Sling The Mesh The Beginning

Transcription

1 Website:

2 Sling The Mesh The Beginning How it began From 20 members to more than 7000 Media is a powerful campaign tool Taboo busting Understanding science with a drama degree

3 Sling The Mesh Membership Total 7100 UK 5424 USA 765 Australia 325 Ireland 147 Canada 108 New Zealand 53 (77%) (11%) (5%) (2%) (1.5%) (0.7%) We also have members from Spain, Sweden, France, South Africa, Portugal, Dubai, Belgium

4 Sling The Mesh Membership Polypropylene mesh 87% Biological mesh 4% No mesh 9% There are 100 posts every hour in the Facebook support group

5 What is vaginal mesh?

6 1996 Boston Scientific launch ProtoGen, the first mesh sling for incontinence 1997 J&J launch TVT Vaginal mesh history Mesh kits flood the market, approved on equivalence to ProtoGen 1998 ProtoGen withdrawn 2002 Prolapse kits launch Mesh kit risks: trocar injuries, blind surgery, polypropylene is not inert

7 Mesh kits contain everything you need to operate except good clinical judgment and skill 1 TVT, the most widely used incontinence mesh sling, causes concern 2003 HTA regulators warn that TVT was rushed in on weak evidence, causing potential harm to thousands NICE calls for long term evidence 2018 Still no long term evidence No databases logging long term complications Norway is the only country with an independent incontinence registry. Only 12 months follow up. TVT risk 9.9% 1 Wall and Brown The Perils of Commercially Driven Surgical Innovation Health Technology Assessment programme funds research on the clinical and cost effectiveness and broader impact of healthcare treatments for the NHS

8 Regulators Fail Women 2012 MHRA commissions the York Report It cherry picks studies and quotes 1-3% risk It omits loss of sex life risk 14.5% Regulators say benefits outweigh risks of harms MHRA quotes this report for the next 5 years 2012 MHRA meeting shows the CE mark is a waste of time 2014 MHRA issues a patient safety alert

9 Regulators Fail Women If a device is causing havoc but functioning normally, it can only be removed from the market if the device itself is not performing properly or was unsafe. MHRA Committee on the Safety of Devices 2012

10 and they say journalists distort the truth Brubaker 1 : 42% risk but says problems resolve. Five years later 10% risk after author receives $136,000 Serati 2 : 30% risk Mesh has very high cure rate with low complications. Ward and Hilton 3 compare mesh with non-mesh. Study funded by Ethicon Nilsson 4 : 17 year study of 56 women. Two trial authors are Ethicon consultants Schimpf 5 : 36% risk of erosion for prolapse mesh but commends efficacy Chang & Lee 6 claim women make a fuss as they are attracted by big pay outs 1. Brubaker 2011; Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Sling (TOMUS) Study 2. Serati 2013; Tension-free vaginal tape for the treatment of urodynamic stress incontinence: efficacy and adverse effects at 10-year follow-up 3. Ward & Hilton; 2002 prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence 4. Nilsson 2013; Seventeen years follow-up of the tension-free vaginal tape procedure for SUI. 5. Schimpf 2016; Graft and mesh use in transvaginal prolapse repair: a systematic review. 6. Chang & Lee 2017; Midurethral slings in the mesh litigation era.

11 The Political Campaign Grows Oct 2017: Westminster Hall debate Nov 2017: All Party Parliamentary Mesh Group Jan 2018: Government announce review into three women s health disasters: Mesh, Sodium Valproate, and Primodos Feb 2018: House of Lords mesh question time on 100 th anniversary of women s right to vote April 2018: House of Commons 3- hour debate July 2018: Mesh suspended awaiting outcome of safety review; outcome due April 2019 October 2018: NICE publish new draft guidelines; not much different to 2003 NHS prepares new guidelines for treatment

12 Sling The Mesh Survey 2018 Mesh Types Incontinence mesh 73% Prolapse mesh 27%

13 Sling The Mesh Survey: September 2018 Complications are significantly under-diagnosed

14 Sling The Mesh Survey: September 2018 Complications are significantly under-diagnosed Patients 31% of women noticed mesh complications within 3 months of surgery 53% of women noticed mesh complications within 6 months of surgery Clinicians 5% of complications were recognised by a clinician and linked to mesh within 3 months of surgery 8% were recognised within 6 months of surgery

15 Sling The Mesh Survey of Complications (n=560) Pain affects daily life 78% Loss of sex life 70% Anxiety and depression 60% UTIs 54% Nerve damage 53% Incontinence 52% Constipation 48% Inability to urinate 30% Erosion into other organs 27% Fibromyalgia 26% Need a colostomy bag 2%

16 Sling The Mesh Survey: Shattered Lives (n=539) Can t enjoy socialising/hobbies 75% Reduced ability to lift shopping, cook, or clean 62% Medication side effects 58% Strain on primary relationship 53% Difficulty sitting in vehicles or on public transport 49% Forced to give up work 32% Reduced working hours 20% Lost marriage 15% Unable to care for children 13% Lost home 3%

17 Sling The Mesh Survey How long women have suffered (n=564) < 1 year 6% 2 to 5 years 23% 5 to 10 years 40% > 15 years 5%

18 Sling The Mesh Survey Most of us were not warned (n=569) Yes 2% No 83% Some risk 13%

19 Some of the pain medications taken by women on Sling The Mesh

20 PR pressure for media acceptance Reps in shiny suits give it a hard sell Promising Promising idea Reports with industry idea funding Standard treatment Doubts creep in Adverse effects: hell hath no fury like a mesh-injured woman with internet access Media use the V word; slowly realise this is a disaster Politicians realise the scale of the disaster It doesn t Promising idea Scott s parabola: adapted from Surgeons blame media and hysterical women; they hope it will blow over Research only