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NEEDLES

V I E W T H E E - C ATA L O G G O T O T H E

H E A LT H C A R E P R O F E S S I O N A L

SECTION OF

W W W. E T H I C O N . C O M
ADHESIVES

SURGICAL MESH

ETHICON, INC. , PO BOX 151, SOMERVILLE, NJ 08876-0151


* TRADEMARK
SM
ETHICON, INC.

2005, ETHICON, INC.

WOUND C LOSURE M ANUAL

SUTURES

WOUND HEALING

W O U N D C L O S U R E M A N UA L

PREFACE

his manual has been prepared for the medical professional who

would like to learn more about the practice of surgerythe


dynamics of tissue healing, the principles of wound closure, and the
materials available to todays practitioners. Most important, it
touches on some of the critical decisions which must be made on a
daily basis to help ensure proper wound closure.

ETHICON PRODUCTS, a Johnson & Johnson company, is the


worlds leading marketer of surgical sutures and is the only U.S.
company that offers an adhesive with microbial protection as an
alternative to sutures for topical skin closure.

ETHICON enjoys a reputation for developing quality products to


enhance the lives of patients and for providing outstanding service
to customers. We hope you find this manual useful. But, above all,
we hope that it reflects our high regard for the men and women
who have chosen the medical profession as a career.

ETHICON PRODUCTS

CONTRIBUTING EDITOR
David, L. Dunn, M.D., Ph. D.
Jay Phillips Professor and Chairman of Surgery,
University of Minnesota

We thank Dr. Dunn for his contributions to the Wound Closure


Manual. Dr. Dunn is currently the Jay Phillips Professor and
Chairman of Surgery at the University of Minnesota. This
department has a long-standing tradition and has attained
national and international recognition for excellence in training
academic general surgeons and surgical scientists. He is also the
Division Chief of General Surgery, Head of Surgical Infectious
Diseases, Director of Graduate Studies, and Residency Program
Director of the Department of Surgery.

Dr. Dunn has published over 400 articles and book chapters in the
areas of Surgical Infectious Diseases and Transplantation. He has
received regional and nationwide recognition in several
academic organizations and is a Past-President of the Surgical
Infection Society, the Association for Academic Surgery, the
Minnesota Chapter of the American College of Surgeons, the
Society of University Surgeons and the Society of University
Surgeons Foundation.

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CHAPTER 1

WOUND HEALING
AND MANAGEMENT

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CHAPTER 2

THE SUTURE



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SYSTEM DURA EYE GASTROINTESTINALTRACT
MUSCLE MYOCARDIUM NERVE PERICHON
DRIUM PERIOSTEUM PLEURA SKIN TENDON
UROGENITALTRACT VESSELS



#IRCLE

BILIARYTRACT CARDIOVASCULARSYSTEM EYE


FASCIA GASTROINTESTINALTRACT MUSCLE
NASALCAVITY ORALCAVITY PELVIS PERI
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UROGENITALTRACT



#IRCLE

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CHAPTER 5

TOPICAL SKIN ADHESIVES



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4RADEMARK



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4RADEMARK

CHAPTER 6

OTHER SURGICAL
PRODUCTS



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CHAPTER 7

PRODUCT TERMS
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4RADEMARK



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%4()#/.TRADEMARKFOR
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ANDIMPURITIESFROMRAWSILKBEFORE
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REDUCECAPILLARITY

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3YNTHETICSUTUREMATERIALMADEOF
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3TRANDMADEOFMORETHANONE
TWISTEDORBRAIDEDFILAMENT

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0$3
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MONOFILAMENTSYNTHETICABSORBABLE
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%4()#/. ).# ASACOATINGFOR
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3YNTHETICMATERIALMADEOFA
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3YNTHETICMATERIALOFANISOTACTIC
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3YNTHETICMATERIALMADEINTO
BUTTONS5SEFULINORTHOPAEDIC
PROCEDURESSUCHASTENDONREPAIR
3UTURESARETIEDOVERBUTTONSTO
RELIEVEUNDERLYINGSKINOFEXCESSIVE
PRESSURE

4RADEMARK



02/$5#44%2-3!.$42!$%-!2+3

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%4()#/.TRADEMARKFORSYNTHETIC
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OFMONOFILAMENTPOLYPROPYLENE

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02)-!290!#+%4

3UTUREPACKETWHICHCONTAINSTHE
STERILESUTURE
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02/,%.%
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%4()#/.TRADEMARKFORMESH
MADEOFPOLYPROPYLENEWHICHIS
KNITTEDBYAPROCESSWHICHINTER
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ANDTISSUEDEFICIENCIES

