LegalView Updates Vaginal Mesh Portal Regarding Potential Legislation
Added: (Tue Feb 21 2012)
LegalView, a leading online legal resource, supports legislation to update the how medical devices are approved by the U.S. Food and Drug Administration. This system, called section 501(k) process has been under scrutiny due to rising number of complaints arising from vaginal mesh, one of the many products on the market thanks to this system.
According to U.S. House Democrats, regulators should be able to clock medical devices based on past issues with safety and effectiveness. House Democrats have cited hundreds of injuries associated with trans vaginal mesh manufactured by Johnson & Johnson and C.R. Bard, Inc.
A bill introduced recently would close a loophole in the FDA's medical device approval process where medical devices can get approval without human testing as long as the manufacturers can show that their product is “substantially similar” to those already on the market.
Vaginal mesh received approval through this process, known as the 501(k) process, even though the original product had been shown to harm women. When a manufacturer creates a medical device, it has to go through a lengthy and stringent approval process, however if manufactures make similar products, they go through the 501(k) process, a system that approves devices if they are similar to products currently on the market.
The bill that has been introduced would allow regulators to deny a product whose predicate, or original product, has been removed from the market or if the FDA was in the process of removing it. There are provisions in the bill that would also require companies to explain why their product is different from any similar recalled devices.
The legislation would also require the agency to determine whether any recalls have been made within a manufacturer's device lineage. A report to Congress would have to be due within three years.
The bill has been led by Democrat, Edward Markey, of Massachusetts.
Many industry leaders, including the Advanced Medical Technology Association, say that the bill is unnecessary because the FDA already has abundant power to carry out its mandate and the burdensome provisions would not contribute to patient safety.
Transvaginal surgical mesh is a synthetic mesh that helps to support the pelvic organ muscles due to a condition called pelvic organ prolapse, or POP, and another condition known as stress urinary incontinence (SUI).
POP occurs when the pelvic organs slip out of place and descend- or bulge into the vagina. Most commonly, this can happen to the bladder and it is caused by undergoing multiple childbirths or a hysterectomy. When a woman undergoes a hysterectomy or multiple childbirths, the pelvic muscles become so weakened that they cannot hold the pelvic organs into place.
SUI is simply involuntary loss of urine during physical activity such as sneezing, coughing, laughing or exercising.
A vaginal mesh is supposed to fix these two conditions, but many complications have been associated with it, including pain, painful sexual intercourse, infection, bleeding, mesh shrinkage, and painful urination. The most commonly reported complication is mesh erosion where the mesh erodes into surrounding tissues.
To learn more about this device, please visit LegalView's vaginal mesh portal located at http://vaginalmesh.legalview.com/. If you or a loved one has experienced any of these symptoms, please contact www.legalview.com/ for a free legal consultation.
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Submitted by:Danielle Franklin