Polypropylene Mesh in Vaginal Surgery A Risk Analysis
Polypropylene Mesh in Vaginal Surgery A Risk Analysis
Polypropylene Mesh in Vaginal Surgery A Risk Analysis
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<strong>Polypropylene</strong> <strong>Mesh</strong> <strong>in</strong> Vag<strong>in</strong>al<strong>Surgery</strong><strong>Risk</strong> <strong>Analysis</strong> & AlternativesMichael T Margolis, MD, FACS, FACOGAssistant Cl<strong>in</strong>ical ProfessorDepartment of Ob/Gyn, UCLA
Conflicts of Interest• Cook Biomedical• Boston Scientific• Wyeth Ayerst• TAP Pharmaceuticals
DEMOGRAPHICS• Average age of menopause US is 50 yrs. & life expectancyof women is 80 yrs thus,• Women live greater than 1/3 of their lives <strong>in</strong> thepostmenopausal years• U.S. Census Data 2006 300 million people <strong>in</strong> the US 152 million women• 60 million women 45 yrs old and greater– 20% of the population
MillionsNET GROWTH IN NUMBER OF WOMEN45 Y/O & OVER (1995-2020)25Million*US Bureau of the Census 1994
DEMOGRAPHICS• S<strong>in</strong>ce the majority of <strong>in</strong>cont<strong>in</strong>ence & prolapseoccurs <strong>in</strong> the late & post-reproductive age group,pelvic floor defects will cont<strong>in</strong>ue to affect largenumbers of women well <strong>in</strong>to the future
LIFETIME RISK OF UNDERGOING ASINGLE OPERATION FOR PROLAPSE ORURINARY INCONTINENCE• Olsen et al Obstet Gynecol 1997;89:501-6• Reviewed literature 50% of parous women have prolapse• Studied women age 20 & up lifetime risk of s<strong>in</strong>gle operation by 80 yrs. 11.1% risk of reoperation = 29.2%
SURGERIES FOR SUIAlmost 200 procedures have been described• Kelly plication• Needle suspension procedures• Retropubic urethropexy: Open, scope & robotic• Sl<strong>in</strong>g operations: Old & new• Periurethral <strong>in</strong>jections• Artificial sph<strong>in</strong>cter• Ur<strong>in</strong>ary diversion
10 YEAR CURE RATES FORVARIOUS PROCEDURES (%)
SOME GENERAL COMMENTSON SLING PROCEDURES
GOEBELL-FRANKENHEIM-STOECKELFASCIA LATA SLING PROCEDURE• First described <strong>in</strong> 1907• Indicated for type III SUI(aka ISD) Characterized by: Absence of urethral hypermobility Low UPP (
SOME GENERAL COMMENTSON SLING PROCEDURES• Sl<strong>in</strong>gs are: by def<strong>in</strong>ition obstructive procedures always done bl<strong>in</strong>dly, thus risk of <strong>in</strong>jury toadjacent organs is high overall, have higher complication rates thanRPU’s
GOEBELL-FRANKENHEIM-STOECKELFASCIA LATA SLING PROCEDURE• Pros:>90% success rate• Cons:Bladder/urethral <strong>in</strong>juriesUrethral obstruction (5-15%)DI
The Fascia Lata Sl<strong>in</strong>g Procedure for Treat<strong>in</strong>gRecurrent Genu<strong>in</strong>e Stress Incont<strong>in</strong>ence ofUr<strong>in</strong>eBeck, RP et al Obstet Gynecol 72:699, 1988• Twenty two year experience with fasciallata sl<strong>in</strong>g• 170 patients• Cure rate 92.4%
SLINGS-Last 15 years• Indications for sl<strong>in</strong>gs liberalized because: Of the <strong>in</strong>crease <strong>in</strong> # of baby boomers reach<strong>in</strong>gmenopause w/ SUI Inexpensive petroleum derived materials arereadily available and cheap Ins companies push<strong>in</strong>g OP procedures over IP Sl<strong>in</strong>gs are easy to teach, easy to perform & fast Sl<strong>in</strong>gs bill out at a high reimbursement rate
What is <strong>Polypropylene</strong>?• Thermoplastic synthetic polymer madefrom the monomer propylene
<strong>Polypropylene</strong>• Applications:Packag<strong>in</strong>gTextilesPlastic partsReusableconta<strong>in</strong>ersIndoor/outdoorcarpet<strong>in</strong>gLaboratoryequipmentLoudspeakersAutomotivecomponentsMedical
What is Propylene?**Dow Product Safety Assessment• Hydrocarbon monomer produced from fossil fuels(petroleum, natural gas and coal)• A colorless, highly flammable gas produced as abyproduct of oil ref<strong>in</strong><strong>in</strong>g & natural gas process<strong>in</strong>g• Dur<strong>in</strong>g oil ref<strong>in</strong><strong>in</strong>g, propylene is produced as aresult of the crack<strong>in</strong>g of hydrocarbon molecules• A major <strong>in</strong>dustrial chemical <strong>in</strong>termediate thatserves as a build<strong>in</strong>g block for an array of chemicaland plastic products <strong>in</strong>clud<strong>in</strong>g polypropylene
