What is Transvaginal mesh (TVM)
Transvaginal mesh (TVM) is used in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). According to the FDA, POP occurs when the internal structures that support the pelvic organs, such as the bladder, uterus, and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. These medical devices are commonly referred to as pelvic mesh, vaginal mesh, and bladder slings and are predominantly made of polypropylene mesh. Johnson & Johnson, Boston Scientific, CR Bard, and American Medical Systems all manufacture TVM devices.
Many of these TVM devices have been associated with severe complications such as pain during urination or intercourse, infection, erosion of the mesh through the vaginal wall and vaginal scarring.
In July 2011 there was a clinic study on transvaginal mesh products had to be stopped after there were 1500 reports of serious consequences from the product. These complaints filed between 2008 and 2010 had increased nearly five times from those reported between 2005 and 2007. Many of the reported problems were related to the painful condition of "erosion" where the skin splits and the mesh protrudes. In July 2011, the FDA issued a warning to physicians about the serious risks of this experimental procedure and clarified that traditional, non polypropylene devices/mesh should be the primary course of treatment.
Another 2011 study by the Journal of Obstetrics and Gynecology Canada (JOGC) stated that "until adequate effectiveness and safety evidence is available, the use of new TVM devices for prolapse repair should be considered experimental and restricted to use in investigative trials."
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Common Transvaginal Mesh Complications
"There are clear risks associated with the transvaginal placement of mesh to treat POP," said William Maisel, MD, MPH, deputy director and chief scientist of the FDA's Center for Devices and Radiological Health, in a news release.
The most consistently reported complication was mesh erosion into the vagina, bladder, intestines and uterus. This erosion can lead to multiple operations to remove the mesh and to repair widespread damage caused by the mesh. Often this leads to permanent problems and ongoing decrease in the quality of life for women. In some cases, even multiple surgeries will not resolve the complication.
Other serious risks include mesh shrinkage or contraction, mesh exposure, vaginal scarring, infections, pelvic pain, urinary, dysuria (painful urination), dyspareunia (painful sexual relations), and other ongoing problems.
In a review of scientific literature over the past 15 years by the FDA, many patients who underwent transvaginal POP repair with mesh were exposed to additional risks compared with patients who underwent POP repair with stitches alone.
Medical device manufacturers have a responsibility to protect the safety of consumers. If they learn of potentially serious side effects caused by their products, proper notification should be given to patients and physicians. The lack of communication deprived many women the opportunity to make informed choices and many are now dealing with permanent pelvic medical conditions.
Harmed by Transvaginal Mesh Implants?
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