Ethical Issues Associated With the Introduction
of New Surgical Devices, or Just Because We
Can, Doesn’t Mean We Should
Sue Ross, BSc, MPhil, PhD, MBA,1,2,3 Magali Robert, BSc, MD,1,4 Marie-Andrée Harvey, MD, MSc,5
Scott Farrell, BA, BEd, MD, FRCSC,6 Jane Schulz, MD,7 David Wilkie, MD,8 Danny Lovatsis, BSc, MD, MSc,9
Annette Epp, MD,10 Bill Easton, BA, BSc, MD, FRCSC, FACOG, FSOGC,11 Barry McMillan, MD,12
Joyce Schachter, MD,13 Chander Gupta, MD,14 Charles Weijer, MD, PhD15,16
1Department of Obstetrics and Gynaecology, University of Calgary, Calgary AB
2Department of Family Medicine, University of Calgary, Calgary AB
3Department of Community Health Sciences, University of Calgary, Calgary AB
4Division of Pelvic Floor Disorders and Reconstructive Surgery, Department of Obstetrics and Gynaecology, University of Calgary, Calgary AB
5Department of Obstetrics and Gynaecology, Queen’s University, Kingston ON
6Department of Obstetrics and Gynaecology, Dalhousie University, Halifax NS
7Department of Obstetrics and Gynecology, University of Alberta, Edmonton AB
8Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver BC
9Division of Urogynaecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynaecology, Mount Sinai Hospital and
University of Toronto, Toronto ON
10Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Medicine, University of
Saskachewan, Saskatoon SK
11Division of Urogynaecology, Department of Obstetrics and Gynaecology, University of Toronto, Toronto ON
12Department of Obstetrics and Gynaecology, University of Western Ontario, London ON
13Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, University of Ottawa, Ottawa ON
14Department of Obstetrics, Gynaecology, and Reproductive Sciences, University of Manitoba, Winnipeg MB
15Department of Philosophy, University of Western Ontario, London ON
16Department of Medicine, University of Western Ontario, London ON
physicians in appropriate studies before releasing new products
and should make balanced presentations of all the available
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
Surgeons should, before using a new surgical device, assess the
surgical devices from the perspectives of the six groups most
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
Health Canada, which is responsible for licensing new surgical
evidence and inform them about possible complications and the
devices, should amend their requirements to include rigorous
surgeon’s level of experience with the new device,
clinical trials that provide data on effectiveness and safety for each
new product before it is marketed.
Patients, who should be given an honest evaluation of the available
evidence, possible complications, and the surgeon’s experience,
Industry should comply with all Health Canada requirements to
should be encouraged to evaluate the evidence and information to
obtain licenses for new products. Until Health Canada requires
their own satisfaction to ensure that fully informed consent is
effectiveness and safety data, industry should cooperate with
Health institutions, responsible for regulating practice within their
Key Words: Surgical devices, ethics, safety, effectiveness,
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
Competing Interests: See Acknowledgements.
competent in the new technology.
Received on September 19, 2007
Professional societies should provide guidance on the early
Accepted on November 21, 2007
adoption of new surgical devices and technologies.
l JUNE JOGC JUIN 2008
Ethical Issues Associated With the Introduction of New Surgical Devices
We urge all those involved in the development, licensing, and use
of new surgical devices to aim for higher ethical standards to
As a group of individuals working together to develop
protect the health and safety of patients requiring surgery. The
clinical practice guidelines in urogynaecology, we are
lowest acceptable ethical standard would require device
concerned that new surgical devices are being marketed
manufacturers to provide surgeons with accurate and timely
information on the efficacy and safety of their products, allowing
without sufficient evidence of effectiveness and safety. Our
surgeons and patients to evaluate the evidence (and the
primary area of interest is urogynaecology, and the exam-
significance of information not yet available) before surgery.
ples we use in this paper relate to the surgical management
of urinary incontinence; however, the ethical issues we dis-
cuss are common to the introduction of any new device into
Les instruments chirurgicaux sont souvent mis sur le marché avant
l’obtention de données fiables quant à leur innocuité et à leur
efficacité. Notre article traite des questions éthiques associées à
A recent editorial by Ostergard discussed the dangers of
la mise en marché précoce et à l’utilisation des nouveaux
instruments chirurgicaux du point de vue des six groupes les plus
early adoption of new surgical products, highlighting as an
example the release of a new tension-free vaginal tape
device for the surgical treatment of stress urinary inconti-
Santé Canada, qui est responsable de l’autorisation des nouveaux
instruments chirurgicaux, devrait modifier ses exigences afin d’y
nence.1 The device was initially released in Canada in Sep-
inclure la tenue d’essais cliniques rigoureux permettant l’obtention
tember 2006 before it had ever been used in a patient.1 In its
de données sur l’efficacité et l’innocuité de chaque nouveau
device brochure, the manufacturer quoted evidence from
produit avant sa mise en marché.
