Flexi-T Safety and Efficacy
Flexi-T Pearl Index Measurement
The cumulative Pearl Index for the Flexi-T 300:
- First year 1.5
- Second year 1.9
- Third year 2.5
- Yearly average of 0.8/0.9
The Flexi-T+ 300 performs in the same way as the 300– both have 300mm² of copper. The Flexi-T+ 380 performs like all other 380 IUDs and has a Pearl Index of 0.4 – 0.7 on a yearly basis. The Pearl Index of a 300 will differ maximum 0.5 from +380. All Flexi-T models remain effective up to five years after being fitted.
About the Copper in Flexi-T
Basically, there is a copper release in the womb. Copper ions demobilize sperms and stops sperm from fertilizing the egg. This means the higher the copper load, the more effective it is. The negative side effect is that more copper can cause heavier bleeding. As such, women who already suffer heavy bleeding during menstruation should be advised to choose a model with a lower copper load (i.e. the 300) 380mm² is the maximum allowed loading for a copper IUD. For this reason, Prosan has the Flexi-T+ 300 and the Flexi-T+ 380. Both with the same size body (for multiparous women) however with choice in copper content. Most other IUDs are limited to 380mm².
Difference between Flexi-T and Comparative Models
There is a real difference between these IUD types, not just the insertion method. The Flexi-T’s size and shape result from extensive in-vivo longitudinal research and measurements. The result is:
- Flexi-T’s are more flexible than comparative models.
- Flexi-T’s are fundus-seeking. This in combination with the slightly smaller size of the Flexi-T’s result in the particular ease of insertion and removal and a minimal incidence of unwanted side effects like additional bleeding and pain.
- Risk of perforation for Flexi-T IUDs are much lower than chances of perforation when using an IUD with a plunger system.
- Unlike other IUD models, the Flexi-T has an integrated single thread while the others use the common double thread knotted at the bottom of the IUD. The advantage of the Flexi-T “single thread without a knot” construction is that it prevents the creep of bacteria up the threads by capillary action, and the subsequent nestling thereof in the knot at the base of the IUD. This decreases the risk of pelvic infections.