TENSION FREE VAGINAL TAPETVT• The most popular of the current sl<strong>in</strong>g proceduresbecause: Outpatient procedure Easy to do & short procedure Tolerable success rate Aggressive market<strong>in</strong>g by <strong>in</strong>dustry• Problem TVT is a sl<strong>in</strong>g & thus has a higher complicationrate than MMK/Burch It carries the risks of polypropylene mesh
PUBLISHED TVTCOMPLICATIONSDeathsMajor vascular <strong>in</strong>jury w/ hemorrhageVisceral <strong>in</strong>juries-bladder/bowelUrethral obstructionDetrusor <strong>in</strong>stabilityPa<strong>in</strong>/dyspareuniaPermanent irreversible synthetic materialrelatedInfection, erosion, fistula
Graft<strong>in</strong>g <strong>in</strong> Gyn <strong>Surgery</strong>-General Theory• Why use graft?OstensiblyStrengthen surgical repairImprove success rateImprove function, anatomy & symptoms of repaired organRequirementsHas to be safeHas to be <strong>in</strong>ertHas to be effectiveComplications have to be lowShould be quickShould be <strong>in</strong>expensiveSHOULD HAVE AN ADEQUATE EXIT STRATEGY-Should beremovable• THE BENEFITS HAVE TO OUTWEIGH THE RISKS
Grafts• BiologicAutologous-selfAllograft-same speciesXenograft-different species• SyntheticPermanent v. absorbableMaterial-polypropyene, gortex, etc.Braided or monofilamentArchitecture (woven or knitted)Pore sizeDensityStiffness
Biology of Prosthetic Implant• Day 3 Inflammation Exudative, then cellular• Day 10 Fibroblastic <strong>in</strong>growth• Week 6 Complete <strong>in</strong>growth• Prosthetic strength doubles from week 3 to 12• Ongo<strong>in</strong>g remodel<strong>in</strong>g of implant persists beyond 12 months* Petit J, J Chir, 1974* Adloff M, Chirugie 1976
EmphasisTransvag<strong>in</strong>al <strong>Polypropylene</strong>• The most common mesh used today• Amid classification type I Macroporous Pore size > 75 microns allows for• High collagen deposition• High capillary penetration• High attachment strength Theoretically resistant to <strong>in</strong>fection• Macrophages enter larger pores
Known Issues to Date Regard<strong>in</strong>g<strong>Polypropylene</strong> <strong>Mesh</strong>• <strong>Mesh</strong> shr<strong>in</strong>kage• <strong>Mesh</strong> ErosionEarly vs Late• <strong>Mesh</strong> Infection• Dyspareunia• Chronic Pelvic Pa<strong>in</strong>• <strong>Mesh</strong> Degradation
<strong>Mesh</strong> Shr<strong>in</strong>kage• <strong>Polypropylene</strong> “cross-hatched” mesh 2D sheets shr<strong>in</strong>k 20% <strong>in</strong> surface area* 3D plugs shr<strong>in</strong>k 75% <strong>in</strong> total volume• Shr<strong>in</strong>kage caused by fibroblast contraction of scar platearound mesh• Results <strong>in</strong> more contraction on adjacent tissue than desired*Amid PK, Hernia 1997
Differences <strong>in</strong> polypropylene shr<strong>in</strong>kage depend<strong>in</strong>gon mesh position <strong>in</strong> an experimental study• Garcia-Urena, MA, et al Am J Surg, 2007Apr;193(4):538-42. <strong>Polypropylene</strong> mesh (5x3.5 cm) implanted <strong>in</strong>to 15rabbits 5 animals each were euthanized at days 30, 60 and 90 <strong>Mesh</strong> areas calculated <strong>Mesh</strong> areas reduced by 25.92%, 28.67% and 29.02%respectively• “These observations support the theory of PP meshshr<strong>in</strong>kage as a consequence of the <strong>in</strong>corporation of thebiomaterial to the scarr<strong>in</strong>g tissue”
<strong>Mesh</strong> Complications ReviewShah & Badlani IJU, 2012• Retraction of tissues surround<strong>in</strong>g the meshis usual with a reduction <strong>in</strong> the size of themesh• Average shr<strong>in</strong>kage is 25-30%• Shr<strong>in</strong>kage may reach 40% of the <strong>in</strong>itialsurface of the implant after surgery
Kl<strong>in</strong>ge U, Klosterhalfen B, et al.Shr<strong>in</strong>k<strong>in</strong>g of polypropylene mesh <strong>in</strong> vivo: an experimentalstudy <strong>in</strong> dogs. Eur J Surg. 1998 Dec;164(12):965-9• 30-50% shr<strong>in</strong>kage rate with polypropylenemesh
Effects of <strong>Mesh</strong> Weight• Heavier (g/m2) mesh associated with Greater and more prolonged <strong>in</strong>flammation Greater scar plat<strong>in</strong>g Less elasticity Ongo<strong>in</strong>g <strong>in</strong>flammation & remodel<strong>in</strong>g at 1 year• Some suggestion that surface area, not justdensity, is responsible.This is why POP kits are moreproblematic than sl<strong>in</strong>gs, there’s moremesh
<strong>Mesh</strong> Erosion
