Synthetic surgical mesh is implanted into about 300,000 women every year for the treatment of pelvic organ prolapse and incontinence. On Thursday, August 25, advocacy group Public Citizen announced it had submitted a petition to the U.S. Food and Drug Administration (FDA) calling for a ban on synthetic mesh used for pelvic surgeries. The consumer group says the risks outweigh the benefits with mesh eroding in the body, migrating, piercing organs, hardening, and causing pain, immobility, and further complications. Public Citizen was joined by two co-petitioners, Dr. L. Lewis Wall, a Professor of Obstetrics & Gynecology from Washington University in St. Louis, and Dr. Daniel Elliott, in the Urology Department at Mayo College of Medicine in Rochester, Minnesota.
POP stands for pelvic organ prolapse where the pelvic organs descend into the vagina largely due to the weakness in the connective tissue of the pelvic floor and the muscles around the pelvic organs. Surgery can be done transvaginally (through the vagina) or abdominally or laproscopically. Public Citizen calls for a ban in the marketing of all synthetic non-absorbable mesh, specifically those used in transvaginal repair of POP and orders the manufacturers to recall them. In the future any synthetic mesh should be classified as the most high-risk or Class III and be subjected to stringent post-market approval involving clinical studies, the group says, instead of being merely cleared for marketing as is currently allowed under the 510K process of the FDA.
The petition follows a July 13 FDA safety announcement saying that complications are “not rare” and have resulted in thousands of complications. From 2008 to 2010, the FDA received almost 3,000 reports of complications associated with surgical mesh used for POP and SUI repair including pain, mesh erosion, exposed mesh through the vagina and infection.
The Florida surgical mesh injury lawyers at Farah & Farah have been hearing from many men and women who are in pain and suffering as a result of a synthetic material that may not be compatible with the human body. Call us at 1-800-533-3555 so we can discuss your injuries to determine whether you have a viable claim.
Sources: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm, http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3405, http://www.citizen.org/documents/Petition_to_Ban_Surgical_Mesh_for_Transvaginal_Repair_of_Pelvic_Organ_Prolapse.pdf, http://www.citizen.org/documents/wall_statement_on_POP_mesh_petition.pdf and http://www.citizen.org/documents/1963-Elliott_statement_in_support_of_HRG_petition.pdf
