FDA Warns Of “Serious Complications From Surgical Vaginal Mesh”
Filled under Damages, Our Firm, Uncategorized on July 14, 2011 - no comments .On July 13, 2011, the Food and Drug Administration (FDA) issued a warning to patients and their healthcare providers to consider alternatives to transvaginal mesh (TVM).
”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
TVM is a medical device implanted surgically to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), conditions that may occur after childbirth and pregnancy. In 2010, more than 75,000 women had vaginal mesh surgery to repair POP.
Recent research shows that at least 10% of women who have received TVM implants suffer from mesh erosion within 12 months of surgery and more than half of these patients require additional surgery to remove the mesh following complications.
The advisory also noted that the FDA will be meeting on September 8-9, 2011 to discuss a potential ban on the mesh. The FDA was prompted to issue this warning after receiving more than 3,875 injury reports associated with the mesh, three of which involved fatalities, from 2005 to 2010.
What Patients Should Do?
• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
• Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
• Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.
If you or a loved one has been harmed by a transvaginal mesh, call the James Esparza Law Firm for a confidential discussion of your legal rights. Our law firm has helped thousand who have been harmed by faulty medical devices. We would like to help you too.
Call Now 1-800-745-4050
Helpful Links:
FDA
Press Release 07/13/2011
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm
Urogynecologic Surgical Mesh
http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf
Los Angeles Times
Revaluating Vaginal Mesh Implants
http://www.latimes.com/news/nationworld/nation/sc-dc-0714-fda-mesh-20110714,0,6030373.story
Washington Post
FDA: Complications From Mesh For Pelvic Organ Prolapse ‘Not Rare’
