FDA Mesh Meeting: Shocking Result

As I recently told you, an FDA Advisory Committee met last week to hear some of the problems women have been experiencing with transvaginal mesh implants.  These devices, made by several different manufacturers, have been used in recent years to treat pelvic organ prolapse and stress urinary incontinence.  Since 2008 the FDA has received 2874 reports of problems associated with this surgery, 1503 with the pelvic organ prolapse procedure and 1371 with the stress urinary incontinence repair.

Last week, during the meeting of the FDA Obstetrics and Gynecology Devices Advisory Committee in Maryland, the Committee indicated that they would support premarket testing of these devices.  Just imagine, the companies that manufacture these devices may now have to do actual clinical testing on them before they are placed in a woman's body.  Shocking!

Some public interest groups wanted these devices taken off the market entirely.  The panel didn't support that.  One reason they didn't support a recall was because they had no data from credible clinical trials and studies to support such a decision.  And why do you think they don't have access to such data?  Because the manufacturers never conducted such studies before putting these devices on the market!

I will keep you updated on this situation as information becomes available.  Please contact us if you are one of the women experiencing TVM problems.  We are prepared to challenge these manufacturers and let them know about the horrendous injuries they have caused some women.