Adverse Event Reports Relating to Surgical Mesh Implants

Transcription

1 Adverse Event Reports Relating to Surgical Mesh Implants Summary of reports received by August 2017 Page 1 of 26

2 Document History Version Number Revision Date Summary of Changes 0 Dec-2013 Reports received to Dec Mar-2014 Addition of reports received to Mar Sep-2014 Addition of reports received to Jun Apr-2015 Document history information added Addition of reports received to Dec-2014 Gynaecological mesh reports divided into separate tables for Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) devices Summary of reports received added Summary of devices supplied in New Zealand added 4 Jul-2015 Addition of reports received to Jun-2015 Removal of duplicate reports POP report (Ref # Original report #14217.) Following an audit of all reports, Event Dates corrected to reflect the implant date of the device (where this information has been provided) Summary of reports received updated 5 May-2016 Addition of reports received to Mar Summary of reports received updated Removal of a duplicate report (#18962) 6 Sept-2016 Addition of reports received to Sept-2016 Summary of reports received updated Event Dates corrected to reflect the implant date of the device (where this information has been provided) 7 Dec-2016 Addition of reports received to Nov-2016 Summary of reports received updated 9 Aug-2017 Addition of reports received up to 21 July-2017 Corrections and additions to reported adverse events as a result of data verification. Reformatted tables to better identify date of implant, and date of report received at. Page 2 of 26

3 Summary of devices supplied in New Zealand for the period 1 Jan 2005 to 31 March 2017 uses adverse event reports to monitor the safety of medical devices. This is part of the ongoing monitoring and compliance activities undertaken by. An adverse event report does not mean that the medical device is the cause of the adverse event. If you are experiencing an adverse event, or think you may be experiencing one, please seek advice from a health professional as soon as possible. Page 3 of 26

4 Table of Contents About... 5 Introduction... 5 Report Period... 5 Key to data tables... 6 Summary of data supplied to... 7 Summary of Reports... 7 Summary tables... 8 Report summaries Reporting a Medical Device Adverse Event Who can report an adverse event? Investigation of reports Page 4 of 26

5 About is the New Zealand Medicines and Medical Devices Safety Authority and is responsible for the regulation of therapeutic products in New Zealand through administration of the Medicines Act is a business unit of the New Zealand Ministry of Health. s Mission is: To enhance the health of New Zealanders by regulating medicines and medical devices to maximise safety and benefit. In working to achieve the stated mission : - applies accepted international practice to the regulation of therapeutic products - provides efficient services measured against agreed stated performance indicators - prepares and maintains regulatory guidelines reflecting sound science and promoting evidence based decisions - applies processes that are consistent, transparent and minimise the costs of regulatory action - provides timely and unbiased information to health professionals and consumers about the safe use of therapeutic products. Introduction Concerns have been raised about the implantation of surgical mesh devices for the treatment of pelvic organ prolapse, stress incontinence, and hernia repair. has been monitoring adverse events relating to surgical mesh devices and has made a commitment to making a summary of these reports available to the public. The first report was published in August For some reports, information has not been available or obtainable. For further information about surgical mesh devices please refer to the information published on the website at the link below: Report Period This report covers adverse event reports received by from 2005 until 21 July Page 5 of 26

6 Key to data tables The table below explains the information contained in this summary. Guide to table Field Report Date Implant Date Adverse Event Sponsor Brand Name Model Batch/Lot Explanation Date the report was received by Date the device was originally implanted in the patient Description of adverse event experienced by patient The New Zealand supplier of the device Model name or family name of device Manufacturer s model number/order code of device (where known) Manufacturer s batch/lot number of device (where known) number for the report in the post market investigation database. Page 6 of 26

7 Summary of data supplied to Summary of Reports Since 2005 has received a total of 144 adverse event reports relating to surgical mesh and stress urinary incontinence devices. By product types the numbers of reports received are: Stress Urinary Incontinence devices 74 Surgical Mesh (Pelvic Organ Prolapse, POP) 61 Surgical Mesh (hernia) These reports have been received from a range of reporters as summarised below: Suppliers of devices (sponsors) 27 Manufacturer of device 2 Healthcare professionals 4 Accident Compensation Corporation (ACC) 118 Patients To better understand the rate of incidents being reported requested information about the quantity of devices supplied in New Zealand between 2005 and March The information supplied by the importers of these devices in New Zealand is summarised in the table on the next page. (Note that these figures relate to the number of devices supplied in New Zealand and not the number of devices implanted.) Page 7 of 26

