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Informed consent cannot be obtained for use of vaginal mesh

Published:November 29, 2010DOI:https://doi.org/10.1016/j.ajog.2010.10.905
      To the Editors:
      I was interested to read the Clinical Opinion “Use of vaginal mesh in the face of recent FDA warnings and litigation.”
      • Mucowski S.J.
      • Jurnalov C.
      • Phelps J.Y.
      Use of vaginal mesh in the face of recent FDA warnings and litigation.
      The authors stress the importance of documenting informed consent, although they state that “it remains difficult for providers to find consistent data to use when counseling patients about long-term follow-up and complications after the use of mesh.”
      I respectfully disagree. It is not merely “difficult”–it is impossible. Sufficient data do not yet exist regarding the use of vaginal mesh in procedures for pelvic organ prolapse. In the absence of these data, obtaining truly informed consent itself is impossible. Therefore, the use of vaginal mesh for prolapse should be treated as experimental, and patients should provide consent on that basis. The American Society for Reproductive Medicine provides a useful definition of the term “experimental”: “Procedures (including tests, treatments, or other interventions) for the diagnosis or treatment of infertility will be considered experimental or investigational until the published medical evidence regarding their risks, benefits, and overall safety and efficacy is sufficient to regard them as established medical practice.”
      Practice Committee of the American Society for Reproductive Medicine
      Definition of “experimental procedures.”.
      Surgeons, and even some savvy patients, may be familiar with the general risks of mesh placement. However, what remains unknown is the true magnitude and consequences of these and other complications. Therefore, patients have no way of balancing the unknown magnitude of these risks against the potential benefits. Even worse, it is impossible to adequately inform patients of the potential benefits of vaginal mesh–based procedures for prolapse.
      In conclusion, obtaining informed consent from patients for vaginal mesh placement during prolapse surgery cannot be achieved in light of the current dearth of data regarding risks and benefits. Women choosing to undergo such procedures should understand their experimental nature. Documentation in the medical record that patients accept the absence of such data and choose to proceed anyway may be a better choice for surgeons who continue to offer vaginal mesh–based procedures for prolapse in their clinical practice.

      References

        • Mucowski S.J.
        • Jurnalov C.
        • Phelps J.Y.
        Use of vaginal mesh in the face of recent FDA warnings and litigation.
        Am J Obstet Gynecol. 2010; 203 (e1-4): 103
        • Practice Committee of the American Society for Reproductive Medicine
        Definition of “experimental procedures.”.
        Fertil Steril. 2009; 92: 1517

      Linked Article

      • Use of vaginal mesh in the face of recent FDA warnings and litigation
        American Journal of Obstetrics & GynecologyVol. 203Issue 2
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          Choosing to use mesh in vaginal reconstructive surgery for pelvic organ prolapse or stress urinary incontinence is perplexing in the face of recent US Food and Drug Administration (FDA) warnings. In October 2008, the FDA alerted practitioners to complications associated with transvaginal placement of surgical mesh. Litigation is another concern. A Google search of “transvaginal mesh” results in numerous hits for plaintiff attorneys seeking patients with complications related to use of mesh. In light of a recent decision by the US Supreme Court and strategies by manufactures of medical devices to escape liability, it is imperative that gynecologic surgeons using transvaginal mesh document proper informed consent in the medical records.
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        American Journal of Obstetrics & GynecologyVol. 204Issue 3
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          First, we would like to thank Dr Weber for appraising our publication on the use of vaginal mesh.1 We agree that the introduction of new medical procedures should be evaluated skeptically and may be considered experimental. However, “good clinicians constantly adapt and modify their clinical approaches in ways they believe will benefit patients,” and in modern practice, using new procedures is considered innovative practice.2 When the use of innovative practices causes opposing views in the field, they may ultimately become the subjects of formal research to help guide evidence-based usage.
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