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Reactie Ocon fabrikant van Ballerine

Ballerine® is safe and highly effective (99%) with a side-effect profile comparable to acceptable scientific rates of traditional IUDs.

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Brief | 10-11-2021

Known and expected side-effects are stated in the IFU of all IUDs and are collected by OCON on a regular basis. In 2019 and 2020 around 8’000 Ballerine® were inserted in The Netherlands and OCON collected the following events:

Total Expulsion Pregnancy Perforation Embedment Other
Ballerine Events 266 164 22 14 3 17
Ballerine Rate 3.3% 2.0% 0.27% 0.17% 0.04% 0.21%

Traditional T-IUDs
Acceptable Scientific Rate

 5-9%1,2 1%3 0.2%4 up to 18%5
  1.  Madden et al. Association of age and parity with intrauterine device expulsion. Obstet Gynecol. 2014 Oct;124(4):718-726. doi: 10.1097/AOG.0000000000000475
  2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018680s069s070lbl.pdf
  3. Aoun et al. Effects of age, parity, and device type on complications and discontinuation of intrauterine devices. Obstet Gynecol. 2014 Mar;123(3):585-592. doi: 10.1097/AOG.0000000000000144.
  4. Bosco-Lévy et al. Safety of levonorgestrel 52 mg intrauterine system compared to copper intrauterine device: a population-based cohort study. Contraception. 2019 Jun;99(6):345-349. doi: 10.1016/j.contraception.2019.02.011. Epub 2019 Mar 12.
  5. Migration of Intrauterine Devices: Radiologic Findings and Implications for Patient Care, Hillary E. Boortz et al. Department of Radiology, University of California at Los Angeles, Ronald Reagan UCLA Medical Center, Published online 10.1148/rg.322115068

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