I would like to know how problems related to new surgical devices are recorded.
I recently had a general anaesthetic for a 10-minute procedure. When I woke up, my throat was very sore and, as the day went on, I began having trouble swallowing. As this problem persisted, I went to my GP, who asked if I had been intubated during the procedure. The hospital told me I had not. My GP then said that my problem could not be related to the anaesthetic as nothing had been put down my throat.
My problem continued for three months, during which time, I underwent a barium swallow, which showed nothing, and was later given steroids and antibiotics for a severe throat infection. By chance, a friend of mine, who is a GP, spoke to an anaesthetist who told her that, nowadays, they use something called an ‘LMA device’ (laryngeal mask device). This is inserted into the throat and inflated, and can cause pharyngeal trauma and acute pharyngeal infection. I rang the hospital and was told that this device had indeed been used on me.
What concerns me is that my GP didn’t seem to be aware of the existence of such a device, and so believed that my swallowing problems had nothing to do with the anaesthesia. Considering how many people have general anaesthesia for minor complaints, how can we know how many other people may be experiencing my kind of problems?
I have had a terrible time and would like to bring this to your attention. If I hadn’t found out about the LMA for myself, I would probably never have got to the bottom of this. Luckily, I am now slowly improving. – M. Kendall, London NW3
WDDTY replies: The preferred way to report adverse events due to devices is online via the Medicines and Healthcare products Regulatory Agency’s website (http://devices.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwSectionsMDA/Reporting+adverse+incidents?Open). Standard report forms can also be downloaded as pdfs, completed and faxed to the Adverse Incident Centre (fax: 020 7972 8109), or posted to: Adverse Incident Centre, Medicines & Healthcare products Regulatory Agency, Room 901, Hannibal House, London SE1 6TQ, or e-mailed to email@example.com