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Informed surgical consent for a mesh/graft-augmented vaginal repair of pelvic organ prolapse

Consensus of the 2nd IUGA Grafts Roundtable: Optimizing Safety and Appropriateness of Graft Use in Transvaginal Pelvic Reconstructive Surgery

  • IUGA Grafts Roundtable 2010
  • Published:
International Urogynecology Journal Aims and scope Submit manuscript

Abstract

Introduction and hypothesis

Complex issues surround informed surgical consent for pelvic reconstructive surgery.

Methods

Vaginally placed mesh/grafts are used with the intent to increase durability of the repair but potentially introduce unique complications, offering new challenges in informed surgical consent counseling.

Results

Informed consent is a process that takes place throughout the entire consultation with the patient. A written document often accompanies that process. This paper outlines necessary components of informed surgical consent and the theory behind each component.

Conclusions

We explore elements that should be included in the consent process with regard to expected benefits, alternatives, and material risks that are specific to the use of a mesh/graft-augmented vaginal repair of prolapse. Included is an appendix that may serve as a template for the creation of a surgeon’s own written informed consent document.

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Conflicts of interest

Dennis Miller, M.D. has received royalties, research grants, and consulting fees from Boston Scientific Corporation and research grants from Ethicon Endosurgery. Alfredo L. Milani, M.D. has received consultancy agreement and speakers bureau fees, research grants, and honoraria for lectures from Ethicon Women’s Health & Urology. Suzette E. Sutherland, M.D. is a consultant, a clinical research PI, and a trainer/speaker of American Medical Systems, Medtronic, Uromedica, and Allergan and a consultant and a trainer/speaker of Uroplasty and Pfizer. Rebecca G. Rogers, M.D. serves as the chair of the Data Safety Monitoring Board for the TRANSFORM trial sponsored by American Medical Systems.

Author information

Authors and Affiliations

  1. Division of Urogynecology, Wheaton Franciscan Healthcare, 201 N Mayfair Rd, Wauwatosa, WI, 53217, USA

    Dennis Miller

  2. Metro Urology, Centers for Continence Care and Female Urology, Center for Pelvic Floor Disorders, Minneapolis and St. Paul, MN, USA

    Suzette E. Sutherland

  3. Division of Urogynecology, University of New Mexico, Albuquerque, NM, USA

    Rebecca G. Rogers

  4. Department of Obstetrics & Gynaecology, Reinier de Graaf Group, Delft, the Netherlands

    Alfredo L. Milani

  5. Stearns Weaver Law, LLC, Fort Lauderdale, FL, USA

    Bonnie Navin

Authors
  1. Dennis Miller
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  2. Alfredo L. Milani
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  3. Suzette E. Sutherland
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  4. Bonnie Navin
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  5. Rebecca G. Rogers
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Corresponding author

Correspondence to Dennis Miller.

Appendix: Sample consent

Appendix: Sample consent

Information about vaginal surgery using mesh: discussion of the benefits, risks, and alternatives

What is a prolapse procedure and what will happen

Prolapse is a weakness of the vagina that allows the pelvic organs to press against the vaginal wall, produce a bulge, and can cause pressure and discomfort. It can sometimes affect sexual activity and limit physical activity. This is not a dangerous or life-threatening condition, but it may be quite distressing and bothersome. With this type of surgery, done through a vaginal incision, the surgeon lifts up the sagging vaginal wall and organs using permanent synthetic mesh that is similar to what is used for fixing hernias. While under anesthesia, when the pelvis is more relaxed, a weakness in the support which was not previously seen may need to be repaired. Women often go home with a catheter (tube to drain the bladder). In a small number of women, this can last for a period of weeks or longer. The general risks of surgery will be discussed separately. With the newer and less invasive vaginal treatments for pelvic organ prolapse, many women can go home the next day, and recovery time may be relatively short. Patients usually do require pain pills and some patients have more pain than expected and/or a slower recovery. Recovery can take 2 to 3 weeks but this is different in each person. Time will be required off of work and lifting and exertion will be limited after the surgery.

