It is estimated that the devastating condition stress urinary incontinence affects nearly 13 million people across the United States, with 85% of the people affected being women. Because the condition can have such a negative affect on the person’s personal life, many people choose to obtain a permanent surgical cure for the condition. The most common cure is the placement of a transvaginal mesh device, such as the Prefyx PPS System by Boston Scientific, into the body to correct the condition.
Stress urinary incontinence typically occurs because the muscles of the pelvic floor become weakened and allows the bladder or the urethra to drop out of its proper position. Because of this displacement, any additional stress that is placed on the abdomen, such as that from laughing, sneezing, coughing, or moving in certain ways, can cause the involuntary leakage of urine, which can be extremely embarrassing when it occurs to an adult in public. The amount of urine that is expelled when the abdomen experiences stress will depend on numerous factors including the severity of the displacement of the relevant organs.
Although stress urinary incontinence can be treated with both surgical and non-surgical procedures, many physicians consider surgery to be a method of last resort after other non-surgical treatment methods have been tried. If the implantation of a transvaginal mesh surgical device is found to be warranted, the physician will schedule the surgical procedure on an outpatient basis and the procedure can be completed in around 30 minutes. A local anesthesia is used and the patient can typically go back to their normal daily activities within a matter of days.
Some physicians prefer to use the Prefyx PPS System for the surgical procedure because it has been designed to improve the safety of the procedure and reduce the length of the surgical procedure. The system is not intended for use in patients that are pregnant, considering future pregnancies, or have not finished their complete adult growth as these factors could cause problems with the positioning of the device in the future. Likewise, any patients that have an autoimmune deficiency, blood disorders, or any condition that may inhibit healing should not undergo a procedure to have the device implanted.
There are a number of complications that have been associated with transvaginal mesh devices, such as the Prefyx PPS System, and have been reported to the US Food and Drug Administration over the last several years. Many of the complications that have been reported involve injuries during the surgical procedure to implant the device, such as perforations of the bladder, major blood vessels in the pelvic area, or the bowel of the patient. Other complications involve a failure of the surgical area to heal properly, including severe infections or the development of abscesses.
In some of the cases that have been reported to the US Food and Drug Administration, the erosion of the device has caused numerous problems for the patients that have undergone the procedure. Because of the high number of complication reports received by the agency, a warning was released alerting patients and physicians of the risks associated with the procedures and the systems that included a transvaginal mesh device. Any person that believed that they were experiencing complications due to the devices was urged to seek medical treatment immediately before the complication became life threatening and further surgical treatments were needed to correct the issue.
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.
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