An Investigative Review into the process of establishing, managing and supporting Independent Reviews in Scotland

Annex 2: Written submission from the petitioners

Dear Prof Britton

We regret we are not able to meet with you in person for several reasons but please consider this our contribution to your review.

The process of ‘The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women’, in our view, seriously undermined the outcome and cannot be trusted. Initially, the above title did not include the word ‘safety’, and when we questioned this we were told it was not the remit. We pointed out that ‘safety’ was in fact the prime point and purpose of the review as per the Terms of Reference. At the next meeting the word ‘safety’ was added to the title without any discussion, and as a result we were sceptical about the process and purpose of the review from the beginning.

Lack of Independence and balance:

• The four surgeon members of the review group were all proponents of mesh.
• There was no anti-mesh surgeon despite repeated pleas from us to address the balance on at least five occasions between: 2 October 2014 – 21 March 2015. In contrast, patients with a positive and negative experience of mesh were represented.
• Three of the surgeons are under litigation – none of them declared this.
• The suspension of mesh called for by former Cabinet Secretary for Health Alex Neil in July 2014 was not adhered to by the two biggest health boards, Glasgow and Edinburgh, who went ahead and continued to implant hundreds of women. Those two boards have lead clinician group members who have clear links to mesh companies (see below). We believe this was not made clear to Mr Neil who has since commented on the issue.
• We have known patient representative Isobel Montgomery for several years and the style/language used on THIS occasion, her contribution to the Final Report, differs from her normal style/language and, therefore, it is our impression that her contribution may not have been her own personal contribution and, therefore we are drawing conclusions about her independence. In contrast, the anti-mesh chapter by women who have been adversely affected by mesh is real – there is no input from experts – it is independent.

Conflicts of Interest:

• It is our opinion that Dr Tracey Gillies, a serving NHS Medical Director who is getting her salary from the same government who instructs her, should never have been appointed as Chair of the so called independent review – this is a conflict. We believe that Dr Gillies came to the review with predetermined opinion that mesh is okay, when she declared that her concern was for two women who contacted her at NHS Forth Valley who were ‘anxiously’ awaiting the recommendations of the review as they are suffering from SUI and/or POP. She told us she felt the need to write to these two women to reassure them that she had only recently joined the review group as she didn't want them thinking she had been involved all along! Dr Gillies has since become an executive on a health board currently facing unprecedented legal claims from mesh injured women. We suspect that in addition to her role as a serving NHS Medical Director, this is another conflict of interest.

• Mr Paul Hilton is a main witness for the NHS Central Legal Office. He was asked to give his general medical and possibly patient specific opinion in the forthcoming civil action for damages brought by an unprecedented number of patients in Scotland, upwards of 420 at the present time. His position on mesh was predetermined and it showed a lack of independence as he had already given his opinion to lawyers and couldn’t change it. Mr Hilton did the ‘Ward and Hilton Study’ sponsored by Johnson and Johnson (biggest mesh manufacturer), and this research justified bringing mesh into the UK in the first instance. He has received research funding from two mesh companies from 1998 to 2003 and 2001 to 2003 respectively.

• Dr Karen Guerrero lead urogynaecologist for NHS Glasgow has in recent months organised training programmes for gynaecologists, which are sponsored and subsidised by Boston Scientific, which faces a possible criminal investigation in the US. The firm, which supplies mesh to NHS Glasgow, faces allegations it used counterfeit polypropylene resin from China to manufacture implants, some of which, it is feared, may have reached Scotland. It is one of a number of companies which is reported to have paid out nearly £3 billion in compensation to mesh injured patients in the US. Dr Guerrero also led a study sponsored by American Medical Systems, the second biggest mesh manufacturer and the firm that collapsed after announcing £1.2 billion pay-outs in out-of-court mesh settlements.

• NHS Lothian consultant Voula Granitsiotis has taken part in mesh research trials and received travel grants from firms, including American Medical Systems, the mesh firm that collapsed after announcing £1.2 billion pay-outs in out-of-court mesh settlements.

• NHS Ayrshire and Arran specialist Dr Wael Agur received travel grants and financial support for workshops from Boston Scientific, Ethicon and CR Bard. Although he declared these and contributed to the review for almost three years, his declaration was not published with the other clinicians in the Final Report.

