Transvaginal mesh implants independent review: final report

Chapter 1: Introduction

Update Since Interim Report

Following publication of its interim report in October 2015, the IR has continued to build on the initial findings given in that report, ultimately reaching the conclusions presented here.

As noted elsewhere in this Report, the consideration of various independent research programmes was an integral, vitally important aspect in the Group's development of its final conclusions. Delays in the publication of the reports into that research work, for example the PROSPECT Report (PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials), meant that the Group was not able to fulfill its original aim of publishing this Final Report in early 2016.

In November 2016 Dr Tracey Gillies, Medical Director, NHS Lothian, was appointed Chair of the Independent Review. She replaced the previous Chair, Dr Lesley Wilkie.

1.1 Background

SUI and POP are conditions affecting a significant number of women and can result in a reduced quality of life for many.

Synthetic polypropylene mesh is an implantable medical material used in a number of operations to correct SUI and POP. Initial estimates, based on English figures, were that between 2000 and 2014, up to 1,500 women suffering from SUI and 350 suffering POP had synthetic mesh implant surgery each year in Scotland.

Concerns about the safety of mesh devices were raised by women experiencing complications. Some women adversely affected by these implants have experienced very serious complications, altering their lives forever.

The former Cabinet Secretary for Health and Wellbeing, Alex Neil MSP, first met with a group of women adversely affected by the use of mesh to treat these conditions in May 2013. Following this meeting, the Cabinet Secretary asked that a Working Group be set-up to address the issues affecting women who have undergone transvaginal mesh surgery.

The Transvaginal Meshes Working Group ( TMWG) was initiated to develop a clearer understanding of the issues affecting women who had suffered complications from mesh surgery. A review of the remit of this working group led to greater clinical representation to review current clinical practice and make recommendations for change. The Expert Group was formed in December 2013 as a development of the TMWG.

The Expert Group was established to look at ways of improving clinical practice, including developing pathways of care for women experiencing complications and to improve the consent process to ensure women are better informed of the risks and benefits of all procedures available to treat these conditions.

1.1.1 Opinion on the Safety of Mesh Devices

It is clear that a number of women have suffered serious, life changing complications following transvaginal mesh implant surgery. It is also evident that many women have benefitted from these procedures. However, due to the way these procedures are coded, it is not possible to provide accurate data on the number of mesh procedures where complications have occurred. This lack of information, allied with the fact that adverse events have been under-reported, has led to opinion being divided on the safety of transvaginal mesh procedures.

Many women have experienced a positive outcome following a transvaginal mesh implant procedure. No procedure is without risk and therefore many people, including the broad clinical community, consider that polypropylene mesh should continue to be used in some circumstances as it presents an acceptable level of risk, supported by a number of studies, including research by the UK regulator for medical devices, the Medicines and Healthcare products Regulatory Agency ( MHRA).

There is broad consensus that work to improve clinical governance of these procedures is required, including improving pathways of care and the informed consent process; work which is being taken forward by the Expert Group.

The Scottish Mesh Survivors ( SMS) brought together women affected by adverse events following mesh surgery to campaign to have these procedures suspended until the six points of their petition had been met. This group campaigned to suspend these procedures as they consider the severity of the complications, which can occur years after the procedure, present an unacceptable level of risk. Similar campaigns exist elsewhere, including: US, Canada, Europe, New Zealand and Australia.

Some women experiencing complications reported that they were not believed, adding considerable distress to their situation. This fact, combined with the absence of accurate data on the number and severity of complications, has led to many people concluding that these procedures should not continue.

1.1.2 The Public Petition Committee of the Scottish Parliament

On 1 May 2014, a public petition was lodged on behalf of the SMS Group. The petition called on the Scottish Parliament to urge the Scottish Government to:

1. Suspend use of polypropylene transvaginal mesh procedures;

2. Initiate a Public Inquiry and/or comprehensive independent research to evaluate the safety of mesh devices using all evidence available, including that from across the world;

3. Introduce mandatory reporting of all adverse incidents by health professionals;

4. Set up a Scottish transvaginal mesh implant register with view to linking this up with national and international registers;

5. Introduce fully informed consent with uniformity throughout Scotland's Health Boards; and

6. Write to the MHRA and ask that they reclassify transvaginal mesh devices to heightened alert status to reflect on-going concerns worldwide.

