American Medical Systems is one of the world’s leading manufacturers of a product sometimes known as vaginal mesh. Vaginal mesh is also sometimes referred to as pelvic mesh or a bladder sling. One of American Medical Systems’ (AMS) main vaginal mesh products is called the In-Fast bladder sling. American Medical Systems (AMS) also manufacturers other medical vaginal mesh products like the BioArc, Elevate, Apogee, MonArc, MiniArc, and Perigree inserts.
Recent studies conducted by the Food and Drug Administration have revealed that there are potentially harmful side effects that may be caused by products like American Medical Systems’ (AMS) In-Fast bladder sling. One of the most commonly reported complications with devices such as American Medical Systems’ (AMS) In-Fast is vaginal mesh erosion. Vaginal mesh erosion can be very painful, and often times very difficult to repair. Back in 2008, the FDA first warned about mesh erosion saying that it occurred in rare occasions. More recently, in 2011, the FDA changed its previous statement to say that incidences of vaginal mesh erosion are no longer thought to be rare.
American Medical Systems’ (AMS) In-fast bladder sling is specially designed to treat patients suffering from stress urinary incontinence (SUI). It focuses on patients who have damaged pelvic tissue and muscles due to pregnancy, childbirth, trauma, radiation, prior surgery, or other issues which have caused the urethra and bladder to shift from their proper positions.
The American Medical Systems (AMS) In-fast bladder sling is a synthetic material placed in the pelvic region to offer support to the urethra. The In-fast bladder sling is meant to cradle the urethra and offer a point of support. There are also two titanium screws placed during the procedure connecting the AMS In-Fast sling to the back of the pubic bone.
According to American Medical Systems (AMS), there are some risks associated with the In-Fast pelvic mesh product. They state that inflammation and irritation may occur after surgery. They also claim that, ‘although rare, some of the most severe risks associated with sling procedures are infection, erosion and vessel or urethra perforation.’ Although the United States Food and Drug Administration (FDA) have amended their statement to say that mesh erosion is ‘not rare,’ American Medical Systems (AMS), the makers of the In-Fast sling and other vaginal mesh products still claim that vaginal mesh erosion is rare.
As mentioned before, the most commonly reported serious complication associated with vaginal mesh products like American Medical Systems’ (AMS) In-Fast bladder sling is mesh erosion. The FDA stated that mesh erosion occurs frequently enough to not be considered rare. Mesh erosion occurs when parts of the vaginal mesh product protrude through the vaginal walls. This can be a very painful experience for women. It may also cause infection in the vaginal walls. Typically when vaginal mesh erosion occurs from a product like American Medical Systems (AMS) In-Fast, surgery is required. The surgery seeks to remove the entire defective vaginal mesh product, but in many cases multiple surgeries are required to remove the entire product. Some patients have reported lingering pain even after undergoing multiple surgeries.
If you or a loved one is suffering from severe complications linked to the use of American Medical Systems’ (AMS) In-Fast, or similar device, you may be a good candidate for a transvaginal mesh lawsuit. Please contact the Willis Law Firm today. We are currently reviewing transvaginal mesh sling cases nationwide, and have female consultants ready to the sensitive issues regarding your potential case.