Pessary management for pelvic organ prolapse: a review of clinical practice and Australian medical device regulations

Abstract

Pelvic organ prolapse affects up to 50% of women throughout life. Management can be conservative or surgical. Pessaries have become an integral component to management of pelvic organ prolapse, providing symptom improvement and enhancing quality of life. After careful clinical assessment, women choosing pessary management are offered either self-care or clinician-based pessary care. Pessary care can be offered by a range of clinicians, including doctors, nurses and physiotherapists. In this article we review the literature on the historical use of pessaries and how they have changed to be the device manufactured today. We then outline the Australian regulation of vaginal pessaries as per the Therapeutic Goods Administration (TGA). We discuss device classification in relation to clinical practice and guidelines. The TGA classifies pessary devices as either Class 1: device which is intended for transient use, Class 2A: to be used continuously for at least 60 minutes but not more than 30 days, and Class 2B: continuous use for more than 30 days. The majority of pessaries available in Australia are classified as 2A devices. The TGA classification of pessaries and commonly accepted standards of care in many Australian centres are not always synergistic. In Australia, varied models of care are offered for pessary management. Recent literature has identified a need for clinician guidelines and training for pessary care. The TGA device classification should be considered in Australian training and guidelines. Information on TGA device classification needs to be discussed with each patient that is offered pessary management. If 2A pessaries are used in conjunction with clinical led care, it is unlikely that the device will be removed every 30 days. Therefore, 2A devices may be used off-label and the patient should be informed of this deviation from the regulation.