ACC Treatment Injury Claims

Transcription

1 ACC Treatment Injury Claims Surgical Mesh-Related Claim Data From 1 July 25 to 3 June 217 (12 fiscal years) 18/1/217 1 P age

2 Contents Contents... 2 Abbreviations... 2 Colour references... 3 Terminology... 3 Introduction... 4 Background... 5 Data Information... 6 Breakdown of surgical mesh-related claim data from 1 July 25 to 3 June 217 (12-fiscal years) Are treatment injury claims increasing? What are the demographics for surgical mesh-related claims? Who is lodging surgical mesh-related claims? What is the breakdown of surgical mesh-related claims by treatment context by event (surgery type groups)? Where are the surgical mesh-related events occurring? What is the breakdown of surgical mesh-related claims by primary and secondary injury/symptoms? What device types relate to the surgical mesh-related claims? What are the costs related to surgical mesh-related claims? What are the key time points for surgical mesh-related claims? Abbreviations Abbreviation ACC DOS DOI POP SUI POP & SUI U.S. FDA TVT TVT-O Description Accident Compensation Corporation Date of surgery Date of injury Pelvic Organ Prolapse Stress Urinary Incontinence Combined Pelvic Organ Prolapse and Stress Urinary Incontinence United States Food and Drug Administration Tension-free vaginal tape Tension-free vaginal tape obturator 2 P age

3 Colour references Burgundy Purple Blue Orange Sage Treatment injury claims Surgical mesh-related claims Surgical mesh-related claims for POP and/or SUI repair surgery Surgical mesh-related claims for Hernia repair surgery Surgical mesh-related claims for Other repair surgery Terminology Terminology Surgical meshrelated claims Description Refers to treatment injury claims that the claimed injury/symptom is directly caused by the surgical mesh or there is a close relationship between the claimed injury/symptom and the mesh used in the surgical event. Fiscal year Surgery year Treatment context Refers to the financial year/s (1 July to 3 June) Refers to the year of the mesh implant surgery. Refers to the over-arching type of treatment that the patient is receiving when the injury occurred. Treatment event Refers to the type of treatment procedure that caused the injury or symptom. For surgical mesh-related claims, treatment event refers to the mesh surgery type that caused the injury or symptom. Surgery type groups Surgery type Primary injury/symptoms Secondary injury/symptoms Device type Refers to a group of similar surgery types. Refers to the surgical event that caused the injury or symptom. Refers to the predominant injury/symptom caused by the treatment event. Refers to the injury/symptom in addition to the primary injury/symptom caused by the treatment event. Refers to the device name, type or brand of mesh. 3 P age

4 Introduction On 2 March 214, a private petition was sent to the Health Select Committee, requesting that an independent inquiry be conducted regarding the safety of surgical mesh in New Zealand. As a result of the petition, ACC undertook a review of all ACC surgical mesh-related claims from 1 July 25 to 3 June 214 and made these findings publicly available. See ACC Surgical Mesh Review 215 Since releasing the ACC Surgical Mesh Review in March 215, ACC s actions have included: meeting regularly with Medsafe; improving the way information is recorded for surgical mesh-related claims to make them easier to identify; providing all its surgical mesh-related claim data to Medsafe, in addition to the belief of risk of harm 1 reporting; and, making system changes in the surgical mesh-related claim data structure to capture additional and more specific information where possible. Following the system changes, ACC retrospectively reclassified all its surgical mesh-related claim data as each claim can reflect an injury or symptom/complication related to the use of surgical mesh, irrespective of whether the claim met the Treatment Injury legislative criteria defined in the Accident Compensation Act 21. This retrospective update means that ACC is now able to provide an additional breakdown of surgical meshrelated claim data, which is outlined in this document and covers claim data over 12-fiscal years from 1 July 25 to 3 June 217. ACC does not have a regulatory function. However, we have a role in passing information to the relevant regulatory authority where issues of safety are raised. The regulatory authority can then make decisions that relate to medical device regulation. ACC will provide Medsafe with the retrospective update of its surgical mesh-related claim data from 1 July 25, and will continue to provide this additional level of information from now on. The Surgical Mesh-Related Claim Data Report was done in collaboration with Mesh Down Under TM and Medsafe, who helped identify what information would be valuable to enhance understanding and inform decisions. This document will be uploaded to ACC s website and will be available to anyone with an interest in surgical mesh-related claims. 1 Section 284 of the Act. 4 P age

5 Background ACC assesses all lodged surgical mesh-related claims for cover under the Treatment Injury legislative criteria (formerly Medical Misadventure) defined in the Accident Compensation Act 21 ( the Act ). On 1 July 25, Treatment Injury amendments were made to the Act. These amendments focused on the treatment outcome, which was more in line with the broader scope and intent of the ACC no-fault scheme. The legislative changes also support regulators by providing information if there is a belief of risk of harm, which is a significant change in ACC s previous role from being an agency that identified and assessed the actions of individual healthcare practitioners. Section 32 of the Act provides ACC cover for people who have an injury that has occurred during treatment. For surgical mesh-related claims to be accepted there must be a physical injury with a direct causal link between the medical treatment and the mesh-related injury claimed. ACC also needs to consider the relevant circumstances that relate to: the person s underlying health condition; and, the clinical knowledge at the time of treatment. ACC s decision therefore needs to be based on the relevant patient and treatment factors, which vary from case to case. When a treatment injury claim is being considered; ACC must also assess for a belief of risk of harm to the public. Surgical mesh-related events that are assessed as serious 2 and sentinel 3 are reported to Medsafe monthly. In addition, as each claim can reflect an injury or symptom/complication related to the use of surgical mesh, ACC provides all surgical mesh-related claim data irrespective of whether the claim is accepted or declined or whether it is assessed as a serious or sentinel event to Medsafe, the regulator of medical devices in New Zealand. 2 A serious event or pattern of events that has the potential to result in death or major permanent loss of function not related to the natural course of the claimant s illness or underlying condition. 3 An event during care or treatment that has resulted in an unanticipated death or major permanent loss of function not related to the natural course of the claimant s illness or underlying condition, pregnancy or childbirth 5 P age

