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FDA Issues Additional Warning

The FDA issued a warning on July 13, 2011 about the frequent complications associated with transvaginal mesh products in their treatment of pelvic organ prolapse (POP). The FDA initially warned against these devices in 2008 but because of the high rate of complications, over 2,000 reported, it recently issued an additional warning. The FDA has also reported that the transvaginal mesh is proven to be no more successful than other vaginal surgeries yet seem to cause far more complications about which manufacturers failed to warn both doctors and patients. These mesh devices have been repeatedly failing, some having to be removed or trimmed due to malfunctions in design and materials used. Numerous women suffering complications have been pursuing legal action in hopes of recovering compensation for damages. By the end of July, over 100 lawsuits had been filed against Bard Avaulta and over 400 others against Johnson & Johnson, two of the main manufacturers of these devices.

Pelvic organ prolapse is a condition that occurs in women when the normal support of the vagina decreases causing the cervix, rectum, bladder, or urethra to drop or sag. The mesh device is used to hold these parts in place and prevent them from dropping. However, hundreds of women have experienced complications with these devices shortly after implantation causing serious discomfort and often requiring removal of the device.

The defective medical device attorneys at Arias, Ozzello & Gignac, LLP are currently investigating claims against the manufacturers of the transvaginal mesh devices. If you or someone you know has suffered complications from these devices, contact our attorneys today. You may be entitled to compensation for your injuries.

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