The History of the Transvaginal Mesh and FDA Involvement
The FDA’s Public Notice involvement with the Transvaginal Mesh Sling begins in 2008. Since then, the FDA has issued two Safety Alerts advising patients and doctors of certain complications due to transvaginal devices. The first public alert warning was issued on October 20th, 2008. That release stated that from 2005 to 2007 the FDA received more than 1,000 adverse event reports of serious side effects due to the mesh sling.
The FDA Safety Alert is hyperlinked here in its entirety: Click Here to read the first FDA Alert Warning
The second FDA Safety Alert released on July 13th, 2011, stated that the FDA had received over 2,800 additional reports of serious side effects from the period January 2008 to December 2010. All of the reported side effects were related to Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI) treatment. The FDA indicated that at least 10% of women suffered migration (movement) or erosion within one year of surgery and at least half of those women required corrective surgery to remove the mesh. Three deaths were also reported. The FDA further reported the additional side effects of mesh contraction and/or shrinkage. The FDA concluded that it was not clear whether vaginal mesh for POP repair is better than non-mesh treatment. It cautioned patients and doctors to use an alternative procedure rather than vaginal mesh implantation.
See the FDA July 13, 2011 in its entirety here: Click Here to read the second FDA Alert Warning
The New England Journal of Medicine has stated that the side effect risks are due to the synthetic vaginal mesh.
See the article in its entirety: Click Here See the Alert in its Entirety
The FDA issued its first Public Safety Alert in October 2008 acknowledging the device’s side effects.
See the article in its entirety: Click Here See the Alert in its Entirety
On July 13th, 2011, the FDA again issued a Transvaginal Mesh Public Health Notification advising patients and doctors to consider alternatives other than Transvaginal mesh implantation.
See the article in its entirety: Click Here See the Alert in its Entirety
If you or your loved one suffered serious side effects or complications from the transvaginal mesh sling please contact one of our transvaginal mesh specialists today. We are representing side effect victims in all 50 states. We will work very hard to obtain a financial recovery for your side effects. Please either call us at 1-800-722-0765 today to speak to a specialist or complete our confidential free case review on the right. We will respond to you within 12 hours.