<strong>Risk</strong> Factors for <strong>Mesh</strong> Erosion• Age > 70• Smok<strong>in</strong>g• Concomittent hysterectomy• Stage of prolapse > 2• Estrogen deficiency• Dosage of mesh• Infection
RCT’s <strong>Mesh</strong> Cure & Erosions forAnterior POP• Iglesia 2010 <strong>Mesh</strong> Cure 40.6% Erosion 15.6%• Withagen 2011 <strong>Mesh</strong> Cure 90.4 % Erosion 16.9%• Niem<strong>in</strong>en 2010 <strong>Mesh</strong> Cure 87% Erosion 19%
<strong>Mesh</strong> related <strong>in</strong>fections after POP repair surgeryEur J Obstet Gynecol Peprod Biol Falagas, et al 2007• Incidence of mesh erosion <strong>in</strong>clud<strong>in</strong>gexposure, extrusion and perforation <strong>in</strong>itiallydescribed <strong>in</strong> the literature varies widelyfrom 0-33%
<strong>Mesh</strong> Erosion From ASCP/TAH• Abdom<strong>in</strong>al Sacral Hysteropexy: a pilot studycompar<strong>in</strong>g sacral hysteropexy to sacral colpopexywith hysterectomy.Cvach K, Geoffrion R, Cundiff GW. Female Pelvic Med Reconstr Surg,2012 Sep-Oct; 18(5):286-90• Graft erosion occurred <strong>in</strong> 33% of patientsundergo<strong>in</strong>g TAH with concurrent ASCP• Thus prov<strong>in</strong>g that the problem arises from theimplantation of synthetic mesh through or next toa contam<strong>in</strong>ated wound Biologically plausible-It makes sense
<strong>Mesh</strong> Complications-2012• Vag<strong>in</strong>al Placement of Synthetic <strong>Mesh</strong> for Pelvic Organ Prolapse• Committee on Gynecologic Practice• Female Pelvic Medic<strong>in</strong>e & Reconstructive <strong>Surgery</strong>. 18(1):5-9,January/February 2012.
Adverse Events over Two Years after Retropubic or TransobturatorMidurethral Sl<strong>in</strong>g <strong>Surgery</strong>: F<strong>in</strong>d<strong>in</strong>gs from the Trial of MidurethralSl<strong>in</strong>g (TOMUS) StudyAm J Obstet Gynecol. 2011 November; 205(5): 498.e1–498.e6.4.7% erosion rate with TVTAs an aside, TOMUS also noted:42% adverse event rate20% serious adverse event rate
Tseng, LH, et al Int Urogyn J (2005) 16: 230-235Randomized comparison of the suprapubic arc sl<strong>in</strong>gprocedure vs TVT for SUI• 19.4 % erosion rate with TVT“Rejection of tape”“Protrusion of tape edge”• 29.1% erosion rate with TVT“Defective vag<strong>in</strong>al wound heal<strong>in</strong>g”
Pathologic evaluation of explanted vag<strong>in</strong>al mesh:<strong>in</strong>terdiscipl<strong>in</strong>ary experience from a referral centerSmith, TM, Delancey, JO et al Female Pelvic Med ReconstrSurg. 2013 Jul-Aug;19(4):238-41• Review of 1 <strong>in</strong>stitutions experience w/ path f<strong>in</strong>d<strong>in</strong>gsof explanted vag<strong>in</strong>al mesh over a 2 year period• 102 explants reviewed• Indications for removal 42% for erosion 28 % for pa<strong>in</strong> Ur<strong>in</strong>ary retention 6% Infection 3% No history provided 25%
Pathologic evaluation of explanted vag<strong>in</strong>al mesh:<strong>in</strong>terdiscipl<strong>in</strong>ary experience from a referral centerSmith, TM, Delancey, JO et al Female Pelvic Med ReconstrSurg. 2013 Jul-Aug;19(4):238-41• What conclusions can be drawn?• <strong>Mesh</strong>/sl<strong>in</strong>g complications are common102 removal <strong>in</strong> 2 years at one <strong>in</strong>stitution• Erosion is common42% of all explants
Graft-related complications and biaxial tensiometry follow<strong>in</strong>gexperimental vag<strong>in</strong>al implantation of flat mesh of variabledimensionsManodoro, S et al BJOG. 2013 Jan;120(2):244-50• Gynemesh M implanted <strong>in</strong>to vag<strong>in</strong>a of 20ewes and sacrificed at 60 & 90 days• 5 x 5 cm mesh implants led to exposures <strong>in</strong>30% of cases• Average contraction rate was 52% +/- 14%• 3.5 x 3.5 cm mesh implants did not erodebut contraction rate was 25% +/-26.3%
Comparison of polypropylene mesh and porc<strong>in</strong>e-derived,cross-l<strong>in</strong>ked ur<strong>in</strong>ary bladder matrix materials implanted<strong>in</strong> the rabbit vag<strong>in</strong>a and abdomen• Fan X, et al; Int Urogynecol J. Nov 29, 2013• Forty rabbits implanted with PP mesh (n = 20) or cUBM(n = 20) <strong>in</strong> the vag<strong>in</strong>a & abdomen. Grafts harvested12 weeks later & processed for histology & biomechanicaltest<strong>in</strong>g.• Vag<strong>in</strong>al PP erosion rate was 67 %, whereas abdom<strong>in</strong>alPP and cUBM showed no erosion.• All patches adhered to vag<strong>in</strong>al mucosa and shrank tovary<strong>in</strong>g degrees, especially PP grafts.
