Bayer plc, a global pharmaceutical company, has received two complaints with regards to its Mirena inserters. The complaints detail that the insertion tube was mounted inversely to the handle, and this has led to an inversion of the insertion depth scale, which may lead to incorrect insertion depth; consequently reducing the efficacy and/or causing injuries.
An investigation has shown that both complaints involve one batch of inserters and a Mirena batch number TU01BPE. The affected batch was first distributed on 29th August 2016, with an expiry in June 2019.
Advice from Bayer
Bayer issued and distributed a letter to healthcare professionals. The pharmaceutical company note that any stock from the named batch should be thoroughly inspected to ensure the tube is mounted onto the handle correctly.
Bayer enclosed a photograph of both the defective and correctly mounted inserters, and below the photograph, additional guidance is given. This is in hope there will not be any further errors and to ensure any of the incorrectly mounted inserters can be rectified.
In the letter, Bayer gives detailed notes to Healthcare Professionals to follow in order to check if the Mirena inserters they hold are within the ‘defective’ batch. They must:
- Check the batch number before use.
- If the batch number is TU01BPE, ensure the insertion tube is correctly mounted (a picture is enclosed for guidance).
- Only use Mirena with a correctly mounted insertion tube.
- The use of a Mirena with an inversely mounted insertion tube may potentially lead to incorrect insertion depth (either too deep or not deep enough) and an incorrect position of Mirena. This in turn, may decrease the effectiveness of Mirena or result in adverse events. Bayer gives an example that if the inserter is advanced too far, injuries to surrounding blood vessels or viscera such as the bladder or intestine may occur (also known as uterine perforation).
Level of risk classification
To date, only two of the inserters have been affected globally. The Medicines and Healthcare products Regulatory Agency (MHRA), who is responsible for protecting and improving public health, also doesn’t seem to be too concerned with the defect. The regulatory agency classified it under Class 4 “Caution in Use”.
The MHRA uses an internationally renowned classification system for medicines recalls:
- Class 1: the defect presents a life threatening or serious risk to health
- Class 2: the defect may cause mistreatment or harm to the patient, but it’s not life threatening or serious.
- Class 3: the defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons, such as non-compliance with the marketing authorisation or specification.
- Class 4: the defect doesn’t pose a threat to patients or no serious defect likely to impair product use or efficacy.
According to the classification system, the Mirena insertion tubes don’t pose a serious risk of injury to the users. Class 4 is the least serious of notifications and are used for minor defects for example, in relation to packaging or other printed materials. Sometimes due to supply concerns, the products or medicines can’t be recalled. In this case, the supplier can issue and distribute alerts to advise healthcare professionals.
First published by Admin on February 14, 2017
Posted in the following categories: Medical and tagged with news