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Indiana Woman Files Lawsuit against Multiple Transvaginal Mesh Makers

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The national law firm of Parker Waichman LLP has filed a lawsuit in U.S. District Court for the Southern District of West Virginia, Charleston Division on behalf of an Indiana woman who allegedly suffered injuries from transvaginal mesh products. The lawsuit names as defendants American Medical Systems, Inc., Analytic Biosurgical Solutions, Mentor Corporation, Johnson & Johnson, Ethicon, Inc., Coloplast A/S, Coloplast Corporation, Coloplast Manufacturing, and other companies who designed, manufactured, and marketed transvaginal mesh products.

According to the lawsuit, the plaintiff has suffered significant physical and mental pain, permanent injury, permanent and substantial physical deformity, and loss of body organs from the transplantation of mesh products in March 2007 to treat pelvic organ prolapsed and stress urinary incontinence. The lawsuit also says that the plaintiff has undergone and will undergo corrective surgeries.

The lawsuit says that these transvaginal mesh products were approved by the FDA through the 510(k) process, and are dangerous and pose unreasonable risks due to their many defects. It also says that the mesh reacts to and abrades human tissue, harboring infection, and becomes embedded in local tissue.

Parker Waichman LLP reports that the Food and Drug Administration’s Obstetrics and Gynecology Devices Advisory Panel recommended that transvaginal mesh products be reclassified as high risk, which will eliminate the possibility of the products being fast-tracked through the FDA approval process, and will require manufacturers to show clinical evidence that supports its safety and efficacy.

 

 

breakinglawsuitnews.com disclaimer: This article: Indiana Woman Files Lawsuit against Multiple Transvaginal Mesh Makers was posted on Wednesday, June 20th, 2012 at 12:21 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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