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.

FDA Alert - Vaginal Mesh

On July 13th 2011, the FDA issued a safety communication regarding 'Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse'.

In other words, serious complications have been linked to the use of vaginal mesh or transvaginal mesh.  As discussed previously, this vaginal mesh is an implant used to strengthen vaginal tissue that can weaken due to childbirth, hernias, etc.  According to the FDA, the purpose of their "serious concerns" are specific to pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  


The most common complication that was reported for these vaginal mesh implants was an erosion of the device through the vagina, also known as a protrusion.  The vast majority of these reports came between 2008 and 2010.


Some of the most important revelations from the FDAs investigation (taken directly from the FDAs website) are as follows:

• Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
• Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
• There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
• While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.

 Patients that experienced either mesh erosion or mesh contraction reported severe pelvic pain and/or discomfort.

If you have had a vaginal mesh implant and have suffered from any discomfort, it is important that you contact your physician immediately.  There are surgical steps that can be taken to repair this damage and/or reduce the pain or discomfort.  If you are interested in legal remedies from such complications, it would be best to speak with a vaginal mesh lawyer.

If you have not had a mesh implant but are considering doing so, please be aware of the alternatives (such as biologic grafts) as well as asking your physician the appropriate questions (recommended by the FDA):

• Are you planning to use mesh in my surgery?
• Why do you think I am a good candidate for surgical mesh?
• Why is surgical mesh being chosen for my repair?
• What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
• What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
• Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
• If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
• What can I expect to feel after surgery and for how long?
• Which specific side effects should I report to you after the surgery?
• What if the mesh surgery doesn’t correct my problem?
• If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
• If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
• If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?