Overall Reported Sl<strong>in</strong>g ErosionRates In Humans4.7% - 19.4% (29.1%)
<strong>Mesh</strong> Infection
NORMAL SKIN FLORA• Staphylococcus epidermidis• Staphylococcus aureus• Other Staphylococcus species• Streptococcus species
NORMAL VAGINAL FLORALactobacillusBacteroidesPeptococcusPeptostreptococcusGardnerellaE. coliStreptococcalStaphylococcusMycoplasmasUreaplasmaEnterobacteriaceaeCandidaMobiluncusAc<strong>in</strong>etobacter
Classification of operative wounds based on degree of microbialcontam<strong>in</strong>ation (Adapted fromBerard F, Gandon J, Ann Surg 1964)•Clean-Elective, not emergency, non-traumatic, primarily closed; no acute<strong>in</strong>flammation; no break <strong>in</strong> technique; respiratory, gastro<strong>in</strong>test<strong>in</strong>al, biliary andgenitour<strong>in</strong>ary tracts not entered.•Clean-contam<strong>in</strong>ated-Urgent or emergency case that is otherwise clean;elective open<strong>in</strong>g of respiratory, gastro<strong>in</strong>test<strong>in</strong>al, biliary or genitour<strong>in</strong>ary tractwith m<strong>in</strong>imal spillage (e.g. appendectomy) not encounter<strong>in</strong>g <strong>in</strong>fected ur<strong>in</strong>e orbile; m<strong>in</strong>or technique break.•Contam<strong>in</strong>ated-Non-purulent <strong>in</strong>flammation; gross spillage fromgastro<strong>in</strong>test<strong>in</strong>al tract; entry <strong>in</strong>to biliary or genitour<strong>in</strong>ary tract <strong>in</strong> the presenceof <strong>in</strong>fected bile or ur<strong>in</strong>e; major break <strong>in</strong> technique; penetrat<strong>in</strong>g trauma 4 hours old.•Rates of <strong>in</strong>fection (Cruse and Foord, 1980/1992) 1-2% or less for cleanwounds, 6-9% for clean-contam<strong>in</strong>ated wounds, 13-20% for contam<strong>in</strong>atedwounds and about 40% for dirty wounds
<strong>Mesh</strong> Infection<strong>Mesh</strong> Complications: ReviewShah & Badlani IJU, 2012• Incidence of <strong>in</strong>fection 0-8%• Cl<strong>in</strong>ical presentation Non specific pelvic pa<strong>in</strong> Persistent vag<strong>in</strong>al discharge or bleed<strong>in</strong>g Dyspareunia Ur<strong>in</strong>ary/fecal <strong>in</strong>cont<strong>in</strong>ence Induration of vag<strong>in</strong>al <strong>in</strong>cision Vag<strong>in</strong>al granulation Dra<strong>in</strong><strong>in</strong>g s<strong>in</strong>us tracts Graft erosion
Bacterial Colonization of <strong>Polypropylene</strong>Vag<strong>in</strong>al <strong>Mesh</strong>Vollebregt, et al Int Urogyn, 2009• Culture swabs of core mesh taken dur<strong>in</strong>gsurgical implantation of vag<strong>in</strong>al mesh• 67 implants cultured• 56 (83.6%) implants cultured positive forvag<strong>in</strong>al bacteria• Conclusions: “Colonization of vag<strong>in</strong>allyimplanted mesh occurs frequently”
Bacteriological analysis of meshes removed forcomplications after SUI & prolapse surgery,Boulnager, et al Int Urogynecol J, 2008• 16 mesh systems removed62% for erosion• Cultures performed• Bacterial contam<strong>in</strong>ation found <strong>in</strong> all meshes
Dyspareunia & Chronic Pelvic Pa<strong>in</strong>In Patients Undergo<strong>in</strong>g Sl<strong>in</strong>g and<strong>Mesh</strong> <strong>Surgery</strong>
Dyspareunia*• Up to 24% <strong>in</strong>cidence with TOT• Pts. undergo<strong>in</strong>g POP surgery 6.2%-24.4%• Causes: <strong>Mesh</strong> erosion <strong>Mesh</strong> <strong>in</strong>fection <strong>Mesh</strong> shr<strong>in</strong>kage/contraction Extensive vag<strong>in</strong>al scarr<strong>in</strong>g & fibrosis*<strong>Mesh</strong> Complications: Review Shah & Badlani IJU, 2012
Comparison of DyspareuniaBetween TVT v Burch Patients• Oktay Demirkesen, et al: International Braz J Urol, Vol 32 (2):214-219, March-April, 2008• Evaluated sexual satisfaction ratesfollow<strong>in</strong>g TVT and Burch 23% of TVT group expressed neg. changes (at 34 months) 9% of Burch group expressed neg. changes (at 89 months) Majority suffered from dyspareunia
Ur<strong>in</strong>ary complications and sexualfunction after the TVT procedureMazouni, C et al; Acta Obstetricia et Gynecologica Scand<strong>in</strong>avica, Vol. 83,Issue 10, pages 955-961, Oct 2004• 71 pts. Evaluated before and after TVT• 20% reported impaired sexual function aftersurgery <strong>in</strong>clud<strong>in</strong>g:14.5% with dyspareunia5.4 % with loss of libido
Vag<strong>in</strong>al Contractility After <strong>Mesh</strong>• Deterioration <strong>in</strong> Biomechanical Properties of the Vag<strong>in</strong>aFollow<strong>in</strong>g Implantation of a High-Stiffness Prolapse <strong>Mesh</strong>.Feola, A et al BJOG. 2013 Jan;120(2):224-32• Implanted Gynemesh PS (Ethicon), Smart<strong>Mesh</strong>(Coloplast) & UltraPro (Ethicon) polypropylenemesh systems <strong>in</strong>to vag<strong>in</strong>as of 45 rhesus monkeys• <strong>Mesh</strong> & vag<strong>in</strong>a excised & studied 3 months later• Vag<strong>in</strong>al contractility decreased by 80% withGynemesh PS, 48% after Smart<strong>Mesh</strong> & 68% afterUltraPro
Vag<strong>in</strong>al degeneration follow<strong>in</strong>g implantation ofsynthetic mesh with <strong>in</strong>creased stiffnessLiang, R et al BJOG 2013 Jan;120(2):233-43• 50 rhesus monkeys implanted with Gynemesh PSor UltraPro <strong>in</strong> vag<strong>in</strong>a• 12 control animals without mesh• Magee-Womens Research Institute at U of Pitt• <strong>Mesh</strong>-vag<strong>in</strong>a complex removed and studied after 3months
Vag<strong>in</strong>al degeneration follow<strong>in</strong>g implantation ofsynthetic mesh with <strong>in</strong>creased stiffnessLiang, R et al BJOG 2013 Jan;120(2):233-43• Results Gynemesh PS caused Substantial th<strong>in</strong>n<strong>in</strong>g of the vag<strong>in</strong>a (p=0.02) Increased apoptosis (process of programmed celldeath) <strong>in</strong> the area of the mesh 20% & 43% decreased collagen and elast<strong>in</strong> content(respectively) Increased collagenase activity(135% p=0.01) GAG (a marker of tissue <strong>in</strong>jury) was highest w/Gynemesh PS compared w/ control & other meshes• Conclusion-Gynemesh PS <strong>in</strong>duced a maladaptive responseconsistent with vag<strong>in</strong>al degeneration
Evaluation and Treatment of DyspareuniaSteege, John F MD; Zolnoun, Denniz MD, MPHObstetrics & Gynecology:May 2009-Vol. 113-Issue 5-pp 1124-1136• Of the many studies report<strong>in</strong>g onsuburethral sl<strong>in</strong>gs:“Most do not adequately evaluatedyspareunia”…..but, those that do <strong>in</strong>quire report denovodyspareunia occur<strong>in</strong>g <strong>in</strong> 8-69% of pts.(average 15-30%)
Chronic Pelvic Pa<strong>in</strong>*• Gro<strong>in</strong> & thigh pa<strong>in</strong> <strong>in</strong> 40% TOT pts.• In POP surgery, the <strong>in</strong>cidence of chronicpa<strong>in</strong> published is 1.9%-24%• Causes: <strong>Mesh</strong> erosion <strong>Mesh</strong> <strong>in</strong>fection <strong>Mesh</strong> shr<strong>in</strong>kage/contraction Extensive vag<strong>in</strong>al scarr<strong>in</strong>g & fibrosis*<strong>Mesh</strong> Complications: Review Shah & Badlani IJU, 2012
Trocar Related Injuries• Bladder Urethra, bladder and ureter• Bowel Rectum and small bowel• Blood vessel Iliac, obturator, <strong>in</strong>ferior epigastric and pudendal• Nerve Obturator, pudendal, iliohypogastric
Bladder Perforation Rate• Wei JT, et al, A midurethral sl<strong>in</strong>g to reduce <strong>in</strong>cont<strong>in</strong>enceafter vag<strong>in</strong>al prolapse repair. N Engl J Med. 2012 Jun21;366(25):2358-67• Bladder perforation rate 6.7%• Andonian, S, et al, Randomized cl<strong>in</strong>ical trial compar<strong>in</strong>gSPARC and TVT: one year results. Eur Urol. 2005Apr;47(4):537-41• Bladder perforation 24% vs 23% (SPARC vs TVT)
Bladder Perforation• U.S. experience with TVT procedure for SUI:assessment of safety and tolerability Tech Urol2001 Dec;7(4):261-5. Niemczyk et al 100 pts. with SUI underwent TVT Bladder penetration occurred <strong>in</strong> 24 (24%) Conclusion “TVT is safe”
Overall Reported BladderPerforation Rates6.7% – 24%
Void<strong>in</strong>g Dysfunction & UrgencyAfter Sl<strong>in</strong>g
Reported Complications of TVT Procedures: AReview. Rapoport, D., et al. BCMJ, Vol. 49, No. 9,November 2007, pages 465-524• Reviewed 31 articles re. TVT complications• Found: De novo urgency & void<strong>in</strong>g dysfunction 31.5% Ur<strong>in</strong>ary retention 19%
