Congress Now Involved with Vaginal Mesh
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- Created on Tuesday, 07 February 2012 14:24
Democrats are calling for a congressional hearing for pelvic mesh and transvaginal mesh products manufactured by Johnson & Johnson and C.R. Bard. Henry Waxman, a Democratic Representative form California led the committee to hold the hearing, demanding documentation from the manufacturers.
As we reported recently, the FDA has required cooperation from all pelvic mesh manufacturers to submit thousands of pages of documents as well as request numerous studies and surgeon reports.
Democrats have acknowledged the abnormally high rate of complications from these pelvic mesh products and are determined to learn more about why there are so many negative reports.
Both Democrats and Republicans are in agreement that some amount of overhaul is necessary with regards to how the FDA rules on medical devices. Currently, if a product is deemed a Class II product, which vaginal mesh currently is, it does not need to undergo the same rigorous series of random trials as Class III products do, to prove its safety and effectiveness. Pelvic mesh has demonstrated one of two things: (1) it either needs to be classified as Class II or (2) Class II medical devices need to undergo much more scrutiny before they are allowed into the marketplace.
Pelvic Mesh Lawyers have done, and continue to do, an incredible job holding pelvic mesh manufacturers' feet to the fire. Many law firms do a great service to the marketplace to ensure that due diligence is being done. A large medical device company experiences the same pressures as all publicly trading companies – grow revenues, cut costs, and ultimately increase shareholder value. Sometimes this is done by rushing products to market, skimping on the testing of a products safety and effectiveness, cutting corners, etc.
The Vaginal Mesh Lawyers at Cates Law Firm are dedicated to making sure that these companies are held responsible when they slip up and put profits ahead of patient safety. It is our primary goal to compensate the victims of negligent behavior and to deter similar behaviors from taking place in the future. If you have experienced any negative side effects from a transvaginally implanted mesh product, contact us for free to learn about what options are available to you. There is no obligation whatsoever, so contact us today to learn more.
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