Welcome to Mesh Medical Device News Desk, aka Mesh News Desk
Mesh News Desk, April 2016 ~ Welcome to Mesh News Desk (MND), also known as Mesh Medical Device News Desk where we following the goings on of the largely unregulated medical device industry and its fallout on the public.
If you are new to the mesh mess you have come to the right place.
There are about 100,000 lawsuits currently filed in the U.S. to address the injuries that come from pelvic mesh. More are filed every day, not just in the U.S. but globally. Despite the product liability litigation, mesh is still used every day. Women are told “It’s different mesh.” It isn’t.
See the story “Top 10 Myths Women are Told Today about Pelvic Mesh” here
Most mesh for pelvic and hernia is made of polypropylene, a polymer from the petroleum industry, is small pore and subject to shrinkage and, in some, inciting a systemic reaction. This in combination to the mechanics of a hard polymer permanently implanted in a soft, nerve-rich pelvic area during a blind procedure, often by under-trained professionals, and there is a huge potential for complications.
Hernia mesh is also made of the same polypropylene and anecdotal reports, as well as those gathered by scientists who deal with complications, show they too are having complications after their implant.
Then again, some folks do fine, least in the short run. At the present time, there is no way of telling which you are – there are no tests and no attempt to identify who will have an “adverse event” as it called.
If you assume the U.S. Food and Drug Administration is watching over you in terms of medical devices, please be aware, the agency relies on the integrity of the industries it regulates to be vigilant and assure safety and efficacy when it comes to clearing the majority of medical devices for market. What we are observing from the defective product trials over pelvic mesh, many of which have been found defective but remain on the market, this is in desperate need of a major shift in thinking. Companies have been shown to clearly put profits ahead of patients.
There is a reason juries have listened to the stories of cover-ups, missteps, and outright fraud and awarded millions in punitive damages to mesh injured patients.
The FDA has issued two reports about pelvic mesh, the first, in 2008, after thousands of reports of complications came into the agency, said pelvic mesh complications were “rare.” By mid-2011 the FDA reversed that stance and said complications were “not rare.”
If you are told you need polypropylene mesh to correct prolapse or incontinence, you will need to direct your own medical care and be a truly informed consumer. We hope these pages help you toward that goal. Unless and until one can predict who will react negatively, the Precautionary Principle is advised.
These pages will attest to that.
If you are to be subjected to any medical device that has received FDA “clearance” (cleared not approved under the 510(k)) please be wary and ask questions. Cleared for sale (510(k) ) is not the same things as premarket approval which requires reaching a higher bar of safety.
Mesh News Desk has a new design on the website. Adding advertiser, Sundown Marketing and David Moyers will help those of you new to the issues find an attorney.
Greg Vigna, MD and JD is dedicated to addressing mesh injuries and will help you create a life plan for your ongoing medical needs.
As always, MND is not a substitute for advice from your medical and legal professionals.
Jane Akre, Editor, Mesh News Desk
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