Study design, materials and methods
Study design: Retrospective audit and patient self-selected follow-up.
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Method: Retrospective audit of all midurethral sling procedures manufactured by Johnson & Johnson at a large tertiary health care network. Patients were identified by item number (coding) search by medical record department as a result of a legal subpoena brought by the class action. All patients who were identified as receiving one of the nine products were contacted by the Health Service, and given the opportunity to attend a dedicated clinical review. These patients were also contacted by the legal firm and offered to join the class action. This paper confines itself to the mid-urethral slings which form the majority of this group.
Interpretation of results
This represents the complete cohort of women who have had a midurethral sling manufactured by Gynecare Ethicon in one teaching hospital network. This cohort have experienced low rates of re-operation for recurrent stress urinary incontinence (2%), for mesh complications (2%) and sling division (1%) which is consistent with the rates quoted in the literature (1).