Surgical mesh adverse reactions

Transcription

1 Surgical mesh adverse reactions A consumer voice on early identification in the GP setting Patricia Sullivan 28 July 2018

2 New Zealand support group

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4 SMAR Surgical Alison with husband Jeff and children Latham, 13, and Jack, 10. Mesh Adverse Reaction

5 Who am I? For outstanding services to nursing and academic achievement G P

6 Risk classification Class II Medium Risk Class III High Risk Trocars

7 Mesh Down Under 2016 Survey

8 Current data collection Existing concern yet slow progress Australian senate inquiry recommendations UK, Ireland & Wales Suspensions as of July 2018

9 Product concerns

10 Surgical mesh treatment injury decided claims Total Cummulative decided Surgical Mesh TI Claims From 1 July 2005 to 28 Feb % increase in Surgical Mesh-related claims in 4 months (n=71) from 31 Oct 2017 to 28 Feb 2018 POP/SUI 33, Hernia 32, other 6

11 Surgical Mesh treatment injury declines Number and percentage of claims being declined has risen Mesh-related claims No. of claims Accept Decline Total Percent acceptance Fiscal year

12 Survey results Analysis of Surgical Mesh Survey (Pilot Study September 2016) Sample size of 60 of the 197 Mesh Injured New Zealanders who are members of the Mesh Down Under support group Response rate = Just over 30%

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14 Post operative complications 1. Pain 2. Erosion 3. Hematoma

15 Post operative complications continued 4. Recurrence 5. Infection 6. Urinary tract infection

16 Post operative complications continued 7. Voiding dysfunction 8. Painful intercourse/intercourse impossible 9. Unexpected bleeding 10. Incontinence (urinary and fecal)

17 GP awareness 76.6% of respondents did not feel that their GP was aware of surgical mesh complications and symptoms

18 Mesh symptoms and complications Physical 1: Groin/leg pain (NEUROPATHIC) 2: Back/abdominal pain 3: Recurrent UTI s 4: Vaginal sloughing 5: Dyspareunia 6: Voiding dysfunction 7: Incontinence (bw/bl) 8: Systemic pain/rashes 9: Auto-immune CFS 10: Fibromyalgia Neurological 1:Anxiety 2:Depression 3:PTSD 4:Adjustment Disorder 5:Suicidal thoughts Other 1: Can occur immediately or up to 15 years later 2: Chronic pain syndrome S-LANSS Pain Score 3: Central Sensitisation Mayer et al, 2013; Neblett et al 2013 C.S Inventory Questionnaire. 4: Huge family impact 5: Loss of general health

19 The role of the GP G P

20 Recall response

21 Medsafe introduces surgical mesh restrictions Medsafe is taking action in New Zealand to remove from supply and effectively limit the use of certain surgical mesh products used for urogynaecological indications. Media release 11 December 2017 Section 38 of the Medicines Act 1981 permits the Director-General of Health to request safety information from a supplier should there be reason to believe that a medical device is unsafe. Under section 38, Medsafe has written to four companies: Boston Scientific NZ Ltd, Culpan Medical, Endotherapeutics NZ Ltd and Johnson & Johnson Medical NZ Ltd requesting safety information or confirmation that the companies will comply with the Australian requirements.

22 Medsafe introduces surgical mesh restrictions. Medsafe invoked Section 38 of the Medicines Act This does not constitute a recall Sticker applied to the outside of packaging. Only the theatre nurses see this!!!

23 NZ Mesh Working Group established and CBA for? Registry Where do we go from here? Severe injuries from surgical mesh recognised globally UK 9 month Suspension Australia Mesh Centres established, wrap around services.

24 UK, Ireland & Wales Suspensions, Australia Senate Inquiry, USA and EU Class Actions UK/Europe $$ USA $$ Mesh Centres $$ Class Actions Australia $$ NZ Working Group

25 ACHIEVING BEST OUTCOMES Prompt diagnosis crucial 1: Generally, a VERY gentle but thorough PV exam will identify vaginal mesh (PENDING) erosion G P 2: Red flag for GP s highlighting mesh implants on hospital discharge notes 3: Appropriate pain relief to prevent chronic pain syndrome 4: Lodge an ACC T.I claim 5: Pelvic Pain does exist

26 Thank you! Any questions? For full survey and detailed analysis see: You can contact me at Or

27 Patricia Sullivan 1, Alex Neill 2, Charlotte Korte 3, Dedicated to support and information sharing for New Zealanders injured by surgical mesh. 1 Bachelor of Nursing, Petitioners Mesh Down Under 2 Statistician 3 Petitioners Mesh Down under 93% of Mesh Down Under 2016 Survey Participants Presented with Pain Complications. N = of the 197 mesh injured New Zealanders from the Mesh Down Under Website participated in the survey. Of these 50% were Age at time of mesh implant 45% were 5-9 years since mesh implantation, and 17% were years since mesh implantation 15 % Reported GP aware of surgical mesh complications 44 made a claim to ACC of which ⅔ were accepted

28 Chronic Mesh Pain The most common surgical mesh adverse reaction 1. Presentation and clinical implications vary greatly. Some suffer pain immediately after the mesh implant. Others start to have trouble much later, it may be a decade or so. Regional and Systemic pain symptoms develop as a result of: neuronal sensitization, cross-talk and pain centralization 3. It is no longer acceptable that pain be just managed. We must accept that pain can be treated. Regional Symptoms Non specific pain 2 Nerve pain (pudendal, obturator) and muscle spasm Dyspareunia (painful sex) Mesh erosion causing discharge, bleeding, Infection Urinary dysfunction (voiding, incontinence, UTI) Incontinence Bowel and Bladder Allergic/immunologic 2 Fibromyalgia hypersensitivity, inflammation, Rash, fever Mental Injury Systemic Symptoms Diabetes Lupus Chronic Fatigue Scleroderma Thyroid problems Allergic or immune reactions to mesh may present immediately or in a delayed postoperative period. Timing of pain onset in relation to tissue incorporation, mesh break-down and shrinkage should be considered. Symptoms of obstructive urination, defecation, or Dyspareunia suggest mesh misplacement. Often associated with retraction of the vaginal epithelium 2.