OPEN LETTER TO HON DOCTOR JONATHAN COLEMAN,

MINISTER OF HEALTH

30 AUGUST 2017


Dear Hon Dr Jonathan Coleman,

Thank you for your reply to our letter dated 2.8.17. ref: 1700909. There was information that we requested from you in our correspondence, which you neglected to include in your reply to us. Can you please confirm the following?


1. During our meeting in Dunedin, you said that you would meet with the Director-General of Health and provide us with feedback regarding this discussion. Did the meeting with the Director-General take place to discuss the surgical mesh issue? Can you please provide detail on the specific discussions that took place and the outcome of these discussions?

2. We asked you for information detailing specific DHB data capture
improvements in coding for mesh procedures. The subsequent information we
obtained, shows that there have been very few improvements made (obtained 
via OIA 17.8.17) Please provide the total percentage of surgical mesh
data capture improvements regarding the revision, division,
implantation and extraction of surgical mesh?

3. We discussed that the new patient electronic reporting system which is to be implemented by the Ministry will not be up and running until at least 2020. It is essential that surgical mesh data is captured and specific improvements need to be established prior to the implementation of this program. Will you confirm if data capture improvements specifically in relation to mesh will be implemented separately of this system and immediately? If not, can you confirm a date when this electronic reporting system will be up and running?

4. A surgical mesh register has been lumped in with the upgrading of the 
Therapeutic products regulatory regime and the implementation of new 
Electronic reporting systems. This needs to be established immediately due to
the severity and ongoing alarming escalation of numbers of surgical mesh
treatment injuries. Will you provide extra funding to the Ministry of Health
and DHBs so the development on a surgical mesh registry can begin 
immediately?


 5.We brought to your attention that intervention by the Ministry of Health is needed to address the ongoing lack of informed consent regarding surgical mesh procedures by doctors. The onus of this responsibility has been left to surgeons to address this problem, yet we hear regularly from patients that this continues to happen on such a large scale. There has been no ‘concrete’ changes implemented or visible evidence of improvement.  In your reply, you have stated that nothing will be done differently to address this problem. This is one of the HSC recommendations, what will you do differently to ensure that proper informed consent about surgical mesh procedures is happening?

6. During our meeting, we spoke about how the only viewpoint that had been 
considered by the Min of Health, the government and medical colleges has been 
Carmel Berry, Patricia Sullivan and Charlotte Korte. The Scottish and Australian 
governments have made the patient perspective about the surgical mesh issue a
priority for their investigations into surgical mesh complications. We were asked
to present evidence to the Australian Senate surgical mesh inquiry recently.
What will the ministry do to ensure that all mesh injured patients are
listened to, (as is happening in Australia) so that a thorough 
understanding of the impact of mesh injuries on the patient can be 
obtained?

7. Mandatory reporting: Stewart Jessamine stated in 2014 that generally there 
as not much difference between countries that had mandatory reporting to those 
countries that didn’t. This is the basis by the MOH for not implementing 
mandatory reporting of surgical mesh complications. Yet Scotland (as a direct 
result of their surgical mesh parliamentary inquiry) is now implementing 
mandatory reporting for surgical mesh adverse events.  Due to the sharp rise in 
claims made to ACC for surgical mesh treatment injuries in such a short time, 
and the severity of surgical mesh complications, we believe that there is a risk to
the public. We believe that it is essential for the reporting of surgical mesh 
adverse events to be made mandatory by all health professionals. Considering 
the alarming escalation of mesh complications and the severity of mesh
injuries, will you reconsider your refusal to implement mandatory 
reporting?


8. The meeting ‘notes’ you mentioned in your recent correspondence, mentions 
the meeting on the 19th Dec 2016 with the College of Surgeons. We feel that this
statement is misleading, the only notes we have received (through the OIA) is
an agenda of what was ‘potentially’ going to be discussed. Chris James 
confirmed in fact that no minutes of any meetings that Medsafe have attended 
have ever been taken or are on record (to May 4th).  At our request, ACC have 
agreed that minutes will be taken from all meetings with Medsafe regarding the 
mesh issue. Considering the seriousness of the surgical mesh issue, can 
you confirm if Medsafe has now adopted a policy to ensure minutes of 
all meetings are taken (regarding the surgical mesh issue) with relevant 
health organisations in the future?

9. Medsafe should provide accessible and up to date information regarding 
potential surgical mesh complications on the Medsafe Website. Even after
repeated requests, the adverse events document has not been updated since
December 2016. We believe that Medsafe need to update their position 
statement surrounding transvaginal mesh for POP to reflect the current 
recommendations of RANZCOG. The website should include information 
pertaining to the reclassification of surgical mesh devices. Please confirm what
you believe is an acceptable time lag and when will Medsafe update its 
website?

10. We gave you a collection of patient stories/experiences from mesh injured 
people. Did you read these? You promised to personally reply to us with your
thoughts after reading them. You only mentioned that you were “happy that
people had taken the time to write these letters”.  Mesh injured people want 
to know that you care, have compassion and that you have listened. Can
you please be more specific detailing your response after reading these
letters?


We look forward to hearing from you shortly in regard to the information that you said that you would provide during our meeting, and in your subsequent reply.


Kind regards

Charlotte Korte
Patricia Sullivan
Carmel Berry