6 Data Information It is important to note that the data provided by ACC is taken from treatment injury claims that have been lodged with and decided by ACC from 1 July 25 to 3 June 217. It is possible that some people may have suffered complications related to the use of surgical mesh, but have not lodged a claim with ACC. This means that ACC data should be considered alongside other sources of surgical mesh-related information. The data in this document excludes pending decisions (surgical mesh-related claims still being assessed) or decisions under review 4. When assessing a claim for treatment injury, ACC collects the information required to establish that a physical injury occurred while a person is seeking or receiving treatment from one or more registered health professionals. Since the change in treatment injury provisions on 1 July 25, ACC does not collect the names of individual health professionals involved in the client s treatment; because ACC is a no-fault scheme. However, the context in which the treatment event occurred is collected. ACC is mandated to collect relevant and sufficient clinical information to reach a cover decision in a timely manner for our clients. This often means that some details are not required for ACC to issue a decision such as technical details (e.g. medical device name s, batch numbers etc.). To prevent the possibility of identifying a person, any result that includes claim counts fewer than four (n=1, 2 or 3) will be presented as. For the tables or graphs with percentages, these are not provided for values. The breakdown of data for Other mesh surgery is limited due to low numbers. The privacy of individuals has been maintained when collaborating with Mesh Down Under TM. 4 Review is a term used in the Act when ACC has made a decision on a claim; the client disagrees with the decision and applies for an independent review. 6 P age

7 Breakdown of surgical mesh-related claim data from 1 July 25 to 3 June 217 (12-fiscal years) ACC s data is captured from information received during the assessment of a claim and may be a subset of the data Medsafe receive from other sources. Following the recent improvements to the surgical mesh-related claim data structure, ACC is now able to provide more specific information to benefit anyone with an interest in the surgical mesh-related claims. The Surgical Mesh-Related Claim Data Report was done in collaboration with Mesh Down Under TM ( and Medsafe ( who helped identify what information would be valuable to enhance understanding and inform decisions. This document is written in a way that each graph or table can stand alone, so some information may be repeated. Any questions in relation to this report, please Treatment Injury Cover Assessment Centre at TI.Info@acc.co.nz 7 P age

8 1. Are treatment injury claims increasing? Figure 1: Number of treatment injury claims accepted and declined by fiscal year Treatment injury claim counts by accepts/declines by fiscal year from 1 July 25 to 3 June 217 1% 9% Number of claims % 7% 6% 5% 4% 3% 2% 1% % Decline Accept Accept rate Figure 1 shows that ACC made cover decisions for more than 114, treatment injury claims over 12-fiscal years. Of the 114, claims, approximately 62% of claims are accepted and 38% of claims are declined. Since the implementation of the Treatment Injury provisions on 1 July 25, claims steadily increased as anticipated. From 28/9 claim volumes plateaued for approximately 4-years and then claims started to increase again from 212/13 onwards. The claim counts almost doubled in 216/17 at over 16, claims compared to 211/12. Explaining why the increase is challenging, as the extent of treatment injuries is not fully known in New Zealand or any other country. There is no single way of measuring this as all health systems rely on various ways to detect where/how/why and whether a person has suffered a personal injury as a result of treatment. These can include reporting systems, reportable events processes and treatment injury claims. It is important to note that treatment injury claim rates are reflective of claims lodged with ACC and are not a proxy for the incidence of injuries caused by treatment or quality of care in the health sector. Anecdotally we understand that the increase in claims can indicate a better understanding and awareness of treatment injuries both from clients and health practitioners. 8 P age

9 Figure 2: Number of surgical mesh-related claims accepted and declined by fiscal year Number of claims Surgical mesh-related claim counts by accepts/declines by fiscal year from 1 July 25 to 3 June / 6 26/ 7 27/ 8 28/ 9 29/ 1 Note: Claim counts fewer than four (n=1, 2 or 3) are presented as 21/ / / / / / / 17 Total decision Decline Accept Accept rate 83% 83% 91% 81% 75% 75% 89% 82% 74% 83% 83% 72% 1% 9% 8% 7% 6% 5% 4% 3% 2% 1% % Figure 2 shows that ACC made cover decisions on 81 surgical mesh-related claims over 12 fiscal years. Of the 81 claims; 64 claims (79%) are accepted and 17 claims (21%) are declined. The accept rate varies across the 12-fiscal years, ranging from 72% to 91%. Since the implementation of the Treatment Injury provisions on 1 July 25, an increase in claims was anticipated. There is initially a 93% increase in the number of surgical mesh-related claims in 28/9 compared to the year before. Claims went from 44 claims in 27/8 to 85 claims in 28/9 and 91 in 29/1. Thereafter the number of claims dipped for 2-fiscal years and started increasing again in 212/13. The claims count peaked in 216/17 at over 15. The pattern for surgical mesh-related claims in 28/9 and 216/17 is similar (except for 21/11 and 211/12) to the overall increase in the treatment injury claim counts - see Figure 1. Explaining why the increase is challenging, as the extent of treatment injuries is not fully known in New Zealand or any other country. There is no single way of measuring this as all health systems rely on various ways to detect where/how/why and whether a person has suffered a personal injury as a result of treatment. These can include reporting systems, reportable events processes and treatment injury claims. It is important to note that treatment injury claim rates are reflective of claims lodged with ACC and are not a proxy for the incidence of injuries caused by treatment or quality of care in the health sector. Anecdotally we understand that the increase in claims can indicate a better understanding and awareness of treatment injuries both from clients and health practitioners. Other reasons could include an increase in the number of people who are having injuries associated with surgical mesh, or more awareness of the potential risks associated with surgical mesh after two U.S. FDA communications in 28 and 211. Also, the Health Select Committee began inquiring into the use of surgical mesh in 214, followed by the ACC Surgical Mesh Review in March 215 as well as the on-going media attention in New Zealand and overseas. 9 P age

