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FDA Continues to Monitor and Issues Updated Warnings Regarding Transvaginal Placement of Surgical Mesh

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

It is important that women are aware of the risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP). Women who have mesh surgery may be at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.

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,

“FDA is issuing an update to inform health care providers and patients that serious complications associated with surgical mesh for transvaginal repair of POP (Pelvic organ prolapse) are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008.”

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,

“Although it is common for adverse event reporting to increase following an FDA safety communication, the agency is concerned that the number of adverse event reports remains high.”

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.