Printed from https://fyi.org.nz/request/26326-correspondence-to-physicians-in-respect-of-the-essure-permanent-iud on April 30, 2024 18:38

Correspondence to physicians in respect of the Essure permanent IUD

Catrina McGregor made this Official Information request to Ministry of Health

Currently waiting for a response from Ministry of Health, they must respond promptly and normally no later than (details and exceptions).

From: Catrina McGregor

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. 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
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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 
 
 

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