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Commentary on the FDA Safety Communication released July 13
The FDA recently put out a safety communication regarding mesh placed vaginally for pelvic organ prolapse (ie cystocele, rectocele and vaginal vault prolapsed) concerning complications that have been reported over the past several years. The notification stated that over the past 3 yrs 1,503 complications have been reported to the FDA (out of approximately 250,000 vaginal mesh procedures performed) regarding mesh placed vaginally for prolapse. They noted that mesh placed transvaginally was associated with adverse events including erosion through the vaginal tissue, pain, infection, bleeding, pain with intercourse, organ perforation during the surgery and urinary and bowel problems. Many of these complications may require further surgery and may not resolve with further surgery. They stated that there has been an increase in complications reported (due to more mesh surgery being completed). The Safety Communication pertains to the transvaginal placement of mesh for treatment of pelvic organ prolapsed and NOT the use of mesh placed abdominally or laparoscopically (i.e. sacralcolpopexy) for prolapse or mesh used in slings for urinary leakage. They concluded that most cases of prolapse may not need mesh to be treated successfully and therefore eliminating the risk of mesh (this conclusion is a very controversial one as it certainly depends on what “most” means, i.e. most surgeons who treat advanced prolapse, recurrent prolapse, and patients at high risk of failure from “traditional” surgery would not agree with this statement as research has shown a MUCH higher cure rate with mesh in these groups), and if mesh is to be used all risks/benefits should be weighed, review all alternatives and all risks with patients and ensure the surgeon has the proper training and experience to not only place the mesh but make the correct patient selection and take care of any complications that may occur.
The FDA did not take the mesh off the market, nor do a recall of any of the mesh products, it was a Notification to patients and surgeons that these complications were being reported and an evaluation of proper use. It should be noted that NO surgery is risk free and Prolapse and Incontinence surgery without mesh also carries many if not most of the same risks that mesh does and that in many cases it carries extra risk of failure. Although risks of erosion, extrusion, pain, scar tissue, etc. are all risks of mesh placed abdominally for prolapse, the FDA excluded this procedure as well as mesh slings from the notification as it seems that not as many complications have been reported and there are adequate studies to support its use. Therefore, this shows that it is NOT the mesh that is the problem, it is how it is placed and in whom. The SAME exact mesh is used in these procedures on the same vaginal tissues and it has been shown to have minimal risk of infection, rejection and is very well tolerated….and gives the benefit of higher cure rates compared to non-mesh surgery. There are multiple published studies totaling thousands of patients that show excellent results with minimal complications when mesh is placed vaginally for prolapse….however all of these studies were completed by very experienced surgeons and surgical experience seems to be KEY in good outcomes and minimizing complications. Prolapse surgery, whether mesh is used or not, is advanced surgery and extra training and expertise is critical to obtaining good outcomes in patients.
Over the past several years many companies have made mesh “kits” for prolapse surgery and trained many new surgeons on their use, therefore the numbers of these type of surgeries have increased greatly. Unfortunately, just because the procedure is in a “kit” it does not make it simple for everyone to perform. Therefore, there has been a great increase in these type of surgeries being performed and in many cases by non-specialists. Most of the complications reported are in regards with these type of “kit” surgeries. Recently, there have been modifications and improvements of some of these kits (including eliminating external needle passes through the groin and buttock and making the mesh lighter) that have resolved many of the issues in regards to complications being reported. However, it does seem to be very clear that many if not most of the complications reported can be minimized greatly by proper surgeon experience and training. Risks of surgery will always be present, however many of the complications may have occurred secondary to surgeons without adequate experience placing the mesh incorrectly in the wrong patient….which of course leads to higher rates of complications. Dr. Moore discussed this very concern in his paper “Mesh Kits for Prolapse: Friend or Foe” published in 2009. The FDA and societies such as the American Urogyn Society have recommended improved training, credentialing and monitoring by hospitals and departments on who should be completing these procedures, which will also help decrease complications. The American Association of Gyn Laparoscopists (a leading organization in the field of Gyn Surgery) recently issued a statement in response to the FDA notification which is very consistent with Dr. Moore’s and Miklos’ views and at the same time also challenged some of the FDA’s findings (Click here to read the AAGL's response). They feel that in their conclusions the FDA did NOT take into the most critical factor in surgical outcomes, i.e. Surgical experience and that the FDA also did not include many studies in the literature that showed excellent outcomes with mesh that were completed by very experienced surgeons.
Dr. Moore and Miklos support mesh use, in prolapse and incontinence, in the right patient. They have used it for many years in their practice with excellent outcomes and have reported many of their results in the peer reviewed medical journals and will continue to use mesh when indicated, with the appropriate informed consent of potential risks as well as alternatives. Without it, they could not get the cure rates they do and they have seen no increase in overall complications when compared to “traditional” surgery without mesh. They support the FDA notification in regards to patients being adequately informed, given all risks/benefits and alternative choices and ensuring that surgeons have adequate training and experience that are performing these procedures. They also make themselves readily available to their colleagues and their patients to assist with any issues or concerns regarding mesh complications secondary to their extensive experience in the field.
When complications of mesh occur, in most cases, it is not the mesh itself that CAUSED the problem; it is how it was placed or how it healed in place, what approach was used and what type of patient it was used in. The American Urogynecologic Society in its response to the FDA notification states “No one approach for mesh placement has been proven to be superior in all cases and there may be particular circumstances when the placement of transvaginal mesh is appropriate”, therefore they too support the use of mesh in prolapse surgery. However, unfortunately, complications are a risk of ANY surgical procedure and one of the most important thing is to RECOGNIZE the complication and be able to adequately take care of the problem. This is true with any complication in regards to surgery, whether mesh is used or not. Many complications that occur unfortunately are either not recognized or the patient’s complaints are ignored in hopes that the situation will improve on its own or with time. This again may be due to surgeon’s experience with these type of surgeries. Most complications are easily handled and typically should be addressed early, especially if the patient’s symptoms are not improving. If the surgeon that placed the mesh is not experienced in handling the complications, then they should refer the patient to a specialist that is. It is also true that some complications of prolapse surgery, again whether mesh is used or not, can result in very complex problems that can result in severe quality of life alterations for women and again it is the utmost importance to get these patients to specialists with extensive experience in handling these type of issues to give the patient the best chance of improvement.
Atlanta Urogynecology Associates Response to FDA Safety Communication dated July 13, 2011