1. Background
Hypothesis / Aims
Interpretation
Association of adverse event reporting with discontinuation of a surgical
device: the case of TVT Secur versus TVT Obturator for treatment of stress
urinary incontinence (SUI) in women
Sue Ross; Ariel Ducey; Magali Robert
Department of Obstetrics and Gynecology, University of Alberta, and
Departments of Sociology and Obstetrics and Gynecology, University of Calgary
Alberta, Canada
Gynecare TVT Secur TM
(TVT S)
 1st
single-incision mini-sling device widely available
in North America and Europe for SUI treatment .
• Initially marketed in 2006.
• Discontinued in March 2013 for commercial
reasons
Gynecare TVT Obturator TM
(TVT O)
 Sling device for SUI, marketed in 2003.
 Still in use today.
FDA MAUDE (Manufacturer and User Facility
Device Experience)
Searchable database of US medical device adverse
events (AEs).
Mandatory reporters: Manufacturers, importers, device
user facilities.
Voluntary reporters: Health care professionals,
patients, etc.
Anonymized details include: device name, text
describing AE, who reported, date report received.
Method
Preliminary Results
Acknowledgements: Thanks to - Laura KarisAllen,
Erica Wiebe, Brad Sullivan
Hypothesis:
Reports of TVT S AEs would occur around the time of
TVT-S discontinuation. Reports of TVT O AEs would
be evenly distributed.
Aims:
To review the MAUDE database to explore timing and
type of AE reports for TVT S compared to TVT O, with
particular interest in date of withdrawal of TVT S.
 Retrospective review of MAUDE database for reports
of AEs, January 2007 to July 2015.
 Reports for TVT S . (Search term :TVT Secur)
 TVT O as comparison - device for same condition,
made by same manufacturer. (Search term: TVT O)
 Data collection:
Year of report.
Classification (malfunction, injury, death).
Mention of attorney.
 Reports were excluded if no classification was made.
 # and type of AE for each device collated by year.
TVT-S AE reports
n = 1659
TVT-O AE reports
n = 5116
Year
# (type) of report # (type) of report
2007 1 (1 M) 1 (1 D)
2008 3 0
2009 3 (1 M) 0
2010 1 4
2011 3 4
2012 7 6
2013* 1537 4739 (2 D, 4 M)
2014 93 305 (8 M)
2015 (Jan
to July)
11 57 (2 M)
* TVT-S discontinued 31 March 2013
Type of report: M = malfunction, D = death, all others injury
2013 TVT-S AE reports TVT-O AE reports
Month # reports, attorney mention
Jan/ Feb 0 0
Mar * 0 0
April/May 0 0
June 135 9 ( 7%) 377 14 ( 4%)
July 220 21 (10%) 708 55 ( 8%)
Aug 370 36 ( 8%) 1174 42 ( 4%)
Sept 218 8 ( 4%) 648 25 ( 4%)
Oct 162 30 (19%) 642 89 (14%)
Nov 248 241 (97%) 676 670 (99%)
Dec 184 172 (93%) 514 431 (84%)
Number and type of AE reports
2013: Number AE reports, mention of attorney
Over the study period, attorneys were mentioned in 609
(37%) TVT S reports, 1585 (31%) TVT O reports.
 Few AEs were reported for either device before March
2013.
 For both devices , the number of AE reports, and the
proportion that were reported by attorneys, peaked at
the end of 2013. The number of reports of AEs then
declined.
 MAUDE does not provide sufficient information to
explain the distribution of AE reports.
 Further investigations are underway.