10 Figure 3: Number of surgical mesh-related claims accepted and declined by treatment event (surgery type groups) Surgical mesh-related claim counts by accepts/declines by surgery type groups from 1 July 25 to 3 June 217 Accept Decline Total 64 (79%) 17 (21%) POP and/or SUI repair 38 (81%) 9 (19%) Hernia repair 22 (76%) 7 (24%) Other mesh surgery 4 (8%) 1 (2%) Figure 3 shows the 81 surgical mesh-related claims by accepts and declines by surgery type groups. ACC collects data relating to the injury and associated treatment events. Treatment event is defined as the type of treatment procedure that caused the injury or symptom. For surgical mesh-related claims, treatment event refers to the mesh surgery type that caused the injury or symptom. ACC data has identified three main surgery type groups, which are: 1. Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI) repair 2. Hernia repair 3. Other mesh surgery (This includes mesh removal surgery, sling surgery for male urinary incontinence, breast reconstruction and other reconstructive surgeries using surgical mesh, with an accept rate of 8%) Of the 81 claims, the accept rate for POP and/or SUI repair surgery is 81% (n=38). This is slightly higher than 76% (n=22) for hernia repair surgery. Overall the accept rates are similar for the different surgery type groups. Ventral mesh rectopexy is a surgical treatment for posterior compartment POP. These claims are captured under POP and/or SUI repair. 1 P age

11 2. What are the demographics for surgical mesh-related claims? Figure 4: Number of surgical mesh-related claims by gender by fiscal year Surgical mesh-related claim counts by gender by fiscal year from 1 July 25 to 3 June 217 Number of claims / 6 26/ 7 27/ 8 28/ 9 29/ 1 21/ 11 Note: Claim counts fewer than four (n=1, 2 or 3) are presented as 211/ 12 Figure 4 shows the 81 surgical mesh-related claims by gender group by fiscal year. Of the 81 claims; 76% (n=615) of claims are associated with the female gender group and 24% (n=195) with the male gender group. Claim counts for female clients are the highest in each fiscal year. Claim counts for male clients have been more sporadic, with some very low volumes in 211/12 and 214/15. However, claims for the male gender group peaked in 29/1 and again in 216/ / / / / / 17 Total decision Male Female P age

12 Figure 5: Number of surgical mesh-related claims by gender by age group 3 Surgical mesh-related claim counts by gender and age group (in years) from 1 July 25 to 3 June 217 Number of claims < > = 8 Total decision Male Female Figure 5 shows the 81 surgical mesh-related claims by gender and age group distribution. The age group relates to the age of the client as at the date of injury 5. Of the 81 claims, the highest number of clients are aged 5-59 years old (32%, n=258), followed by the 6-69 age group (28%, n=222) and the 4-49 years age group (2%, n=163). Claim counts for male clients are highest in the 5-59 and 6-69 age groups. Claim counts for female clients are highest in the 5-59 years age group. 5 Date of injury refers to the date the person first seeks or receives treatment for the symptoms of that personal injury. AC Act 21, section 38: subsection (1) and (2) applies. 12 P age

13 Figure 6: Number of surgical mesh-related claims for POP and/or SUI repair by gender and age group Surgical mesh-related claim counts for POP and/or SUI repair by gender and age group (in years) from 1 July 25 to 3 June 217 Number of claims < > = 8 Female Note: Claim counts fewer than four (n=1, 2 or 3) are presented as Figure 6 shows the 47 surgical mesh-related claims for POP and/or SUI repairs by gender and age group distribution. 1% of claims relate to the female gender group. Of the 47 claims, noticeably the 5-59 age group have the highest number of claims (36%, n=168), followed closely by the 6-69 (28%, n=133) and then 4-49 (21%, n=1) age group. 13 P age

14 Figure 7 Number of surgical mesh-related claims for hernia repair by gender and age group Note: Claim counts fewer than four (n=1, 2 or 3) are presented as Figure 7 shows the 29 surgical mesh-related claims for hernia repair by gender and age group distribution. Of the 29 claims, the highest number of claims (28%, n=81) both for the male (17%, n=5) and female (11%, n=31) gender group is in the 6-69 years age group. Claims are the highest for male clients across all age groups. This seems consistent with current knowledge about hernia development - that men are more likely to develop a hernia and more likely to need a hernia repair compared with women 6.. Number of claims Surgical mesh-related claim counts for hernia repair by gender and age group (in years) from 1 July 25 to 3 June < > = 8 Total decision Male Female Brooks, D. C., Obeid, A., & Hawn, M. (214). Classification, clinical features and diagnosis of inguinal and femoral hernias in adults. UpToDate. Waltham, MA: UpToDate. 14 P age

15 Figure 8: Number of surgical mesh-related claims for hernia repair by gender and surgery type Surgical mesh-related claim counts for hernia repair by gender and surgery type from 1 July 25 to 3 June 217 Male Female Total 182 (63%) 18 (37%) Groin hernia repair 87 (82%) 19 (18%) Ventral hernia repair 86 (51%) 84 (49%) Other hernia repair 9 (64%) 5 (36%) Figure 8 shows the breakdown of the 29 surgical mesh-related claims for hernia repair by gender and surgery type (type of hernia repair). ACC data has identified three main surgery types for hernia repair, which are: 1. Groin hernia repair 2. Ventral hernia repair 3. Other hernia repair (This includes hiatus hernia, perineal hernia, parastomal hernia or the hernia type is unknown). Of the 29 claims, the number of groin hernia repair is significantly higher (82%, n=87) in the male gender group than that of females (18%, n=19), while the number of ventral hernia repairs is almost the same between male (51%, n=86) and female (49%, n=84). 15 P age