8 Summary tables Table 1 summarises the number of different devices supplied in New Zealand. Table 2 summarises the number of adverse reports submitted to. Table 1: Summary of devices supplied in New Zealand for the period 1 Jan 2005 to 31 March 2017 Product Grouping Units Total Urinary Incontinence Products (male) Urinary Incontinence Products (female) Pelvic Organ Prolapse Products Hernia products in relation to groin, ventral repairs , Total to 31 March Page 8 of 26

9 Table 2 Summary of adverse event reports received by by year report received for the period 1 Jan 2005 to 21 July 2017 Product Grouping Stress Urinary Incontinence Devices Pelvic Organ Prolapse Devices Hernia Devices Product Grouping Stress Urinary Incontinence Devices Pelvic Organ Prolapse Devices Hernia Devices Total number Page 9 of 26

10 Report summaries The following tables provide summary data on the adverse reaction reports provided to. Table 3 summarises reports concerning stress urinary incontinence devices. Table 4 summarises reports concerning pelvic organ prolapse surgical mesh reports provided to. Table 5 summarises reports concerning hernia mesh device reports provided to. Table 3: Stress Urinary Incontinence (SUI) Devices Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 2/04/2015 Mesh Transvaginal Tape /01/ /05/2015 Erosion TVT mesh /05/ /06/2015 Abdominal pain 29/11/ /07/2011 Infection 3/12/ /05/2014 Chronic pain and dyspareunia Ethicon Gynecare TVT device Monarc Subfascial Hammock Monarc Subfascial Hammock /01/2005 3/02/2009 Infection Tyco IVS Tunneller 13/01/ /03/2014 Mesh Tyco IVS Tunneller 6/05/2005 3/10/2011 Bladder perforation Ethicon Gynecare TVT Device B Zealand Covidien NZ Covidien NZ Zealand 5/08/ /09/2008 Infection TVT Prolene /10/ /04/2008 Protruding tape SPARC Sling Page 10 of 26

11 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 5/07/ /04/ /07/ /04/2008 7/09/ /03/ /10/2006 4/08/ /11/2006 2/05/ /11/ /08/2016 1/01/2007 9/02/2015 1/01/ /05/ /01/ /04/ /08/2007 4/12/2015 Erosion, vaginal tear Blood loss, procedural complications Lower body pain, incontinence Extrusion of the tape Ongoing leg and vaginal pain Pain and incontinence Mesh exposure and Tissue damage, pelvic pain Urinary retention Bilateral s Ethicon Gynecare TVT B Ethicon Gynecare TVT Tyco Healthcare IVS Tunneler IVS-02 04H-109 Zealand Zealand Covidien NZ TVT Mesh Monarc Subfacial Sling AMS Monarc Sling (AMS) Apogee and Perigee mesh s Tyco IVS Tunneller IVS-02M 06C269 Gynecare Gynamesh PS Mesh TVT-O (tension free vaginal tape obturator) SUI GPSL XAD746 Covidien NZ Zealand Page 11 of 26

12 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 11/10/ /04/2008 1/01/ /08/2014 1/01/ /05/2015 Ongoing pain, Erosion, recurrent Urinary infections Erosion, pelvic pain 17/10/2008 2/04/2017 Infection 27/11/ /06/2013 Mesh 28/11/ /09/2013 2/12/ /03/ /12/ /09/2013 1/01/2009 9/02/2015 Pain and mesh Small abscess, infection Pain and mesh Pain and mesh Textile Hi-tec THT Gynecare TVT Tape/ Colposuspension Gynecare PROLIFT Posterior Pelvic Floor Repair Monarc TVT Sling (SUI) AdVance Transorburator Sling Ethicon TVT Obturator Ethicon TVT Obturator Ethicon TVT Obturator Monarc Transobturator Tape B PFRP Surgical Supplies Limited NZ Zealand Zealand Zealand Zealand Zealand Zealand Page 12 of 26

13 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 1/03/2009 9/02/2015 4/04/ /02/2013 Abdominal pain, Constant pain, urinary retention 18/05/ /07/2015 Mesh Monarc tape SPARC Transvaginal Sling Gynecare TVT Obturator /06/ /07/2009 Pain Ethicon TVTO /06/2007, 20/09/2009 1/12/2015 Urethral stenosis 3/12/2009 9/02/2015 Tissue damage 1/01/2010 9/02/2015 Vaginal ulcer 24/05/ /04/2016 Severe pains 2/08/ /08/2013 injury 18/11/ /03/2014 Tape SPARC Sling/TVT Tape/Colposuspension Ethicon Transobturator tape Trans Vaginal Tape (TVT) AMS Monarc Sling Obtryx Single Sling Ethicon Gynecare TVT Tape , Zealand Zealand B Boston Scientific NZ Zealand 8/12/2010 7/06/2017 Mesh TVT Tape /01/2011 9/06/2016 Erosion TVT Tape/Colposuspension Page 13 of 26

