Northwest Ohio Center for Urogynecology’s Official
Response to the FDA Warning Regarding Vaginal Mesh
In 2008, the FDA put out a safety communication regarding vaginally placed mesh for pelvic organ prolapse (POP) regarding complications reported over the recent past few years. The notification and its 2011 update detailed that the FDA has received over 1,500 reports of complications during the past several years (out of approximately 250,000 vaginal mesh procedures completed) regarding vaginally placed mesh for prolapse or incontinence. Adverse events included erosion, pain, infection, bleeding, pain with intercourse, organ perforation during the surgery and urinary and/or bowel problems. Many complications potentially require further surgery or treatment and may not resolve completely. The increase in complications reported was due to more mesh surgery being performed. The communication pertained primarily to vaginal mesh placement for treatment of POP. The FDA mandated a recall in 2012 of any of the vaginally placed POP mesh products, particularly the “kits.” Companies producing vaginal mesh kits for POP did start to remove these products from the market as early as 2012.
In 2014, the FDA proposed a reclassification of vaginally placed meshes from a mild to moderate risk class II device (FDA example given of a condom) to a class III device that carries significant risk and requires pre and post market surveillance along with substantial scrutiny of performance and complications (FDA example given of a heart valve).
Although risks including but not limited to erosion, pain, and scar tissue are all risks of mesh placed abdominally for POP or vaginally for SUI, the FDA excluded sacrocolpoxies and incontinence slings from the notification as it seems that not as many complications have been reported with these procedures and there are extensive studies supporting the mesh use for these procedures, thus qualifying them as the current “gold standard” for POP and SUI surgical treatment. The use of mesh abdominally or laparoscopically (i.e. sacralcolpopexy) POP and the mesh used in slings for SUI was effectively EXCLUDED and EXONERATED by the FDA; therefore these specific meshes were not reclassified as a high risk device.
Although there are many published studies including hundreds of patients that show excellent results with minimal complications when mesh is placed vaginally for prolapse, newer conclusions have been made that most cases of prolapse do not need mesh for successful treatment therefore eliminating the risk of mesh. If mesh is to be used at all for vaginal POP repair, risks/benefits/alternatives should be extensively reviewed with the patient and all other treatment options should be exhausted. The surgeon must ensure he/she has the proper training to correctly select patients with indications for mesh, to place vaginal mesh, and to take care of any complications that may occur.
It is important to note that NO surgery is risk free. Prolapse and incontinence surgery without mesh may be extremely complex and thus, carries similar risks of mesh augmented surgery. In many cases, non-meshed surgery carries extra risk of failure.
Therefore, this implies that it is NOT the mesh that is the problem in every instance. The problem may lie in how mesh is placed and in whom. Whether mesh is used or not, prolapse and incontinence surgery is advanced surgery and extra training and expertise is critical to obtaining good outcomes in patients.
Up until 2012, many companies marketed mesh “kits” for POP and SUI surgery as providing a “minimally invasive surgery” that “anyone” can learn. These companies trained many new surgeons on their use, most of whom have had minimal training in pelvic floor reconstruction. Altruistically, these surgeons had the goal of truly helping their patients with a very frustrating problem or recurrent prolapse or incontinence- they were looking for a better tool. Consequently, from 2002-2012, there was a great increase in these type of surgeries being performed and in many cases by non-specialists. Unfortunately, just because the procedure is in a “kit,” it does not make ithe procedure simple for everyone to perform. Most of the complications reported are in regards with these “kit” surgeries. Despite modifications and improvements to some of these kits, issues complications still arose. It does seem to be very clear that many of the complications reported can be minimized tremendously by proper surgeon experience and training. However, risks of surgery will FDA approved or recalled mesh will always be present. The FDA, the American Urogynecologic Society (AUGS), the Society of Urodynamics Female Pelvic Medicine and Urogenital Reconstruction (SUFU) and the American Association of Gynecologic Laparoscopists have all released official position statements supporting FDA approved mesh usage and all have recommended improved training, credentialing and monitoring by hospitals on who should be completing these procedures, which will help decrease complications.
Dr. Croak supports mesh use in POP and SUI surgery for the right patient. He has used it for many years in his practice with excellent outcomes and has reported his results in the peer reviewed medical journals. Dr. Croak will continue to use mesh when indicated, while appropriately providing informed consent of potential risks of mesh as well as alternatives such as biologic grafts. Without using augmentative materials, Dr. Croak would not get high cure rates when compared to “traditional” surgery without mesh in people with poor tissue strength. He supports the FDA notification entirely. The Northwest Ohio Center for Urogynecology and Women’s Health wishes to make themselves readily available to their colleagues and patients to assist with any issues or concerns regarding mesh complications. Many complications are small extrusions and may be simply handled if they are addressed early and appropriately!
If litigation, either class-action or directed, is being considered by the patient, it is imperative that they inform Dr. Croak of this consideration.
He is sympathetic to every patients’ situation but will need to review the case individually, and does reserve the right to decline acceptance of care. Please understand that Dr. Croak needs to do his job as a physician and keep his priorities on his office and hospital practice first and foremost. By taking on mesh complication cases out of his willingness to help those with problems, he unfortunately has been forced to delegate an ever increasingly disproportionate amount of time towards subsequent litigatory efforts. This is not why Dr. Croak became a physician. It is with great reluctance, that as litigation regarding mesh complications has increased, Dr. Croak has begun to limit the cases he will see because of this burden to his practice. To put this sensitive point in perspective, several of the best and largest academic medical centers in the country have recently instituted policies of refusing to even see mesh complications if their surgeons did not perform the original surgery.
Please be expected to sign a waiver relinquishing Dr. Croak from any and all risk of litigation if you wish to have him assist you with your situation.