Serious Health Dangers Associated with Surgical Mesh
Used in Vaginal Procedures

Surgical mesh used in reconstructive surgery to treat Pelvic Organ Prolapse (POP) may pose signficant safety risks for women. The Food and Drug Administration (FDA) reported that surgical mesh manufacturers have received more than 1,000 reports of complications including infection, vaginal scarring, bowel or bladder perforation, erosion through the vaginal wall, as well as the recurrence of prolapse or incontinence.

A new FDA warning has been issued about the use of surgical mesh used to treat POP and Stress Urinary Incontinence (SUI). The defective vaginal mesh has led to serious complications in some women causing severe harm and requiring intervention, including medical or surgical treatment and hospitalization.

On July 13, 2011, the FDA issued a Safety Communication titled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." In it, the FDA recommends that health care providers who implant surgical mesh or care for patients who have recieved surgical mesh be aware of the risks and get specialized training before using the mesh. Also, the FDA told physicians to watch for complications such as erosion and infection; inform patients about the potential for serious complications and their effect on quality of life; and provide patients with the patient labeling from the mesh manufacturer.

"The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh," deputy director of the FDA's Center for Devices and Radiological Health, William Maisel, MD, MPH, said in a press release.

As of today, only the Mentor OB vaginal sling/tape has been withdrawn from the market because of a defect in design. Physicians now believe both the design of the mesh and the material used causes side effects. It is thought that the mesh keeps the surrounding tissue from receiving necessary nutrients and oxygen. This interaction may lead to vaginal erosion as the tissue covering the mesh literally recedes away exposing the implanted mesh causing urinary problems, intensive pelvic pain, infection and discomfort during intercourse (by both partners), perforations of the bowel, bladder, or the adjacent blood vessels, reoccurrence of the original Stress Urinary Incontinence and/ or Pelvic Organ Prolapse condition, urinary problems as well as vaginal scarring and neuropathic pain.

The FDA also emphasizes for patients who are considering or have received a surgical mesh implant to repair pelvic organ prolapse and/or stress urinary incontinence that the implantation of surgical mesh is permanent, and that removal of mesh due to complications may involve multiple surgeries and significantly impair the patient's quality of life.

The most frequent complications noted in the FDA's literature review were related to mesh erosion through the vagina. Mesh erosion and mesh shrinkage (a previously unindentified risk) can lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men have reported experiencing irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion. There were also reports of:

• recurrent prolapse,
• neuro-muscular problems,
• vaginal scarring/shrinkage,
• organ perforation,
• urinary problems, and
• emotional problems.

The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.

The first FDA safety warning about surgical mesh in transvaginal POP surgery was actually issued in 2008. At that time, the FDA identified it as an area of "continuing serious concern." (See the FDA's Public Health Notification from October 2008 titled "Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence"). However, between 2008 and 2010 adverse event reports increased more than five times the rate documented from 2005 to 2007. So the FDA issued its 2011 update to inform the public that serious complications associated with surgical mesh for transvaginal repair of POP are not rare.

The FDA plans to convene the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee on September 8-9, 2011. The panel will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for POP and SUI.

To date, these vaginal mesh devices have not been taken off the market despite reports of severe complications by women who have been injured by their use. So if you or a loved one believe that you have suffered complications as a result of the surgical mesh, we can help. CLICK HERE to complete an online Surgical Mesh Questionnaire.

Or, if you prefer... you can complete and mail the Surgical Mesh Questionnaire. CLICK HERE to open/download the questionnaire as a Word document.

When it comes to dangerous medical devices, Fonvielle Lewis Foote and Messer represents clients throughout the United States. We can assist you wherever you live. Call for a Free Consultation — (800) 876-7773.