16 3. Who is lodging surgical mesh-related claims? Figure 9: Number of surgical mesh-related claims by lodging provider group by fiscal year Surgical mesh-related claim counts by lodging provider group by fiscal year from 1 July 25 to 3 June Number of claims / 6 26/ 7 27/ 8 28/ 9 29/ 1 21/ / / / / / 16 Other Private Clinic or Hospital GP DHB Total / 17 Note: Claim counts fewer than four (n=1, 2 or 3) are presented as Figure 9 shows the 81 surgical mesh-related claims by lodging provider group by fiscal year. Of the 81 claims, 43% (n=35) of claims are lodged by private clinics or hospitals, 29% (n=235) of claims are lodged by GPs and 27% (n=216) of claims are lodged by DHBs. Other includes e.g. Ambulance, Community Clinics or providers not listed. 16 P age

17 Figure 1 Number of surgical mesh-related claims for POP and/or SUI repair by lodging provider group by fiscal year Surgical mesh-related claim counts for POP and/or SUI repair by lodging provider group by fiscal year from 1 July 25 to 3 June Number of claims / 6 26/ 7 27/ 8 28/ 9 29/ 1 21/ / / / / / 16 Other 1 GP DHB Private Clinic or Hospital Total / 17 Note: Claim counts fewer than four (n=1, 2 or 3) are presented as Figure 1 shows the 47 surgical mesh-related claims for POP and/or SUI repair by lodging provider group by fiscal year. Noticeably private clinics or hospitals lodged most of the POP and/or SUI repair claims across all fiscal years. Of the 47 claims for POP and/or SUI repair, 6% (n=28) of claims are lodged by private clinics or hospitals, 24% (n=112) of claims are lodged by GPs and 16% (n=77) of claims are lodged by DHBs. Other includes e.g. Ambulance, Community Clinics or providers not listed. 17 P age

18 Figure 11: Number of surgical mesh-related claims for hernia repair by lodging provider group by fiscal year Number of claims Surgical mesh-related claim counts for hernia repair by lodging provider groups by fiscal year from 1 July 25 to 3 June / 6 26/ 7 27/ 8 28/ 9 29/ 1 21/ / / / / / 16 Other GP DHB Private Clinic or Hospital Total / 17 Note: Claim counts fewer than four (n=1, 2 or 3) are presented as Figure 11 shows the 29 surgical mesh-related claims for hernia repair by lodging provider groups by fiscal year. Overall, DHBs lodged most of the hernia repair claims across all fiscal years, followed closely by GPs. Of the 29 claims, 41% (n=12) of claims are lodged by DHBs, 38% (n=111) of claims are lodged by GPs and 18% (n=52) of claims are lodged by private clinics or hospitals. Other includes e.g. Ambulance, Community Clinics or providers not listed. 18 P age

19 4. What is the breakdown of surgical mesh-related claims by treatment context by event (surgery type groups)? Table 1 Number of surgical mesh-related claims by treatment context by surgery type groups Surgical mesh-related claim counts by treatment context by surgery type groups from 1 July 25 to 3 June 217 All POP and/or SUI repair Hernia repair surgery Other mesh surgery Treatment Context n Treatment Context n Treatment Context n Treatment Context n Gynaecology 432 Gynaecology 427 General Surgery 29 General Surgery 22 General Surgery 32 Urology 35 Plastic And Burns 15 Urology 37 General Surgery 8 Other context 6 Plastic And Burns 15 Gynaecology 5 Other context 6 Urology Note: Claim counts fewer than four (n=1, 2 or 3) are presented as Table 1 shows the 81 surgical mesh-related claims by treatment context by surgery type groups. Treatment context is defined as the over-arching type of treatment that the patient is receiving when the injury occurred. ACC data has identified three main surgery type groups for the surgical mesh-related claims, which are: 1. Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI) repair 2. Hernia repair 3. Other mesh surgery (This includes mesh removal surgery, sling surgery for male urinary incontinence, breast reconstruction and other reconstructive surgeries using mesh) Of the 81 claims, 53% (n=432) of claims related to the Gynaecology treatment context and 4% (n=32) of claims related to the General Surgery treatment context. Urology accounts for around 4.5% (n=37) of all surgical mesh-related claims, followed by Plastic and Burns 2% (n=15) and other contexts 1% (n=6). Other mesh surgery contexts include dental, orthopaedics, vascular surgery, ophthalmology, cardiothoracic and oncology. ACC does not collect data specifically related to the colorectal surgery treatment context. If the surgery is performed by a colorectal surgeon, the treatment context would be captured under General Surgery. For example, ventral mesh rectopexy, commonly performed by a colorectal surgeon, is a surgical treatment for posterior compartment POP. These claims are captured under POP and/or SUI repair with General Surgery as the treatment context. 19 P age

20 Figure 12: Number of surgical mesh-related claims by surgery type groups by fiscal year 16 Surgical mesh-related claim counts by surgery type groups by fiscal year from 1 July 25 to 3 June Number of claims / 6 26/ 7 27/ 8 28/ 9 Note: Claim counts fewer than four (n=1, 2 or 3) are presented as 29/ 1 21/ / / / / / / 17 Other mesh surgery Hernia repair POP and/or SUI repair Total Figure 12 shows the 81 surgical mesh-related claims by surgery type groups. ACC collects data relating to the injury and associated treatment events. Treatment event is defined as the type of treatment procedure that caused the injury or symptom. For surgical mesh-related claims, treatment event refers to the mesh surgery type that caused the injury or symptom. ACC data has identified three main groups of surgery types for the surgical mesh-related claims, which are: 1. Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI) repair 2. Hernia repair 3. Other mesh surgery (This includes mesh removal surgery, sling surgery for male urinary incontinence, breast reconstruction and other reconstructive surgeries using mesh) Of the 81 claims, the most significant increase in the number of claims is in 216/17 and is related to hernia repair surgery. Hernia repair claims increased by 138% (n=4) in 216/17 compared to the year before. Claims related to POP and/or SUI repair surgery increased by 31% (n=18) in 216/17 compared to the previous year. 2 P age

