The Mini-Arc mini sling by American Medical Systems (AMS) is one of the few devices that have been approved by the US Food and Drug Administration for the treatment of female stress urinary incontinence. The device was considered to be an improvement over other types of transvaginal mesh devices when it was released to the public in 2007 and many physicians began to use the devices for their patients with moderate to severe stress urinary incontinence. Because the procedure was considered to be minimally invasive, the treatment method could be performed on an outpatient basis in less than an hour and the patient could return to their typical daily activities in a matter of days.
The introduction of the Mini-Arc mini sling was a breakthrough for technology because the device only required a single incision for placing and securing the device into the proper position. The entire process is completed vaginally and the technique that is used for the placement of the device is considered to be a permanent solution to the problem of stress urinary incontinence. The device is made out of polypropylene monofilament mesh, which could cause a reaction in the individuals that are sensitive to polypropylene products.
Procedures using a transvaginal mesh product have been performed more than one million times on patients around the world and are generally considered to be an effective treatment option for stress urinary incontinence. However, in recent years, the US Food and Drug Administration has received numerous reports of life threatening complications occurring in the patients that have had these devices implanted. Although many of the common complications reported are merely uncomfortable for the patient, some of the complications reported are severe enough to require surgical intervention to preserve the health of the patient.
The most serious complications that have been linked to the placement of a transvaginal mesh device include bowel perforation, bladder perforation, nerve damage in the pelvic area, and injury to the large blood vessels in the location. In some cases, the patients experienced difficult or painful sexual intercourse due to nerve damage or scarring in the vaginal area. Patients that experienced the erosion of the device after it was implanted often require surgery to remove the device and repair the damage that the erosion caused.
Experts have estimated that as many as 20% of the people that have used one of these transvaginal mesh devices will experience complications associated with the device. The number of reports of adverse events that the US Food and Drug Administration have received in the last few years has numbered nearly 1,000 and the number is expected to rise as more people that have not noticed mild complication symptoms advance into more serious ailments. Many of the complications can be reversed or cured with prompt medical intervention but some cannot be cured by any medical treatment and can affect the patient for the rest of their life.
Do I Have a Transvaginal Mesh Lawsuit?
If you or somebody you know has been injured or suspect that you may have a serious complication directly linked to a Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) procedure, and/or the placement of a transvaginal mesh product, you should contact and Injury Help Network attorney immediately. You may be entitled to compensation for your injuries and our lawyers can help.
Please use the form below or call toll free 24 hrs/day by dialing (866) 588-0600 to contact us for a free case evaluation of your potential transvaginal mesh claim.
Secure 128-bit SSL Encrypted Email Communication