other similar devices they make to treat urinary inconti-
L’industrie devrait se plier à toutes les exigences de Santé Canada
nence and “data on file” from animal and cadaver studies.2
en ce qui a trait à l’autorisation des nouveaux produits. Jusqu’à ce
que Santé Canada en vienne à exiger des données sur l’efficacité
The manufacturer met all the requirements of the licensing
et l’innocuité, l’industrie devrait collaborer avec les médecins,
authority before marketing this product, although it was
dans le cadre d’études appropriées avant de lancer de nouveaux
unclear why there was so little information from human
produits, et présenter de façon équilibrée toutes les données
studies specific to this new device.
Les chirurgiens devraient, avant d’utiliser un nouvel instrument
As of September 2007, in Canada 34 trained clinicians
chirurgical, évaluer les données disponibles sur son efficacité et
(urogynaecologists, urologists, and gynaecologists) had
son innocuité, et s’assurer de disposer de la formation et des
implanted 1021 of these devices. (Personal communication,
compétences nécessaires. Les chirurgiens devraient offrir à leurs
patientes une évaluation des données disponibles et les aviser
Johnson & Johnson, 7 August 2007.) Evidence of cure rates
des complications possibles et de leur expérience quant à
is beginning to emerge, suggesting that use of the device is
l’utilisation du nouvel instrument en question.
more difficult to learn than initially predicted3–8 and that
Les patientes, qui devraient bénéficier d’une évaluation honnête des
highly specialized training is required.
données disponibles, des complications possibles et de
l’expérience du chirurgien, devraient être incitées à évaluer les
We are concerned that such activity heralds a trend towards
données et les renseignements jusqu’à ce qu’elles soient
earlier, and possibly premature, marketing of surgical
satisfaites, et ce, afin d’assurer l’obtention d’un consentement
devices. Six parties are involved in early marketing and
adoption of surgical devices.
Les établissements de santé, responsables de la réglementation
de la pratique en leur sein, devraient analyser les nouveaux
• Health Canada licenses products for use in Canada.
instruments afin d’en déterminer l’innocuité, l’efficacité et les
• Industry manufactures and markets new products.
répercussions économiques avant d’en permettre l’utilisation. Ils
devraient également limiter l’utilisation des nouveaux instruments
• Surgeons adopt new devices.
chirurgicaux aux chirurgiens formés et compétents quant à
• Patients receive new devices as part of surgical
Les sociétés professionnelles devraient fournir des lignes
• Health institutions are responsible for regulating
directrices au moment de l’entrée en jeu des nouvelles
practice within their walls.
technologies et des nouveaux instruments chirurgicaux.
• Professional bodies may provide guidance on the
Nous incitons toutes les parties intéressées au développement, à
early adoption of new surgical devices.
l’autorisation et à l’utilisation des nouveaux instruments
chirurgicaux à viser l’atteinte de normes éthiques accrues, afin de
protéger la santé et d’assurer la sécurité des patientes nécessitant
une chirurgie. La norme éthique minimalement acceptable
contraindrait les fabricants à fournir aux chirurgiens des
Four medical ethics principles are relevant to a discussion
renseignements précis et opportuns sur l’efficacité et l’innocuité
about the introduction of new surgical devices.9
de leurs produits, ce qui permettrait aux chirurgiens et à leurs
patientes d’évaluer les données disponibles (et l’importance des
refers to the clinician’s obligation to
données non encore disponibles) avant la chirurgie.
provide benefit (effective treatments) to their patients.
• Non-maleficence denotes the obligation to avoid
J Obstet Gynaecol Can 2008;30(6):508–513
harm by providing safe treatments.
JUNE JOGC JUIN 2008 l
• Autonomy in this context means the patient’s right
changing FDA requirements.1 Guidelines have suggested
and ability to make an informed choice about whether
that regulatory bodies require minimum standards for
to have a particular procedure.
data14 instead of accepting manufacturers’ statements of
• Justice may be interpreted as the equal and fair
expected (versus actual) benefits.15
availability of safe treatments for patients in similar
There is growing evidence that manufacturers can and do
circumstances, and it is also relevant to responsible
influence research findings and how they are published.16,17
stewardship of resources and compensation for patient
Thus there is also a need for independent research. It is
encouraging to note that industry is beginning to support
In the discussion that follows, we examine the roles of the
such research: for example, Boston Scientific and Johnson
six key parties in light of the ethical issues associated with
and Johnson have provided grant-in-aid funding for inde-
the adoption of new surgical devices. We do not consider
pendent clinical trials. Unfortunately, designing and carry-
the development and testing of new devices or the role of
ing out rigorous randomized trials is complex and costly.12
the six parties in that context.