• Patient representative Isobel Montgomery who was said to have had a positive experience with mesh was invited to participate to bring ‘balance’ to the group. She was involved in several mesh research trials, for which she received almost £3,000 in fees. She is also listed a ‘research grant holder’. Her declaration of interest failed to list this.

• Urogynaecologist Mr Ash Monga, a former Chair of the British Society of Urogynaecology (BSUG) sat on the review to represent clinical society and professional bodies. He received expenses from American Medical Systems for a research project which did not go ahead. He was involved in writing a damning survey, which found that only 27 per cent of surgeons were reporting mesh complications to medical device watchdogs. Despite this shocking evidence, Mr Monga failed to push for a mesh registry or mandatory reporting of adverse events to MHRA, leaving it to patients to lobby Health Secretary Shona Robison.

• Urologist Mr Roland Morley, a former President of the British Association Urological Surgeons (BAUS) and member of both Scottish and UK review group was also involved in the damning survey, which found that only 27 per cent of surgeons were reporting mesh complications to medical device watchdogs. He did not push for either a registry or mandatory reporting to a health watchdog, shamefully leaving it to patients to lobby the Health Secretary.

Transparency:

• Scottish Government’s Dr Sara Davies told us there was no new evidence since the Interim Report published in October 2015. We did a literature search and found pertinent Cochrane evidence, which Dr Davies later told us she was actually aware of. We later realised that the Cochrane evidence was the subject of the serious disagreement between surgeons and most likely the reason we were not invited to any meetings and kept in the dark for 10 months. This important evidence was removed and eventually hidden in an appendix in the Final Report. The process of transparency had failed.

• 11 November 2016: Dear Dr Davies we were surprised to hear that you are unaware of any new evidence to include in Chapter 3 of the Final Report. To our knowledge, there have been 3 relevant and important Cochrane reviews published since the Interim Report, there may even be others we've missed. We thought Dr Mackie and or the clinicians in the group would have kept you informed. Are they all unaware of these reviews and potential evidence? If so, this is concerning and only serves to lessen our confidence in the scientific and evidence part of the review. We feel strongly that there is information in these reviews that must be included in the Final Report. We want to see this in a table format like Dr Agur and Dr Mackie did for TVT-O vs Retropubic last year please.

• 30 November 2016: Dr Davies informed us by email of Dr Gillies’s appointment as Chair. She added that a date for the ‘final meeting’ will be circulated shortly and that the draft Final Report will be sent out two weeks before the meeting. We had not been invited to any meetings for eight months at this point and we were told there was no new evidence as we awaited a date for the ‘final meeting’!

• 9 January 2017: Dear Dr Davies, In addition to the three Cochrane reviews we sent to you on 11 November 2016, can you ask Dr Agur and Dr Mackie to include this latest Cochrane review in our requested table please? This is fairer than someone interpreting the results and is the easiest format for lay people to see at a glance risks v benefits.

Despite at least five requests two written and three verbal that the Cochrane evidence reviews be put in the same table format as the Interim Report to make the information understandable for patients, we were not sent these tables.

• 21 February 2017: Dr Agur circulated his comments regarding the Final Report to the whole review group and it was then we learned that the patient friendly ‘tables’ we had been requesting since November 2016 were in existence since July 2016 and had been prepared by Dr Agur – no one told us! We soon discovered that tables and alternative evidence that did not favour mesh was hidden in an appendix or website amongst obscure data. There was a complete lack of transparency.

• Failure to contain vital information about the EU reclassification of all surgical mesh to highest risk category Class III by using date discrepancies. The Cabinet Secretary and CMO stated that the EU reclassification took place in the first week of April 2017, a few days after the whitewash mesh report was published, and that is why the report did not mention the reclassification. Our understanding is the reclassification was approved on 22 February (5 weeks before the report was published) and adopted on 7 March by EU Council. We asked the Chair to include the reclassification on 27 February. The Final Report says; “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”. The report then goes on to down-play the significance of reclassifying surgical mesh to highest risk category by saying; “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.” This new ruling would require mesh manufacturers to prove that their product was safe and not based on equivalence as is currently the case.

