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It appears that the failure rate of a long approved medical device has reached alarming proportions. So much so that a Transvaginal 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 use of their product. Just like the person who tried to sue McDonalds because he ate so many cheeseburgers that he became fat, or the smokers trying to sue tobacco companies because they got lung cancer, were trying to rely on a tort. Both those examples are on shaky ground as it is well known that burgers and chips are full of fats and salts and MSGs so anyone eating them is aware of the risks of weight gain. For the last 20 years the links between smoking tobacco and lung disease, and in addition many states insist that health warnings are placed on every packet of cigarettes so the smoker cannot claim not to have known that inhaling tobacco is unhealthy.

But it is different with a medical device. They are definitely not meant to cause harm. All medical devices undergo lengthy and stringent tests and field trials before the FDA allows them to registered. So when the FDA issues a safety warning in connection with a device previously thought to be safe there is cause for concern.

In this case it is about a medical implant known as Transvaginal Mesh. This device has been used for over 15 years as a permanent implant in the repair of Pelvic Organ Prolapse (POP) and for the repair of Sudden Urinary Incontinence (SUI). These are particular woman’s ailments which usually occur in later years after child bearing and possible hysterectomies. Many women suffer but, fortunately for them the symptoms are usually fairly mild and can be treated with exercises and/or with a temporary pessary which is removable by the patient herself.

However in the United States 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 stage the adverse reactions were apparently largely unreported and regarded as “Rare”. The upgraded FDA safety warning issued on 13 July 2011 states that adverse reactions should no longer be considered “rare” and that there was serious concern regarding the device. In the 2 years following the 2008 safety warning the FDA had picked up over 1500 reports of Vaginal Mesh Injury for POP repair alone plus another 1100 for SUI repair.

The manufacturers met with the FDA on 9 September at which meeting they stated that they believed additional clinical trials were needed. In addition they agreed to change the labeling to insert a warning about the potential risks involved. For the moment the device has not been withdrawn from the market but a set of procedures has been recommended including giving potential patients detailed information regarding the risks involved prior to in implant being performed.