, Transvaginal Mesh