Thursday, July 21, 2011

Georgia: Transvaginal Mesh Patch Failure News

Transvaginal Mesh Patch Failure

A July 2011 FDA alert warns of serious complications associated with transvaginal mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The FDA has received more than 3,800 reports of adverse effects caused by the surgical mesh or during implantation of the patch.
According to the FDA, significant complications resulting from transvaginal mesh patches are not rare and commonly include serious issues such as:
  • Erosion of the vaginal tissue
  • Infection
  • Bleeding
  • Pain
  • Urinary problems such as incontinence
  • Pain during sexual intercourse (dyspareunia)
  • Organ perforation (puncturing) from surgical tools during mesh implantation
Less frequent problems included
  • Return of POP
  • Neuro-muscular problems
  • Vaginal scarring/shrinkage
  • Emotional problems

FDA Alerts and Research Find Transvaginal Patches Unsafe

2011 FDA Alert – Serious and painful complications are associated with the transvaginal placement of surgical mesh, and their occurrence is not rare. FDA also finds the risky surgical mesh treatment of POP to be no more effective than traditional treatment.

2011 Study Published – The New England Journal of Medicine published research showing an increased risk of complications associated with transvaginal mesh implants. Compared to colporrhaphy, a traditional treatment of POP, surgical mesh had a higher risk of defect including:
  • 7 times the risk of bladder perforation
  • Nearly twice the risk of urinary incontinence (loss of bladder control)
  • 3.2 percent of women required follow-up surgery to correct problems
2008 to 2010 – FDA received 2,874 more reports of adverse complications linked to transvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings the total adverse reports to over 3,800.

2010 Study Published – A study featured in the Obstetrics & Gynecology journal had to be terminated due to the extent of injuries to participants who received the transvaginal mesh patch. Of the women who were treated with the surgical mesh, 15 percent experienced erosions, and other complications included two cystotomies (bladder incision) and one blood transfusion.

2005 to 2008 – FDA received more than 1,000 reports from nine surgical mesh manufacturers about complications related to the device and its treatment of POP and SUI.
Over 200 Lawsuits Filed Already
More than 200 women across the United States have filed lawsuits against three of the makers of transvaginal mesh patches:
  • C.R. Bard
  • Johnson & Johnson’s Ethicon
  • American Medical Systems
Complications have been reported for several other manufacturers of surgical mesh as well including:
  • Boston Scientific Scimmed
  • Sofradim
  • Caldera
  • Mentor Corporation
What Should You Do?
If you have suffered complications due to the implantation of a transvaginal patch to treat POP, you are not alone, and you have a right to compensation. By filing a claim against the surgical mesh manufacturer, you could receive compensation for medical costs, other financial burdens and the pain and suffering caused by this defective medical device. You will also send a clear message to the manufacturer that it is unacceptable to sell medical devices that harm innocent people.