Transvaginal retropubic sling systems: efficacy and patient acceptability

Figures & data

Table 1 Available retropubic sling kits

Kit	Material classification	FDA 510(k) premarket notification* date	References	Number of patients per reference
RetroArc (American Medical Systems)	Type I, knitted macroporous, monofilament polypropylene mesh	November 20, 2013	N/A
SPARC (American Medical Systems)	Type I, knitted macroporous, monofilament polypropylene mesh	August 1, 2001	Andonian et al^Citation25	84
			Deval et al^Citation45	104
			Dietz et al^Citation24	106
			Heidler et al^Citation47	46
			Hodroff et al^Citation49	445
			Kobashi and Govier^Citation50	150
			Lord et al^Citation26	301
			Paick et al^Citation28	94
			Primus^Citation48	103
			Siddiqui et al^Citation46	100
			Tseng et al^Citation27	62
Align (Bard)	Type I, knitted macroporous, monofilament polypropylene mesh	March 21, 2007	Kawasaki et al^Citation21	28
Advantage (Boston Scientific)	Type I, knitted macroporous, monofilament polypropylene mesh	N/A	Basu and Duckett^Citation52	33
			Lim et al^Citation22	664
			Renganathan et al^Citation51	70
Lynx (Boston Scientific)	Type I, knitted macroporous, monofilament polypropylene mesh	N/A	Agarwala and Griffin^Citation23	83
			Noblett et al^Citation53	102
Desara (Caldera)	Type I, knitted macroporous, monofilament polypropylene mesh	May 8, 2008	N/A
Supris (Coloplast)	Type I, knitted, macroporous, monofilament polypropylene mesh	June 24, 2011	N/A
Gynecare TVT (Ethicon)	Type I, knitted, macroporous, monofilament polypropylene mesh	October 26, 2011	Abouassaly et al^Citation59	241
			Agarwala and Griffin^Citation23	83
			Andonian et al^Citation25	84
			Dietz et al^Citation24	106
			Hong et al^Citation42	375
			Karram et al^Citation58	350
			Kawasaki et al^Citation21	28
			Klutke et al^Citation39	598
			Kuuva and Nilsson^Citation32	1,455
			Levin et al^Citation33	241
			Lim et al^Citation22	664
			Lord et al^Citation26	301
			Meschia et al^Citation30	404
			Nilsson et al^Citation34	80
			Nilsson et al^Citation35	101
			Nilsson et al^Citation37	85
			Nilsson et al^Citation41	69
			Olsson and Kroon^Citation38	51
			Paick et al^Citation28	94
			Paick et al^Citation44	274
			Rezapour and Ulmsten^Citation36	34
			Shippey et al^Citation56	109
			Tamussino et al^Citation31	2,795
			Tincello et al^Citation29	437
			Tseng et al^Citation27	62
			Tsivian et al^Citation43	55
			Tsivian et al^Citation61	200
			Ulmsten et al^Citation40	50
			Wang^Citation60	600

Notes:

* FDA 510(k) Premarket Notification is a premarketing submission made to the FDA to demonstrate that the device to be marketed is as safe and effective as (or substantially equivalent to) a legally marketed device that is not subject to premarket approval. Premarket notification (510[k]) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements.

Abbreviations: FDA, US Food and Drug Administration; N/A, not available.

Table 2 Discontinued suburethral retropubic sling kits by manufacturer

Sling kit name	Manufacturer	Year discontinued	Number of MAUDE* complaints
Avaulta Plus	Bard	2012	>500
Pelvilace	Bard	N/A	182
Uretex	Bard	N/A	154
ProteGen	Boston Scientific	1999	19

Notes: Table is based on data from Drugwatch.com.⁵⁷

* The FDA MAUDE database lists reported adverse events associated with each sling kit.

Abbreviations: N/A, not available; FDA, US Food and Drug Administration; MAUDE, Manufacturer and User Facility Device Experience Database.