Such trials may also prove difficult to undertake after
devices have been widely marketed, because surgeons may
consider it unethical to withhold accepted devices.18
In Canada, licensing of medical devices is governed by the
Trials conducted after favourable initial reports sometimes
Health Canada Therapeutic Products Division Medical
show less benefit than predicted, or even show harm15; later
Device Regulatory Framework.10 The framework classes
trials may lead to denunciation of a device after its earlier
medical devices according to level of risk (based on
widespread clinical use.18,19
invasiveness) and describes the types of information
required. For devices of moderate risk (including
The imperative of industry is to satisfy company owners
urogynaecology mesh devices), manufacturers must pro-
and shareholders by seeking market share and financial suc-
vide detailed information about the medical condition the
cess. While this may be the primary motivation, no com-
device is intended to treat, the device itself, and the manu-
pany will consciously ignore patient safety and satisfaction,
facturer, including design philosophy, marketing history,
but will rely upon regulatory authorities to build sufficient
and manufacturing standards. A summary of safety and
safeguards into the regulations. In order to meet the ethical
effectiveness studies is also needed,10 although detailed
obligations of beneficence and non-maleficence industry
investigation is not required.11 Additional safety or effec-
should be prepared to cooperate with physicians in the
tiveness evidence is not required to license new “family
appropriate study of their products before releasing them
members” (devices made by the same manufacturer for the
for general use, and to make balanced presentations of the
same intended use10) over that provided for the first device
in the family. It is notable that practising clinicians may
assume that a device approved by Health Canada has met
rigorous criteria,12 but clinicians are not permitted to review
Physicians desire to introduce new technologies for many
confidential evidence provided to Health Canada.
reasons. Of utmost importance is benefit for patients. Sur-
geons expect that new surgical procedures will be effective,
Health Canada, the licensing agency, is responsible for
and that they will be safer for patients and less costly than
ensuring that surgeons have timely access to approved
established procedures.15,19 Surgeons may also be prompted
devices for surgical procedures. It appears that Health
by self-interested desires to learn new techniques, be leaders
Canada is failing in ethical roles of beneficence and
in their field, be reimbursed at an enhanced level,15 or main-
non-maleficence by failing to ensure that new devices are
tain “market share” of patients.13 New procedures requiring
effective and safe.
medical devices are appealing because they tend to be less
invasive and are claimed to have shorter operative times.
The apparent ease of use may lead to adoption by less
Industry should comply with all requirements to obtain
product licenses. Unless directed to provide effectiveness,
safety, and economic data, device manufacturers are
As stressed in a recent AJOG editorial,19 and the ACOG
unlikely to carry out expensive clinical trials, which delay the
Committee on Ethics statement,20 surgeons should insist
release and increase the cost of new products.13 A first step
on the best level of evidence to guide clinical choices, rather
towards higher standards would be to petition Health
than allow themselves to be persuaded by the intensive pro-
Canada to enforce more stringent regulations requiring
motion of new products and fears of being left behind their
complete clinical and economic evidence before the release
peers. Unfortunately, newer industry-driven procedures
of new devices. Similar suggestions have been proposed for
may not offer improvements over more established
l JUNE JOGC JUIN 2008
Ethical Issues Associated With the Introduction of New Surgical Devices
procedures,15,20 and premature adoption may compromise
• surgeons should independently evaluate all available
the ability to determine device effectiveness and safety.17,20
The ACOG statement advised clinicians not to adopt new
• surgeons should ensure they are adequately trained to
treatments until evidence is available from rigorous ran-
use the device;
domized clinical trials.20
• surgeons should provide the patient with an honest
According to the principles of beneficence and non-
evaluation of the available evidence and address the
maleficence, surgeons should provide benefit to patients,
suitability of the device for treating that patient;
while avoiding harm. Ultimately, individual surgeons are
• patients should evaluate the evidence to their own
responsible for setting their own standards when introduc-
satisfaction before consenting to have the procedure
ing new technologies.21 Surgeons should assess (independ-
ent of marketing claims or industry training22) the evidence
The medical system, which includes all of the parties dis-
on effectiveness and safety of the treatment and their own
cussed earlier, should ensure that each of these criteria is
competence in its use. If surgeons have doubts about either
fulfilled to ensure that patients can truly give informed
aspect, they should not use the new treatment.21
Patients trust surgeons to possess all the information neces-
sary for their best care, and they expect to be given all avail-