Goals of the surgery (possible benefits)

Mesh is chosen because your doctor believes that there is evidence that shows mesh is relatively safe and the aim of the procedure is to make the results last longer. That means making it less likely that the bulge will come back in the future. The goal is to get rid of any symptoms that are caused by the bulge. Some symptoms are less certain to go away especially if they are caused by reasons other than the bulge. There is evidence that this surgery is safe and successful, although long-term research is still needed. Your doctor has received thorough training in the performance of this procedure.

Complications specific to the use of mesh

In the USA, the Food and Drug Administration (FDA) has issued a safety communication regarding the use of mesh. The FDA described that after a very large number of mesh procedures were performed in women, there were reported a significant number of complications. Many of these complications are possible with any prolapse operation, but a few are directly caused by the use of mesh. These include exposure (poking) through the vaginal skin, mesh infection, and vaginal scarring and sometimes pelvic pain that lasts longer than is considered normal, including during intercourse or even without any activity at all. They also noted that mesh can contract (shrink), causing tightening or pain. There can be injury to the bowel, bladder, and/or blood vessels related to placement of the mesh. Treatment of the complications can include more procedures (some to remove the mesh or part of it), blood transfusion, and drainage of blood or other fluids which can collect and sometimes get infected.

The FDA recommended the following for patients:

  • Before surgery:

    1. 1.

      Be aware of the risks associated with transvaginal POP repair.

    2. 2.

      Know that having a mesh surgery may increase the risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.

    3. 3.

      Ask their surgeons about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why their surgeons may be recommending treatment of POP with mesh.

  • After surgery:

    1. 1.

      Continue with annual and other routine check-ups and follow-up care. Patients do not need to take action if they are satisfied with their surgery and are not having complications or symptoms.

    2. 2.

      Notify their health care providers if they develop complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after the last follow-up appointment.

    3. 3.

      Let their health care providers know if they have surgical mesh, especially if planning to have another related surgery or other medical procedures.

    4. 4.

      Talk to their health care providers about any questions or concerns.

Additional information for patients, including questions to ask the doctor, is available at the FDA Consumer website at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

Other types of things can go wrong with this surgery

  1. 1.

    Injury to the bowel, bladder, or the tube that goes to the kidney, with possible return to surgery for repair. This could happen because of the instruments used in this procedure.

  2. 2.

    More than what is considered normal bleeding or infection requiring a return to the operating room, a longer hospital stay or a blood transfusion.

  3. 3.

    A change to an abdominal, instead of a vaginal, approach may be necessary especially if complications occur (this is uncommon).

  4. 4.

    Keep in mind that these complications can occur regardless of how the surgery is done but in some cases are specific to the use of the mesh.

The long-term effects the procedure could have

  1. 1.

    Exposure of the graft in the vagina and extremely rarely erosion (poking) into the bowel or bladder may occur and is usually easy to treat, but occasionally is more complicated. Smoking or being overweight may increase this possibility

  2. 2.

    Failure to achieve the desired results or the prolapse can come back. The operation can fail

  3. 3.

    A prolonged inability to urinate, the need for a bladder catheter, the need for self-catheterization, or even another procedure

  4. 4.

    Pain with sexual intercourse. This happens in only some patients, but can be very difficult to cure and in some instances has been permanent

  5. 5.

    Pelvic, buttock, or vaginal pain. This uncommon complication is serious when it occurs because it is difficult to cure

  6. 6.

    Mesh shrinkage can occur very rarely, which is very difficult to treat

  7. 7.

    Overactive bladder symptoms or stress urinary incontinence. It is known that after any prolapse operation (by any technique used), women may develop a variety of urinary symptoms or urinary leakage. These can have long-term effects on bladder control

My other choices for treatment

  1. 1.

    You have the option of not being treated for prolapse. If the symptoms are tolerable, it does not require treatment. You can return for observation over time.

  2. 2.

    You can try using a pessary (which does not require surgery) and sometimes pelvic exercises can improve these types of symptoms.

  3. 3.

    The surgery can be performed with no mesh and it can also be approached from the abdomen with or without mesh. While your doctor is offering you the vaginal approach using mesh at this time, you can further discuss each of these options. You can also choose these other options.

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Miller, D., Milani, A.L., Sutherland, S.E. et al. Informed surgical consent for a mesh/graft-augmented vaginal repair of pelvic organ prolapse. Int Urogynecol J 23 (Suppl 1), 33–42 (2012). https://doi.org/10.1007/s00192-012-1680-8

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