Response to FDA Safety Communication dated July 13, 2011
September 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 some physicians demonstrate 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.
Understandably, the FDA tends to “hear” from physician groups as well as patients 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 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. The physicians at The Institute for Female Pelvic Medicine & Reconstructive Surgery have helped develop the proper techniques, have trained the most physicians, and lead the region and the county in experience with proper mesh placement.
We have been using mesh during vaginal surgery in our practice for many years with excellent 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 transvaginal mesh and continue to monitor our patients long after they have had the mesh implanted.
Our data base contains over 1,000 patients from our practice. In fact, some of the patients had mesh implanted over eight years ago. The most common risks of mesh placement include exposure of mesh material. Our patient database reflects that when we perform the surgery less than 3% of our patients have developed this complication. And when we ask our patients how they eel about their experience, 9 out of 10 of our patients report that they are satisfied with the results of their surgery.
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.
Vincent Lucente, MD , FACOG, MBA
Miles Murphy, MD, FACOG, MPH
Nina Bhatia, MD
Cristina Saiz, MD
Institute for Female Pelvic Medicine & Reconstructive Surgery
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