Surgical mesh products are nothing new, they’ve been used for decades for procedures such as abdominal hernia repairs. However, in recent times, surgeons have used surgical mesh to repair pelvic organ prolapse (POP) in women.
In 2002, the USA Food & Drug Administration (FDA) approved transvaginal mesh implants/products for POP, and it had also approved pelvic mesh for stress incontinence in the late 1990s.
Notably, many pelvic/vaginal mesh products were derived from earlier abdominal mesh products, but while these mesh products worked fine in the limited-flex areas of the abdomen, the mesh products simply do not translate well to the highly flexible and much more delicate areas of the pelvis/vagina. The inflexible/stiff mesh does not mate well with the underlying tissues and will degrade over time. As the mesh degrades, it can shrink and become rigid, pulling and cutting at the fragile tissue.
The subsequent pain and damage to women as a result of defective vaginal mesh products are serious and horrible, to say the least.
On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.
The situation has since escalated, and the FDA is now considering pulling these products from the market completely. Simultaneously, hundreds of women across the country have filed lawsuits against mesh manufacturers for negligence and defective product design.
Wed, Nov 9, 2011
General