Transvaginal Mesh Patch (TVM) Injuries Noted by FDA
Posted by: Stephen Leshner
August 29, 2011
Topic: PRODUCT LIABILITY
A transvaginal mesh (TVM) patch is a surgically implanted device that stretches across the vaginal wall (which is also known as the pelvic floor) to add support to tissues damaged as a result of an injury, childbirth or surgery. Transvaginal meshes have been used in the treatment of pelvic organ prolapse, a condition in which the bladder, uterus, vagina, urethra, bowels or rectum slides out of place due to weak pelvic floor tissues, or stress urinary continence, which is a lack of control over urination, which can cause women to urinate when laughing, sneezing or coughing.
In 2011, the FDA issued a public notice to doctors and TVM patients after 2,875 injuries relation to the mesh were reported between 2008 and 2011. Reported complications included devices from nine (9) different manufacturers, including the Avaulto support system by C.R. Bard, Gyncare Prolift and Gynemesh Prolene by Ethicon (Johnson & Johnson), AMS Prolapse Repair System by American Medical Systems, Pinnacle Pelvic Floor Repair Kits by Boston Scientific, and Polyform Synthetic Mesh by Proxy Biomedical, Ltd.
Transvaginal mesh systems have been linked to a number of dangerous problems, including reports of infection, pain, urinary problems and bowel, bladder and blood vessel perforations. There have been complaints of recurrences of pelvic organ prolapse, and vaginal mesh erosion. In fact, a 2009 clinical trial was stopped after 15% of the women implanted with the mesh suffered vaginal mesh erosion after only three months.
If you or someone close to you has suffered damages caused by a transvaginal mesh (TVM), please contact Steve Leshner for a free consultation and case evaluation.
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