Tagged Articles

transvaginal surgery 2 articles

FDA reviews safety of transvaginal mesh

The Food and Drug Administration (FDA) this week is reviewing the safety of surgical mesh used to repair pelvic floor disorders based on a recent report that found transvaginally implanted mesh fail to lead to better outcomes than non-mesh repairs and should be reclassified as posing a high risk to patients. Patient groups are also demanding a recall of the so-called moderate risk devices, saying they were permanently injured by the products. Surgical mesh products are made of non-absorbable synthetic material and are used during transvaginal surgery to repair pelvic organ prolapse (POP), a common condition in women caused by ... Read More

Watchdog group urges FDA to ban transvaginal mesh products

The watchdog group Public Citizen is taking aim at a type of surgical mesh used to repair pelvic floor conditions, arguing that the Food and Drug Administration (FDA) should ban the devices because they offer no significant benefits and that they expose patients to serious risks and the potential for permanent life-altering harm. Public Citizen is a national nonprofit consumer advocacy organization that is most recently known for petitioning the FDA to remove the painkillers Darvon and Darvocet based on data that showed the drugs were dangerous to consumers. The drugs were subsequently banned from the U.S. market earlier this ... Read More