Transvaginal mesh implants independent review: interim report

Preface

This Independent Review (IR) into the use of transvaginal mesh in surgery for incontinence and pelvic organ prolapse came about because of growing public concern about the number of women experiencing serious complications. This was linked with under-reporting of adverse events and a poor understanding as to why these complications have occurred. Women felt that their voice had not been heard as they raised concerns about the side effects a number of them had suffered. Many of them eventually felt that the only way to bring this to the attention of the "powers that be" was to lodge a petition bringing the issue to the attention of the Petitions Committee of the Scottish Parliament. At that Committee the then Cabinet Secretary for Health and Wellbeing, Alex Neil MSP, promised an Independent Review and asked NHS Scotland to suspend transvaginal mesh procedures pending the outcome of this review.

From the outset, we were charged with listening to and valuing the views of patients, both those with a good result and those with a poor result, including those living with significant impacts on their day to day life. We were asked to review the best available research evidence, statistics and both patient and expert opinion to find out the nature and scope of the problem.

We have tried to do this by involving women who have undergone such surgery; the local clinical experts in this surgery; clinical experts from around the UK; the Scottish Public Health Network for an objective review of the research literature; the Information Services Division of National Services Scotland, for an objective epidemiological review of the information from routine data; MHRA, the statutory regulatory body; the professional bodies, including the Royal College of Obstetricians and Gynaecologists (RCOG), the standard setting body for the profession; and input from the Chief Medical Officer's office and the Division of the Scottish Government Health and Social Care Directorate which deals with medical devices. We have been very ably supported throughout by a member of that latter Division.

During this Independent Review we heard evidence from women who are disabled as a result of the surgery they had undergone. They also felt that they had not been listened to, or even believed which only increased their distress. We also heard of lives transformed and improved by the same surgery with statistical and research evidence showing poor outcomes to be in the minority of procedures done. We also acknowledged that adverse events could not be totally excluded from any surgery, as any surgery carries a risk. What we have tried to do is to take an objective view of both the results of the research and of the information review but also what they did not tell us, what was missing, what the patient stories can tell us and what the experience of clinicians in practice can tell us.

We found some concerning features about how new techniques are introduced into routine practice, how and for how long they are followed up, how women are informed of the risks and benefits so that they can give true informed consent and also how adverse events are reported and to what extent.

Our conclusions focus on the need for improved governance around both the introduction of new procedures or techniques and also of how women are assessed and treated, both initially and in the event of any side effects following surgery. Reporting of adverse events is another area where we feel that a tighter, more explicit practice is required and we suggest ways the government should consider to ensure this area is improved. We differentiate between the use of mesh in the treatment of stress urinary incontinence and when it is used in the repair of pelvic organ prolapse. We see the need for an Expert Group to oversee the implementation of an improved way of working, and of organising services. We are aware that some of our conclusions have wider implications and see the need to embed this in the Patient Safety and Clinical Governance strands of the NHS.

As Chairman, I hope that this report goes some way towards ensuring above all that patient voices continue to be heard, believed and valued and that women with these conditions can be assured that the treatment which they receive within the NHS is evidence based, audited and likely to produce a good result while keeping to a minimum the possibility of an adverse effect.

The following report sets out what we did, how we did it, what we concluded and why and what we consider should be done as a result.

This Report was the work of many people and disciplines. I am extremely grateful for all their contributions. Readers of this report may notice differences in styles in the chapters arising from this collaborative process.

Lesley Wilkie