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Petitioning FDA and 2 others

Force studies that were never conducted on surgical mesh and its affect on the human body. Hold makers accountable for their products.


Appalling Oversight in Surgical Mesh Safety Testing !

Autoimmune disease onset and exacerbation post synthetic mesh implantation in humans has not been formally recognized, researched, and acknowledged .


We the undersigned in the interest of public safety are petitioning government and health authorities to demand a non mesh manufacturer directed or influenced study to examine the links between autoimmune disease onset and exacerbation, the population of patients experiencing FBR to medical mesh implants. Furthermore we demand that permanent implant devices be immediately reclassified by the FDA as class three devices. Autoimmune exacerbation and onset rates are alarmingly high among patients experiencing medical mesh complications such as mesh erosion, infection, extrusion, migration, fragmentation, chronic pain, and high levels of inflammation. Alarming is the fact, considering mesh implants are designed to be permanent parts of the human body, the FDA failed to class synthetic biomaterial mesh implant materials as level 3 devices needing extensive long term studies studies to protect patients implanted with these understudied and often untested permanent devices. By admission the FDA recognizes a biomaterial may elicit autoimmune responses and acting as an adjuvant material may induce a harmful autoimmune response. Nearly 60,000 lawsuits have been filed against companies that manufacture transvaginal mesh products. This does not include the number of women who have yet to understand the link between their autoimmune diseases and the mesh they have implanted in them, nor does this include the hundreds of thousands of men and women with similarly constructed biomaterial implants for hernia repairs that are suffering from autoimmune responses. Because mandatory reporting of mesh complications was not required the true devastation of may never be recognized. Petition Request written for TVT NO , by Nonie Wideman researching and advocating on behalf of mesh injured patients

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  • World Governments
  • doctors

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