MDND: Welcome July 2013
July 2, 2013 ~ Welcome. I’m Jane Akre, the Editor of MDND.
There is a lot of stuff brewing this month. C.R. Bard, a mesh maker, will face off against Donna and Don Cisson in a federal court in West Virginia. This is the first of four bellwether cases, as they are called, in this court where thousands of cases from six manufacturers have been consolidated. With Judge Joseph R. Goodwin presiding, the thought is that they will move through the system much more readily than if they are heard individually. It’s difficult to believe there are about 24,000 cases filed in this case alone and still there is very little media coverage.
Speaking of which- Bloomberg News did a great story on some of the court documents filed. If you haven’t read it please do – what’s most damning is the evidence that the company understood the polypropylene resin (plastic) that surgical mesh is made of was not supposed to be implanted in people. Instead, the company apparently created a dummy company to serve as a third party to purchase the mesh raw material. It will be interesting to see how that information is handled in court.
Bard Implants Knowing Not Fit For Humans
Some American Medical Systems cases have recently been resolved through a settlement. Though we don’t know how many (estimates are 1,600) Endo Health Solutions Inc. has agreed to pay $54.5 million to settle product liability lawsuits over the AMS Perigee, Apogee and Elevate transvaginal mesh implants. AMS was purchased by Endo Health Solutions in 2011.
July marks the two year anniversary of the strongly-worded caution by the U.S. Food and Drug Administration about transvaginal mesh. Please see it here.
“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.
The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.”
So here we are two years later and the FDA has not issued any update on mesh for stress urinary incontinence (SUI) but many of you have had the same sorts of complications – mesh erosion, infection, pain etc.
Please visit the MDND Facebook page where I will hopefully cover much of the Bard trial as well as have a day’s wrap up under legal on this site. And please pass MDND onto your friends. That helps it to percolate in the search engines. Friends of MDND also have valuable information from a patient and first-person perspective.
“Putting a Face on Adverse Events” continues to be the goal of MDND.
Advertisers and contributors welcome! Seriously!! Here is what drives me personally, and please Stay well ~ Jane A.