Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn't mean we should.
Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate with physicians in appropriate studies before releasing new products and should make balanced presentations of all the available evidence. Surgeons should, before using a new surgical device, assess the evidence on its effectiveness and safety and ensure they are properly trained and competent in using the device. Surgeons should provide their patients with an evaluation of the available evidence and inform them about possible complications and the surgeon's level of experience with the new device. Patients, who should be given an honest evaluation of the available evidence, possible complications, and the surgeon's experience, should be encouraged to evaluate the evidence and information to their own satisfaction to ensure that fully informed consent is given. Health institutions, responsible for regulating practice within their walls, should review new devices for safety, effectiveness, and economic impacts, before allowing their use. They should also limit the use of new surgical devices to surgeons trained and competent in the new technology. Professional societies should provide guidance on the early adoption of new surgical devices and technologies. We urge all those involved in the development, licensing, and use of new surgical devices to aim for higher ethical standards to protect the health and safety of patients requiring surgery. The lowest acceptable ethical standard would require device manufacturers to provide surgeons with accurate and timely information on the efficacy and safety of their products, allowing surgeons and patients to evaluate the evidence (and the significance of information not yet available) before surgery.
Ross
Sue
S
Department of Obstetrics and Gynaecology, University of Calgary, Calgary AB; Department of Family Medicine, University of Calgary, Calgary AB; Department of Community Health Sciences, University of Calgary, Calgary AB.
Robert
Magali
M
Department of Obstetrics and Gynaecology, University of Calgary, Calgary AB; Division of Pelvic Floor Disorders and Reconstructive Surgery, Department of Obstetrics and Gynaecology, University of Calgary, Calgary AB.
Harvey
Marie-Andrée
MA
Department of Obstetrics and Gynaecology, Queen's University, Kingston ON.
Farrell
Scott
S
Department of Obstetrics and Gynaecology, Dalhousie University, Halifax NS.
Schulz
Jane
J
Department of Obstetrics and Gynecology, University of Alberta, Edmonton AB.
Wilkie
David
D
Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver BC.
Lovatsis
Danny
D
Division of Urogynaecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynaecology, Mount Sinai Hospital and University of Toronto, Toronto ON.
Epp
Annette
A
Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Medicine, University of Saskachewan, Saskatoon SK.
Easton
Bill
B
Division of Urogynaecology, Department of Obstetrics and Gynaecology, University of Toronto, Toronto ON.
McMillan
Barry
B
Department of Obstetrics and Gynaecology, University of Western Ontario, London ON.
Schachter
Joyce
J
Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, University of Ottawa, Ottawa ON.
Gupta
Chander
C
Department of Obstetrics, Gynaecology, and Reproductive Sciences, University of Manitoba, Winnipeg MB.
Weijer
Charles
C
Department of Philosophy, University of Western Ontario, London ON; Department of Medicine, University of Western Ontario, London ON.
D026690:Ethics, Clinical; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000941:ethics* / Q000379:methods*; D006801:Humans; D018570:Risk Assessment; D012449:Safety