Medical Product Defects: Transvaginal Mesh & Surgical Mesh
As of 2013, few recalls of transvaginal mesh products have actually been announced. These products, sometimes referred to as mesh slings, are used to repair pelvic organ prolapse (POP) and stress urinary incontinence in women.
In early 2012, the US FDA issued post market surveillance study orders, 522 in all, to all the manufacturers of these surgical mesh products. The study is sometimes viewed as one step short of an official recall because some mesh manufacturers subtly pulled their products from the market following the FDA orders.
The orders were made after thousands of women across the US experienced post-surgery complications ranging from severe bleeding to infection. Some of these complications were also accompanied by cases of the synthetic mesh cutting into vaginal walls and eroding nearby organs. Other reported injuries cited claims of urinary problems and recurrence of prolapse or incontinence. Severe cases involved erosion of the mesh and vaginal scarring, where additional surgery was necessary to remove mesh that eroded into the vagina.
Many patient and consumer advocates, as well as legal and medical experts, have pushed for a recall and ban on all synthetic mesh devices. Reports of injuries and complications were not linked to a single brand of mesh model. Thousands of mesh injuries in women have prompted numerous lawsuits against mesh device manufacturers.
While the FDA has still not yet issued an official product recall, any women who have experienced problems with transvaginal mesh are encouraged to contact the FDA and an experienced defective medical product attorney.