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Number Of Transvaginal Mesh Lawsuits Continue To Increase

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Nearly 500 lawsuits against transvaginal mesh manufacturers, including Johnson & Johnson and C.R. Bard, have been filed over problems with transvaginal mesh used as a treatment for pelvic organ prolapse.

Marci Sutin Levin who has sued J&J over injuries caused by the mesh said the FDA failed her when they cleared the mesh through the agency’s 510 (k) process, instead of requiring extensive testing. The 510 (k) program allows a product to move through the approval process quickly and without substantive studies if the product is “substantially equivalent” to a like product on the market.

According to Bloomberg, Levin, aged 65, is one of nearly 75,000 women a year who have the mesh implanted for pelvic organ prolapsed. She told Bloomberg her pain is so intense she can’t work, sleep through the night, or have sex with her husband.

The FDA issued a warning in July concerning a rise in mesh related injuries and said the transvaginal mesh should be reclassified from moderate risk to high risk. This change would require new clinical data.

An FDA advisory committee is meeting to determine if the mesh is safe and effective for pelvic organ prolapsed and stress urinary incontinence.

An FDA review of 110 studies of 11,785 women showed the mesh had erosion within 12 months in 10 percent of study participants. Seven death were also reported, with four due to medical complications not directly related to the mesh placement surgical procedure.


 

 

Number Of Transvaginal Mesh Lawsuits Continue To Increase

breakinglawsuitnews.com disclaimer: This article: Number Of Transvaginal Mesh Lawsuits Continue To Increase was posted on Thursday, September 8th, 2011 at 6:47 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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