The transvaginal mesh class action: a tertiary teaching hospital experience of all mid-urethral sling procedures performed between 1999 and 2017.

Abstract

<h4>Introduction and hypothesis</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%.<h4>Conclusion(s)</h4>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.