Table 3 Adverse effects of retropubic sling kits

Sling kit name (name of company)	Study	N	Number of patients reporting adverse effects (% with respect to N)
			Persistent SUI	Worsening SUI	De novo overactive bladder symptoms	Hematoma	UTI	Intraoperative bladder perforation	Vaginal erosion
Gynecare TVT (Ethicon)	Abouassaly et al^Citation59	241	14 (5.8%)		33 (13.6%)	4 (1.9%)	25 (11.8%)	14 (5.8%)	2 (0.8%)
	Hong et al^Citation42	375			12 (3.2%)	4 (1.1%)	5 (1.3%)	35 (9.3%)
	Karram et al^Citation58	350	6 (1.7%)			6 (1.7%)	38 (10.9%)	17 (4.9%)	3 (0.9%)
	Klutke et al^Citation39	598	1 (0.1%)
	Kuuva and Nilsson^Citation32	1,455			11 (0.8%)	34 (2.3%)	59 (4.1%)	56 (3.8%)
	Levin et al^Citation33	241	16 (6.6%)		20 (8.3%)				4 (1.7%)
	Meschia et al^Citation30	404						24 (5.9%)
	Nilsson et al^Citation34	80			5 (6.3%)		6 (7.5%)
	Nilsson et al^Citation35	101		2 (2.0%)
	Paick et al^Citation44	274			3 (1.7%)		1 (0.4%)	13 (4.7%)
	Tamussino et al^Citation31	2,795				19 (0.7%)	475 (17%)	75 (2.7%)
	Tincello et al^Citation29	437		1 (0.2%)	15 (3.4%)	2 (0.5%)	9 (2.1%)	10 (2.3%)	7 (1.6%)
	Tsivian et al^Citation43	55						3 (5.8%)	2 (3.8%)
	Tsivian et al^Citation61	200					9 (4.5%)	1 (0.5%)	4 (2.0%)
	Wang^Citation60	600						5 (0.8%)
SPARC (American Medical Systems)	Deval et al^Citation45	104			12 (11.5%)
	Heidler et al^Citation47	46			5 (10.9%)
	Kobashi and Govier^Citation50	150				4 (2.9%)
	Siddiqui et al^Citation46	100				1 (1.0%)		1 (1.0%)	1 (1.0%)
Advantage (Boston Scientific)	Basu and Duckett^Citation52	33	1 (3.0%)
	Renganathan et al^Citation51	70	4 (5.7%)		2 (2.9%)
Lynx (Boston Scientific)	Noblett et al^Citation53	102			6 (5.9%)				5 (4.9%)

Abbreviations: N, total number of patients in study; SUI, stress urinary incontinence; UTI, urinary tract infection.

Table 4 Positive and negative treatment outcomes of retropubic sling kits

Sling kit name	Study	NT	N with positive treatment outcomes (% with respect to NT)			N with negative treatment outcomes (% with respect to NT)
			Objective cure*	Subjective cure*	Recommend to a friend	Failed operation**	No change
Gynecare TVT (Ethicon)	Hong et al^Citation42	375	335 (89.3%)	341 (91.0%)
	Klutke et al^Citation39	598				17 (2.8%)
	Meschia et al^Citation30	404	364 (90.1%)	377 (93.3%)
	Nilsson et al^Citation34	80	65 (81.3%)	65 (81.3%)
	Nilsson et al^Citation35	90	42/46 (91.3%)	48/55 (87.3%)			5 (5.0%)
	Nilsson et al^Citation37	85	72 (84.7%)	72 (84.7%)		4 (4.7%)
	Nilsson et al^Citation41	69	55 (79.7%)	53 (76.8%)
	Olsson and Kroon^Citation38	51	46 (90.2%)	46 (90.2%)		2 (3.9%)
	Paick et al^Citation44	274	249 (90.9%)	249 (90.9%)
	Rezapour and Ulmsten^Citation36	34	28 (82.4%)	28 (82.4%)		3 (8.8%)
	Tamussino et al^Citation31	2,795				68 (2.4%)
	Tsivian et al^Citation43	55	41/52 (78.9%)	41/52 (78.9%)
	Ulmsten et al^Citation40	50	43 (86%)	43 (86%)
SPARC (American Medical Systems)	Deval et al^Citation45	104	94 (90.4%)	75 (72.1%)
	Heidler et al^Citation47	46	35 (76.0%)	24 (52.2%)	45 (97.8%)
	Hodroff et al^Citation49	445			374 (84.0%)
	Primus^Citation48	103	87 (84.5%)	77 (74.8%)
Lynx (Boston Scientific)	Noblett et al^Citation53	102	92 (90.2%)	92 (90.2%)		10 (9.8%)

Notes:

* Objective outcomes were determined by a negative cough, stress test in standing position, or pad test. Subjective outcomes were determined by patient self-reported responses to a validated questionnaire such as the Incontinence Impact Questionnaire, the Urogenital Distress Inventory, or the Patient Global Impression of Improvement.