Ur<strong>in</strong>ary complications and sexual functionafter the TVT procedureMazouni, C et al; Acta Obstetricia et Gynecologica Scand<strong>in</strong>avica, Vol. 83,Issue 10, pages 955-961, Oct 2004• 71 pts. evaluated (with urodynamics andquestionnaire) before and after TVT• Postop f<strong>in</strong>d<strong>in</strong>gs:Void<strong>in</strong>g difficulty <strong>in</strong> 60%Ur<strong>in</strong>ary urgency <strong>in</strong> 47%Sig. outflow obstruction <strong>in</strong> 34.5%Ur<strong>in</strong>ary frequency <strong>in</strong> 33%
Problems With Synthetic Sl<strong>in</strong>gsUrogynecology & Reconstructive Pelvic <strong>Surgery</strong> 3 rd Ed.Walters & Karram, 2007• Foreign body <strong>in</strong>flammatory reactionresult<strong>in</strong>g <strong>in</strong> higher risk of erosion & fistulacompared with autologous material• Incidence of void<strong>in</strong>g disorders 2%-37%• Incidence of DI 3%-30%• Erosion 5%• Sl<strong>in</strong>g revision or removal 1.8%-35%
Underreport<strong>in</strong>g ofComplications After Sl<strong>in</strong>g
Am J Obstet Gynecol. 2014 Feb;210(2):163 Evaluation andmanagement of complications from synthetic mesh after pelvicreconstructive surgery: a multicenter study.Abbott S, Unger CA, Evans JM, Jallad K, Mishra K, Karram MM, IglesiaCB, Rard<strong>in</strong> CR, Barber MD.• Physicians who perform mesh proceduresmay not be aware of the complications theirpatients experience and these providers maybe responsible for future mesh-relatedcomplications with no awareness of theexist<strong>in</strong>g magnitude of the issue
Am J Obstet Gynecol. 2014 Feb;210(2):163 Evaluation andmanagement of complications from synthetic mesh after pelvicreconstructive surgery: a multicenter study.Abbott S, Unger CA, Evans JM, Jallad K, Mishra K, Karram MM, IglesiaCB, Rard<strong>in</strong> CR, Barber MD.• Most of the women who seek managementof synthetic mesh complication after POP orSUI surgery have severe complications thatrequire surgical <strong>in</strong>tervention & a significantproportion require >1 surgical procedure
Effect of the Material• Is polypropylene truly <strong>in</strong>ert?No-If it were, the immune system wouldnot mount a foreign body rxn to it!“Chronic foreign body giant cell rxn”• Inflammation, oxidation and degradationoccurs with polypropylene implants• What are the effects of the degradationproducts………? Unknown, nobody everstudied it before tak<strong>in</strong>g it to market!Patel H, Int Urogynecol J (2012) 23:669-679
<strong>Polypropylene</strong> as a re<strong>in</strong>forcement <strong>in</strong> pelvic surgery isnot <strong>in</strong>ert: Comparative analysis of 100 explantsClave, et al Int Urogynecol J 2010• Contrary to the prevail<strong>in</strong>g understand<strong>in</strong>g ofpolypropylene as an <strong>in</strong>ert material whenused <strong>in</strong> vag<strong>in</strong>al surgeries, Clave, et al <strong>in</strong>their study of 100 explants noted that allshowed evidence of degradation on SEMafter 3 months
<strong>Polypropylene</strong> as a re<strong>in</strong>forcement <strong>in</strong> pelvic surgery isnot <strong>in</strong>ert: Comparative analysis of 100 explantsClave, et al Int Urogynecol J 2010• <strong>Mesh</strong> damage <strong>in</strong>cluded Superficial degradation with peel<strong>in</strong>g of thefiber surface, transverse cracks <strong>in</strong> the implantthreads, significant cracks with dis<strong>in</strong>tegratedsurfaces & partially detached material &superficial & deep flak<strong>in</strong>g <strong>Polypropylene</strong> implants degraded more <strong>in</strong> thepresence of <strong>in</strong>fection or <strong>in</strong>flammation (common<strong>in</strong> vag<strong>in</strong>al implants)
Chevron PhilipsMaterial Safety Data Sheet1/28/2004• MARLEX POLYPROPYLENES (ALLGRADES)• MEDICAL APPLICATION CAUTION:Do not use this Chevron Phillips ChemicalCompany LP material <strong>in</strong> medicalapplications <strong>in</strong>volv<strong>in</strong>g permanentimplantation <strong>in</strong> the human body orpermanent contact with <strong>in</strong>ternal body fluidsor tissues.
