Surgical mesh adverse reactions - A consumer voice on early identification in the GP setting
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Surgical mesh adverse reactions A consumer voice on early identification in the GP setting Patricia Sullivan 28 July 2018
New Zealand support group
SMAR Surgical Alison with husband Jeff and children Latham, 13, and Jack, 10. Mesh Adverse Reaction
Who am I?
“For outstanding services to nursing and
academic achievement”
GP
Risk classification
Class II “Medium Risk” Class III “High Risk”
Trocars
Mesh Down Under 2016 Survey
Current data collection
Existing concern yet slow
progress…
Australian senate inquiry recommendations UK, Ireland & Wales Suspensions as of
July 2018
Product concerns
Surgical mesh treatment
injury decided claims
943 Total Cummulative decided Surgical
Mesh TI Claims From 1 July 2005 to 28 Feb
2018
1000
900
800
700
600
500
400
300
200
100
0
2004 2006 2008 2010 2012 2014 2016 2018 8% 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 6Surgical Mesh treatment ▪Number and percentage of
injury declines claims being declined has risen
Mesh-related claims
200
180
160
140
120
No. of claims 100 Accept
80 Decline
60
Total
40
Percent acceptance
20
0
Fiscal yearSurvey 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%Post operative
complications
1. Pain
2. Erosion
3. HematomaPost operative
complications continued
4. Recurrence
5. Infection
6. Urinary tract infectionPost operative
complications continued
7. Voiding dysfunction
8. Painful intercourse/intercourse
impossible
9. Unexpected bleeding
10. Incontinence
(urinary and fecal)GP awareness 76.6% of respondents did not feel that their GP was aware of surgical mesh complications and symptoms
Mesh symptoms and
complications Other
1: Can occur immediately
or up to 15 years later
Physical Neurological 2: Chronic pain syndrome
1: Groin/leg pain 1:Anxiety S-LANSS Pain Score
(NEUROPATHIC) www.bpac.org.nz
2: Back/abdominal pain 2:Depression
3: Recurrent UTI’s 3: Central Sensitisation
4: Vaginal sloughing 3:PTSD Mayer et al, 2013;
5: Dyspareunia Neblett et al 2013
4:Adjustment C.S Inventory
6: Voiding dysfunction
Disorder Questionnaire.
7: Incontinence (bw/bl)
8: Systemic pain/rashes 5:Suicidal
9: Auto-immune – CFS 4: Huge family impact
thoughts 5: Loss of general health
10: FibromyalgiaThe role of the GP
GPRecall response
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. “
Medsafe introduces surgical Medsafe invoked Section 38 of the Medicines Act mesh restrictions. This does not constitute a recall Sticker applied to the outside of packaging. Only the theatre nurses see this !!!
Where do we go from here?
Severe injuries
from surgical
mesh recognised • UK 9 month Suspension
globally
• Australia Mesh Centres
established,
wrap around services.
• NZ Mesh Working Group
established and CBA for
? RegistryUK/Europe
$$
USA
$$
Australia
NZ
$$
‘Working
Mesh Centres Group’
$$ Class Actions
UK, Ireland & Wales Suspensions, Australia Senate Inquiry , USA and EU Class
ActionsACHIEVING BEST OUTCOMES Prompt diagnosis crucial
1: Generally, a VERY gentle but thorough PV exam will
identify vaginal mesh (PENDING) erosion
GP
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 existThank you! Any questions? For full survey and detailed analysis see: www.meshdownunder.co.nz You can contact me at patricia@meshdownunder.co.nz Or charlotte@meshdownunder.co.nz
Dedicated to support and information sharing for New Zealanders injured by surgical mesh.
www.meshdownunder.co.nz 1 Bachelor of Nursing, Petitioners Mesh Down Under
2 Statistician
Patricia Sullivan1, Alex Neill2, Charlotte Korte3, 3 Petitioners Mesh Down under
93% of Mesh Down Under 2016 Survey Participants Presented with Pain Complications.
N = 60
60 of the 197 mesh injured New Zealanders from the Mesh
Down Under Website participated in the survey.
Of these 50% were Age 40-49 at time of mesh implant
45% were 5-9 years since mesh implantation, and
17% were 10-14 years since mesh implantation
15 % Reported GP aware of surgical mesh
complications
44 made a claim to ACC of which ⅔ were acceptedChronic Mesh Pain
The most common surgical mesh adverse reaction1.
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 centralization3.
It is no longer acceptable that pain be just managed.
We must accept that pain can be treated.
Regional Symptoms Systemic Symptoms
Non specific pain2 Allergic/immunologic2
Nerve pain (pudendal, obturator) and muscle spasm Fibromyalgia Diabetes
Dyspareunia (painful sex) hypersensitivity, Lupus
Mesh erosion causing discharge, bleeding, inflammation, Chronic Fatigue
Infection Rash, fever Scleroderma
Urinary dysfunction (voiding, incontinence, UTI) Mental Injury Thyroid problems
Incontinence Bowel and Bladder 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 epithelium2.You can also read
