CURRENT ADR NETWORK REPORT
Intrauterine devices: caution - risk of breakage
Four years after having it fitted, a 31-year-old woman had her copper coil removed (GYNELOD 375 [no longer on the market in Germany], among others). Removal was easy, with no resistance. Inspection of the T-shaped intrauterine device (IUD) revealed that one of the small crossarms was missing. Although sonography allowed location within the uterus, the fragment could not be retrieved. It was ejected spontaneously during menstrual bleeding (NETZWERK report 17.568). Another doctor reported that the removal threads broke at the point where they are joined to the copper IUD. The contraceptive had to be removed surgically (12.915). Breakage of copper coils has also been described in the literature (1-3). Moreover, the Netherlands pharmacovigilance centre Lareb is currently warning of the breakage of the levonorgestrel-releasing IUD, MIRENA. Since September 2011, the centre has received 24 reports related to this. Seventeen of these describe further complications, such as uterine perforation, attachment to the uterine wall and difficulties when fitting the device, which may have favoured breakage. In some women, the recommended duration of use (five years) was exceeded. In some cases, the removal of a fragmented hormone-releasing coil required surgical intervention (4). In contrast to prescribing informations in the US (5,6), German Summaries of Product Characteristics (SPCs) for levonorgestrel-releasing IUDs do not explicitly refer to the breakage risk of intrauterine devices. They merely advise that the coil's integrity should be checked following its removal (7). Conversely, SPCs for some copper coils in Germany also provide the information that fragments of an IUDs may be left behind after removal (8). In the interest of informed consent, we believe it is necessary to advise patients of the breakage risk and the possible consequences associated with this prior to fitting an IUD.
| 1 | MOHANTY, K.: Int. J. STD AIDS 2009; 20: 512-4 |
| 2 | BLAAUWHOF, P.C., GOLDSTUCK, N.D.: Adv. Contracept. 1988; 4: 217-20 |
| 3 | GRIFFITHS, M.: J. Obstet. Gynaecol. (Lahore) 1989; 9: 256-7 |
| 4 | Lareb: Intrauterine device with levonorgestrel MIRENA and device breakage; August 2018; http://www.a-turl.de/?k=amdo |
| 5 | e.g. Bayer: US-Prescribing information MIRENA, as at June 2017; http://www.a-turl.de/?k=oitz |
| 6 | Teva: US-Prescribing information PARAGARD T380A, as at June 2013; http://www.a-turl.de/?k=erlt |
| 7 | e.g. Jenapharm: SPC MIRENA, as at June 2018 |
| 8 | e.g. Hexal: SPC FEMENA CU 375, as at Dec 2017 |
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