14 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 26/05/ /06/2015 Mesh exposure TVT device /11/2011 9/02/2015 Erosion 1/01/ /03/2013 Mesh 8/02/ /03/2017 Mesh extrusion 26/03/ /05/ /06/2012 6/06/ /09/ /03/ /10/ /08/2016 Mesh stricture & Vaginal discharge Dyspareunia due to Vaginal discharge and discomfort 6/05/2013 6/04/2017 Erosion 18/06/ /04/2016 Abdominal and pelvic pain, Trans Vaginal Tape (TVT) Ethicon Gynecare TVT Obturator Trans vaginal tape (TVT) Zealand Tension free trans vaginal tape Smith & Nephew Monarc Sling Ehticon Gynecare TVT Sling (for SUI) Ethicon Gynecare Exact TVTRL B Smith & Nephew Zealand Zealand 29/08/2013 6/03/2015 Mesh TVT device /09/ /05/2017 Unable to void Monarc Subfascial Hammock Page 14 of 26

15 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 7/10/2013 8/07/ /12/ /08/2015 1/02/2014 8/06/2015 Bladder infections, pain, Urethral-vaginal fistula,, pain Mesh, voiding dysfunction A M I Multi-Purpose Sling Transvaginal (TVT) Tape Ethicon Gynecare TVT Exact device AMI CE0297 Batch: PFR5021 Lot: Endoventure TVTRL Zealand 11/03/2014 6/01/2015 Mesh exposure Transobturator Sling /04/2014 6/01/ /04/ /02/2017 Incontinence, Pain and trouble urinating Tension Free Vaginal Tape Gynecare TVT Exact Continence TVTRL /07/ /07/2015 Mesh TVT device /07/ /11/2015 Erosion of vaginal mesh 1/08/2014 8/06/2015 Mesh exposure AMS SPARC Sling Ethicon Gynecare TVT Exact device TVTRL /08/2014 9/02/2015 Mesh Alcon Monarc Mesh /10/ /07/2015 Vaginal pain, 23/03/2015 7/09/2015 Mesh exposure Monarc Subfascial Hammock Gynecare Tension Free Blue ProleneVaginal Tape B Zealand Zealand Page 15 of 26

16 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 30/03/ /11/2015 Erosion Ethicon Gynecare TVT B Zealand 8/04/2015 7/06/2017 Right groin pain TVT-O /04/2015 9/02/2016 Exposed mesh 20/08/2015 7/06/2017 Pudendal & Obturator nerve neuropraxia 9/09/ /04/2017 Severe pain Ethicon Gynecare TVT Abbrevo Zealand Monarch Tape Ethicon Gynecare TVT-O Sling /09/2015 9/02/2016 Erosion Ethicon TVT Tape /12/2015 4/08/2016 Exposed TVT Gynecare TVT Exact Continence TVTRL Zealand 29/02/ /05/2017 Pain in groin Monarc Sling /05/ /05/2017 Tape TVT Tape Page 16 of 26

17 Table 4: Reports - Pelvic Organ Prolapse (POP) Surgical Mesh Devices Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 1/01/ /05/2015 1/01/ /05/2015 1/03/ /03/2013 Pelvic pain, incontinence Pelvic pain, incontinence Pain and incontinence Ethicon Gynecare TVT system Prolift Pelvic Floor Repair Gynemesh Prolene Soft Mesh PFRA GPSLL02 ZLB416 1/03/2015 7/06/2017 Recurrent UTI Uphold Mesh /06/2012 3/07/2013 Pain and discomfort 1/12/2008 7/01/2011 Pain 10/02/2011 9/10/2013 Pain and 10/03/ /02/2017 Pain in pelvic region 11/03/ /09/2013 Pain and 11/05/2010 7/11/2016 Superficial mesh 11/05/ /03/2014 Mesh Ethicon Mesh Prolift Pelvic Floor Repair Prosima Pelvic Floor Repair Polypropylene tape Ethicon Gynemesh PS surgical mesh Vaginal Pro-lift Mesh Caldera Ascend AC Mesh PFRA GPSL ZLB Rev A Mediflex Surgical Products Page 17 of 26