21 Figure 13: Number of surgical mesh-related claims for POP and/or SUI repair by surgery type by fiscal year Surgical mesh-related claim counts for POP and/or SUI repair by surgery type by fiscal year from 1 July 25 to 3 June % Total % % Number of claims /6 26 /7 27 /8 28 /9 Note: Claim counts fewer than four (n=1, 2 or 3) are presented as POP & SUI repair SUI repair POP repair Total 29 /1 POP repair SUI repair POP & SUI repair Total Figure 13 shows the 47 surgical mesh-related claims for POP and/or SUI repair by surgery type by fiscal year. ACC data has identified three main surgery types for POP and/or SUI repair which are: 1. Pelvic Organ Prolapse (POP) 2. Stress Urinary Incontinence (SUI) repair 3. Combined Pelvic Organ Prolapse & Stress Urinary Incontinence (POP & SUI) repair (NOTE: Combined POP & SUI repair refers to one single claim for one surgical event to treat both POP and SUI Of the 47 claims, POP repair has the highest number of claims (41%, n=194) among the three surgery types. Of the 194, the highest claim count (15%, n=29) for POP repair is in 28/9. 21 / / /13 The highest claim count in each fiscal year is for POP & SUI repair claims. 213 / / / /17 21 P age

22 Figure 14: Number of surgical mesh-related claims for hernia repair by surgery type by fiscal year Surgical mesh-related claim counts for hernia repair by surgery type by fiscal year from 1 July 25 to 3 June % Total % 17 59% Number of claims Ventral hernia repair Groin hernia repair Other hernia repair Total / 6 26/ 7 27/ 8 28/ 9 29/ 1 21/ / / / / / 16 Other hernia repair Groin hernia repair Ventral hernia repair Total / 17 Note: Claim counts fewer than four (n=1, 2 or 3) are presented as Figure 14 shows the 29 surgical mesh-related claims for hernia repair by surgery type by fiscal year. ACC data has identified three main surgery types for hernia repair, which are: 1. Groin hernia repair 2. Ventral hernia repair 3. Other hernia repair (This includes hiatus hernia, perineal hernia, parastomal hernia or the hernia type is unknown). Of the 29 claims, ventral hernia repair has the highest number of claims (59%, n=17) among the three surgery types. Since 213/14 ventral hernia repairs represent the highest claim count up until 216/17. The highest number of claims received is in 216/17 with a total of 69. Groin hernia repair increased the most by 275% from 8 claims in 215/16 to 3 claims in 216/17. However, in 216/17 there is also an increase of 52% (n=11) in ventral hernia repair and 1% (n=7) in other hernia repair compared to 215/ P age

23 5. Where are the surgical mesh-related events occurring? Figure 15: Number of claims for surgical mesh-related events in public or private facilities by mesh implant surgery year Surgical mesh-related claim counts in public or private facilities by mesh implant surgery year Private Public 216/17 215/16 214/15 213/14 212/13 211/12 21/11 29/1 28/9 27/8 26/7 25/6 24/5 23/4 22/3 21/2 2/1 1999/ 1998/ / / / / / /8 Other 13 (36%) 24 (41%) 15 (5%) 22 (5%) 25 (48%) 29 (5%) 22 (38%) 44 (56%) 6 (63%) 45 (64%) 37 (62%) 49 (86%) 18 (51%) 15 (65%) 9 (47%) (64%) 34 (59%) 15 (5%) 22 (5%) 27 (52%) 29 (5%) 36 (62%) 35 (44%) 36 (38%) 25 (36%) 23 (38%) 8 (14%) 17 (49%) 8 (35%) 1 (53%) Note: Claim counts fewer than four (n=1, 2 or 3) are presented as ; percentages are not provided for the years with value. Figure 15 shows the 81 surgical mesh-related events in private or public facilities by surgery year. Other includes 8 claims where either the surgery year or the facility is unknown. The 28/9 surgery year had the highest claim count (6) for private facilities. From 211/12 to 213/14 the claim counts are somewhat evenly spread across both private and public facilities. 215/16 and 216/17 shows that of the claims for those years; 59% (n=34) and 64% (n=23) related to surgery in the public sector. 23 P age

24 Figure 16: Number of claims for surgical mesh-related events in public or private facilities by DHB region Surgical mesh-related claim counts in public or private facilities by DHB region from 1 July 25 to 3 June 217 Private Public Auckland 13 (79%) 34 (21%) Capital & Coast Canterbury Waitemata Waikato Bay of Plenty Counties Manukau Hutt Valley Southern Hawkes Bay Northland Taranaki Mid Central Nelson Marlborough Lakes Tairawhiti Whanganui South Canterbury West Coast Wairarapa Other 77 (68%) 62 (6%) 43 (45%) 47 (63%) 13 (42%) 5 (17%) 1 (37%) 12 (44%) 1 (53%) 4 (22%) 4 (25%) 6 (38%) 5 (36%) 4 (44%) 37 (32%) 42 (4%) 52 (55%) 28 (37%) 18 (58%) 24 (83%) 17 (63%) 15 (56%) 9 (47%) 14 (78%) 12 (75%) 1 (63%) 13 9 (64%) 9 5 (56%) 6 6 (1%) Note: Claim counts fewer than four (n=1, 2 or 3) are presented as ; percentages are not provided for the regions with value. Figure 16 shows the 81 surgical mesh-related events in private or public facilities by DHB region. Other includes 8 claims where either the facility is overseas or unknown. Auckland DHB region has the highest claim count (164) and most of these events (79%, n=13) occurred in private facilities. 68% (n=77) of the surgical mesh-related events in Capital & Coast DHB region occur in private facilities. Where Waitemata DHB region has the highest count of events (55%, n=52) in public facilities. The DHB region is a geographic area where the treating facility is located; it includes the public facilities and private facilities within the same region. Population numbers in different regions and facility types will play a key part in the number and type of surgeries performed. Higher and lower level tertiary facilities are represented in the top P age

