Tuesday, September 6, 2011

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.

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