Transvaginal mesh implants independent review: interim report

Chapter 1: Introduction

1.1 Background

Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are conditions affecting a significant number of women and can result in a reduced quality of life for many. Synthetic polypropylene mesh is a permanent implantable medical device used in a number of operations to correct SUI and POP. 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.

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 these procedures 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 product Regulatory Agency (MHRA). Many women have experienced a positive outcome and because of this, combined with less successful outcomes associated with alternative surgical procedures, consider that they are the most effective way to treat these distressing conditions.

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 has been taken forward by the Expert Working Group.

The Scottish Mesh Survivors Group (SMSG) brought together women affected by polypropylene mesh 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 occurring, allied with under-reporting of these adverse events, has understandably 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 Scottish Mesh Survivors Group. The petition called on the Scottish Parliament to urge the Scottish Government to:

1. Suspend use of polypropylene Transvaginal Mesh (TVM) 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 TVM devices to heightened alert status to reflect ongoing 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 Independent Review of transvaginal mesh surgery was necessary to establish the facts. The former Cabinet Secretary for Health and Wellbeing, Alex Neil MSP, announced the Independent Review 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 Review has reported its findings.

1.2 Remit of the Independent Review

The published remit of the Independent Review is to evaluate both the efficacy and the extent and causes of adverse incidents and complication rates associated with stress urinary incontinence and for pelvic organ prolapse. The Independent Review recognises that these are different conditions, each managed by several different procedures and will take account of this.

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

1.2.1 Purpose

1. To determine the safety of vaginal mesh implants for both stress urinary incontinence and pelvic organ prolapse 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 stress urinary incontinence and pelvic organ prolapse 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.
• Whether the information provided to patients before undergoing these procedures should be updated.

The full remit and membership of the Independent Review is set out at Appendix A and B.

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 to review current clinical practice and make recommendations for change. The following areas are currently being considered by the Expert Group:

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 stress urinary incontinence^[1] which was published 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 Independent Review has a distinct remit and constitution. The Expert Group suspended its activities during the period of the Independent Review's main work programme and re-formed in August 2015.

1.4 What are Medical Devices?

A medical device means: 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.

MHRA regulates devices placed on the market by the manufacturer, but the healthcare services or clinical procedures they are used for 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 this function by the member states competent authorities. Once Notified Body certification is obtained and their other obligations under the Medical Devices Regulations are being met the manufacturer can put the CE marking on the device and place it on the EU market.

The MHRA as the Competent Designating Authority in the UK oversees UK Notified Bodies, for example, the British Standards Institute a list of which may 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 conduct regular audits of Notified Bodies quality assurance processes, monitor their certification and sample witness their compliance assessments of manufacturers to ensure that they operate to high standards:

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

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 in compliance 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 demonstrate verify that they the devices meet the relevant essential requirements laid down in the regulations for things such as including for example biocompatibility, toxicity, technical specifications, clinical data, sterilisation, right through to packaging and labelling and quality management systems.

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, whether or not they are considered to be active (i.e. have a power source), particularly invasiveness, duration of continuous contact, nature of the tissue contact, and distinction between non-active and active devices. For transvaginal use, Polypropylene mesh, used in urogynaecological surgery is a class IIb device, while meshes containing or which are entirely made of biological material (outside the remit of this Review) are Class III devices.

Classification of medical devices varies across the world and while there is some read across with the United States, there is not equivalence. Therefore a direct comparison between US and EU criteria is not possible. The FDA classifies mesh devices as Class II and this remains the case as of 21 Sep 2015.

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 April 2014 the FDA issued two proposed orders to reclassify mesh devices and a decision on these orders is awaited.

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 devices as non-active implantable devices.

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

The Independent Review'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. In part this is because the reports on some important research work have not yet been published and has led the Review to publish an Interim Report. Once other evidence strands become 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 Independent Review will be 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.