What does this article add?
As demonstrated by our observational study, this may partly be due to a
lack of awareness amongst surgeons of the contents of these products,
highlighting a need for increased education.
The authors recommend that the use of biological products should be
added to a surgical consent, allowing surgeons to have an open and
transparent discussion, whilst upholding their duty to ensure that their
clinical practice is patient centred.
INTRODUCTION: Global medical advances within the field of healthcare have
subsequently led to the widespread introduction of biological products.
Medication, dressings, implants and tissue grafts derived from human or
animal material have become part of routine
practice.11Jolly, K.,
Darr, A., Aslanidou, A., Bowyer, D., & Ahmed, S. (2019). The
intra‐operative use of biological products: A multi‐centre regional
patient perspective of a potential consenting conundrum. Clinical
Otolaryngology. doi:10.1111/coa.13367 Although these products have
been used by doctors for many decades, this subject is frequently not
discussed during the consent process and remains a controversial
topic.22Enoch, S., Shaaban, H., Dunn, KW. (2005). Informed
consent should be obtained from patients to use products (skin
substitutes) and dressings containing biological material. Journal of
Medical Ethics, 31(1), 2–6. doi:10.1136/jme.2003.005272 ,33Eriksson,
A., Burcharth, J. & Rosenberg, J. Animal derived products may
conflict with religious patients’ beliefs. BMC Med
Ethics 14, 48 (2013).
https://doi.org/10.1186/1472-6939-14-48 The majority of
biological materials used intra-operatively in modern surgery contain
porcine or bovine derivatives, the most common of which is
gelatin.1 Gelatin is found in collagen extracted from
dermal and skeletal structures of cows (bovine) and pigs (porcine). The
use of gelatin has been evaluated by different faith groups, however
general consensus remains a contentious issue.3
Broadly speaking biological materials can be divided into three main
categories based upon their primary use: grafts, haemostats, and
sealants (Table 1). The evolution of new surgical techniques has been
facilitated by the development of a range of materials used as grafts
and sealants to repair defects and promote wound healing, as well as
haemostats to stop bleeding and reduce infection. Consideration is
required with their use to ensure that it does not conflict with the
patient’s ethical, personal, or religious beliefs. It has been
documented that Buddhists, Christians (including of Jehovah’s witnesses)
and Jews accept the use of dressings, implants or medication which are
of animal or human origin.3 Amongst other faiths,
Hindus and Sikhs do not permit the use of any products derived from
bovine material3,44Sattar,
S. P., Ahmed, M. S., Majeed, F., & Petty, F. (2004). Inert
Medication Ingredients Causing Nonadherence Due to Religious Beliefs.
Annals of Pharmacotherapy, 38(4), 621–624. doi:10.1345/aph.1d324 ,
and Muslims object to the use of porcine-derived materials. However, in
general, most faiths agree that in an emergency life-threatening
situation the use of any product biological or otherwise is
permitted.55Easterbrook, C. (2008). Porcine and Bovine
Surgical Products. Archives of Surgery, 143(4), 366.doi:10.1001/archsurg.143.4.366 The major exception to this is in the
Jehovah’s witness community where it is strictly forbidden to receive
primary human blood components (red blood cells, plasma,
platelets)1, however the use of human-derived mesh is
unclear.66Dixon JL, Smalley MG. Jehova’s Witnesses: the
surgical/ethical challenge. JAMA 1981;246:2471–2472. A recent study
demonstrated that in 534 patient respondents, 44% wanted to be informed
if biological products were to be used and 17% objected to their use.
The reason for objection was multifactorial and often not motivated by
religious beliefs.1
Owing to the routine use of biological products in surgical practice and
patient’s stated desire to be informed if this is to be the case, it is
essential that this forms part of the consent process. Anecdotally the
authors found that the use of these products are not routinely being
discussed pre-operatively with patients in the United Kingdom (UK); we
believe that may partially be due to a lack of knowledge of the
constituents of biological materials by the clinician.
We sought to investigate on a national scale what proportion of surgeons
from a range of specialties routinely consent for the intra-operative
use of biological materials, whilst assessing awareness of these
products and their derivatives. We hope this study will strengthen and
support our belief that informed consent for the use of biological
products intra-operatively should be added to the standard consent form
template for all surgery.