Trans Vaginal Mesh Lawsuits Mount

Jan. 2012 – Veritas Legal Media – 757-582-1836 –

 Have you ever had an oper­a­tion or a sur­gi­cal pro­ce­dure that caused more prob­lems than the con­di­tion it was meant to rec­tify?  If so, you can prob­a­bly sym­pa­thize with hun­dreds of women who are tak­ing out law­suits over vagi­nal mesh implants.

Lit­i­ga­tion on this issue moved for­ward on Jan. 26, 2012, at a hear­ing in Miami, FL, when lawyers sought to coor­di­nate the many trans­vagi­nal sur­gi­cal mesh law­suits that are presently being brought across the USA.  Lawyers have filed motions with the U.S. Judi­cial Panel on Mul­ti­dis­trict Lit­i­ga­tion (JPML) rep­re­sent­ing women who say they suf­fered injuries after being implanted with vagi­nal mesh, which has been used for the treat­ment of stress uri­nary incon­ti­nence (SUI) and pelvic organ pro­lapse (POP).

Massivelaw­suits are now being brought against three man­u­fac­tur­ers — Amer­i­can Med­ical Sys­tems, Inc., Boston Sci­en­tific Corp. and Ethicon, Inc.

This has been a prob­lemacross the US for some years and it’s not as if the reg­u­la­tors haven’t had time to make patients aware of the dan­gers.  In Octo­ber 2008, the U.S. Food and Drug Admin­is­tra­tion issued a notice about trans­vagi­nal sur­gi­cal mesh.  It said the FDA had received more than 1,000 reports from nine sur­gi­cal mesh man­u­fac­tur­ers of com­pli­ca­tions that were asso­ci­ated with sur­gi­cal mesh devices.  Painful com­pli­ca­tions listed by the FDA included  bowel, blad­der, and blood ves­sel per­fo­ra­tion dur­ing inser­tion of the mesh and pain and dis­com­fort in the wake of operations.

The reg­u­la­tion, or in this case, the lack of reg­u­la­tion of these prod­ucts, is a cause for con­cern. These vagi­nal mesh prod­ucts were approved through the FDA’s con­tro­ver­sial 510(k) fast-track approval process, a sys­tem that’s more than 35 years old and under fire.  Unlike drugs there is no test­ing require­ment under 510 (k). The only require­ment is that a prod­uct should be sub­stan­tially equiv­a­lent to a device that has already been approved for sale. This highly con­tro­ver­sial approval process was also used for DePuy hip trans­plants – another device that has led to intense suf­fer­ing for patients, not to men­tion mul­ti­ple lawsuits.

Recently the FDA sent out a let­ter to man­u­fac­tur­ers of mesh prod­ucts call­ing for new post-marketing stud­ies on trans­vagi­nal mesh.  This seems like a clear case of clos­ing the sta­ble door after the horse has bolted, although if it helps bring change in the reg­u­la­tion of sur­gi­cal devices, some good will have come out of it.

Unfor­tu­nately, change has come too late to help many women who have been left in pain by faulty devices that stud­ies have shown pro­vide lit­tle clin­i­cal benefit.


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Filed under Defective products, Medical malpractice, Trans Vaginal mesh

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