The U.S. Food and Drug Administration has come under fire after approving Transvaginal Mesh as a Class II device prompting no need for safety or further testing because similar products were already on the market. In 2011, the FDA sent out numerous warnings after reports of serious complications and injuries surfaced stemming from Transvaginal Mesh usage in women.The FDA requires hospitals to report any complications, injuries or death involving Transvaginal Mesh. Between 2008 and 2010, 2,874 reports of complications involving Transvaginal Mesh used in POP and SUI surgeries were documented.After the advisory panel of pelvic surgeons met last year they urged the FDA to upgrade the class of Transvaginal Mesh so that there were stricter testing precautions taken. They also urged doctors to update their training on how to repair the mesh and pay close attention to signs of complication after completing an operation for POP or SUI. The FDA furthers urges women to educate themselves of the dangers and benefits associated with Transvaginal Mesh and to learn about other forms of treatment for POP and SUI.
1996 – The first surgical mesh product, ProteGen Vaginal Sling created by Boston Scientific is used for treatment of stress urinary incontinence. The FDA originally approved Trans-vaginal Mesh as a Class II device which meant that since it was similar to products that were already cleared by the FDA, it did not need to go through human trials to prove its safety.January 1999 – Boston Scientific withdraws its ProteGen vaginal mesh product after receiving reports of women reporting pain during intercourse, damage to vaginal tissue and infection.2002 – The first surgical mesh product designed for pelvic organ prolapse is cleared by the FDA.October 20, 2008- The FDA puts out its first public health notification about complications associated with surgical mesh to treat POP and SUI.July 13, 2011 – The FDA upgrades its warning after receiving reports of serious complications and injuries, and changed its statement from October 2008 and said that complications are not rare and that TVM carried more risks than other surgical options.September 2011- FDA starts an advisory panel of pelvic surgeons to study and discuss Transvaginal Mesh products and recommend that the vaginal mesh be reclassified from a class II device, requiring more tests.January 4, 2012 – The FDA decided during their advisory panel to order manufacturers of Trans-vaginal Mesh to do comprehensive studies to research the risks associated with their products safety and effectiveness.
If you or someone you love has experienced a problem with vaginal mesh it is important to know that you are not alone. The FDA receives thousands of complaints every year and the manufacturers of these products have a duty to make their products safe for women’s use.
Call Sheff Law Today
To find out about your legal options, call Sheff Law at(888) 423-4477 or 617-227-7000. Sheff Law is a group of skilled attorneys who understand the seriousness of Transvaginal Mesh and will help you with the legal process that may result from a defective medical device.