Here is a timeline for the related events:

• 15 June 2016: Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. EU Reclassification of all surgical meshes to class III, Annex, Page 338, 4.4., Rule 8: http://data.consilium.europa.eu/doc/document/ST-9364-2016-REV-2/en/pdf

• 22 February 2017: Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. EU Reclassification of all surgical meshes to class III, Annex VIII, Page 12, 5.4, Rule 8: http://data.consilium.europa.eu/doc/document/ST-10728-2016-INIT/en/pdf

• 8 March 2017: Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC - Adopted by the Council on 7 March 2017. EU Reclassification of all surgical meshes to class III, Annex VIII, Page 12, 5.4, Rule 8: http://data.consilium.europa.eu/doc/document/ST-10728-2016-REV-4/EN/pdf

• The link Cabinet Secretary Shona Robison provides in her answer to Neil Findlay MSP above is the same link that we provided, which confirms that the reclassification of all surgical meshes to highest risk Class III was adopted by EU Council on 7 March 2017, and the letter confirming this was dated 8 March, well before the Final Report was published. Dr Gillies confirmed to the Committee that reclassification was 8 March.

• Failure to mention the criminal investigations ongoing against mesh manufacturers in three states in America:
  24 May 2016: WASHINGTON AG FILES MAJOR LAWSUIT AGAINST JOHNSON & JOHNSON OVER CONCEALED RISKS OF PELVIC MESH: http://www.atg.wa.gov/news/news-releases/ag-files-major-lawsuit-against-johnson-johnson-over-concealed-risks-pelvic-mesh
  24 May 2016: CALIFORNIA ATTORNEY GENERAL KAMALA D. HARRIS FILES LAWSUIT AGAINST JOHNSON & JOHNSON FOR DECEPTIVE MARKETING OF SURGICAL MESH PRODUCTS: https://oag.ca.gov/news/press-releases/attorney-general-kamala-d-harris-files-lawsuit-against-johnson-johnson-deceptive
  16 August 2016: KENTUCKY AG FILES A MAJOR LAWSUIT AGAINST JOHNSON & JOHNSON OVER CONCEALED RISKS OF PELVIC MESH: https://www.youtube.com/watch?v=ShrmwhsmW90&app=desktop Kentucky:

Consistency:

• Despite being fully-informed by the Cabinet Secretary that it was our express will ALL our input must be removed from the report as we did not want our name associated with such a biased report that we believe exposes women to unnecessary harm, Dr Gillies, ignored us and the Cabinet Secretary and went ahead and published all of our input in the Final Report, removing only our Minority Opinion, which was ‘too late’ to be included in the Interim Report. She sent us a letter with a mistake in the dates. It is unacceptable that a Chair of a review expects lay-members of the group to respond to a serious email within only 24-48 hours, depending on the way the mistake in the dates is understood. When asked by the Public Petitions Committee, Dr Gillies was inconsistent in her answers as to why she published our input when the Cabinet Secretary asked her not to. In one instance, she appeared to blame the Cabinet Secretary for lack of clear communication but in another instance she appears to shift the responsibility for the decision to publish our input to the members of the review themselves. If the Review Group members decided to include our input against our wish, we would like to see written minutes of the meeting or email evidence please. Such inconsistency is a clear indication of unnecessary miscommunication which resulted in the loss of accuracy in relation to our request for our input to be removed. When asked about this matter, the Cabinet Secretary clearly and consistently shifted the responsibility to the review Chair.

Here is a timeline of events in relation to this miscommunication:

• 16 March – Scottish Mesh Survivors (SMS) ask Cabinet Secretary to remove ALL our input from the Final Report, this was acknowledged and said it would be conveyed to Dr Gillies.

• 22 March 18:22 – Dr Gillies wrote that she understood from the Cabinet Secretary that we wanted our contribution removed. She listed ALL items we had contributed and asked us to confirm AGAIN that we wanted them ALL removed. She asked that we respond by 10:00 on Thursday 24th .Thursday was the 23rd not 24th. This email was unnecessary, harassing, confusing and pressurising. This gave us less than 24 hours (or 48 hours, depending on which date was correct) to respond.

• 23 March 23:57 – We did respond although it felt unnecessary to do so, we again asked Dr Gillies and the Cabinet Secretary to remove ALL our input from the Final Report, including our Minority Opinion from the Interim Report.

• 27 March – Cabinet Secretary wrote to say we had subsequently asked for 'more' input to be removed and this would not be possible – we were too late. We repeatedly asked that ALL our input from the Final Report be removed. We did NOT want associated with the report and it was NOT in our name. Quite simply we were used in order that the Final Report could publish without it appearing completely biased.

