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A transvaginal mesh patch is a surgically implanted device that stretches across the vaginal wall (also known as the pelvic floor) to add extra support to tissues damaged during an injury, childbirth and/or surgery.
While a healthy pelvic floor bolsters the pelvic region by supporting some organs and keeping others in place, once injured or dramatically stretched, damaged vaginal walls can add pressure to the bladder and cause abdominal organs to slip out of place.
By adding strength to damaged vaginal walls, transvaginal mesh patches can be effective treatments for:
However, despite being an effective treatment for some patients, hundreds of women have developed a range of serious health problems after using a transvaginal mesh patch.
To date, the Food and Drug Administration (FDA) has received over 1,000 patient reports regarding potentially fatal complications associated with the use of transvaginal mesh patches.
FDA Medical Alert
On July 13, 2011, after receiving over 1500 adverse event reports relating to serious injuries caused by the implantation of polypropylene transvaginal device/mesh, the FDA issued a comprehensive medical alert to physicians warning that, in most instances, the risk of serious injury outweighed all purported benefits associated with the use of these devices. Specifically, the FDA found that traditional procedures, which did not utilize polypropylene devices/mesh, should be the primary course of treatment and that implantation of these devices should limited to procedures of last resort.
Recent Research Indicates Serious Risks and Complications
Victims of defective transvaginal mesh and pelvic/bladder support products are filing suit against the manufacturers nationwide following the shocking results of a clinical study. The study was stopped before completion because the problems they were seeing in patients were too severe to continue the research. More than 15 percent of women in the study experience the dangerous and painful condition known as “erosion,” in which the skin splits and the mesh protrudes.
Uses of These Devices
The transvaginal products (mesh, tape and sling devices) are marketed as solutions for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Many patients have reported experiencing serious problems, including:
According to a recent article in the Journal of Obstetrics and Gynecology, patients would have been better off with traditional treatment.
Prior Transvaginal Mesh Warnings From the FDA
In 2008, the FDA issued a Safety Alert to doctors and the public. This alert reported that the most frequent complications included:
Cesare Costanzo is the author – you can find him on google plus.
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