** Criteria for a failed operation vary by study, but they include slight or no improvement in SUI symptoms and low patient satisfaction. Nilsson et al³⁴ and Tsivian et al⁴³ list a different number of participants (N_T) because original studies began with 90 and 55 women respectively; however, at follow up, not all women could be reached so the number of participants that were able to report was reduced.

Abbreviations: N_T, total number of patients in study; N, number of patients; SUI, stress urinary incontinence.

AndonianSChenTSt-DenisBCorcosJRandomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): One-year resultsEur Urol200547453754115774255

 PubMed Web of Science ®Google Scholar

DevalBLevardonMSamainEA French multicenter clinical trial of SPARC for stress urinary incontinenceEur Urol200344225425912875946

 PubMed Web of Science ®Google Scholar

DietzHPFooteAJMakHLJWilsonPDTVT and Sparc suburethral slings: a case-control seriesInt Urogynecol J2004152129131

 Web of Science ®Google Scholar

HeidlerSOfner-KopeinigPPuchweinEPummerKPrimusGThe suprapubic arch sling procedure for treatment of stress urinary incontinence: a 5-year retrospective studyEur Urol201057589790119819616

 PubMed Web of Science ®Google Scholar

HodroffMASutherlandSEKeshaJBSiegelSWTreatment of stress incontinence with the SPARC sling: Intraoperative and early complications of 445 patientsUrology200566476076216230134

 PubMed Web of Science ®Google Scholar

KobashiKCGovierFEPerioperative complications: the first 140 polypropylene pubovaginal slingsJ Urol200317051918192114532807

 PubMed Web of Science ®Google Scholar

LordHETaylorJDFinnJCA randomized controlled equivalence trial of short-term complications and efficacy of tension-free vaginal tape and suprapubic urethral support sling for treating stress incontinenceBJU Int200698236737616879679

 PubMed Web of Science ®Google Scholar

PaickJSOhSJKimSWKuJHTension-free vaginal tape, suprapubic arc sling, and transobturator tape in the treatment of mixed urinary incontinence in womenInt Urogynecol J2008191123129

 Web of Science ®Google Scholar

PrimusGOne year follow-up on the SPARC sling system for the treatment of female urodynamic stress incontinenceInt J Urol200613111410141417083393

 PubMed Web of Science ®Google Scholar

SiddiquiKRajHFlynnRJGraingerRThornhillJAMinimally invasive treatment of female stress urinary incontinence: 100 cases using SPARC slingIr J Med Sci20081771394218172575

 PubMed Web of Science ®Google Scholar

TsengLHWangACLinYHLiSJKoYJRandomized comparison of the suprapubic arc sling procedure vs tension-free vaginal taping for stress incontinent womenInt Urogynecol J2005163230235

 Web of Science ®Google Scholar

KawasakiAEdenfieldALViscoAGWuJMWestreichDSiddiquiNYComparing the risk of urethrolysis for the treatment of voiding dysfunction between two retropubic mesh slings: a case-control studyInt Urogynecol J201324458959422911449

 PubMed Web of Science ®Google Scholar

BasuMDuckettJThree-year results from a randomised trial of a retropubic mid-urethral sling versus the Miniarc single incision sling for stress urinary incontinenceInt Urogynecol J201324122059206423712578

 PubMed Web of Science ®Google Scholar

LimYNDwyerPMullerRRosamiliaALeeJStavKDo the Advantage slings work as well as the tension-free vaginal tapes?Int Urogynecol J20102191157116220440476

 PubMed Web of Science ®Google Scholar

RenganathanABasuMDuckettJA series of Advantage suburethral slingsJ Obstet Gynaecol201131652152321823855

 PubMedGoogle Scholar

AgarwalaNGriffinJA Randomized Comparison of GYNECARE TVT and Boston Scientific Lynx Suprapubis Mid-Urethral SlingObstet Gynecol2006107446S47S

 Web of Science ®Google Scholar

NoblettKLShenBLaneFLLynx® midurethral sling system: A 1-year prospective study on efficacy and safetyInt Urogynecol J200819912171221

 Web of Science ®Google Scholar

AbouassalyRSteinbergJRLemieuxMComplications of tension-free vaginal tape surgery: a multi-institutional reviewBJU Int200494111011315217442

