Vaginal Mesh Update

An advisory committee, appointed by the FDA, met late last week to determine whether the approval process for mesh devices should be left in place.  The mesh devices in question are used to treat women with urinary incontinence, pelvic organ prolapse, or a general weakening of vaginal tissues.  In these and similar cases, the mesh implants are implanted to strengthen these weakened tissues. 

The advisory committee determined that (though no formal vote was conducted) the devices do not need to be reclassified but that additional data would be useful.  "The FDA does not believe that mesh used for SUI repair should be reclassified from Class II to Class III," the committee stated.  Any device that is classified as Class III may be required by the FDA to undergo a series of randomized trails that demonstrates its safety and efficacy; whereas, Class II devices are not nearly tested to such high standards.

What is rather shocking, is that the panel expressed numerous safety concerns and the majority supported reclassifying the devices from Class II to Class III after the first day of their two day meeting; however, by the end day two, the panel indicated that a reclassification was not necessary.  Further, the FDA back in July, warned doctors and patients to avoid mesh products. Stating, "…the transvaginal placement of surgical mesh to treat POP may carry more risks than other surgical options, without any evidence of greater benefit."  It is important to note that while the FDA is not required to follow the advice of its advisory committee, if often chooses to.

Whether or not this device gets reclassified is moot at this point anyway for many.  Both the FDA and their advisory panel have made strongly worded statements against using these devices and have documented the undue risk of using them.  For those who have already had such procedures and have experienced complications, as thousands of other women have, a reclassification doesn't change anything.  It is logical (after speaking with your physician of course, as your health needs to be your top priority) to seek the advice of a professional on how to cope with the distress of this unnecessary pain.  Should you choose to seek the assistance of a qualified vaginal mesh attorney, remember that in some cases the manufacturers of these devices may have known about the risks of their products but chose not to disclose them.  These companies need to be held responsible for these decisions that have negatively affected so many.