Training Hub
Consilient Health are committed to ensure HCP’s are trained on the correct insertion and removal techniques. Training on the correct insertion technique has a positive impact on the number of expulsions encountered. In a study, on an earlier prototype, expulsion rates, at 12 month follow-up, dropped from 13.79% to 4.81% after the inserters were trained on correct insertion technique.2
The IUB™ is supplied sterile, pre-loaded in a scaled PVC insertion tube. Also supplied are a solid purple polycarbonate push rod and a sliding flange, the latter is fitted on the insertion tube and aids in gauging the depth of insertion through the cervical canal and into the uterine cavity.
Before Placement
- Make sure that the patient is an appropriate candidate for IUB™ and that she has read the Patient information leaflet.
- Exclude pregnancy and confirm that there are no other contraindications to the use of the IUB™.
- Follow the insertion instructions exactly as described in order to ensure proper placement of the IUB™.
- Insertion may be associated with some pain and/or bleeding or vasovagal reactions. Use of an analgesic before insertion is at the discretion of the patient and the clinician.
- Establish the size and position of the uterus by pelvic examination.
- Insert a speculum and cleanse the vagina and cervix with an antiseptic solution.
- Application of a tenaculum to the cervix is optional for gentle traction of the cervical canal to align it with the uterine cavity.
- Gently insert a sterile sound. Measure the depth of the uterine cavity in centimetres, check the patency of the cervix, confirm cavity direction and detect the presence of any uterine anomaly.
- The uterus should sound to a depth of 6 to 9 cm except when inserting the IUB™ immediately post-abortion or post-partum. Insertion of the IUB™ into a uterine cavity measuring less than 6 cm may increase the incidence of expulsion, bleeding, pain, and perforation.
- If you encounter cervical stenosis, avoid undue force. Dilators may be helpful in this situation.
Proceed with insertion only after completing the above steps and ascertaining that the patient is appropriate for the IUB™. Ensure use of aseptic technique throughout the entire procedure.
How to Place the IUB™
STEPS A & B
Open the sterile package; Use the flange to mark on the insertion tube the uterine depth that you measured with the sound. Insert the push rod into the insertion tube gently -stop before the first bead to make sure not to deploy the IUBtm yet. Pass the loaded insertion tube through the cervical canal until the gauge is in touch with the cervical external os.
CAUTION: applying excess force may cause injury, perforation or bending of the insertion tube.
Pull the insertion tube back approximately 2-3 mm.
STEP C
Insert the push rod into the insertion tube and push forward in moderation to deploy the IUB™ into the uterine cavity. To ensure the IUB™ is properly positioned avoid insertion tube withdrawal before or during deployment. The push rod must be pushed fully into the insertion tube for the IUB™ to properly deploy.
STEP D
Pull out the rod fully and then gently pull out or wiggle out the insertion tube.
STEP E
Cut the threads perpendicular about 2cm out of the cervix by using a sharp, curved scissor, cutting threads at a flat angle may create sharp tips. Do not apply tension or pull on the threads when trimming to avoid IUB™ displacement.
STEP F
If you suspect that IUB™ is not in the correct position, in the center of the uterine cavity, check placement with ultrasound. Ultrasound imaging is recommended to be performed in at least two different plains. If the IUB™ is not positioned completely within the uterus, remove it and replace it with a new IUB™. Do not reinsert an expelled or partially expelled IUB™.
IUB™ insertion is now complete
PATIENT FOLLOW UP
- Following placement, examine the patient after her first menses to confirm that the IUB™ is still in place. You should be able to see or feel only the threads. If the IUB™ has been partially or completely expelled, remove it. You can place a new IUB™ if the patient desires and if she is not pregnant. Do not reinsert a used IUB™. Evaluate the patient promptly if she complains of any of the following: abdominal or pelvic pain, cramping, or tenderness; malodorous discharge, bleeding, fever or a missed period. The length of the visible threads may change with time. However, no action is needed unless you suspect partial expulsion, perforation, or pregnancy.
- If you cannot find the threads in the vagina, check that the IUB™ is still in the uterus. The threads can retract into the uterus or break, or the IUB™ may have perforated the uterus or expelled. Radiography or sonography may be required to locate the IUB™. If there is evidence of partial expulsion, perforation or breakage, remove the IUB™.
How to Remove the IUB™
The IUB™ should not remain in the uterus for more than 5 years.
- Prepare sterile gloves and sterile forceps. Remove the IUB™ with forceps, pulling gently on the exposed threads.
- Inspect to assure the integrity of the IUB™, specifically to the presence the leading and trailing copper balls (see image below).
- In case of absence of visible threads or breakage of the IUB™ removal can be difficult. Analgesia and cervical dilation may assist in removing the IUB™. An alligator forceps or other grasping instrument may be helpful. Hysteroscopy may also be helpful.
You may immediately insert a new IUB™ if the patient requests so and has no contraindications.
Ultrasound Guide
ULTRASOUND GUIDANCE WEBINAR
Reference
1. Ballerine IFU
2. Baram, I. and A. Weinstein, 2016.