(PRWEB) November 16, 2012
The Food and Drug Administration is reporting that many women who have undergone operations for the conditions known as pelvic organ prolapse (POP) and urinary incontinence have suffered severe side effects that raise questions about the safety of transvaginal mesh implants.
The lawyers at Resource4thePeople want these women to know that these side effects have been reported in such increasing numbers to the FDA that the agency has issued warnings about these problems to physicians and patients.This report and warning are contained in a July 13, 2011 health alert:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm (See highlights below.)
Our team of transvaginal mesh lawyers point out that there has been a long history of devastating side effects associated with transvaginal mesh and that various models have been the subject of recalls and significant numbers of transvaginal mesh lawsuits.
The volume of these lawsuits has caused the federal court system to consolidate them into groups of what are called multi-district litigations that are overseen by judges for pre-trial evidence-gathering. (U.S. District Court, Southern District of West Virginia: MDL2325, MDL2326 and MDL2327.) These side effects, which were documented in the July 13, 2011 health alert issued by the FDA, are now contained in transvaginal mesh lawsuits that will have to be proven in court.
Women who have suffered these problems are being advised by Resource4thePeople to report them to their physicians and to take steps to preserve whatever legal options may be available to them to be compensated for medical costs, loss of wages, loss of consortium, pain and suffering and other expenses caused by their condition.
They are also advised to familiarize themselves with the history of complaints filed with the FDA involving products produced by such companies as DePuy, Biomet, Stryker, Rejuvenate and Prefemur.
At first the FDA responded to these “adverse events” reports from transvaginal mesh as an “area of continuing serious concern.” However, as more transvaginal mesh problems were reported and more victims filed lawsuits the seriousness of these dangerous side effects were significantly upgraded.
In its most recent warning (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm) the agency said:
“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 FDAs activities involving surgical mesh for the transvaginal repair of POP.”
So, what are these complications? The lawyers for Resource4thePeople have found the following to be the most common complaints, according to FDA data: