Mesh News Desk, August 2, 2016 ~ The TGA (Therapeutic Goods Administration) is the Australian version of our U.S. Food and Drug Administration. The following notice was posted by the government today.
TGA urges reporting of adverse events
As part of its ongoing monitoring of the safety of urogynaecological surgical meshes, the TGA is urging consumers and health professionals to report any adverse events experienced in association with these medical devices.
The TGA believes that adverse events involving these devices are most likely under-reported and that some patients may not realise that their symptoms are associated with an adverse event.
Urogynaecological meshes (sometimes known as transvaginal meshes and supplied in a variety of forms including ‘sling’, ‘tape’, ‘ribbon’, ‘mesh’ and ‘hammock’) are used to treat a variety of conditions affecting women – most commonly pelvic organ prolapse and stress urinary incontinence. Pelvic organ prolapse occurs when a woman’s pelvic muscles weaken and the pelvic organs – including the bladder, rectum and uterus – drop into the vagina.
The TGA has been monitoring surgical meshes since 2008 and has continued to publish information for the public and health professionals.
From July 2012 to 1 June 2016, the TGA received 99 adverse events reports involving urogynaecological surgical meshes. The most frequently reported adverse events were pain and erosion.
Reports by consumers and health professionals to the TGA provide important information, building a picture of the safety profile of a product and assisting with our safety monitoring program. A list of adverse events associated with urogynaecological meshes is published in the ‘Additional information’ section below.
Consumers and health professionals are encouraged to report problems with medical devices. The most convenient method for most people to report is via the TGA’s online form(link is external). A hard-copy form can also be downloaded. Further information on what to report and how we use these reports can be found on the TGA’s Incident Reporting and Investigation Scheme (IRIS) webpage.