Abstract
Introduction and hypothesis
Class action against Ethicon (J&J), manufacturer of transvaginal mesh devices, including mid-urethral slings (MUS), was brought to the Federal Court of Australia in 2016 by Shine Lawyers. As a result, subpoenas to all hospitals and networks were received, which overrode patient privacy concerns. This medical record search allowed a complete audit and communication with patients to offer clinical review. This enabled a review of complications, readmission and re-operation for women who underwent a MUS for stress urinary incontinence.
Methods
A cohort study of women who underwent MUS treatment for stress urinary incontinence (SUI) at a single tertiary teaching hospital between 1999 and 2017 was carried out. The main outcome measures were the rate of readmission and re-operation following MUS procedures. These include voiding dysfunction managed by sling loosening or sling division, mesh pain or exposure managed by mesh removal and reoperation for recurrent stress urinary incontinence.
Results
Between 1999 and 2017, a total of 1,462 women were identified as having a MUS; of these, 1,195 (81.7%) had full patient records available. Voiding dysfunction requiring surgical intervention with sling loosening or division was 3%, excision for mesh exposure was 2%, and partial or complete excision for pain was 1% at a median of 10 years from index surgery. The reoperation rate for recurrent stress urinary incontinence was 3%.
Conclusion(s)
This audit of all MUS procedures performed at a tertiary centre confirms an overall low rate of readmission for complications and recurrent SUI surgery; this justifies its continued availability with appropriate informed consent.
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Acknowledgements
The authors would like to thank Prof. Beverley Vollenhoven (Head of Gynaecology, Monash Health) Peter Ryan (Chief Legal Officer, Monash Health), Emma Pelham-Thorman (legal department, Monash Health) and Hayley Capiron (Medical Information Technology) for their involvement in the review.
Authors’ contributions
M. Kulkarni: study design, database, manuscript preparation; Y. Liu: database, manuscript preparation; M. Silagy: database, manuscript preparation; D. Rolnik: statistical analysis, manuscript preparation; A. Rosamilia: study design, database, manuscript preparation.
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Kulkarni, M., Liu, Y., Silagy, M. et al. The transvaginal mesh class action: a tertiary teaching hospital experience of all mid-urethral sling procedures performed between 1999 and 2017. Int Urogynecol J 34, 2573–2580 (2023). https://doi.org/10.1007/s00192-023-05575-5
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DOI: https://doi.org/10.1007/s00192-023-05575-5