Kia ora Catrina,
  
Thank you for your request for official information. The reference number
for your request is: H2024039036
  
As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/  
  
If you have any queries, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account. 

Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [3][email address] or by calling 0800
802 602.

Ngā mihi 
 
OIA Services Team 
[4]Ministry of Health information releases 
 
 

------------------- Original Message -------------------
From: Catrina McGregor <[FOI #26326 email]>;
Received: Fri Apr 05 2024 15:13:21 GMT+1300 (New Zealand Daylight Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Correspondence to physicians in
respect of the Essure permanent IUD

Dear Ministry of Health,

Other than a recall notice being placed on the MedSafe website, did the
Ministry of Health or MedSafe notify physicians or gynaecologists of the
recall of the Essure permanent contraceptive implant recall in 2017?  If
so, when and how did this take place?

Other than a recall notice being placed on the MedSafe website, did the
Ministry of Health or MedSafe notify physicians that Essure recipients
were required to be monitored?  If so, when and how?

Would Ministry of Health or MedSafe please produce dated copies of the
letters, emails or templates sent to notify physicians of the Essure
device recall, and the requirement to monitor implant recipients?

Did the Ministry of Health or MedSafe supply physicians with any updated
information and advice for patients in relation to the previously
unnotified side effects?
Did Ministry of Health or MedSafe notify physicians of the Black Box
warning and updated list of side effects that was issued in the USA in
2016?

Has the Ministry of Health made physicians aware of the Bayer/FDA extended
5-year post recall 522 study in relation to Essure?

At any time, has Ministry of Health taken any steps to notify patients
directly regarding the recall of Essure?

Yours faithfully,

Catrina McGregor

 

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Kia ora Catrina,

Thank you for your request for official information received on 5 April
2024 requesting:

1.       Other than a recall notice being placed on the MedSafe website,
did the Ministry of Health or MedSafe notify physicians or gynaecologists
of the recall of the Essure permanent contraceptive implant recall in
2017?  If so, when and how did this take place?

2.       Other than a recall notice being placed on the MedSafe website,
did the Ministry of Health or MedSafe notify physicians that Essure
recipients were required to be monitored?  If so, when and how?

3.       Would Ministry of Health or MedSafe please produce dated copies
of the letters, emails or templates sent to notify physicians of the
Essure device recall, and the requirement to monitor implant recipients?

4.       Did the Ministry of Health or MedSafe supply physicians with any
updated information and advice for patients in relation to the previously
unnotified side effects?

5.       Did Ministry of Health or MedSafe notify physicians of the Black
Box warning and updated list of side effects that was issued in the USA in
2016?

6.       Has the Ministry of Health made physicians aware of the Bayer/FDA
extended 5-year post recall 522 study in relation to Essure?

7.       At any time, has Ministry of Health taken any steps to notify
patients directly regarding the recall of Essure?

The Ministry of Health has decided to extend the period of time available
to respond to your request under section 15A of the Official Information
Act 1982 (the Act) as consultations are necessary to make a decision on
the request are such that a proper response to the request cannot
reasonably be made within the original time limit.

You can now expect a response to your request on, or before, 11 June 2024.

You have the right, under section 28 of the Act, to ask the Ombudsman to
review my decision to extend the time available to respond to your
request.

Ngā mihi 

  

 

OIA Services Team

Manatū Hauora | Ministry of Health

M[1]inistry of Health information releases 
U[2]nite against COVID-19 

 

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legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
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Kia ora Catrina, 

 

Please find attached the response for your request for official
information. 

 

Ngā mihi 

 

OIA Services Team

Manatū Hauora | Ministry of Health

M[1]inistry of Health information releases 
U[2]nite against COVID-19 

 

****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************

References

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1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/

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