 PubMed Web of Science ®Google Scholar

HongBParkSKimHSChooMSFactors predictive of urinary retention after a tension-free vaginal tape procedure for female stress urinary incontinenceJ Urol2003170385285612913715

 PubMed Web of Science ®Google Scholar

KarramMMSegalJLVassalloBJKleemanSDComplications and untoward effects of the tension-free vaginal tape procedureObstet Gynecol20031015 Pt 192993212738152

 PubMed Web of Science ®Google Scholar

KlutkeCSiegelSCarlinBPaszkiewiczEKirkemoAKlutkeJUrinary retention after tension-free vaginal tape procedure: incidence and treatmentUrology200158569770111711343

 PubMed Web of Science ®Google Scholar

KuuvaNNilssonCGA nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedureActa Obstet Gynecol Scand2002811727711942891

 PubMed Web of Science ®Google Scholar

LevinIGroutzAGoldRPauznerDLessingJBGordonDSurgical complications and medium-term outcome results of tension-free vaginal tape: A prospective study of 313 consecutive patientsNeurourol Urodyn20042317914694449

 PubMed Web of Science ®Google Scholar

MeschiaMPifarottiPBernasconiFTension-free vaginal tape: Analysis of outcomes and complications in 404 stress incontinent womenInt Urogynecol J2001122S24S27

 Web of Science ®Google Scholar

NilssonCGFalconerCRezapourMSeven-year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinenceObstet Gynecol200410461259126215572486

 PubMed Web of Science ®Google Scholar

NilssonCGPalvaKAarnioRMorcosEFalconerCSeventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinenceInt Urogynecol J20132481265126923563892

 PubMed Web of Science ®Google Scholar

NilssonCGKuuvaNFalconerCRezapourMUlmstenULong-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinenceInt Urogynecol J2001122S5S8

 Web of Science ®Google Scholar

NilssonCGPalvaKRezapourMFalconerCEleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinenceInt Urogynecol J200819810431047

 PubMed Web of Science ®Google Scholar

OlssonIKroonUBA three-year postoperative evaluation of tension-free vaginal tapeGynecol Obstet Invest199948426726910592431

 PubMed Web of Science ®Google Scholar

PaickJS1KuJHShinJWOhSJKimSWComplications associated with the tension-free vaginal tape procedure: the Korean experienceInt Urogynecol J Pelvic Floor Dysfunct200516321521915875237

 PubMed Web of Science ®Google Scholar

RezapourMUlmstenUTension-free vaginal tape (TVT) in women with recurrent stress urinary incontinence – a long-term follow upInt Urogynecol J2001122S9S11

 Web of Science ®Google Scholar

ShippeySHGreenICQuirozLHHandaVLGutmanREMidurethral sling outcomes: Tension-free vaginal tape versus PelvilaceInt Urogynecol J200819911991204

 Web of Science ®Google Scholar

TamussinoKFHanzalEKölleDRalphGRissPAAustrian Urogynecology Working GroupTension-free vaginal tape operation: results of the Austrian registryObstet Gynecol2001985 Pt 173273611704161

 PubMed Web of Science ®Google Scholar

TincelloDGBothaTGrierDThe TVT Worldwide Observational Registry for Long-Term Data: safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in womenJ Urol201118662310231522014817

 PubMed Web of Science ®Google Scholar

TsivianAMogutinBKesslerOKorczakDLevinSSidiAATension-free vaginal tape procedure for the treatment of female stress urinary incontinence: long-term resultsJ Urol20041723998100015311022

 PubMed Web of Science ®Google Scholar

TsivianAKesslerOMogutinBTape related complications of the tension-free vaginal tape procedureJ Urol20041712 Pt 176276414713805

 PubMed Web of Science ®Google Scholar

UlmstenUJohnsonPRezapourMA three-year follow up of tension free vaginal tape for surgical treatment of female stress urinary incontinenceBr J Obstet Gynaecol1999106434535010426241

 PubMedGoogle Scholar

WangACThe techniques of trocar insertion and intraoperative urethrocystoscopy in tension-free vaginal taping: an experience of 600 casesActa Obstet Gynecol Scand200483329329814995927

 PubMed Web of Science ®Google Scholar

Transvaginal Mesh Recall [webpage on Internet]OrlandoDrugwatch.com2014 Available from: http://www.drugwatch.com/transvaginal-mesh/recall.phpAccessed September 30, 2014

 Google Scholar