Public Citizen Pushes FDA for Recall of Surgical Mesh
Media outlets reported that the consumer advocacy group Public Citizen has formally petitioned the US Food and Drug Administration (FDA) for the recall of all non-absorbable synthetic surgical meshes used in the repair procedure of pelvic organ prolapse (POP).
Public Citizen is asking the FDA to recall and ban all marketing of all non-absorbable mesh products designed and labeled for the use in transvaginal repair of POP on the grounds that they offer no significant benefits over absorbable mesh and expose female recipients to serious complications and potential injury. The group is also asking that future versions of these products be labeled as Class III medical devices, which are required to undergo much more stringent testing in humans before being approved for widespread use.
These requests come in the wake of the release of a safety statement made by the FDA in July that said that mesh complications during transvaginal POP repair are “not rare.” The report also stated that it is “not clear” whether performing the operation with mesh is more effective than the traditional surgery that does not use mesh, and that using the mesh may actually expose patients to greater risk.
From 2008 to 2010, the FDA received over 1,500 reports of complications related to surgical meshes used in POP procedures, including vaginal mesh erosion, infection, pain and incontinence. Public Citizen added that, in some cases, the complications included vaginal scarring and mesh erosion, which resulted in discomfort for the patient and significant decrease in their quality of life.
As a Los Angeles personal injury attorney, I’m familiar with these types of surgical product defects and know the damage they can cause in the lives of patients that have to live with them everyday. If you’ve been adversely affected by a defective surgical product, contact a product liability lawyer in your area. You may be entitled to compensation for your pain.