Non-Profit Group Petitioning For Ban of Surgical Mesh Products
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
A non-profit advocacy group, Public Citizen, is strongly encouraging the FDA to remove from the market synthetic surgical mesh products that treat a condition called pelvic organ prolapse and sudden urinary incontinence. Public Citizen made a point on August 25th to intensify the inspection of the devices after it was released that a large number of women who had the mesh implanted surgically were now suffering from injuries due to complications, such as injury to pelvic organs and erosion of their vaginal walls due to the mesh implant. Pelvic organ prolapse occurs when connective tissues and muscles around the bladder, rectum, or uterus weaken and cause organs to slip into the vagina. Nearly 300,000 women in the US underwent surgery for this problem -- 67,500 of which had the mesh product vaginally implanted.
These mesh implants were not required to be tested in patients before the product went out on the market and had undergone the controversial 510k approval process. Typically for products like prescription drugs, years and years of testing are applied before they can be marketed to the public. However, these particular devices -- which are constructed from Tupperware-like material - have been used in their current capacity since around 2006. In July 2011, the FDA issued a safety warning about the mesh, stating that "there are clear risks associated with the transvaginal placement of mesh to treat pelvic organ prolapse."
In their petition to the six different medical device companies that make this product, Public Citizen emphasized the FDA's concern that reviews of scientific literature show that there are no clinically significant benefits to the mesh implants. They also note the high rates of serious complications and state that requirements should include mandatory testing to ensure safety and effectiveness.