In the light of growing public concern about the number of women experiencing complications, linked with under-reporting of adverse events and a poor understanding as to why these complications have occurred, the Scottish Government considered that an IR of transvaginal mesh surgery was necessary to establish the facts.

The former Cabinet Secretary for Health and Wellbeing, Alex Neil MSP, announced the IR on 17 June 2014 and the acting Chief Medical Officer, Dr Aileen Keel, wrote to all Health Boards requesting that they consider suspending routine use of synthetic mesh for these procedures until the IR reported its findings.

1.2 Remit of the Independent Review

The published remit of the IR is to evaluate both the efficacy and the extent and causes of adverse incidents and complications associated with transvaginal mesh surgery for SUI and for POP. The IR recognises that these are different conditions, each managed by several different procedures and will take account of this.

The IR includes members of both the clinical and patient community and has the means of both identifying and determining the causes of issues where this is possible, and of finding and implementing solutions.

1.2.1 Purpose

1. To determine the safety of vaginal mesh implants for both SUI and POP in Scotland and to compare it to international standards. Information on how many women are experiencing complications and possible reasons for these complications will be examined.

2. To determine the relative efficacy of surgery for SUI and POP with and without the use of mesh or tapes.

1.2.2 Scope

In determining the appropriate course of action on this issue, the group is able to consider:

• the available data on procedures using mesh implants for pelvic floor surgery, including data on efficacy and complications compared to alternative surgical and non-surgical treatments;
• identifying best practice standards in management of SUI and POP;
• any issues that may lead to clinical practice not conforming to best practice standards;
• reported safety issues with devices
• including improvement in reporting adverse events;
• barriers to regular prospective auditing of results of surgical procedures;
• short, medium and long-term patient follow-up;
• identification of best practice in managing both treatment failure and complications, and resources to do so; and
• whether the information provided to patients before undergoing these procedures should be updated.

The full remit and membership of the IR is set out at Appendix B and Appendix C.

1.3 Remit of the Expert Group

The Scottish Government led Expert Group first met in February 2014 and has a remit to develop a clearer understanding of the issues affecting women who had suffered complications from mesh surgery. The working group includes clinical and patient representation, and has the purpose of reviewing current clinical practice and making recommendations for change. The areas currently being considered by the Expert Group include:

Informed Consent - a minimum standard of information to be provided to women considering surgery.

New Care Pathways -specifically for women who may require complex surgery; and for those who have suffered complications.

The Group has produced a new patient information and consent booklet for SUI, ^[1] which was published in June 2014 on the Scottish Government website. This booklet clearly demonstrates the risks associated with this procedure and the alternatives available before women make a decision on whether they wish to proceed.

Whilst overlapping with the Expert Group, the IR has a distinct remit and constitution. The Expert Group suspended its activities during the period of the IR's main work programme and re-formed for a single meeting in late 2015 with the imminent publication of the interim report. Following the publication, the Expert Group met before again suspending its activities pending the publication of this report.

1.4 What are Medical Devices?

The official definition of a medical device is: any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
• investigation, replacement or modification of the anatomy or of a physiological process;
• control of conception;
• and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Medical devices in the UK are regulated by the MHRA, an Executive Agency of the Department of Health, and the UK's Competent Designating Authority.

MHRA regulates devices placed on the market by the manufacturer, but the healthcare services they are used in is not within its remit.

CE marking

Apart from the very lowest risk products, medical devices are certified by independent conformity assessment organisations called Notified Bodies who are designated and monitored as competent to undertake conformity assessment activities by the EU member states' Competent Authorities. A CE Mark is applied by the manufacturer and means that the device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe. In order to be compliant with the requirements of the Medical Device Regulations and obtain Notified Body certification, manufacturers should be able to support their safety and performance claims for the device. This involves appointing a Notified Body who oversees the process, to verify that the devices meet the relevant essential requirements laid down in the regulations including, for example, biocompatibility, toxicity, technical specifications, clinical data, sterilisation, right through to packaging and labelling and quality management systems.

