Lawsuits against Transvaginal mesh manufacturers
The US manufacturers of a medical device commonly known a vaginal mesh, also nicknamed “Hammock” or “Sling” met with the Food and Drug Administration on 9 September in response to a safety warning issued by the FDA on 13 July 2011.
It appears that the failure rate of a, long approved, medical device has reached alarming proportions. So much so that a Vaginal Mesh Attorney is opening a mass tort lawsuit against the manufacturers.
A tort is a failure in the civil duty of care that a manufacturer has to the users of his product. It is an implicit duty of the manufacturer that no harm will be caused by the application of their ware. Many “tort” actions have been brought against car manufacturers for example which have led to many improvements in safety such as Seat belts, non collapsible seats and child proof window switches amongst others.
A medical device needs to be even more stringent in the care it owes its users. They are definitely not meant to cause harm. All medical devices undergo lengthy and stringent tests and field trials before the FDA entertains registration. So when the FDA issues a safety warning in connection with a device, previously thought to be safe, there is alarm.
In this case it is about the medical implant known as vaginal mesh. This device was used for hernia repairs 30 years ago and more recently been developed to act as a permanent implant in the repair of Pelvic Organ Prolapse (POP) and of Sudden Urinary Incontinence (SUI). These are specific woman’s ailments which commonly occur in later age after child bearing and possibly hysterectomies. The symptoms suffered by most women who have this problem are moderate and can be treated with exercises and/or with a temporary pessary which is removable by the patient herself.
However in the United States alone some 350,000 operations were carried out for POP repair alone in 2010 and roughly a quarter of these had mesh implants. In October 2008 the FDA had issued a safety warning concerning vaginal mesh but at that point the adverse reactions were apparently largely unreported and regarded as “Rare”. In the 2years following this safety warning the FDA had picked up over 1500 reports of Vaginal Mesh damage for POP repair alone plus different 1000 for SUI repair. The upgraded FDA safety signal issued on 13 July 2011 states that adverse reactions should no longer be considered “rare” and “serious concern” was expressed regarding the device..
The manufacturers met with the FDA on 9 September at which making they stated that they believed additional clinical trials were needed. They agreed to switch the labeling to insert a warning about the potential risks involved as well. For the moment the device has not been withdrawn from the market but a band of procedures has been recommended including giving likely patients detailed material regarding the risks involved prior to in implant being performed.
In the meantime many a Vaginal Mesh Lawsuit has been filed against the manufacturers. Thus far they are facing over 500 different complaints about the breakdown of the device they have been selling.