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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.