Bloomberg Bus<strong>in</strong>essweekJune 26, 2013• Managers at Bard’s Davol unit used polypropylene made byChevron Phillips Chemical Co. to produce vag<strong>in</strong>al-meshproducts after Chevron officially registered a warn<strong>in</strong>g that itshouldn’t be permanently implanted <strong>in</strong> people, accord<strong>in</strong>g toe-mails and documents <strong>in</strong> a lawsuit over Bard’s implants.• In 2004 and 2007 e-mails filed <strong>in</strong> federal court <strong>in</strong> WestVirg<strong>in</strong>ia, a Davol executive warned colleagues not to tellChevron Phillips or other res<strong>in</strong> makers that the company wasus<strong>in</strong>g the material <strong>in</strong> medical devices placed <strong>in</strong> humans.
AR Without Synthetic <strong>Mesh</strong>• Gandi 2005, AC success rate 71%• Meschia 2007, AC success rate 81%• Hviid 2010, AC success rate 85%• Randomized trial of 3 techniques of AR (nopolypropylene) Chmielewski, et al AJOG201188% success rate
AR vs Transvag<strong>in</strong>al <strong>Mesh</strong>Altman et al. NEJM 2011• Multi-center RCT• AR vs Anterior Prolift• Outcome at 12 mo. POPQ stage 0-1 andabsence of bulge sx’sGood News for <strong>Mesh</strong> Proponents:• <strong>Mesh</strong> objective failure rate 14 v. 49%• <strong>Mesh</strong> subjective failure rate 17 v 28%
AR vs Transvag<strong>in</strong>al <strong>Mesh</strong>Altman et al. NEJM 2011• Bad News for <strong>Mesh</strong> Proponents• AR had less de novo apical & posterior prolapsethan mesh 9.5% v. 17.7%• <strong>Mesh</strong> had longer OR times & greater blood loss• <strong>Mesh</strong> had greater cystotomy rate 3.5 % v. 0.5 %• <strong>Mesh</strong> had more postop de novo SUI 12.3% v.6.3%
AR vs Transvag<strong>in</strong>al <strong>Mesh</strong>Altman et al. NEJM 2011• Bad News for <strong>Mesh</strong> Proponents• <strong>Mesh</strong> erosion rate 10.4%• <strong>Mesh</strong> had higher reoperation rate 10.2% v. 5.8%Quality of Life “The universally agreed upon most importantoutcome parameter def<strong>in</strong><strong>in</strong>g success rate” NO DIFFERENCES BETWEEN MESH ANDSTANDARD AR• Conclusions-mesh should not be used
Regard<strong>in</strong>g the Evidence for Use of Synthetic<strong>Mesh</strong> <strong>in</strong> the Anterior CompartmentOther studies have corroborated the Altman studyand have concluded that there is no benefit of us<strong>in</strong>gpolypropylene mesh <strong>in</strong> the anterior compartment
Maher, et al April 30, 2013Cochrane Summaries:Surgical Management of POP• Review of 56 published trials <strong>in</strong>clud<strong>in</strong>g5954 women• ASCP better than SSLF• Transvag<strong>in</strong>al grafts (biologic and synthetic)reduce risk of prolapse when compared tonative tissue repair• HOWEVER……………………..
