Pelvic Mesh not approved by FDA – 510(k) Controversy

It seems the height of absurdity that the predicate device for a 510(k) “approved” product was withdrawn, and yet all the subsequent devices are still allowed to lean on that predicate; but that is only part of the absurd legal tangle that exists. Plaintiff’s lawyers from Matthews & Associates and other firms have repeatedly pointed out in court trials that the makers of pelvic mesh are leaning on a predicate that was not legitimate, was “adulterated” and “misbranded.”  More often than not, juries have agreed.

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Matthews & Associates continues to successfully pursue transvaginal mesh lawsuits across the country. If you or someone you love was injured by pelvic mesh, contact an experienced transvaginal mesh lawyer today for a free legal consultation. Please see our testimonials for evidence in how we have helped others.


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