POP Mesh Complications Not Rare, Says FDA

An FDA press release has confirmed the long-suspected risks associated with transvaginal placement of surgical meshes for pelvic organ prolapse (POP). The agency has advised the public that patients being implanted with a mesh through the vagina to repair pelvic organ prolapse may be put at a greater risk for complications, which were once described as rare.

A number of reports also cited that a number of patients who underwent a transvaginally-implanted surgical mesh required subsequent surgeries or hospitalization to treat complications or totally remove the implanted mesh.

The most common risk reported with transvaginal mesh procedures is mesh erosion, a condition in which the surgical mesh becomes exposed or protrudes out of the vaginal tissue. Mesh contraction, or shrinkage, a previously unidentified risk of transvaginal mesh surgeries, can cause vaginal shortening, vaginal tightening, and pain. Other issues frequently associated with transvaginal meshes used in POP repair are pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the transvaginal surgical procedure, as well as urinary problems.

A number of reports also cited that a number of patients who underwent a transvaginally-implanted surgical mesh required subsequent surgeries or hospitalization to treat complications or totally remove the implanted mesh. According the FDA, since the surgical mesh is a permanent implant, the process is often irreversible – in many cases, complete removal of a transvaginally-implanted surgical mesh may be impossible, even with multiple surgeries. In such cases, the patient may never experience relief from the complications associated with surgical mesh failure.

Though the FDA has said that no one brand of surgical meshes is more prone to mesh complications, C.R. Bard was one of the mesh manufacturers from which the agency received complaints. The company's surgical meshes have been the target of various Avaulta mesh lawsuits, alleging that the company knowingly exposed patients to unnecessary risks by failing to provide proper warnings about the dangers associated with surgical meshes, and compromised patient safety by continuing to market an unsafe and potentially defective product.

If you or someone you love has been affected by a transvaginal mesh surgical procedure, you are not alone. From January 2008 through December of 2010, over 2,874 reports of surgical mesh complaints were filed with the FDA. Patients who elect to take legal action for their POP mesh complications may be able to seek recover for the cost of their medical bills, pain and suffering, lost wages and other damages.