More than 500 adverse events related to medical devices have been reported in India in 2018, The Indian Express reported on Monday as part of the International Consortium of Investigative Journalists’ investigation into the global medical devices industry.
A year-long investigation by the consortium and its media partners in 36 countries scrutinised all devices used in medical procedures. The result is a series of reports called the Implant Files, which the consortium and its partners began publishing on Sunday evening.
A medical device adverse event, or MDAE, report marks the first stage to ascertain whether a medical device is defective and can possibly result in commercial recall. India started reporting MDAEs only in 2014, when 40 events were recorded. These events are still not made public, though there have been 556 MDAEs reported this year. The incidents are recorded by 13 medical device adverse event monitoring centres across the country and reports compiled from the data are maintained by the Indian Pharmacopoeia Commission, which is an autonomous institution under the health ministry.
Of the 556 MDAEs reported this year, about a dozen are deaths after stent implants, The Indian Express found. Since 2014, as many as 903 adverse events have been reported, the report said. Of this, 325 are linked to cardiac stents, 145 to orthopaedic implants, 83 to intrauterine contraceptive devices, 58 to intravenous cannulas, 21 to catheters, and 271 adverse events of various other medical devices.
India’s medical devices market is worth Rs 35,000 crore and imported devices account for 70% of medical devices sold.
Abbott, the world’s leading manufacturer for drug-eluting stents, with a 40% share of the Indian cardiac stent market, was linked to as many as 290 of the 556 medical device adverse events for 2018. The vast majority were for its top-selling Xience Prime, Xience Xpedition and Xience Alpine drug-eluting coronary stents. Of the 13 cases of death in the 2018 reports, only one case was not linked to a drug-eluting stent manufactured by Abbott.
The Indian Express noted that in many cases, there was a mention of blood vessels getting dissected after a stent was placed and a few cases mentioned stent thrombosis (when a stented artery shuts due to a blood clot) or narrowing. However, the final conclusions varied from the “adverse event” either being caused or not caused by the device, incomplete investigations or the cause of death not being provided.
An Abbott spokesperson told The Indian Express that their Xience series of stents are recognised as the “gold standard and are among the world’s most used and studied stents with an unparalleled safety record”.
German pharmaceutical major Bayer AG was named in 36 MDAE reports, mostly for its hormone-releasing intra-uterine device called Merina recommended by gynaecologists across India for birth-control or for reducing heavy menstrual and uterine bleeding. The reports either observed that the complaint is one of expulsion of the device within a few days or that the device caused vaginal or uterine bleeding or genital haemorrhage.
“The reported adverse events for Mirena have been already listed in the prescribing information among the common reactions following an insertion,” Bayer told The Indian Express in a statement. “Mirena should only be prescribed after full discussion and evaluation of all contraceptive options has been made.”
Dr S Eswara Reddy, who heads the Central Drugs Standard Control Organisation, which regulates pharmaceuticals and medical devices, told The Indian Express that they were yet to be informed by the Indian Pharmacopoeia Commission about any patterns from the adverse events received.