Statement of Principles concerning INCISIONAL HERNIA (Reasonable Hypothesis) (No. 73 of 2016) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986. Dated 26 August 2016 The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of: Professor Nicholas Saunders AO Chairperson Contents 1 Name 2 Commencement 3 Authority 4 Application 5 Definitions 6 Kind of injury, disease or death to which this Statement of Principles relates 7 Basis for determining the factors 8 Factors that must exist 9 Relationship to service 10 Factors referring to an injury or disease covered by another Statement of Principles Schedule 1 - Dictionary 1 Definitions 1 Name This is the Statement of Principles concerning incisional hernia (Reasonable Hypothesis) (No. 73 of 2016). 2 Commencement This instrument commences on 26 September 2016. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Application This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies. 5 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 6 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about incisional hernia and death from incisional hernia. Meaning of incisional hernia (2) For the purposes of this Statement of Principles, incisional hernia means: (a) a protrusion of intra-abdominal tissue through a fascial defect in the abdominal wall at the site of a previous surgical incision; and (b) includes incisional hernia that recurs following surgical repair of an incisional hernia. (3) While incisional hernia attracts ICD‑10‑AM code K43.0, K43.1 or K43.2, in applying this Statement of Principles the meaning of incisional hernia is that given in subsection (2). (4) For subsection (3), a reference to an ICD‑10‑AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD‑10‑AM), Ninth Edition, effective date of 1 July 2015, copyrighted by the Independent Hospital Pricing Authority, ISBN 978‑1‑76007‑020‑5. Death from incisional hernia (5) For the purposes of this Statement of Principles, incisional hernia, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's incisional hernia. Note: terminal event is defined in the Schedule 1 – Dictionary. 7 Basis for determining the factors The Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that incisional hernia and death from incisional hernia can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the MRCA. Note: relevant service is defined in the Schedule 1 – Dictionary. 8 Factors that must exist At least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting incisional hernia or death from incisional hernia with the circumstances of a person's relevant service: (1) having an incision for a surgical procedure before the clinical onset of incisional hernia, where the hernia is at the site of that incision; (2) having a pre-existing scar at the site of the incision for a surgical procedure before the clinical onset of incisional hernia, where the hernia is at the site of that incision; (3) having a superficial infection of the affected incision within 30 days of the surgical procedure, in the five years before the clinical onset of incisional hernia; Note: superficial infection of the affected incision is defined in the Schedule 1 - Dictionary. (4) having a deep infection of the affected incision within 90 days of the surgical procedure, in the five years before the clinical onset of incisional hernia; Note: deep infection of the affected incision is defined in the Schedule 1 - Dictionary. (5) having wound dehiscence as specified of the affected incision before the clinical onset of incisional hernia; Note: wound dehiscence as specified is defined in the Schedule 1 - Dictionary. (6) being obese before the clinical onset of incisional hernia, and at the time of the surgical incision at the affected site; Note: being obese is defined in the Schedule 1 - Dictionary. (7) being treated with sirolimus or everolimus as specified before the clinical onset of incisional hernia, where the treatment occurred within the three years following the surgical incision; Note: being treated with sirolimus or everolimus as specified is defined in the Schedule 1 - Dictionary. (8) being treated with systemic bevacizumab before the clinical onset of incisional hernia, where the treatment occurred within the one year following the surgical incision; (9) having ascites, abdominal distension, or chronic ambulatory peritoneal dialysis before the clinical onset of incisional hernia, where these conditions occurred within the one year following the surgical incision; (10) having Marfan syndrome before the clinical onset of incisional hernia; (11) having increased intra-abdominal pressure as specified at the time of the clinical worsening of incisional hernia; Note: increased intra-abdominal pressure as specified is defined in the Schedule 1 - Dictionary. (12) inability to obtain appropriate clinical management for incisional hernia. 9 Relationship to service (1) The existence in a person of any factor referred to in section 8, must be related to the relevant service rendered by the person. (2) The factors set out in subsections 8(11) and 8(12) apply only to material contribution to, or aggravation of, incisional hernia where the person's incisional hernia was suffered or contracted before or during (but did not arise out of) the person's relevant service. 10 Factors referring to an injury or disease covered by another Statement of Principles In this Statement of Principles: (1) if a factor referred to in section 8 applies in relation to a person; and (2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(2) of the VEA; then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time. Schedule 1 - Dictionary Note: See Section 5 1 Definitions In this instrument: being obese means having a Body Mass Index (BMI) of 30 or greater. Note: BMI is also defined in the Schedule 1 - Dictionary. being treated with sirolimus or everolimus as specified means treatment with sirolimus or everolimus for the purpose of immunosuppression, and does not include drug eluting stents that slowly release these drugs. BMI means W/H2 and where: W is the person's weight in kilograms; and H is the person's height in metres. deep infection of the affected incision means: (a) an infection involving the deep soft tissues (fascial and muscle layers) of the incision; or (b) an infection of any part of the anatomy, other than the incision, which was opened or manipulated during the surgical procedure, including organs and spaces. incisional hernia—see subsection 6(2). increased intra-abdominal pressure as specified means acute or chronic (intermittent or continuous) elevation of pressure within the abdominal cavity due to: (a) anti-G straining manoeuvre; (b) ascites; (c) chronic ambulatory peritoneal dialysis; (d) extensive intra-abdominal neoplastic disease; (e) lifting heavy weights; (f) physical trauma to the abdomen involving a direct blow to the abdomen; (g) pneumoperitoneum; (h) pregnancy; (i) significant coughing; (j) significant sneezing; (k) straining at micturition due to bladder outlet or urethral obstruction; or (l) straining at stool due to constipation or diarrhoea. MRCA means the Military Rehabilitation and Compensation Act 2004. relevant service means: (a) operational service under the VEA; (b) peacekeeping service under the VEA; (c) hazardous service under the VEA; (d) British nuclear test defence service under the VEA; (e) warlike service under the MRCA; or (f) non-warlike service under the MRCA. Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary. superficial infection of the affected incision means an infection involving only the skin or subcutaneous tissue of the incision, other than a stitch abscess in which there is minimal inflammation and discharge confined to the points of suture penetration. terminal event means the proximate or ultimate cause of death and includes the following: (a) pneumonia; (b) respiratory failure; (c) cardiac arrest; (d) circulatory failure; or (e) cessation of brain function. VEA means the Veterans' Entitlements Act 1986. wound dehiscence as specified means disruption of all layers of a surgical wound, including the fascia, that occurs within 30 days of the surgical procedure.