The mesh in question is a nylon-like material called Prolene or polypropylene mesh. It has been used for many decades for hernia repair but only for the past several years for vaginal prolapse repair. Vaginal mesh is typically inserted for a “dropped bladder” or cystocele; or a rectal bulge into the vagina or rectocele; or sometimes for a dropping of the top of the vagina or vaginal prolapse. These are significant sized sheets of mesh that are placed through vaginal incisions. The FDA initially noted more complications than expected back in 2008 and put out a warning on the FDA Website at that time. Since then a lot more mesh has been used and the FDA saw fit to put out a stronger warning about these products in the summer of 2011. This is only about vaginally inserted mesh for prolapse, not mesh slings for urinary incontinence or abdominally placed mesh for prolapse.
The FDA is now requiring that all the companies manufacturing the mesh fund a registry of all patients who have this implanted. They are also requiring more research on these products already on the market and are suggesting they be used only by specially trained pelvic surgeons with urogynecology experience and only in certain cases, perhaps after a prior failed prolapse surgery.
The complications noted were mild and severe. The mild problems are mesh erosion with bleeding from the vagina, or extrusion that causes pain with intercourse. Sometimes this heals with some estrogen cream and other times it must be removed surgically and another method of prolapse repair must be utilized. Extra surgeries are not as successful as the first attempt. Severe problems involve mesh erosion into other organs such as the bladder or rectum. This requires major surgery with significant risk.
There are good studies that indicate that natural tissue repairs may not “look as tight” as those done with mesh but they are as functionally beneficial without the added mesh risk. For the strongest longest lasting repair, mesh is used through the abdominal route, either through an incision, with a laparoscope or with the De Vinci Robot. The latter 2 choices get you out of the hospital in 24 hours with a 2 week recovery. This option works well for those who need extra strong repairs and long lasting repairs with minimally invasive surgery. I recommend seeing a surgeon who does all these types of repairs so you are getting what is best for you not just what the individual surgeon knows how to do.
I am trained and experienced in all techniques and therefore can discuss the risks and benefits of all approaches to best design a treatment plan for each individual woman.
It is always best to be armed with information. The full FDA warning can be read on the www.FDA.gov website.
