Warning over exposure risk with TVT-Secur mini-sling

By Joanna Lyford, Senior medwireNews Reporter

The TVT-Secur mini-sling is associated with a higher risk of prosthesis exposure than another mini-sling from the same manufacturer, shows a large study by French researchers.

Writing in the European Journal of Obstetrics & Gynecology and Reproductive Biology, the team advises against using this type of suburethral transobturator sling in women undergoing surgery for urinary incontinence.

“Patients must know the risk involved, which is greater for the TVT-[Secur] type of mini-sling which we no longer use in our department”, write Cédric Bourdy (Hopital Jeanne de Flandre, Centre Hospitalier Régional Universitaire de Lille) and co-authors.

They add: “Surgery must aim to be the least invasive and traumatic for tissues so as to reduce the risk of exposure.”

The study examined complication rates among women treated with either the Gynecare TVT-O or the TVT-Secur (both, Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA). Suburethral slings are considered the gold standard treatment for urinary incontinence but are known to be associated with a risk of sling exposure, potentially leading to infection.

Bourdy’s team identified all women who received TVT-O (n=342) or TVT-Secur (n=29) between 2002 and 2008 at their centre. The women’s average age was 57.3 years and 35.3% underwent simultaneous prolapse surgery with a prosthesis in a tension-free vaginal mesh.

All women were re-assessed a median of 49 months after surgery. Prosthesis exposure was reported by 16 women, giving a rate of 4.31%. However, this figure was significantly higher among women with a TVT-Secur, at 13.8%, than for those with a TVT-O, at 3.5%.

Ten cases of sling exposure were diagnosed at the postoperative consultation. The most frequent location was suburethral while the size ranged from 2 mm to 2 cm. Associated symptoms included dyspareunia, bladder irritation, pain, leucorrhoea and urge incontinence; in four cases the exposure was asymptomatic.

Fourteen of the women with prosthesis exposure underwent partial resection and vaginal suture while two had just a suture. Following treatment, four of the women had a repeat exposure of the suburethral sling, which was surgically treated, at 1, 2, 14 and 43 months following the initial operation.

Of 15 women who had a resection of their prosthesis, just one had a recurrence of stress urinary incontinence requiring placement of tension-free vaginal tape.

Finally, use of TVT-Secur rather than TVT-O was associated with an increased risk of sling exposure whereas concomitant prolapse surgery and younger age were associated with a reduced risk of the complication.

The authors write: “Our study shows that exposure is not an infrequent complication of [suburethral slings] and that it must be diagnosed and treated.”

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