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Implications of the FDA Statement on Transvaginal Placement of Mesh: The Aftermath

  • Female Urology (K Kobashi, Section Editor)
  • Published:
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Abstract

The release of the U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh (TVM) for pelvic organ prolapse (POP) has resulted in changes in the pelvic reconstruction community. This monograph reviews the implications of the FDA statements over the last 18–24 months. Recent findings show that there have been significant developments in the areas of regulatory mandates, media and medico-legal activity, and statements from surgical societies. In summary, well-publicized communications from the FDA and major medical organizations are defining a change in the use of TVM for POP.

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References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

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Conflict of Interest

Dr. Michelle E. Koski received travel/accommodations expenses covered or reimbursed by American Medical Systems.

Dr. Eric S. Rovner has served as a consultant for American Medical Systems.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

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Authors and Affiliations

  1. Department of Urology, Medical University of South Carolina, 96 Jonathan Lucas Street, Charleston, SC, 29451, USA

    Michelle E. Koski & Eric S. Rovner

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  1. Michelle E. Koski
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  2. Eric S. Rovner
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Correspondence to Michelle E. Koski.

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This article is part of the Topical Collection on Female Urology

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Koski, M.E., Rovner, E.S. Implications of the FDA Statement on Transvaginal Placement of Mesh: The Aftermath. Curr Urol Rep 15, 380 (2014). https://doi.org/10.1007/s11934-013-0380-3

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  • DOI: https://doi.org/10.1007/s11934-013-0380-3

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