Maher, et al April 30, 2013Cochrane Summaries:Surgical Management of POP• Disadvantages of polypropylene mesh<strong>in</strong>clude: Longer operat<strong>in</strong>g time Greater blood loss Prolapse <strong>in</strong> other areas of the vag<strong>in</strong>a New onset SUI <strong>Mesh</strong> erosion rate was 18%• “there is a lack of evidence to supporttransvag<strong>in</strong>al mesh operations used <strong>in</strong> apicalor posterior compartment surgery”
Three-Year Outcomes of Vag<strong>in</strong>al <strong>Mesh</strong>for Prolapse-A RCTGutman, et al Obstet Gynecol Vol. 122, No. 4, October 2013• Planned 3 yr f/u of 65 women study thatwas halted because of 15.6% erosion rate• “We found no significant differences <strong>in</strong>cure rates at 3 years between the meshand no-mesh groups regardless of thedef<strong>in</strong>ition used”• <strong>Mesh</strong> group had a greater than 15% risk ofmesh exposure
FDA• In October 2008, FDA issued a warn<strong>in</strong>g onhigher-than-expected complications reported foruse of mesh <strong>in</strong> transvag<strong>in</strong>al surgeries• The FDA warn<strong>in</strong>g states: "Over the past threeyears, the FDA has received over 1,000 reportsfrom n<strong>in</strong>e surgical mesh manufacturers ofcomplications that were associated with surgicalmesh devices used to repair POP and SUI…
FDA• Complications <strong>in</strong>cluded: erosions through vag<strong>in</strong>al epithelium <strong>in</strong>fection pa<strong>in</strong> ur<strong>in</strong>ary problems recurrence of prolapse and/or <strong>in</strong>cont<strong>in</strong>ence. bowel, bladder, and blood vessel perforationdur<strong>in</strong>g <strong>in</strong>sertion
FDAvag<strong>in</strong>al scarr<strong>in</strong>g and mesh erosion led toa significant decrease <strong>in</strong> patient quality oflife due to discomfort and pa<strong>in</strong>, <strong>in</strong>clud<strong>in</strong>gdyspareunia
FDA• On July 13, 2011, the FDA stated <strong>in</strong> a news release: "There are clear risks associated with the transvag<strong>in</strong>alplacement of mesh to treat POP.” "The FDA issued a safety communication <strong>in</strong> 2008 dueto <strong>in</strong>creas<strong>in</strong>g concerns about adverse events associatedwith the transvag<strong>in</strong>al placement of mesh. S<strong>in</strong>ce then,the number of adverse events has cont<strong>in</strong>ued to climb.From 2008 to 2010, the FDA received 1503 adverseevent reports associated with mesh used for POP repair,five times as many as the agency received from 2005 to2007.”
FDASurgical mesh for POP was subsequentlyreclassified from Class II to Class III,requir<strong>in</strong>g premarket and postmarket studies.
• Regrettably, the <strong>in</strong>structions for use (IFU’s)and directions for use (DFU’s) published bythe sl<strong>in</strong>g and mesh manufacturerssuperficially touch on only some (not all) ofthe complications described here<strong>in</strong> and eventhen <strong>in</strong> a wholly <strong>in</strong>adequate manner
What about the argument thatus<strong>in</strong>g polypropylene mesh <strong>in</strong>abdom<strong>in</strong>al hernias is ok sotherefore it must be ok to use it <strong>in</strong>the vag<strong>in</strong>a?
The anatomy, mechanics andbiology of implant<strong>in</strong>g a piece ofmesh <strong>in</strong> the abdom<strong>in</strong>al wall…
…is fundamentally differentthan implant<strong>in</strong>g the same mesh<strong>in</strong> the vag<strong>in</strong>a
Is There A Conflict of Interest Regard<strong>in</strong>g <strong>Mesh</strong> Use<strong>in</strong> The Medical Community?• AUGS has been a vigorous champion ofpolypropylene mesh describe mesh as the “gold standard”• 2011 - AUGS received > $220,000 <strong>in</strong> <strong>in</strong>dustry support• 2014 - 7 of the 14 AUGS BOD receive <strong>in</strong>dustry $$• 2014 - AUGS BOD refused to acknowledge a conflictof <strong>in</strong>terest <strong>in</strong> their public statements support<strong>in</strong>g mesh• Key op<strong>in</strong>ion leaders that promote mesh receivesignificant <strong>in</strong>dustry $$
Misuse Of The Phrase“Gold Standard”• BMJ. May 14, 2005; 330(7500): 1121. Thegold standard: not a golden standardJurgen AHR Claassen• Between 1995 and 2005 over 10,000publications have mentioned “gold standard”• Medl<strong>in</strong>e Search 4/8/2014 for “gold standard”showed over 170,000 citations
What is the Gold Standard forSUI <strong>Surgery</strong>?• Karram 2012 says its the pubovag<strong>in</strong>al sl<strong>in</strong>g• TeL<strong>in</strong>de’s Operative Gynecology 2014 saysits the Burch• AUGS 2014 says its the polypropylenesl<strong>in</strong>g• So who’s right?• Nobody, the term is 100% subjective andtherefore mean<strong>in</strong>gless
Putt<strong>in</strong>g It All Into Perspective• 1907 Goebell Stoeckel fascia lata sl<strong>in</strong>g was<strong>in</strong>troduced• 1996 Ulmsten 1 st described TVT for SUI• 2001 CPT panel of the AMA added 57287(removal/revision of sl<strong>in</strong>g) to the codebook• 2006 CPT panel of the AMA added 57295(removal of mesh) to the codebook
Ulmsten• 1996 Ulmsten 1 st described the TVT forSUI. Subsequently, he was paid $400,000by Ethicon to publish what would becomethe landmark study on TVT but paymentwas cont<strong>in</strong>gent on two required f<strong>in</strong>d<strong>in</strong>gs:The study had to show TVT was effectiveThe study had to show TVT was safe
Conclusions• The risks of polypropylene mesh <strong>in</strong> prolapseand SUI surgery clearly outweigh thebenefits• There are several superb alternatives to meshthat have a 0% mesh complication rate