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TVT Secur Dangers of a Mini Sling

TVT Secur Dangers of a Mini Sling

TVT Secur Dangers of a Mini Sling are far reaching. For women who were given these mesh tapes as treatment for incontinence they quickly found that they caused injury rather than cure.

From around 2007 – 2012 some hospitals were choosing the TVT Secur as a continence option for women. At that time, surgical options for stress urinary incontinence included urethral injections, polypropylene slings, fascial slings and colposuspension. All of these treatments were approved by NICE 2006 which was the guideline applicable at the time. The various surgical treatments have differing risks/benefits.

The TVT Secur was a variant of the TOT sling, being a “single incision mini-sling”. The product was manufactured by Johnson & Johnson (J&J) and the registered name was “Secur”.

Single incision slings were much shorter than retropubic TVT’s or TOT’s. The TVT secur measured 8 cm. A retropubic TVT was 45 cm and about 20cm of mesh was left in the body depending on Body Mass Index. Rather than placing the mesh through the obturator muscle into the groin, the sling was fixed into the obturator muscle without extension into the groin itself. The Secur sling was fixed into the obturator membrane with plastic “anchors”.

These mini-slings had the potential advantage over TOT of removing the risk of obturator nerve damage. However, the results were entirely unknown. The product was described as “novel” and was being marketed prior to publication of outcome data.

It was not known whether the shorter mesh and the fixation into the obturator membrane would compromise outcome. The tape was anatomically very different from the retropubic TVT that had been subject to rigorous randomised clinical trials.

NICE Warning

It wasn’t until 2008 that NICE published guidance on these new shorter single incision “mini tapes”.

They stated:

Guidance

1.1 Current evidence on the safety and efficacy of single-incision sub-urethral short tape insertion for stress urinary incontinence in women is inadequate in quality and quantity. Therefore this procedure should be carried out only in the context of research studies or through submission of data to a national register (at the British Society of Urogynaecology [www.rcog.org.uk/bsug] or the Female and Reconstructive Urology Section of the British Association of Urological Surgeons [www.baus.org.uk]).

1.2 This procedure should only be carried out by a clinician with specific training in this technique.

1.3 Systematic long-term follow-up is essential. The Institute may review the procedure upon publication of further evidence.

Hospitals were aware that there was no outcome data to support the use of TVT Secur. The also knew that reducing the length of the sling would theoretically compromise outcome.

The TVT-Secur was not to be used outside of a clinical trial.

Event data was eventually published and from 2010-12 studies it confirmed that the shortened tape had poor outcomes when compared with conventional full length TVT and TOT polypropylene slings.

There has been significant litigation against J&J for this product and J&J withdrew this product from the marketplace in 2012.