Vaginal Vaginal Mesh devices have been a popular new treatment for women who have suffered weakening in the pelvic region. These Transvaginal Mesh products are usually implanted after a women has a pelvic organ prolapse or a POP. A POP is not that uncommon following a pregnancy or other situatiosn where the vaginal tissue is weakened. During a POP a female will experience the shifting of organs including: bladder, uterus and bowels. Also Transvaginal l Mesh Devices are used in cases of Stress Incontinence which is an involuntary loss of urine that occurs during physical activity, such as sneezing, coughing, laughing, or exercise. In 2008 the FDA (Food and Drug Administration) sent letters to doctors regarding serious complications and possible side effects associated with transvaginal mesh. The FDA has updated it's information on Transvaginal mesh and Vaginal Mesh is now a serious concern.
Much of the Vaginal Mesh side effects stem from the mesh protruding out of the vaginal tissue. Serious side effects caused by the vaginal mesh include urinary problems and infections, urine leakage, severe pain, discomfort, scaring and the erosion of the mesh into the vaginal tissue. Again if you have suffered from any of the following symptoms from vaginal mesh devices contact your attorney: urinary infection, severe pain, urine leaking, pain, vaginal scaring, urinary problems, recurrence of prolapse. There are other side effects caused by the actual insertion of the mesh products. These side effects include bowel perforation or bladder perforation and/or blood vessel perforation. Some of these same side effects have been reported when the Mesh Device needs to be removed.
In October of 2008 the FDA sent letters to surgeons and medical professionals advising them on the potential side effects of Vaginal Mesh Devices. At that time the FDA declared these complications to be "rare". The FDA stated from 2005 through 2008 they recieved over 1,000 reports from nine different Vaginal Mesh manufacturers that complications were associated with Vaginal Mesh devices. The complications listed by the FDA included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. Some cases mesh erosion led to "a significant decrease in the patient quality of life."Vaginal Mesh devices were cleared under what's called the FDA's 510(K) process. The 510(K) process allows products to be approved without extensive studies if the product "substantially equivalent" to other products in the market. The FDA is meeting to determine if Vaginal Mesh Devices will be moved to the "High Risk" category. On Sept 8th The FDA’s Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee will meet to discuss the category changes to Vaginal Mesh Devices. Should the FDA classify Surgical Mesh Devices as high risks, manufacturers of these products will be required to conduct post market studies and give that data to regulators for regular review. It is noted that the FDA received over 1,500 reports of complications from surgical mesh devices from 2008 to 2010. Patient groups like Public Citizen have petitioned the FDA to recall Surgical Mesh Devices.
First if you have suffered any of the symptoms from your Vaginal Mesh device, immediately contact your doctor. Also, if you have been adversely effected from a Vaginal Mesh device you may be entitled to compensation. To have your Vaginal Mesh claim evaluated by an attorney, complete our Vaginal Mesh Claims Form Case Evaluation Form.
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