There are clear ethical roles for institutions (such as health
able facts in order to give informed consent.1,20 Ethical prin-
authorities and hospitals), in the introduction of new tech-
ciples mandate that surgeons should be scrupulously honest
nologies21 First, institutions should ensure that patients
in providing full information on the effectiveness, safety,
receive effective and safe treatments (beneficence and
and rates of complications of the proposed treatment.23
non-maleficence). Many hospitals and health authorities
They should provide the same information about any other
review the introduction of new technologies; however, the
appropriate treatments, acknowledge any lack of evidence
quality of the review process has been questioned in some
about the new device, and be open about their own level of
institutions because of lack of standardization.12 In addi-
experience with that device.13,19 The ideal method for
tion, good evaluation of new technologies requires careful
surgeons to discharge the duty of disclosure is currently
review of published literature.27 If such evidence is not
available, institutions should refuse to allow the use of the
The early adoption into clinical practice of new devices with
new technology. If institutions rely on physician request
no or limited evidence of safety or effectiveness may mean
rather than careful evaluation of evidence, they will be open
that patients do not receive a reasonably expected standard
to criticism for failing to fulfil their responsibilities12,21 As a
of care in particular circumstances.25 As final arbiters of the
further safeguard, institutions should consider limiting the
introduction of new medical devices, physicians carry the
use of new devices to named surgeons who are
greatest moral and ethical responsibility.
The ethical principle of justice means ensuring both the
equitable availability of treatments and the responsible
Patients are sometimes criticized for driving the demand for
stewardship of resources. Health institutions should con-
new surgical techniques.15 They are particularly at risk
sider their full range of patients, not only urogynaecology
because of their readiness to seek a cure for their condi-
patients. Inevitably, economic issues sometimes cause insti-
tion26 and their sometimes misplaced belief that new must
tutions to apply arbitrary quotas as a result of constrained
be better.13 Patients are the most vulnerable of the parties
budgets. Sometimes newer devices are marketed at higher
involved in the introduction of new medical devices; it is
prices than standard devices, without supporting evidence
they who suffer the consequences of a new device used
of health care savings. Thus the principle of justice, ensur-
inappropriately or by an inadequately trained surgeon.
ing that the medical needs of all patient groups are given
Therefore it is clear that the surgeon should provide a bal-
equal consideration, may prevent some patients from
anced presentation of information to ensure that patients
having a particular new device.
are truly informed before consenting to the use of a new
device13,15,20 The surgeon should bear in mind that patients
may be unable to fully evaluate the quality of evidence.26
Professional societies such as SOGC endeavour to take
In order that the patient’s autonomy is not compromised in
responsibility by providing guidance on a wide range of
issues. Among the concerns of SOGC is the ethical intro-
• industry should provide adequate and honest evidence
duction of new medical treatments and surgical devices.
of safety and effectiveness;
SOGC has developed training standards for laparoscopic
JUNE JOGC JUIN 2008 l
surgery and has endeavoured through CME programs to
surgeons are trained and competent in their use, and inform
provide training in new technologies that does not rely on
patients candidly about the available information, the expe-
industry.19 ACOG has developed specific guidelines on eth-
rience of their surgeon, and other available treatments.
ics and innovative practice.20 Such initiatives will only affect
the practice of surgeons affiliated with professional
Professor Sue Ross has received grants in aid from Boston
Professional societies have an important role in highlighting
Scientific and Johnson & Johnson as contributors towards
the ethical issues surrounding the introduction of new tech-
evaluations of surgical devices. Dr Wilkie has spoken at
nologies and encouraging all members to undertake rele-
meetings with sponsorship from Pfizer, and he has received
vant ethics education.21
honoraria for teaching and grants-in-aid from Johnson &
Johnson, AMS, and Boston Scientific. Dr Jane Schulz is a
consultant for Pfizer, Astellas, Triton, Paladin, and
Gynecare, and she has participated in industry-funded trials
Most people assume that the standard of evidence required
of Pfizer, Purdue, Gynecare, and Astellas. Dr Chanda
for new surgical devices is similar to that required for new
Gupta received financial support for the original work on
pharmaceutical products and that any surgical device
TVT surgeries in 2000, and support from Johnson and
licensed in Canada must be safe for human use. As things
Johnson for an ovarian cancer fundraising event.
currently stand, this assumption is not justified.
The early marketing and adoption of surgical devices brings
potential hazards for patients and surgeons.19 We urgently
need new Canadian standards to ensure full disclosure to
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