Dealing with mesh complications following mesh surgery for pelvic organ prolapse

Vaginal prolapse is not like the abdominal hernias. It is not static. It is more like the human mouth. It is a functional organ that is associated with ordinary activities such as urination, defecation, and sexual intercourse that we take for granted except when they don’t work any longer, and women become miserable. Pelvic floor dysfunction patients are some of the most grateful patients. The surgeon reconstructs the anatomy, returning function to the appreciative patient. When complications of recurrent prolapse, pain, pudendal neuralgia, recurrent bladder infections, voiding, and defecatory dysfunction occur, this has significant quality-of-life implications for the patient. When patients have vaginal mesh complications, they may not be referred to a referral center by their surgeon [1].

By early 2010, a major portion of our patient volume seemed to be vaginal mesh kit complications. It turned out that it was not the surgeons who were bad. The vaginal mesh kit was undergoing contraction and freezing the function of the vagina, bladder, or rectum. The mesh arms were irritating the major nerve going to the pelvis. To use an analogy, the vagina is a functional organ similar to the human mouth. It would be inconceivable for an oral surgeon to place the mesh in the mouth chicks or next to the trigeminal nerve that supplies the whole face. If they did, the risks would be constant pain, migraines, nerve paralysis or irritation, inability to eat or drink, and a life of constant misery. No one would consent to such an oral procedure, so why did the vaginal mesh kit industry make such a device? Why did so many doctors implant the vaginal mesh kits? How did so many women consent to the procedure? In many ways, the failure of mesh kits represented a perfect storm where failure occurred at multiple levels concurrently:

• Level I: Failure of innovation, ideation, and industry
• Level II: Failure of regulation
• Level III: Failure of medical school education, evidence-based medicine, professional societies, and post-graduate education
• Level IV: Failure of local regulations: hospital credentialing of the product, physician peer review, patient consenting, and education

With the growing number of reported complications to the FDA’s Manufacturer and User Device Experience (MAUDE) database, the FDA issued an updated Public Health Notification in July 2011 and included a significantly stronger warning for transvaginal POP mesh kits [2] [3] [3][4] [4]. The only available estimate is from FDA for 2010. FDA market data from manufacturers indicated that in 2010 approximately 300,000 women underwent surgical procedures in the United States for POP. According to the FDA, approximately one-third (100,000) of POP surgeries used mesh, and of those, three-fourths (75,000) utilized vaginal mesh. The mean rate of vaginal mesh complications from the literature is 14.5% [2]. Combining these data, it can be estimated that 10,875 patients had complications due to vaginal mesh procedures for POP in 2010 alone [5]. Almost 11,000 patient harms per year should have been enough to sound the alarm in any other industry. Multiplying this number of harms by all the years that the vaginal mesh kits have been sold underscores the enormity of the problem and begs for solutions so that such a grave failure does not happen again.

In May 2014, the FDA proposed to reclassify surgical mesh for transvaginal POP repair from class II devices to class III, thus requiring increased safety and efficacy data for mesh kits before FDA approval [6].

Through the course of understanding why vaginal mesh kits failed in the market, I came to realize that the cycle of innovation, medical device introduction, failure, litigation, and device withdrawal was prevalent in the medical device industry [7]. Ample literature exists to prevent mistakes of the past and perform the safest surgeries to give the best quality of life to the patients.

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References

1. Rostaminia G, Shobeiri SA, Quiroz LH, Nihira MA. Referral pattern for vaginal mesh and graft complications to the University of Oklahoma Pelvic and Bladder Health Clinic. The Journal of the Oklahoma State Medical Association. 2012;105(9):356-8.
2. Murphy M, Holzberg A, Raalte HV, Kohli N, Goldman HB, Lucente V; Pelvic Surgeons Network.Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”. Int Urogynecol J 2012;23(1):5–9.
3. Manonai J, Rostaminia G, Denson L, Shobeiri SA. Clinical and ultrasonographic study of patients presenting with transvaginal mesh complications. Neurourol Urodyn. 2016;35(3):407-11.
4. Javadian P, Quiroz LH, Shobeiri SA. In vivo ultrasound characteristics of vaginal mesh kit complications. Female Pelvic Med Reconstr Surg. 2017;23(2):162-7.
5. Javadian P, Shobeiri SA. The disability impact and associated cost per disability in women who underwent surgical revision of transvaginal mesh kits for prolapse repair. Female Pelvic Med Reconstr Surg. 2017;doi: 10.1097/SPV.0000000000000489. [Epub ahead of print]
6. U.S. Food and Drug Administration. Reclassificaiton of urogynecologic surgical mesh instrumentation. Executive Summary. Gastro-entrology-Urology Medical Devices Advisory Committee Panel. 26 Feb 2016.
7. Paul M. Littman D, Patrick J. Culligan M. The rapid evolution of vaginal mesh delivery systems for the correction of pelvic organ prolapse, Part I: Clinical data. The Female Patient. 2009;34:32-8.