Intrauterine devices or IUDs rank second, behind coronary stents, in the adverse event report list of medical devices for 2018 which is being compiled and analysed by the Indian Pharmacopoeia Commission (IPC).
Of the 556 adverse event reports logged this year, there are 36 for devices manufactured by German pharmaceutical major Bayer, and they are all for Mirena, the hormone-releasing IUD commonly recommended by gynaecologists across India for birth-control or for reducing heavy menstrual and uterine bleeding. The side-effects of Mirena have been the subject of several studies, including those by the US Food and Drug Administration, as well as lawsuits in several countries.
Of the 468 MDAE (medical device adverse event) reports for 2018, at least 26 have been filed for Bayer’s Mirena coils.
The number of MDAEs is in fact higher because IPC scientists said they first began monitoring the side-effects of the IUDs as part of their partnership with the World Health Organisation (WHO) and the Uppsala Monitoring Centre (UMC), a Sweden-based independent foundation involved in drug monitoring in several countries including India.
This was till 2017-end when IUDs were still included in the list of “drugs” and, therefore, under the ambit of the 1940 Drugs and Cosmetics Act. From 2018, IUDs came under the ambit of the new Medical Device Rules and their adverse event reports have been logged under the Materiovigilance Programme (MvPI) of the IPC.
Scientists at the IPC told The Indian Express that they have been receiving approximately 10 adverse event reports related to the Mirena IUD every month. Thus, while several of the almost-identical reports have earlier been fed into a separate database for the UMC programmes, they now also figure in the IPC’s main database along with other medical devices.
Each report has either of these observations: the complaint is one of “expulsion” within a few days (the IUD is supposed to be explanted after five years) or has caused vaginal/uterine bleeding or genital haemorrhage.
The reports are for women as young as 28 years and the “expulsion” of the Mirena IUD has been reported, at the earliest, after four days of implantation, and the longest after eight months. There are other cases where genital haemorrhage following Mirena coil insertion have been reported as an MDAE with the IPC.
The MDAE reports do not, however, identify the patient or the place of occurrence. Following one case of expulsion, for instance, it noted, “the relationship of the expulsion of the device to treatment with Mirena was not reported…”
A statement from Bayer on the large number of adverse events connected to the IUD noted, “Mirena is marketed in 117 countries and is approved in India for contraception, menorrhagia and endometrial hyperplasia during estrogen replacement therapy in women. The reported adverse events for Mirena have been already listed in the prescribing information among the common reactions following an insertion.”
“Bayer routinely conducts numerous scientific activities aimed at increasing physician awareness to proper use of Mirena as well as providing repeated insertion trainings to the healthcare professionals. They are advised to refer to the prescribing information and accordingly prescribe Mirena based on a comprehensive evaluation of the benefits and risks for the individual woman. All contraceptive options should be discussed with a woman so that an informed decision can be made. Mirena should only be prescribed after full discussion and evaluation of all contraceptive options has been made,” it stated.