What Do We Really Know About Recalled Transvaginal Mesh?
What do we know about any of the polypropylene meshes that are being removed from the market by Johnson & Johnson’s Ethicon division.
The four involved mesh products are:
- The TVT Secur;
- The Prosima Pelvic Floor Repair System;
- The Prolift Pelvic Floor Repair System; and
- The Prolift MTM Pelvic Floor Repair System.
The Prolift mesh is probably the most notable. Not only did J & J sneak it onto the market in 2005 without any FDA approval in a suspect approach to marketing mesh, but it didn’t exactly go to the front of the class during a clinical trial of women suffering from pelvic organ prolapse.
This study, “Vaginal Mesh for Prolapse: A Randomized Controlled Trial,” took place from January 2007 to August 2009. The results were published in the August 2010 issue of the journal, Obstetrics & Gynecology. Sixty-five women were recruited from three academic sites:
- Washington Hospital Center, (Washington, D.C.)
- Stanford University
- Yale University
Some of the women received Prolift synthetic mesh kits donated to the project by Ethicon. The study was supported by a grant from the AUGS Foundation (American Urogynecologic Society which supports mesh use among other treatments) and the MedStar Health Research Institute Intramural Grant Program. No conflicts were reported.
The women had prolapse in stage 2 which means the vaginal wall falls slightly through the vagina up to stage 4 – where the entire vagina protrudes through the opening. Women received sutures of the relaxed vagina with and without mesh. The success was to be measured at three months when the pelvic organ prolapse was expected to be measured at stage 1 or lower.
Study was Stopped
The study had to be halted early in August 2009 when an unusually high number of women began suffering erosion of the mesh at the nine month mark. Erosion is a wound breakdown when mesh is infected. In fact, 15.6% of the women experienced erosion which was seen with propylene mesh and not with sling mesh. Three out of five required additional surgeries to remove the mesh.
The study concluded there was a high vaginal erosion rate of 15.6% with no difference in the cure rates. Because this number had surpassed the criteria of the study of 15%, the trial was halted.
Erosion can cause pain, scarring, and further infiltration into the bladder and bowel. Just as we are seeing in real life, many of these problems are requiring additional medical and surgical treatments and hospitalizations. Those patients experiencing complications spend thousands of dollars just to get the mesh removed. And because there is scarring and erosion, many women will have to undergo substantial reconstruction surgery to try and make them as close as possible to their appearance “pre-mesh”. Many women will simply never be the same no matter how much reconstructive surgery is performed.
No one knows the actual number of real-life complications because reporting to the FDA’s adverse event website is random and up to the device maker to determine if the injury is due to the device. Sort of like the fox reporting himself to the farmer after all the chickens are gone.
J & J isn’t out of the mesh business by any definition. It has asked the FDA to allow it to continue to sell the Gynecare Gynemesh PS while a label change is underway. And don’t be surprised if the company has a new arsenal of meshes it’s waiting to launch.
Meanwhile, the FDA has no alert on its current website to let people and their doctors know what is going on.