18 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 11/07/2008 2/10/ /08/2009 2/05/2014 Rectal bleeding, Bowel and hip pain, nausea 11/12/ /04/2008 Erosion 13/01/ /03/2014 Bleeding and pain, 13/03/ /04/2008 Mesh extrusion 13/04/ /09/2013 Pain and 13/09/2011 1/02/2012 Nocturnal urinary incontinence, pain, infection, Ethicon Gynecare Vaginal mesh Ethicon ULTRAPRO Mesh Gynecare Gynemesh PS Ethicon Gynecare mesh Gynecare Gynemesh PS Ethicon Gynemesh PS surgical mesh AMS Elevate Mesh Repair UMN3 GPSL L02 BD8JXWRO XBE /09/ /05/2017 Haematoma /07/ /04/2008 Haematoma, 16/10/ /07/2009 Mesh 17/01/ /09/2013 Pain and AMS Apogee & Perigee s ETHICON Gynemesh PS Prolift Pelvic Floor Repair GPSL.LOZ ZHE Page 18 of 26

19 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 17/06/ /11/2008 Mesh 17/11/2009 7/11/2011 Erosion, vaginal tear 18/05/ /07/2015 Mesh 18/11/ /03/2014 TVT tape eroded 19/04/2010 7/09/ /05/ /04/ /05/2010 4/07/2014 Mesh penetration into rectum Bleeding and discharge, Pain and infection 20/05/2010 7/11/2014 Chronic pain 20/10/ /02/2010 Erosion, infection 21/09/2008 9/02/2016 Mesh exposure 21/12/ /07/2014 Erosion AMS Perigee mesh with IntePro Atrium Prolite Mesh Ethicon PROLIFT Pelvic Floor Repair Prolift Pelvic Floor Repair AMS Interpro-Y Graft Mesh AMS Apogee & Perigee s Perigee polypropylene Mesh AMS Perigee AMS Intepro Lite surgical mesh Ethicon Prolift Mesh Ethicon Gynecare Mesh 3/0 Ethibond PFRT PFRA Atrium NZ Limited Page 19 of 26

20 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 23/09/ /11/ /09/2004 9/10/2013 Further prolapse, pain Pain and mesh 24/03/ /02/2013 Pain 24/03/2010 8/07/2013 Pain and inflammation 24/03/ /08/2016 Exposed mesh 25/01/ /04/ /05/ /06/ /09/ /04/2016 Mesh, urinary retention Severe pain and bleeding Infection, pain, mesh exposure 26/01/ /03/2017 Mesh extrusion 27/11/ /06/2013 Erosion 28/09/ /08/2013 injury Gynemesh PS Surgical Mesh Gynemesh Ethicon ULTRAPRO Mesh Ultra Pro Mesh UMN3 Ethicon Prolift Pelvic Floor Repair Gynecare Gynemesh PS UMN3 UMN3 BL8MQJRO BL8MQJRO APRA GPSL XAD746 Pty Surgical mesh AMS Apogee & Perigee s PROLIFT Vaginal Mesh Apogee & Perigee s with Intepro Uphold Vaginal Support M Boston Scientific NZ Page 20 of 26

21 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 28/09/ /02/2014 Severe pain 28/11/ /09/2013 Pain and 29/05/2006 2/05/2017 Mesh 29/05/2006 2/05/2017 Mesh 29/09/ /09/2013 Pain and 31/03/ /09/2013 Pain and 31/08/ /01/2013 Erosion 4/08/ /09/2013 Pain and 5/05/2003 6/03/2015 Abdominal pain, 6/08/2002 8/06/2015 Mesh Perigree Monarc Uphold Subfascial Hammock Ethicon Gynemesh PS AMS Apogee & Perigee s AMS Monarc Sling Prolift Pelvic Floor Repair Prolift Pelvic Floor Repair Uphold Vaginal Support Prolift Pelvic Floor Repair Ethicon VYPRO II Mesh, 15x10cm Ethicon Gynemesh PROLENE Mesh M ML Boston Scientific NZ M PVM2N3 ML RH8GTQD0 6/09/2006 9/10/2013 Pain and Prolift Mesh Boston Scientific NZ Page 21 of 26

