Well-known health product manufacturers nowadays are facing vaginal mesh lawsuits after claiming that the mesh items they designed are “substantially equivalent” to formerly approved meshes that have recently been recalled, industry observers say. These exposed dangers of vaginal mesh have nowpermeated the mainstream media.
The introduction of these flawed items to medical consumers has cut through all the red tape by going under an approval system known as the 510 (k) process. This method, which was created and managed by the U.S. Food and Drug Administration (FDA), has gained consistently negative reviews from medical practitioners, individual patients, and even women support groups. Criticism such as this may had been expected from the public since the federal product evaluation regimen did not test products on actual patients. For products to be approved and marketed, they only have to show similarities with any of the items that have gained market approval in the past. There were some patients and a few advocacy organizations which believed that this evaluation process by the FDA is partly to blame for the surge of complications experienced by patients who opted to receive these types of implants.
Vaginal mesh implants, slings, and its kits are uncontrollably and recklessly used in primary health clinics for women patients in the US. These are surgically implanted during a minimally invasive procedure through the vaginal opening. Devices such as these are intended for the anatomical correction of slipped pelvic organs (otherwise known as pelvic organ prolapse) and stress urinary incontinence, a condition in which a small amount of urine leaks from the bladder due to sudden pressure in the pelvic and abdominal area (often triggered by sneezing, coughing, laughing, and during exercises).
Boston Scientific Corporation’s Protegen mesh implant is the only type of implant that has ever been recalled by the FDA after recipients complained of a rising number of complications. After these products were pulled from the market, it was unbelievable how other products with the same material and use as this type of mesh remained in the medical market for public use. Following the recall of Protegen, several other mesh products were also reported by many patients who received them to be causing complications that they believe are associated with the material and design. Because of the vagueness of the side effects, and the lack of medical explanation as to how these complications may have occurred, the FDA is unsure which action to take. However, to answer back to the appeals made by concerned groups and individuals, the agency has been conducting reviews and further researches on the nature of the complications and finding ways to determine whether they are related to the mesh products that have been utilized.
Until now, the vaginal mesh implants available in the market are still continuously distributed for surgical use throughout the gynecology facilities worldwide. Moreover, the 510 (k) process is still used to grant marketing clearances to most of the medical devices. This faulty product evaluation process has been pointed out by many to be the reason for the flood of vaginal mesh lawsuit claims that had been swept into the United States.
References:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm262299.htm
http://www.bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html
http://www.webwire.com/ViewPressRel.asp?aId=154797
Vaginal Mesh Complications 