U.S. health regulators ordered new safety studies for surgical mesh implants that are used to hold pelvic organs in place, citing a spike in the number of complications seen for female patients, including erosion and infection. Many Tucson woman have suffered significant pain, disability, and interruptions in their normal life because of complications from surgical mesh. The Food and Drug Administration also said it may reclassify the devices in a higher-risk category that would require manufacturers, such as Boston Scientific and a unit of Johnson & Johnson, to conduct clinical trials in people before receiving approval for sale. The FDA said it received more than 1,500 reports of complications related to the repairs with mesh from 2008 to 2010, including cases in which the mesh eroded into the vagina or caused bleeding and infection. The rate of problems was five times the rate reported from 2005 to 2007. The FDA sent letters this week to 35 manufacturers of transvaginal surgical mesh, requesting three-year studies of several hundred women each to study side effects, as well as the women's overall quality of life.US FDA Wants New Studies on Surgical Mesh Implants
We have seen first hand the trauma that our Tucson and Arizona clients have endured because of mesh product failures and medical malpractice. If you have suffered because of a pelvic mesh procedure or medical malpractice, please contact James Campbell at 520-545-1675.
By James Campbell
By James Campbell
