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Pelvic organ prolapse surgical management in Portugal and FDA safety communication have an impact on vaginal mesh

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Abstract

Introduction and hypothesis

Pelvic organ prolapse (POP) surgery has lately gained importance in gynecological practice. This study aims to characterize the evolution of POP surgical procedures conducted in Portugal in the last decade and the impact of an FDA 2011 safety communication on mesh POP surgeries.

Methods

Trends in the surgical management of POP were assessed using the Portuguese National Medical Registry. We considered all records of women with diagnosis of genital prolapse from 1 January 2000 to 31 December 2012. Additionally, we also conducted a survey among members of the Portuguese Society of Urogynecology to evaluate current practices in the surgical management of POP.

Results

From 2000 to 2012, 46,819 diagnoses of genital prolapse were registered, with a 105 % increase during the study period (2,368 in 2000 to 4,941 in 2012). POP mesh surgery represented only 6 % of total prolapse diagnoses, but mesh use greatly increased up to 2011, when only a slight increase was registered. Among gynecologists who responded to the questionnaire, there was considerable variability on the procedures of choice to treat POP. Fifty-seven per cent of respondents performed vaginal mesh POP surgery, but only 27 % of those actually reported having changed their practice after the FDA 2011 safety communication.

Conclusions

Surgical procedures for POP conducted in Portugal greatly increased over the last decade. The use of surgical meshes is still limited, but despite FDA safety communication it has increased over the years, with a slight increase in 2012, which illustrates the need for further analyses in the coming years.

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Abbreviations

FDA:

Food and Drug Administration

ICD-9-CM:

International Classification of Diseases, 9th revision, Clinical Modification

IUGA:

International Urogynecological Association

POP:

Pelvic organ prolapse

PSUG:

Portuguese Society of Urogynecology

SPG:

Portuguese Society of Gynecology

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Acknowledgements

The authors would like to thank the Central Administration of the National Health System (Administração Central do Sistema de Saúde) for providing access to the Portuguese National Medical Registry (clinical/administrative data).

Funding

This study received no external funding.

Financial disclaimer/conflict of interest

None.

Ethics/institutional review board approval

This study is not subject to approval by the ethics/institutional review board, since data were retrieved from a national database (the Portuguese National Medical Registry, clinical/administrative data) from which patient-identifying information is not available to the research team (all patient-identifying information is encrypted).

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Authors and Affiliations

  1. Department of Gynecology and Obstetrics, Hospital S. João, Faculty of Medicine of Porto University, Alameda Professor Hernâni Monteiro, 4200-319, Porto, Portugal

    Teresa Mascarenhas

  2. Faculty of Medicine of Porto University, Porto, Portugal

    Miguel Mascarenhas-Saraiva Jr

  3. Department of Social Sciences and Health, Faculty of Medicine of Porto University, Porto, Portugal

    Amélia Ricon-Ferraz

  4. Department of Obstetrics and Gynecology, Hospital S. João, Porto, Portugal

    Paula Nogueira

  5. Centre for Research in Health Technologies and Information Systems (CINTESIS), Faculty of Medicine of Porto University, Porto, Portugal

    Fernando Lopes & Alberto Freitas

Authors
  1. Teresa Mascarenhas
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  2. Miguel Mascarenhas-Saraiva Jr
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  3. Amélia Ricon-Ferraz
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  4. Paula Nogueira
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  5. Fernando Lopes
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  6. Alberto Freitas
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Corresponding author

Correspondence to Teresa Mascarenhas.

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Mascarenhas, T., Mascarenhas-Saraiva, M., Ricon-Ferraz, A. et al. Pelvic organ prolapse surgical management in Portugal and FDA safety communication have an impact on vaginal mesh. Int Urogynecol J 26, 113–122 (2015). https://doi.org/10.1007/s00192-014-2480-0

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  • DOI: https://doi.org/10.1007/s00192-014-2480-0

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