Response to FDA Safety Communication dated July 13, 2011
August 1, 2011
To Our Patients and Women of the Community:
In the past few months there has been some conflicting information released about the use of synthetic mesh materials for the repair of pelvic organ prolapse. Clinical research, by many physicians demonstrates very favorable results with improvement in anatomy and quality of life, while other studies suggest no benefit and potential risks. Interestingly these studies are often conducted on the very same mesh or procedure, yet yield very different outcomes and conclusions. The FDA recently released a new statement (July 13, 2011) concerning the complications that have been reported about vaginal mesh. The FDA did not take the mesh off of the market, nor do a recall of the mesh, they were simply reporting that complications concerning the placement of mesh vaginally for prolapse have been reported to the FDA and surgeons and patients need to be aware of these. The FDA also encourages patients to ensure their surgeon has discussed why they feel mesh is indicated in their particular case, review alternatives and ensure the surgeon has adequate training and experience with mesh placement. The notification is specifically in regards to mesh placed vaginally for prolapse and not Mesh Slings nor Mesh placed abdominally (i.e. Laparoscopic Mesh Sacralcolpopexy). (Click here to read the FDA notification)
Understandably, the FDA tends to “hear” from patients and physician groups only about the negative outcomes or problems. Unfortunately, complications can occur during any surgical procedure and mesh complications can and do happen. The key to decreasing the risk of these complications is to use the proper mesh (i.e. a Type I macroporous polyppropylene mesh) and to place the mesh properly. This requires the correct surgical technique for dissection (preparing the space within the pelvis in which the mesh will ‘lie’), delivery (bringing the mesh to the optimal attachment sites) and setting or “adjusting” the mesh material. However despite meeting these criteria: choosing the correct mesh, performing the appropriate technique, being a well trained surgeon in the application of mesh, discussing the risks, benefits and alternatives to the surgery, it is impossible to guarantee a risk – free surgery. The surgeons at Atlanta Urogynecology Associates have helped develop the proper techniques, have helped improve outcomes and minimize complications with mesh placement both laparoscopically and vaginally and are known throughout the country and the world to have excellent outcomes with their surgical procedures. Dr. Moore and Miklos have trained surgeons throughout the United States and the world and are considered some of the foremost experts in the world on mesh used in prolapse surgery. It is clear by the published literature that when placed by experienced surgeons that outcomes using mesh are very favorable, risks are minimal and cure rates are much higher than when mesh is not used. Mesh is NOT indicated in all patients, however when it is, it needs to be placed by very experienced surgeons to minimize the risks of complications.
Here at Atlanta Urogynecology Associates we have utilized the same type of mesh during vaginal and laparoscopic surgery in our practice on the majority of our patients since 1998. Some patients received mesh for the treatment of incontinence and others for prolapse and still others had mesh for both problems. For more than 13 years we have utilized Type 1 macroporous mesh for the treatment of prolapsed and incontinence with minimal complications and very good results. In order for us to feel confident about counseling our patients on the success we have using vaginal mesh, we have done extensive research on both laparoscopic and transvaginal mesh and continue to monitor our patients long after they have had the mesh implanted. We have been involved with many clinical trials evaluating its use and have published many peer-reviewed articles in major Gynecology, Urogynecology and Urology journals and have presented our research and results at national and international Scientific Conferences around the world. Our outcomes have been very favorable with much higher cure rates compared to traditional non-mesh surgery and complication rates that are similar to when mesh is not used. We do not recommend mesh in all patients and discuss alternatives in all cases, however when we do recommend it, we feel very strongly that the benefits far outweigh the risks (which we discuss with all patients extensively). We also feel that many, but not all of the complications reported to the FDA are secondary to inexperienced surgeons placing the mesh and we agree with the FDA that this needs to be monitored better and that patients need to do due diligence on their part by ensuring proper experience and informed consent by their surgeon (click here to see the 13 questions that the FDA recommends patients to ask their surgeon).
Our database contains over 5,000 patients from our practice of which a majority have received mesh for either prolapse or incontinence. The most common risks of mesh placement include exposure of mesh material, and/or pain with intercourse and when these complications occur, they are typically very treatable. Here at Atlanta Urogynecology we describe mesh erosion as mesh that creates a hole in an internal organ (i.e. rectum, bladder, bowel, urethra) and we define extrusion as the expulsion of the mesh out of the vaginal skin. With the exception of mesh extrusion/erosion, all risks present with mesh surgery are also present in prolapse surgery without mesh. Our patient database reflects that when we perform the surgery less than 2% of our patients have developed any of these complications. In fact, over 90 % of our patients have reported that are very satisfied with the results and our glad they had the procedure completed. Many state that we have “given them their life back”. Unfortunately, complications are a risk of any surgical procedure, whether mesh is used or not. The surgeons at Atlanta Urogynecology Associates review all of these risks in detail prior to any surgical procedure and review all alternatives in order for the patient to make an educated decision regarding their surgical procedure. We hope this information provides you with a better understanding and a more balanced perspective to vaginal mesh surgery and also relieves you of any unnecessary concerns.
FDA Mesh Response