Vaginal Mesh Surgeons Respond to FDA

A group of surgeons has recently published their collective response to the 'Safety Communication Update' provided to the FDA by an advisory committee, regarding the use of transvaginal placement of surgical mesh (TVM) for pelvic organ prolapse (POP).  You can read the entire report here:  http://www.cfurogyn.com/Surgeons%20Reply%20to%20FDA%20Report.pdf

Earlier this month, the advisory committee concluded that these mesh devices do not need to be reclassified from Class II to Class III.  While the committee acknowledged that there are very real and significant risks involved with these devices, they did not find enough evidence to reclassify them.  Basically, 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.  

The surgeons do agree with the FDA that implantation of mesh does carry such risks as mesh erosion, pain, infection, bleeding, pain during intercourse, organ perforation, and urinary problems but they take issue with one of the quotes from the FDAs most recent update:  “Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.”  This group of surgeons argues that patients should be aware that with the exception of mesh erosion, these are all risks of traditional non-mesh surgery as well.  In other words, they feel that the FDAs statements imply that there are multiple risks of TVM that do not exist with traditional repairs and they feel that this is not accurate and is misleading to the public.

Well, all POP surgical procedures carry a certain level of risk and all methods of treatment will have its share of complications.  But the question is about mesh and if the benefits outweigh the risks.  When the surgeons say "...with the exception of mesh erosion…" they change the discussion.   The FDAs advisory committee didn't meet to discuss POP repair 'with the exception of mesh erosion'; they met to discuss mesh and mesh erosion and if the benefits of using mesh outweigh the risks.  It's not entirely clear what the motivation is of this report and it's not clear how many surgeons assisted in writing this report or how many agree with it.

If you are interested in seeking recovery from the manufactures of these mesh devices that caused you pain, please contact a vaginal mesh lawyer.  We suggest finding an attorney who will not make you part of a class action lawsuit and one that that is knowledgeable and successful in this type of complex litigation.

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.

Vaginal Mesh – Advisory Committee to Meet This Week

A committee has been established (Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee) to make recommendations and to provide advice to the FDA.  On September 8th and 9th the committee will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh used for the repair of pelvic organ prolapse (POP). 

Many adverse effects have been documented with these mesh products.  The committee will be asked to provide evidence of the risks and benefits of these products and if the benefits outweigh the risks when compared to alternative treatments that tend to have fewer complications.  These implants have been used for years to treat urinary incontinence, pelvic organ prolapse, hernias, and to support weakening of vaginal tissues due to childbirth.  In 2008, it came to the attention of the FDA that a substantial percentage (as high as 10%) of recipients of these mesh implants have, or will, experience complications.  The FDA recently warned against using these devices until an advisory committee could be organized to discuss their findings further.  These advisory meetings will be held later this week in Gaithersburg, MD. 

If you have not undergone a procedure involving transvaginal mesh implants and are exploring your options, perhaps the hearings that take place this week will be enlightening.  If you are a recipient of one of these implants and you have not had any adverse side effects, again, hopefully you can gain a better understanding of risk factors and what you can expect going forward.  If you are a recipient of one of these implants and you have had adverse side effects, talk to your physician as soon as possible.  There are treatment options available but they do vary in their effectiveness depending on the severity of your personal situation. 

If you are one the many women who have experienced pain or discomfort from a mesh implant, you owe it to yourself to seek additional recovery.  In our litigious society the thought of another lawsuit might be a turnoff but think of it in the following way.  Oftentimes  manufactures/corporations/businesses/etc make decisions based on profitability.  In some cases they have even do so at the expense of being negligent.  If your pain was caused by a negligent company who only cared about increasing their bottom line, do you really think you owe them the consideration and empathy that was not shown for your well-being?  It is imperative that you speak with a qualified vaginal mesh lawyer to discuss your options.  There is no cost to have a simple conversation just to see what options are available to you.  In many cases you can play a large role in protecting future consumers to ensure that all of the necessary precautions have been put into place to increase the safety of everyone.  Even though this is foremost a health issue, sometimes negligent companies only pay attention when it becomes a financial one.