22 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 7/09/ /03/2013 Lower body pain, incontinence 7/09/2006 2/09/2016 Infection 8/05/2013 2/08/2013 Erosion 9/03/2007 8/06/ /09/ /01/2014 Bleeding and discharge, Tissue, pain, bleeding Experiencing complications Ethicon Gynecare Prolift Mesh Prolift Pelvic Floor Repair Uphold Vaginal Support Prolift Pelvic Floor Repair Surgical mesh for vaginal application PERT PFRT M PFRT Boston Scientific NZ Surgical Mesh Page 22 of 26

23 Table 5: Hernia Mesh Devices reports Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 26/10/ /05/2017 Bowel obstruction Blood vessel perforation PROCEED Ventral Patch Pty /06/2017 Wound infection /06/2017 Infected mesh /08/2000 7/10/ /10/2003 8/06/2015 1/01/ /05/2015 Bowel perforation Bowel fistula, fistula, organ failure 30/01/ /12/2012 Immense pain 1/01/ /05/ /03/ /08/ /12/ /12/2009 Recurrence of hernia Recurrence of hernia Bowel obstruction Surgipro Prolene Mesh ETHICON Prolene Mesh Ethicon Prolene 6" x 6" mesh Atrium Medical Prolite Mesh Covidien NZ Atrium NZ Limited Surgipro Mesh SPM35 A6G Bard Composix Kugel Mesh HUTD /01/ /08/2016 Mesh separated Surgipro Mesh SPMM66 A9F /08/ /05/2017 Scar tissue /06/2011 7/06/2017 Infection /06/ /04/2016 Infection TycoHealthcare Parietex 8257 TEC1510 SLE00394 Covidien NZ Page 23 of 26

24 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 28/10/2011 1/04/2017 Severe pain 1/01/ /09/2012 Scarring 2/03/2012 1/04/2017 Incisional hernia Atrium Prolite mesh Physiomesh Composite mesh Atrium CQur Mesh PHY1520V Atrium NZ Limited Atrium NZ Limited 22/05/ /05/2017 Fluid collection /05/ /05/2017 Infection /10/ /09/2016 Foreign body reaction 16/11/ /11/2013 Mesh tore TYCO Parietene Surgical mesh Covidien Parietex PCO Mesh SNF0078, SND /05/2014 4/12/2016 Mesh shrunk C-QUR V-Patch /05/ /05/2016 Failure to integrate forming a hard mass Permacol Biological mesh Covidien NZ PCO3020OSX PLL00147 Covidien NZ Maquet Australia Pty (NZ) /07/ /05/2017 Pain /08/2014 9/06/2016 Pain and nausea. J&J Vypro mesh VYPRO II Mesh; PVN2P3 GK8HQGQ0 24/03/ /05/2017 Small recurrence /11/2015 1/04/2017 Constant pain. Ethicon Physiomesh PHY1520V JHBGPMCO /01/ /05/2017 Infection /02/ /05/2017 Tissue loss /04/2016 9/01/2017 Infection Parietex TECR1510 SPK0527X Page 24 of 26

25 Implant Date Report Date Adverse Event Brand Name Model Batch/Lot Sponsor 3/06/ /05/2017 Recurrence of hernia /06/ /05/2017 Persistent pain /07/2016 7/06/2017 Wound infection /08/2016 7/06/2017 Thigh numbness /09/ /05/2017 Burning pain /09/ /05/2017 Seroma /01/ /05/2017 Inflamed wound /01/ /05/2017 Haematoma /02/ /05/ /02/2017 7/06/2017 Perforation in bowel Wound break down /02/ /05/2017 Haematoma /02/ /05/2017 Infection /03/ /05/2017 Extra-peritoneal collection /03/2017 6/06/2017 Haematoma /05/ /07/2017 Infected mesh 23/05/ /07/2017 Infected mesh Right Bard 3DMax Mesh Left Bard 3DMax Mesh HUAX HUAX0039 1/01/2018 7/06/2017 Incisional hernia Page 25 of 26

26 Reporting a Medical Device Adverse Event Adverse events that cause injury and that are associated with medical devices should be reported to. Such events may be indicative of a quality or safety issue that needs to be addressed in some form. By reporting these to seemingly isolated incidents may be collated and responded to. Who can report an adverse event? Anyone can submit an adverse event report. Patients, caregivers, healthcare professionals and suppliers are all encouraged to lodge an adverse event report if an incident has occurred and there is a concern about the safety of the device or its use. See information on the link below: Investigation of reports All adverse events are reviewed by with both safety and quality issues being considered. As part of these reviews further information may be requested from the reporter and/or the device supplier. If necessary, may also contact overseas regulatory agencies to ascertain whether they have received similar reports about the device. All reports received are retained by. Page 26 of 26