25 Table 2 Number of claims for surgical mesh-related events by DHB regions by surgery type groups Surgical mesh-related claim counts by DHB regions by surgery type groups from 1 July 25 to 3 June 217 DHB regions POP and/or SUI repair Hernia repair Other mesh surgery n % Region n % Region n % Region Auckland 114 7% 39 24% 11 7% Capital & Coast 89 78% 19 17% 6 5% Canterbury 67 64% 32 31% 5 5% Waitemata 51 54% 41 43% -% Waikato 41 55% 27 36% 7 9% Bay of Plenty 21 68% 9 29% -% Counties Manukau 11 38% 15 52% -% Hutt Valley 12 44% 11 41% 4 15% Southern 8 3% 17 63% -% Hawkes Bay 1 53% 9 47% % Northland 6 33% 9 5% -% Mid Central 6 38% 9 56% -% Taranaki -% 1 63% -% Nelson Marlborough 8 5% 8 5% % Lakes 4 29% 1 71% % Tairawhiti -% 8 73% % Whanganui 4 44% 5 56% % South Canterbury -% 5 71% % West Coast -% -% -% Wairarapa % 4 1% % Other 7 88% -% % Note: Claim counts fewer than four (n=1, 2 or 3) are presented as ; percentages are not provided for the values. The percentages are in relation to the number of events for each DHB region. Table 2 shows the 81 surgical mesh-related events by DHB region by surgery type groups. Other includes 8 claims where either the facility is overseas or unknown. ACC data has identified three main surgery type groups for the surgical mesh-related claims, which are: 1. Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI) repair 2. Hernia repair 3. Other mesh surgery (This includes mesh removal surgery, sling surgery for male urinary incontinence, breast reconstruction and other reconstructive surgeries using mesh) Auckland DHB region shows the highest claim count (114) for POP and/or SUI repair, where Waitemata DHB region shows the highest claim count (41) relating to hernia repair. The DHB region is a geographic area where the treating facility is located; it includes the DHB facilities and private facilities within the same region. Population numbers in different regions and facility types will play a key part in the number and type of surgeries performed. 25 P age

26 Figure 17: Number of claims for surgical mesh-related events in public or private facilities by surgery type groups Surgical mesh-related claim counts in public or private facilities by surgery type groups from 1 July 25 to 3 June 217 Private Public Total 442 (55%) 364 (45%) POP and/or SUI repair 317 (68%) 15 (32%) Hernia repair 16 (37%) 183 (63%) Other mesh surgery 19 (38%) 31 (62%) Other Figure 17 shows the 81 surgical mesh-related events in public or private facilities by surgery type groups. Other includes 4 claims where the facility is unknown. ACC data has identified three main surgery type groups for the surgical mesh-related claims, which are: 1. Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI) repair 2. Hernia repair 3. Other mesh surgery (This includes mesh removal surgery, sling surgery for male urinary incontinence, breast reconstruction and other reconstructive surgeries using mesh) Of the 81 claims, 55% (n=442) of the events occurred in private facilities and 45% (n=364) in a public facility. For the POP and/or SUI repair events 68% (n=317) occurred in private facilities, whereas hernia repair events 63% (n=183) occurred in a public facility. 26 P age

27 Figure 18: Number of claims for surgical mesh-related events for POP and/or SUI repair in public or private facilities by DHB region Surgical mesh-related claim counts for POP and/or SUI repair in public or private facilities by DHB region from 1 July 25 to 3 June 217 Private Public Auckland 98 (86%) 16 (14%) Capital & Coast Canterbury Waitemata Waikato Bay of Plenty Hutt Valley Counties Manukau Hawkes Bay Southern Nelson Marlborough Mid Central Northland Lakes Whanganui Tairawhiti Taranaki West Coast South Canterbury Other 66 (74%) 45 (67%) 3 (59%) 32 (78%) 12 (57%) 7 (58%) 4 (36%) 6 (6%) 23 (26%) 22 (33%) 21 (41%) 9 (22%) 9 (43%) 5 (42%) 7 (64%) 4 (4%) Note: Claim counts fewer than four (n=1, 2 or 3) are presented as ; percentages are not provided for the regions with value. The percentages are in relation to the number of events for each DHB region. Figure 18 shows the 47 surgical mesh-related events for POP and/or SUI repair in a public or private facility by DHB region. Other includes 7 claims where either the facility is overseas or unknown. Of the 47 claims for POP and/or SUI repairs, the majority 67% (n=317) of the events occurred in private facilities see figure 17. The highest claim counts are for the Auckland DHB region with 114 (24%), followed by Capital & Coast DHB region with 89 (19%). Most of the events in DHB regions occurred in private facilities, except for Counties Manukau DHB region. The DHB region is a geographic area where the treating facility is located; it includes the DHB facilities and private facilities within the same region. Population numbers in different regions and facility types will play a key part in the number and type of surgeries performed. 27 P age

