To review the short and long term complication and re-operation rates in women undergoing midurethral sling procedures using Johnson & Johnson products. This was performed in the context of a class action brought by Shine Lawyers in Australia.

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.

From 1999 to 2017, 858 women underwent 869 midurethral sling procedures with Johnson & Johnson products to treat stress urinary incontinence. Their median age was 57 years old (range 28-94 years old). Sixty-two (7%) of the procedures were performed by the Urology unit, with the remaining 807 procedures performed by the Gynaecology or Urogynaecology units. Half (433) of the procedures were performed in conjunction with other pelvic floor or laparoscopic surgery. The average length of hospital stay was 1.93 nights. The types of midurethral sling utilised and their chronology is shown in Graph 1.

The average duration of follow up in clinic was 2.6 years (range 6 – 7112 days) and chart-review follow up ranged from 3.8 to 21.8 years.

One hundred and twelve (13%) women had a readmission to the health network at any time-point following the index surgery. 7 (0.8%) patients had infection complications within 21 days of their index surgery, most of these were in women with concomitant surgery. Eight (1%) patients required sling loosening within 28 days of their initial procedure. Sixteen (1.8%) women underwent cystoscopy to investigate recurrent urinary tract infections at any time later. 

Eleven (1.2%) women required sling division (3 patients within 3 months; 2 patients within 6 months; 2 patients within 12 months; and 2 patients within 24 months of the index surgery). Twenty (2.3%) patients required repeat surgery for mesh complications (exposure/erosion). There was 1 patient death due to a perforated viscus which was not due to the sling procedure. 

Eighteen (2%) patients required repeat slings or further procedures such as bulking for recurrent stress urinary incontinence. 

Eighty-one (9.4%) women contacted the dedicated mesh support service offered by the Urogynaecology unit after receiving communication from the hospital. Thirty women declined the offer of clinical review instead having their queries addressed by telephone. Fifty-one (5.9%) women contacted the unit and accepted the offer of a clinical review. Two women have postponed their clinical review. The outcomes of these reviews are still pending.

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).

Midurethral sling procedures performed in a teaching hospital with chart follow-up ranging up to 22 years have a low rate of short and long term complications, and a low repeat surgery rate for recurrent stress incontinence within their original health service. Only 6 % accepted the offer of a clinical review in the context of a class action. These reviews are still ongoing.

Ford  AA, Rogerson  L, Cody  JD, Aluko  P, Ogah  JA. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database of Systematic Reviews 2017, Issue 7. Art. No.: CD006375. DOI: 10.1002/14651858.CD006375.pub4