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Boston Scientific, American Medical System Accused In Transvaginal Mesh Lawsuit

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Boston Scientific Corp., and American Medical Systems Holding Inc., have been named in a lawsuit alleging that the companies sold transvaginal mesh products that were defective and caused severe injuries to women who had the products implanted to reinforce and support organs that prolapsed (Pelvic Organ Prolapse or POP)into the vagina due to various causes, including childbirth, obesity and age.

The lawsuit follows other complaints filed against C.R. Bard for the Avaulta transvaginal mesh. The lawsuits allege that the mesh causes tissue erosion, infections, and tend to migrate from the implant site. Because tissue weaves through the mesh to hold it in place, the mesh is nearly impossible to totally remove.

An FDA new release in July said ”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”

The release also said “The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems.  Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.”

The FDA has scheduled a two-day meeting to formulate recommendations for the use of the mesh.

 

breakinglawsuitnews.com disclaimer: This article: Boston Scientific, American Medical System Accused In Transvaginal Mesh Lawsuit was posted on Wednesday, August 31st, 2011 at 8:09 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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