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TVM (Transvaginal Mesh)

There's no way to "put it delicately" when talking about transvaginal mesh.  Yes, yes, they say getting older is not for sissies.  But let’s face it, things are really bad when you can’t laugh through an old Mel Brooks movie without wetting your pants.  Or your doctor tells you the reason it feels like you’re sitting on a ball is because your pelvic organs are literally falling through your vagina.  

 POP and SUI

You know and we know that women may be the "fairer sex," but they are far from the "weaker sex."  Just ask any one of our clients who’ve lived through multiple childbirths, only to suffer years later with pelvic organ prolapse (POP) or stress urinary incontinence (SUI) as a result.  What’s worse is that you’re expected to suffer in silence.  Face it, most folks would look at you like they’d found something rotten in the back of the ‘fridge if you told them what it’s really like.  

Transvaginal Mesh Surgery

It’s not surprising, then, that 200,000 American women annually undergo surgery to correct the problem.  Manufacturers have been claiming for years that women’s problems with POP or SUI can be solved or greatly reduced with a transvaginal prolapse repair kit containing pre-cut pieces of vaginal mesh and long needles or another pre-made fastening system for inserting the mesh through the vagina, deep into the pelvis and securing it to the pelvic floor.

Vaginal Sling Side Effects  

The problem is that vaginal sling surgery can have side effects.  Mostly it’s just minor little triflings like when the mesh works itself loose and moves around up in there like an infected splinter or some other foreign object festering inside your body, trying to find its way out.  Or, the mesh could cause vaginal scarring, or erosion of the vaginal wall or of the urinary tract.  The mesh can do damage to other organs nearby.  It could make sex painful for you or the mesh could migrate into the vagina and lacerate your partner’s penis.  It can wedge itself into a spot between your legs that makes it painful just to walk.  Or, you might have to undergo painful corrective surgery (or surgeries) and hope for better luck next time.  You know, gals, side effects! 

FDA

The U.S. Food & Drug Administration has analyzed Medicare databases and found that patients undergoing prolapse repair with transvaginal mesh as opposed to traditional surgical methods were 2.26 times more likely to require subsequent corrective surgeries to repair damage done by the surgical mesh.  In 2008, the FDA warned that between 2005 and 2007, it had received over 1,000 reports of serious complications from transvaginal mesh. 

In 2011, the agency issued a safety alert in which it cautioned that at least ten percent of women treated with the vaginal sling for pelvic prolapse or stress incontinence experienced movement of the mesh sling or erosion during the first year after surgery.  Half of those patients were forced to undergo corrective surgery to take out the mesh.  According to the FDA – rocket scientist organization that it is – vaginal mesh just might not be better for POP repair than traditional, non-mesh treatment.  Ya’ think?  Now the FDA is cautioning women and their doctors to rely on an alternative to transvaginal mesh implantation.

Still, in 2012, the FDA has yet to recall transvaginal mesh products from the market.  Instead it’s ordered mesh manufacturers to test their products’ efficacy and safety.   Hmmm… maybe they shoulda’ done that before you had your surgery?  

Lawsuits & Recalls

For the thousands of women whose bodies have been mangled by a transvaginal mesh fix-it kit, the situation couldn’t be more serious.  And it’s finally getting serious for the manufacturers as well.  Injured women have filed hundreds of lawsuits against several manufacturers of the dangerous mesh products, including Johnson & Johnson, Endo Pharmaceuticals Holdings Inc. and C.R. Bard Inc.  In 2012, a California jury awarded $5.5 million in the first trial against C.R. Bard Inc. for injuries caused by the Avaulta Plus mesh product.  And the Ethicon unit of Johnson & Johnson has announced that it will end sales of four of the company’s vaginal mesh implants, including Prolift, Prolift+ M, Prosima and TVT Secur systems. 

If you’ve been "treated" with a transvaginal mesh patch and now you’re experiencing the same symptoms suffered by thousands of other women, the first thing you need is excellent medical care to fix the problem.  You may also want to discuss your legal options with another woman who gets it.  The women on our trial team at Hendler Lyons Flores are here to listen.  Let us use our years of experience with dangerous product cases to help you recover the legal compensation you deserve. These are cases that hit a little too close to home; we’re fighting back.

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