28 Table 3: Number of claims for surgical mesh-related events for POP and/or SUI repair by DHB regions by surgery type Surgical mesh-related claim counts for POP and/or SUI repair by DHB regions by surgery type from 1 July 25 to 3 June 217 POP repair SUI repair POP & SUI repair DHB regions n % Region n % Region n % Region Auckland 48 42% 3 26% 36 32% Capital & Coast 25 28% 17 19% 47 53% Canterbury 33 49% 9 13% 25 37% Waitemata 23 45% 8 16% 2 39% Waikato 27 66% -% 11 27% Bay of Plenty 7 33% 12 57% -% Hutt Valley -% 7 58% -% Counties Manukau 7 64% -% -% Hawkes Bay 6 6% -% -% Southern % 6 75% -% Nelson Marlborough -% 5 63% -% Northland -% -% -% Mid Central -% -% -% Lakes -% -% -% Whanganui -% -% -% West Coast -% % % Tairawhiti -% -% -% Taranaki % -% -% South Canterbury -% % -% Other -% -% -% Note: Claim counts fewer than four (n=1, 2 or 3) are presented as ; percentages are not provided for the values. The percentages are in relation to the number of events for each DHB region. Table 3 shows the 47 surgical mesh-related events for POP and/sui repair by DHB regions by surgery type. Other includes 7 claims where either the facility is overseas or unknown. ACC data has identified three main surgery types for POP and/or SUI repair which are: 1. Pelvic Organ Prolapse (POP) 2. Stress Urinary Incontinence (SUI) repair 3. Combined Pelvic Organ Prolapse & Stress Urinary Incontinence (POP & SUI) repair (NOTE: Combined POP & SUI repair refers to one single claim for one surgical event to treat both POP and SUI Of the 47 claims for POP and/or SUI repairs, most (68%, n=321) of the events are from treating facilities located in the Auckland, Capital & Coast, Canterbury and Waitemata DHB regions. Auckland DHB region shows the highest claim counts for POP repair, where Capital & Coast DHB region shows the highest claim counts for POP & SUI repair. The DHB region is a geographic area where the treating facility is located; it includes the DHB facilities and private facilities within the same region. Population numbers in different regions and facility types will play a key part in the number and type of surgeries performed. 28 P age

29 Figure 19: Number of claims for surgical mesh-related events for hernia repair in public or private facilities by DHB region Surgical mesh-related claim counts for hernia repair in public or private facilities by DHB region from 1 July 25 to 3 June 217 Private Public Waitemata Auckland Canterbury Waikato Capital & Coast Southern 12 (29%) 25 (64%) 15 (47%) 13 (48%) 7 (37%) 1 (59%) 29 (71%) 14 (36%) 17 (53%) 14 (52%) 12 (63%) 7 (41%) Counties Manukau 14 Hutt Valley Taranaki Lakes Mid Central Hawkes Bay Bay of Plenty Northland Tairawhiti Nelson Marlborough Whanganui South Canterbury Wairarapa West Coast 4 (44%) 4 (44%) (%) (%) (56%) 5 (56%) 9 (1%) 7 8 (1%) 7 4 Other Note: Claim counts fewer than four (n=1, 2 or 3) are presented as ; percentages are not provided for the regions with value. The percentages are in relation to the number of events for each DHB region. Figure 19 shows the 29 surgical mesh-related events for hernia repair in a public or private facility by DHB region. Other includes claims where the facility is unknown. Of the 29 claims for hernia repairs, the majority (63%, n=183) of the events occurred in a public facility see figure 17. Most of the DHB regions events occurred in public facilities, except Auckland and Southern DHB regions. The highest number of claims (1%, n=29) relating to hernia repair events occurred in a public facility in the Waitemata DHB region. The second highest claim count (9%, n=25) relating to hernia repair events occurred in private facilities in the Auckland DHB region. The DHB region is a geographic area where the treating facility is located; it includes the DHB facilities and private facilities within the same region. Population numbers in different regions and facility types will play a key part in the number and type of surgeries performed. 29 P age

30 Table 4: Number of claims for surgical mesh-related events for hernia repair by DHB region by surgery type Surgical mesh-related claim counts for hernia repair by DHB region by surgery type from 1 July 25 to 3 June 217 DHB regions Groin hernia repair Ventral hernia repair Other hernia repair n % Region n % Region n % Region Waitemata 16 39% 23 56% -% Auckland 17 44% 18 46% 4 1% Canterbury 11 34% 2 63% -% Waikato 8 3% 18 67% -% Capital & Coast 5 26% 14 74% % Southern 8 47% 8 47% -% Counties Manukau -% 14 93% % Hutt Valley -% 7 64% -% Taranaki 4 4% 6 6% % Lakes 6 6% 4 4% % Mid Central 4 44% 5 56% % Northland -% 6 67% % Bay of Plenty -% 6 67% % Hawkes Bay 4 44% 5 56% % Tairawhiti -% 6 75% -% Nelson Marlborough 5 63% -% % Whanganui -% -% -% South Canterbury -% -% % Wairarapa -% -% % West Coast % -% % Other % % -% Note: Claim counts fewer than four (n=1, 2 or 3) are presented as ; percentages are not provided for the values. The percentages are in relation to the number of events for each DHB region. Table 4 shows the 29 surgical mesh-related events for hernia repair by DHB region by surgery type. Other includes claims where the facility is unknown. ACC data has identified three main surgery types for hernia repair, which are: 1. Groin hernia repair 2. Ventral hernia repair 3. Other hernia repair (This includes hiatus hernia, perineal hernia, parastomal hernia or the hernia type is unknown). Of the 29 claims for hernia repairs, the highest count of the ventral hernia repairs relates to treatment facilities located in the Waitemata DHB region (23), followed by Canterbury DHB region (2). For groin hernia repairs, the highest count relates to treatment facilities located in the Auckland DHB region, followed by Waitemata DHB region. The DHB region is a geographic area where the treating facility is located; it includes the DHB facilities and private facilities within the same region. Population numbers in different regions and facility types will play a key part in the number and type of surgeries performed. 3 P age

