Transvaginal Mesh

The Food and Drug Administration has released an urgent advisory warning of serious complications related to transvaginal mesh (TVM). The FDA is recommending that patients and doctors consider alternatives before turning to transvaginal mesh procedures.

This FDA public notice comes after a rise in reported complications related to the surgical mesh implant used in transvaginal mesh procedures. According to the FDA, 2,875 injuries relating to the mesh used in transvaginal mesh procedures were reported between 2008 and 2010.

The most common complications reported were:

• Vaginal mesh erosion
• Infection
• Recurrence of pelvic organ prolapse
• Stress urinary incontinence

All of these are medical problems TVM implants are intended to fix. Transvaginal mesh complications are not particular to any one manufacturer as problems have been reported with mesh devices from nine manufacturers.

What is TVM?

TVM is implanted to relieve pelvic organ prolapse, which occurs when a woman’s uterus, bladder or rectum slip out of place. It is mainly used for the treatment of pelvic organ prolapse and stress urinary incontinence.

Problems stemming from transvaginal mesh complications include:

• Painful intercourse
• Mesh erosion
• Infections
• Chronic pain

Important Facts About TVM

Approximately 10 percent of women who receive transvaginal mesh implants experience mesh erosion within 12 months of surgery. More than half of reported complications require further surgery to remove the TVM implant.

In 2010, manufacturers estimate more than 75,000 women had TVM surgery to repair pelvic organ prolapse.

A 2009 Government Accountability Office report criticized the FDA for its medical device approval process. The report cited the FDA’s failure to reclassify medical devices in order to prompt more detailed reviews, which, according to the report, could have a negative impact on patient safety.

Free Consultation

If you have been affected by TVM complications, please contact the Birmingham attorneys of Pittman, Dutton, Hellums, Bradley & Mann today. The attorneys handling this litigation are Chris Hellums and Mike Bradley. We are centrally located in Birmingham, Alabama, right next to the Jefferson County Courthouse.  We have the experience and the resources to help you through your case. We are serving clients nationwide.