FDA Continues to Monitor and Issues Updated Warnings Regarding Transvaginal Placement of Surgical Mesh
In a recent communication directed towards patients, the FDA issued recommendations for women with pelvic organ prolapse (POP) who may be considering surgery to repair POP.
With the rising numbers of women suffering dramatic, and often permanent, damage from the use of the mesh, the FDA has made it clear that this has become a critical health matter.
To the medical community, the FDA updated its prior assessment on this issue and stated,
Not rare. Complications reported include chronic pain, erosion through the vaginal wall and vaginal tissue, infection, urinary problems, and recurrence of prolapse and/or incontinence. During insertion of the mesh, some patients experienced bowel, bladder, and blood vessel perforations. A decrease in patient quality of life is unfortunately common because of chronic pain, additional surgeries needed to repair damage, which are not always successful, as well as cases of dyspareunia (painful sexual intercourse). The FDA goes on to state,
Earlier this year, the FDA updated the Urogynecologic Surgical Mesh Implant website to include more information for patients about an additional condition – stress urinary incontinence (SUI). The update provides the FDA’s current assessment regarding the use of surgical mesh for repair of SUI. It is based on an analysis of adverse events reported to the FDA, findings reported in the scientific literature and input received from the Sept. 9, 2011 meeting of the Obstetrics and Gynecology Devices Panel of the Medical Device Advisory Committee.
If you or a loved one have suffered the pain, and loss of quality of life due to a pelvic mesh implant malfunction, contact us. We are here to help you. Stop waiting. Stop feeling ashamed. Stop the silence. Call us today.