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The use of synthetic mesh to augment vaginal prolapse surgery has increased hugely over the last 5 years. Most recently, premanufactured kits of shaped mesh attached to needle introducers have been developed and launched by several companies, based on the concepts of DeLancey’s three levels of vaginal support.1 The mesh kits use anchoring arms, similar to midurethral tension-free tapes to provide fixation of the mesh insert in a tension-free manner, reproducing the support from anatomical structures. All these kits have been launched, despite the lack of good quality evidence supporting their use.

The systematic review by Feiner et al.2 reports a meta-analysis of data on the use of these kits. The authors conducted a robust systematic review of published literature and conference proceedings, identifying 30 studies involving more than 2500 women. Staggeringly, only three of the identified studies were randomised trials, and two-thirds were conference proceedings. Although a systematic review is only as good as the studies analysed, Feiner et al.’s article not only confirms the efficacy of mesh to provide anatomical success in the short term but also demonstrates that significant complications are common. The Dindo classification is a means of identifying complication severity on the basis of the magnitude of intervention required, and using this, up to 10% of women suffered a complication requiring surgical intervention under anaesthesia, most often erosion of the mesh.

Feiner et al.’s review and the systematic review of all forms of mesh published in this journal recently3 throw a harsh light on the urogynaecological community. New drugs require extensive research, including pilot studies, phase II and phase III randomised controlled trials before they receive a license, while medical devices (which include mesh and mesh kits for prolapse surgery) do not require such extensive patient data before launch. The manufacturers themselves have a vested interest in not conducting randomised trials with long-term follow up because that would delay the launch of a new product. New devices are released to market with little evidence of long-term efficacy and safety, and we urogynaecologists eagerly adopt their use while simultaneously acknowledging the need for robustly designed, long-term randomised trials. Why do we never motivate ourselves to conduct the trials we say we need? Several factors are at work, but one is the sheer amount of work and effort required to devise, fund, plan and deliver any large randomised trial now that the European Clinical Trial Directive has become law.4 Although surgical trials are not subject to all the legislation, the requirements for data handling, adverse event reporting and trial monitoring do apply. Thus, we have a paradox where the legislation created to protect the safety of patients and ensure accurate reporting of adverse events and trial outcomes is preventing clinicians from taking up the challenge of properly evaluating this new technology.

The situation is unlikely to change without a change of attitude from urogynaecology as a specialty. If we were to refuse to adopt any mesh device that had no data on efficacy and safety from randomised trials, the market for new devices would soon dry up, and the manufacturers would have no choice but to work with the profession to set up and complete the trials we require. Until that happens, the conduct of randomised trials of prolapse surgery will require cooperation on at least a national basis, and funding from government or medical research agencies such as the National Institutes of Health in the USA and the Medical Research Council and Health Technology Assessment Programme (HTA) in the UK.

The HTA Programme has recently provisionally agreed to commit to funding just such a trial, subject to certain provisions which are currently being negotiated, and we hope, therefore, that it will begin in the UK. The PROSPECT study (Prolapse Surgery, Pragmatic Evaulation by Randomised Controlled Trial) funded by the NIHR HTA Programme and run through the Clinical Trials Unit of the Health Services Research Unit in the University of Aberdeen, will recruit up to 2500 women into a randomised trial comparing standard prolapse repair, site-specific fascial repair, mesh repair and mesh repair with one of the mesh kits reported in Feiner et al.’s paper. Details of the study can be obtained by contacting the principal investigator (the PROSPECT Study Office, 01224 559030). This study is being supported by the British Society of Urogynaecologists, and it is hoped that this endorsement will encourage gynaecologists across the country to contribute by enrolling patients into the study. Although this is an ambitious undertaking, this kind of collaborative approach among a team of skilled clinical trialists, a national specialist society and its members is a template for the way forward for the conduct of complex surgical trials in future.

The International Urogynaecology Association and its affiliated national groups have the clinical and scientific expertise to lead the way in other trials of this nature, and perhaps it is the time for us to reclaim the initiative back from the device manufacturers, take control of the research agenda and lead the way in evaluating new technology in a scientifically robust manner, rather than remaining the victims of market forces.

Disclosure of interest

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The author is chairman of the research subcommittee of the British Society of Urogynaecology. He has received research grants for investigator-initiated studies from Ethicon, UCB Pharma and Astellas. He is currently an investigator on a worldwide registry of Gynecare TVT devices funded by Ethicon, two drug trials funded by Pfizer and Lilly, and is a consultant for Gynecare, Pfizer and Astellas.

Contribution to authorship

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  2. Disclosure of interest
  3. Contribution to authorship
  4. References

D.G.T. wrote the whole article. The opinions expressed in this editorial are his own.

References

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  3. Contribution to authorship
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