• 27 March – SG Final Report published. NONE of our input into this Final Report was removed! The only thing removed was our Minority Opinion from the Interim Report.

• 29 March – POSTAL LETTER received, dated 23 March BUT the envelope dated 27 March from Dr Gillies writes; “Further to my email to you yesterday, I have not heard from you”. She goes on to say that we had asked only that our Minority Opinion from the Interim Report be removed.

• 18 May – Dr Gillies told the Petitions Committee that the review group had had a meeting to discuss our request to remove ALL our input before the Final Report published on 27 March. “It is right to listen to requests but, that does not mean I would necessarily accede to those requests.”

• 18 May – Cabinet Secretary: “I met the Chair on 22 March, I relayed to her ALL the concerns that the women had expressed. She then contacted them to ask about a number of pieces of information and to seek clarification of what should be removed. The women responded on, I think, 23 March with a list of information that they wanted to be removed. It was, ultimately, the chair’s decision on whether to accede to that request. She clearly agreed with some of it: she agreed to remove, for example, the minority report and gave her reasons earlier about why she did not remove the other material.”

A timeline of email correspondence in relation to this miscommunication can be provided for the Committee

Membership:

• Scottish Government’s Dr Catherine Calderwood did not attend any meetings in Scotland despite being included in group emails. She did however participate in some English group meetings.

• Mr Ash Monga and Mr Roland Morley have disappeared from group emails and were not replaced. That raises questions about the clinical societies not being involved in government decisions about the review and suggests lack of independence.

• MHRA’s Dr Neil McGuire, BSUG’s Mr Ash Monga, BAUS’s Mr Roland Morley, Scottish Government’s Dr Catherine Calderwood and Dr Wael Agur were members of both the Scottish and English mesh reviews. No explanation was given to patients either side of the border why members could wear two hats and support mesh suspension in Scotland but not in the rest of UK.

Funding:

• The Scottish Government spent less than £4,500, the cost of a business class ticket to attend Tartan Week in New York for the First Minister, it has been said, on a report which completely fails to adequately address the issue due to the flawed process. This would suggest that funding was inadequate and or wrongly zoned in our opinion. There was a lack of communication, and transparency and trust was lost after Dr Wilkie resigned. The review lost its independence, purpose, and lost its way.

In short, instead of mesh injured women being at the heart of the review, we were very much lone voices. Our comments and information we believed were important to the review were either not used, not documented in the minutes or they were dismissed.

Meeting minutes were not verbatim and were selective to the point we questioned whether we had actually been at the same meeting! The review process and lack of independent leadership after Dr Lesley Wilkie resigned, took its toll on our health.

The Interim Report says; “The Independent Review expressed serious concern that some women who had adverse events found they were not believed.” In the Final Report that changes to; “The Independent Review expressed serious concern that some women who had adverse events felt they were not believed”. We feel strongly that this compounds the idea that Dr Gillies does not believe that we were not believed.

We still have women being told their pain is ‘all in their head’ and being sent for psychiatric treatment. Women are suffering prolonged mesh complications because some doctors are still not knowledgeable enough or because they are simply not believed.

Some surgeons are still assuring patients that they won’t be using mesh - they will be using tape. They don’t tell patients it is a ‘mesh tape’. Some surgeons are still misinforming patients that the mesh they use is not the ‘bad mesh’ that is being negatively reported in the media.

We have women who have lost their jobs, careers, their homes, their husbands and partners. Thousands of women across Scotland could find in 10-15 years they have devastating medical problems due to the mesh implanted inside them, and no way of knowing whether it has been caused by potential counterfeit mesh from China.

We have women who are not being given the incontinence products they need because of the injuries they have suffered. And we have the NHS facing the biggest medical claim in Scottish legal history while the mesh manufacturers who have already paid out $3billion in the US are likely to walk away leaving the public to pick up the tab.

We strongly believe some of the recommendations of the Final Report are unsafe and expose women to unnecessary harm. All of the above process issues undermined the report and trust was lost. We tried our best but when independence, transparency consistency and trust was lost, our hopes were shattered. We hope your review uncovers the truth and includes our views and experience when it is published.

Yours sincerely

Elaine Holmes and Olive McIlroy
http://www.scottishmeshsurvivors.com/

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