MHRA Drug Alert: Mirena® (January 2017)
Date: 09 Jan 2017
Type: FSRH News and Information
The CEU reports on a MHRA drug alert issued on 05/01/2017 regarding a batch of Mirena® LNG-IUS inserters that has been manufactured with the insertion tube mounted the wrong way on the inserter handle.
MHRA Drug Alert: Mirena®
The Medicines and Healthcare Regulatory Authority (05/01/17) reported that a batch of Mirena® LNG-IUS inserters has been manufactured with the insertion tube mounted the wrong way on the inserter handle. This means that the scale on the insertion tube that measures insertion depth is inverted (see image below). This could potentially result in incorrectly placed Mirena devices or uterine perforation.
Bayer plc has received two complaints globally. A very small number of inserters are thought to be affected. The affected batch number is TU01BPE (first distributed 29/8/16). Not all devices in this batch are affected.
Any incorrectly mounted insertion tubes identified should be reported to Bayer plc by telephone, 01635 563116 or by email to firstname.lastname@example.org.
The CEU recommend that clinicians ensure that they check Mirena batch numbers and do not use any devices from the affected batch unless they have checked that the inserter tube is correctly mounted. If a clinician is concerned that they have inserted a Mirena from this batch incorrectly because of the inverted depth scale, they should contact local Sexual and Reproductive Health services for advice regarding follow up of their patient. If there is any concern regarding uterine perforation or if threads are not identified by the woman or her healthcare provider at 3-6 weeks after insertion, an ultrasound scan should be arranged as soon as possible.