Transvaginal Mesh Studies
In early 2012, the Food and Drug Administration (FDA) ordered 33 transvaginal mesh manufacturers to conduct three years of trials on the safety and effectiveness of their implants. The required mesh patch studies came as a response to a 2011 FDA report revealing that the number of deaths, injuries and malfunctions tied to transvaginal mesh implants had increased five fold since 2007.
The FDA stated that transvaginal mesh complications were more common than the agency had previously believed. Manufacturers are using the ordered clinical trials to study rates of organ damage, transvaginal mesh complications and the quality of life for female implant patients.
Additional Transvaginal Mesh Studies
A 2005 study appearing in the Journal of Obstetrics and Gynecology determined that transvaginal mesh implants do not provide greater benefits than traditional surgical treatment where patients’ own ligaments are used to strengthen the vaginal wall.
In May 2013, the Journal of the American Medical Association published a study reporting that transvaginal mesh fails in nearly one third of all patients within 7 years of receiving the device. The study followed 215 women who received transvaginal mesh to treat pelvic organ prolapse for 7 years.
A Georgetown University study published in the September 2013 edition of the Journal of Obstetrics and Gynecology also revealed that treatment with transvaginal mesh implants did not increase cure rates among patients suffering from pelvic organ prolapse.
If you or a loved one underwent surgery with transvaginal mesh and have experienced complications, you may be eligible to file a lawsuit. For a free legal consultation, contact the lawyers at Hissey Kientz, LLP by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form located on the right side of this page.