Synthetic Vaginal Tapes for Stress Incontinence: Proposals for Improved Regulation of New Devices in Europe

Abstract

The regulations governing the introduction of new drugs and new medical devices are very different, with a widespread view that devices should be scrutinised more carefully than is currently the situation before being introduced into clinical practice. The timing of this paper is very appropriate given the series of papers published by the British Medical Journal in May 2011 [1]. These papers centred on concerns about the regulations of devices with respect to a certain metal used in metal hip replacements. In the field of stress urinary incontinence (SUI), a number of new devices including synthetic vaginal tapes have become widely used in the last decade. This paper results from a workshop held at the Medicines and Healthcare Products Regulatory Agency (MHRA) in March 2011 and arose through concerns from the MHRA with respect to the number of adverse events reported following insertion of synthetic tapes for female SUI. The MHRA, the UK government organisation responsible for the regulation of medical devices, contacted urologists and gynaecologists active in this field and also invited some of the relevant manufacturers to attend a day-long meeting. The MHRA has received an increasing number of reports of adverse events resulting from the use of tapes for SUI from manufacturers, users, and the public, with 42 reports in 2010. The total number of tapes implanted in 2010 is unknown, and therefore the denominator is not clear. However, there is also an underlying concern at MHRA of a marked underreporting of the complications from these devices. This paper reports on the issues discussed at the meeting under the headings of product development, clinical adoption, clinician training, the reporting of outcomes and adverse events, and finally, it lists the proposed responsibilities for manufacturers, the regulator, and clinicians.