31 6. What is the breakdown of surgical mesh-related claims by primary and secondary injury/symptoms? Table 5 Number of surgical mesh-related claims by primary and secondary injury/symptom Surgical mesh-related claim counts by primary and secondary injury/symptom from 1 July 25 to 3 June 217 Primary injury/symptom n % Secondary injury/symptom n % Mesh erosion 324 4% Infection 115 2% Infection % Pain 57 1% Hernia 49 6% Sexual dysfunction 54 1% Pain 45 6% Perineal injury 52 9% Nerve injury 36 4% Mesh erosion 42 7% Haematoma - bruising 28 3% Mesh migration 27 5% Mesh migration 15 2% Wound dehiscence 23 4% Perineal injury 14 2% Haematoma - bruising 22 4% Seroma 11 1% Vascular injury 19 3% Scarring 1 1% Hernia 17 3% Urinary tract injury 1 1% Fistula - other 14 2% Sexual dysfunction 1 1% Scarring 12 2% Bowel injury 9 1% Seroma 11 2% Fistula - other 8 1% Urinary tract injury 9 2% Gastrointestinal injury 8 1% Mesh contraction 8 1% Hydrocele 5 1% Tissue injury / damage 7 1% Mesh contraction 5 1% Necrosis 7 1% Tissue injury / damage 5 1% Bowel injury 7 1% Urinary Incontinence 5 1% Nerve injury 7 1% Inflammation 4.5% Gastrointestinal injury 5 1% Wound dehiscence 4.5% Urinary Incontinence 5 1% Other 17 injuries/symptoms 27 3% Perforation - Other 5 1% Urethral injury 4 1% Failure internal staples / sutures 4 1% Other 17 injuries/symptoms 3 5% Total 81 Total 563 Note: Percentages may not add to 1% due to rounding. Table 5 shows the 81 surgical mesh-related claims by primary injury and secondary injury. Of the 81 claims, mesh erosion (4%, n=324) and infection (22%, n=178) are the most common primary injuries. Infection (2%, n=115) is also the most common secondary injury, followed by symptom of pain (1%, n=57) and sexual dysfunction (1%, n=54). Sexual dysfunction mostly related to dyspareunia (painful sexual intercourse). Even though pain is not represented by high claim counts, this does not mean that pain isn t present. I.e. Mesh erosion may be the primary injury but pain is a key symptom. Please note that a single claim can have only one primary injury/symptom, but may have up to two secondary injuries/symptoms. 31 P age

32 Figure 2: Number of surgical mesh-related claims by surgery type groups, surgery type and primary injury or symptom from 1 July 25 to 3 June 217 Other hernia repair 14 2% Groin hernia repair 16 13% Ventral hernia repair 17 21% Hernia repair 29 36% Other mesh surgery 5 6% Other mesh surgery 5 6% Total 81 SUI repair % POP repair % POP and/or SUI repair 47 58% POP & SUI repair 163 2% Figure 2 is a multi-level visual chart which provides an overview of the 81 surgical mesh-related claims by surgery type groups, surgery type and primary injury or symptom. Read the multi-level chart from inside > out: The centre ring shows that of the 81 claims, 58% are related to POP and/or SUI repair, 36% are related to hernia repair and 6% are related to other mesh surgeries. The middle ring provides a breakdown of surgery types. Of the 81 claims, 24% are related to POP repair and 21% are related to ventral hernia repair. The outside ring provides a breakdown of primary injury or symptom associated with the surgery type. 32 P age

33 Table 6: Number of surgical mesh-related claims by surgery type groups by primary injury/symptom Surgical mesh-related claim counts by surgery type groups by primary and secondary injury/symptom from 1 July 25 to 3 June 217 POP and/or SUI repair Hernia repair Other mesh surgery Primary injury/symptom n % Primary injury/symptom n % Primary injury/symptom n % Mesh erosion 37 65% Infection 14 48% Infection 15 3% Pain 27 6% Hernia 44 15% Mesh erosion 7 14% Infection 23 5% Pain 16 6% Nerve injury 5 1% Nerve injury 17 4% Nerve injury 14 5% Fistula - other 5 1% Haematoma - bruising 14 3% Haematoma - bruising 12 4% Hernia 5 1% Perineal injury 13 3% Seroma 11 4% Other 9 injuries/symptoms 13 26% Sexual dysfunction 1 2% Mesh erosion 1 3% Scarring 9 2% Mesh migration 1 3% Urinary tract injury 9 2% Gastrointestinal injury 5 2% Urinary Incontinence 5 1% Hydrocele 5 2% Mesh migration 5 1% Bowel injury 5 2% Mesh contraction 4 1% Other 13 injuries/symptoms 18 6% Other 17 injuries/symptoms 27 6% Total 47 Total 29 Total 5 Secondary n % Secondary n % Secondary n % injury/symptom injury/symptom injury/symptom Sexual dysfunction 53 17% Infection 6 29% Infection 13 3% Perineal injury 52 17% Mesh migration 2 1% Wound dehiscence 5 12% Infection 42 13% Wound dehiscence 18 9% Mesh erosion 4 9% Pain 39 13% Pain 16 8% Other 14 injuries/symptoms 18 49% Mesh erosion 32 1% Hernia 15 7% Vascular injury 15 5% Seroma 1 5% Scarring 1 3% Haematoma - bruising 1 5% Urinary tract injury 9 3% Fistula - other 1 5% Haematoma - bruising 9 3% Mesh erosion 6 3% Nerve injury 6 2% Bowel injury 6 3% Urinary Incontinence 5 2% Gastrointestinal injury 4 2% Mesh contraction 5 2% Necrosis 4 2% Perforation - Other 5 2% Vascular injury 4 2% Mesh migration 5 2% Other 16 injuries/symptoms 25 12% Fistula - other 4 1% Urethral injury 4 1% Other 1 injuries/symptoms 17 5% Total 312 Total 28 Total 43 Note: Percentages may not add to 1% due to rounding. Table 6 shows the 81 surgical mesh-related claims by surgery type groups by primary injury and secondary injury/symptom. 33 P age