Once Notified Body certification is obtained, and their other obligations under the Medical Devices Regulations are met, the manufacturer can put the CE marking on the device and place it on the EU market.

The MHRA oversees UK Notified Bodies, for example, the British Standards Institute. A list of the UK Notified Bodies can be obtained from the MHRA website at:
https://www.gov.uk/government/publications/medical-devices-uk-notified-bodies/uk-notified-bodies-for-medical-devices.

The MHRA conducts regular audits of Notified Bodies, including their quality assurance processes, certification activities and compliance with the medical device regulations.

MHRA also witnesses the assessor's competency during routine assessments of manufacturers to ensure that they operate to high standards.

https://www.gov.uk/government/publications/notified-bodies-for-medical-devices/notified-bodies-for-medical-devices

Classification system

There are a vast range of products falling within the broad definition of medical devices; hence the level of conformity assessment to which a device is subjected to varies according to the degree of its inherent risk.

The aim is to balance the burden of regulatory control relative to the perceived risk whilst at the same time protecting public safety. It is the stated intended purpose of the device, assigned by the manufacturer, which determines the class in which a device is categorised. The classification of devices is therefore a risk-based system. 'General' medical devices are grouped into four classes as follows:

• Class I - generally regarded as low risk;
• Class IIa - generally regarded as medium risk;
• Class IIb - generally regarded as medium to high risk; and
• Class III - generally regarded as high risk.

Medical devices are classified according to general specific criteria, which include duration of use, whether the device is invasive via a body orifice or surgically invasive, whether devices are implantable, and whether or not they are considered to be active ( i.e. have a power source). For transvaginal use, polypropylene mesh is a class IIb device, while meshes wholly or partly consisting of biological material are Class III devices according to the Council Directive 93/42/ EEC. It is anticipated the new EU Medical Device Regulations will include a change to the classification so all "surgical mesh" devices intended for "long term or permanent use" will be Class III.

Classification of medical devices varies across the world and, while there is some similarity with the United States, there is not equivalence. Therefore a direct comparison between US and EU criteria is not possible.

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=otn

In Sept 2011 the FDA's Obstetrics and Gynecology Devices Panel recommended that surgical mesh for transvaginal POP be reclassified from class II to class III and require premarket approval. In January 2017 the FDA has issued new classification on surgical instrumentation for use with urogynaecological surgical mesh: from class I (general controls) to class II (special controls), and subject to premarket notification. Background information on this change can be found here:

https://www.federalregister.gov/documents/2017/01/06/2016-31862/obstetrical-and-gynecological-devices-reclassification-of-surgical-instrumentation-for-use-with

From a European perspective the current position is that reclassifying these medical devices would not confer any material difference as they are already in the medium to high risk category as non-active implantable devices.

1.5 Approach to the Independent Review: evidence, its limits and interpretation

The IR's approach was set out in the first meeting in August 2014 - "to be conducted in an atmosphere of trust and openness, where transparency would underpin open discussion in the knowledge that participants may do so in confidence".

The aim has been to discuss the scientific evidence from the literature, understand the data from Scottish information sources, hear patients' and clinicians' opinions, appreciate the work of bodies such as the Chief Scientist Office, the NHS Incident Reporting and Investigation Centre and NHS Central Legal Office, and base the conclusions on the best analysis of all the material.

As with any review of evidence and the deliberative work to gain an understanding of complex real world situations, there are limitations to this work. For the Interim Report the outputs from some important research work were not published. However, as the other evidence strands are now available, notably the Opinion of the European Commission and its Scientific Committee on Emerging and Newly Identified Health Risks Opinion ( SCENIHR) and the results of the PROSPECT (PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials) study, the IR is able to conclude its final report. In addition, it is expected the conclusions directed to the Expert Group and researchers will continue to improve our knowledge base. What is most important is listening to and working with patients and health professionals. In order to support understanding and transparency, this Report has included the full analysis and review of evidence so others can follow our interpretations.