Vaginal mesh or surgical mesh was first used in the 1950s as a treatment for abdominal hernias. The doctors started using transvaginal mesh in 1970s to treat female stress urinary inconsistence (SUI), a medical condition marked by an involuntary leakage of urine from the urethra of a woman during moments of stress. It is also used to treat pelvic organ prolapse (POP), a condition in which a woman’s internal organ such as the bladder, rectum, bowels, and/or reproductive organs slip down into her vaginal opening.
For decades, this frail medical procedure has been in existence. Massive reports have established connection of many adverse effects to transvaginal mesh. The FDA has been prompted by the drastic rise in deaths and injuries originating from transvaginal mesh thus in response, it then issued a statement notifying the doctors and patients to consider alternative treatments to transvaginal mesh in July 2011.
How Safe and Effective is Transvaginal Mesh Implant?
Current studies shows that a lot of side effects are intimately connected with transvaginal mesh implants. Most common symptoms are namely bleeding, vaginal pain, vaginal erosion, infection, shrinkage and pain during sex. The FDA, took a lot of security measures to caution the doctors and patients while the review of the product is ongoing. Advisory panel to the FDA met in September 2011 to discuss whether transvaginal mesh should be reclassified as a high-risk product , which would require manufacturers to undergo rigorous clinical safety testing to continue marketing. They are still continuing to analyze the safety and effectiveness of the device through the following methods, according to the FDA:
- · Reports on the review and analysis of medical device submitted to the agency.
- · Medical studies conducted on surgical mesh to determine its safety and effectiveness as part of knowing its possible ill effects.
- · By Understanding fully the post market performance of the device through the collaborative efforts of professionals and other members of the society.
- · Reports and information on newly- introduced surgical mesh devices are being collected and reviewed.
Warnings and several updates has been issued by the FDA as early as 2008 to apprise the doctors and patients on the potential ill effects of the product. Consumers are now considering to file a lawsuit against the manufacturers as reports about the risk of vaginal mesh reaches new heights which you can read more about in a mesh lawsuit blog. Nevertheless, there has been no explicit and clear-cut statement issued by the FDA regarding the safety and efficiency of surgical mesh as the ongoing assessment and debate on the matter is still pending. In lieu of surgical mesh the FDA suggested that resort to alternative treatments might be a better option.
Sources:
fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf
fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm
{ 0 коментара… прибавете свой сега }