On July 13, 2011, the Food and Drug Administration released an urgent updated advisory recommending patients and doctors think about alternatives to transvaginal mesh (TVM).
This urgent notice came following a spike in reported complications in women with the surgical mesh implant which is used to strengthen vaginal tissue. The advisory also said that the FDA will meet to discuss a potential ban on the mesh altogether.
TVM is implanted vaginally or abdominally to improve pelvic organ prolapse, in which a woman’s uterus, bladder, or rectum can slip out of place. The device is also frequently used to correct stress urinary incontinence. Problems have arisen with TVM including painful intercourse, mesh erosion, infections, chronic pain, and additional required surgeries.
The latest research shows that roughly ten percent of women who have received TVM implants experience mesh erosion within 12 months of surgery and more than half of these patients need further surgery to remove the mesh following complications.
In 2010, manufacturers estimate more than 75,000 women had TVM surgery to repair pelvic organ prolapse.
Complaints of severe complications linked with prolapse repair have jumped five-fold, and include erosion, when the skin breaks and the device protrudes, and contraction of the mesh that leads to vaginal shrinkage.
In a report published in 2009, the Government Accountability Office criticized the FDA for its medical device approval process, saying the failure to reclassify medical devices to prompt more detailed reviews was hurting patient safety.