%4()#/.TRADEMARKFORSYNTHETIC
NONABSORBABLESUTUREMATERIALMADE
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PROPYLENE 
02/8) 342)0
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%4()#/.TRADEMARKFORADHESIVE
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2%,!9
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PACKAGINGOFSINGLESTRANDAND
MULTISTRANDSUTURES0ROVIDES
DELIVERYOFONESUTUREATATIME
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PARKS ANDSTRAIGHT TANGLE FREE
SUTURESREADYFORUSE
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3URGICALTUBINGUSEDTOSHEATH
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CAPSTANTOPERMITPOSTOPERATIVE
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THESKIN

2%6%23%#544).'.%%$,%

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0RODUCTS WHICHHAVETRIANGULAR
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TISSUECUTOUT.EEDLESWITH
LONGITUDINALGROOVESONTHEINNER
ANDOUTERFLATTENEDCURVATURES2IBS
ENGAGETHENEEDLEHOLDERJAWAND
HELPTOMINIMIZEMOVEMENTOFTHE
NEEDLEINTHENEEDLEHOLDER
3!"2%,/#
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OPHTHALMICNEEDLES3IDE CUTTING
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3!&%49/2'!.):%242!9

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3%#/.$!29#,/352%

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4ERMINOLOGYUSEDTODESCRIBETHE
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.EEDLEWITHABODYTHATGRADUALLY
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OTHERDEVICEASBLOODVESSELSARE
TIEDSUTURELIGATURESTRANDONA
NEEDLEUSEDTOTRANSFIXSUTURE A
LARGEBLOODVESSELTOENSURESECURITY
AGAINSTKNOTSLIPPAGESTICKTIEA
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LIGATURE

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%4()#/.TRADEMARKFORMESH
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GLYCOLIDEANDLACTIDE!NABSORBABLE
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HEALING

4RADEMARK



02/$5#44%2-3!.$42!$%-!2+3

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%4()#/.TRADEMARKFORMESH
PREPAREDFROMACOPOLYMEROFGLY
COLIDEANDLACTIDE!NABSORBABLE
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FORGUIDEDTISSUEREGENERATION
6)3) ",!#+
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3EPARATIONOFWOUNDEDGES

4RADEMARK

CHAPTER 8

PRODUCT INFORMATION

02/$5#4).&/2-!4)/.



#OATED6)#29,

0OLYGLACTIN 3UTURE

$ONOTRESTERILIZE$ISCARDOPENEDPACKAGESANDUNUSEDSUTURES
!SWITHANYFOREIGNBODY PROLONGEDCONTACTOFANYSUTUREWITHSALTSOLUTIONS
SUCH AS THOSE FOUND IN THE URINARY OR BILIARY TRACTS MAY RESULT IN CALCULUS
FORMATION !S AN ABSORBABLE SUTURE COATED 6)#29, SUTURE MAY ACT
TRANSIENTLYASAFOREIGNBODY!CCEPTABLESURGICALPRACTICESHOULDBEFOLLOWED
FORTHEMANAGEMENTOFCONTAMINATEDORINFECTEDWOUNDS

530 %8#%04&/2$)!-%4%2
$%3#2)04)/.
#OATED 6)#29,
 POLYGLACTIN  SUTURE IS A SYNTHETIC ABSORBABLE STERILE
SURGICALSUTURECOMPOSEDOFACOPOLYMERMADEFROMGLYCOLIDEAND
, LACTIDE#OATED6)#29,SUTUREISPREPAREDBYCOATING6)#29,SUTUREMATERIAL
WITHAMIXTURECOMPOSEDOFEQUALPARTSOFCOPOLYMEROFGLYCOLIDEANDLACTIDE
POLYGLACTIN  AND CALCIUM STEARATE 0OLYGLACTIN  COPOLYMER AND
POLYGLACTIN  WITH CALCIUM STEARATE HAVE BEEN FOUND TO BE NONANTIGENIC
NONPYROGENIC AND ELICIT ONLY A MILD TISSUE REACTION DURING ABSORPTION
4HESUTURESAREAVAILABLEDYEDANDUNDYEDNATURAL 
#OATED6)#29,SUTURESARE530EXCEPTFORDIAMETERSINTHEFOLLOWINGSIZES
-!8)-5-35452%/6%23):%).$)!-%4%2MM &2/-530
530 35452%3):%$%3)'.!4)/.
 
 
 
 
 


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ANDOR LIGATION INCLUDING USE IN OPHTHALMIC PROCEDURES BUT NOT FOR USE IN
CARDIOVASCULARANDNEUROLOGICALTISSUES

02%#!54)/.3
3KIN SUTURES WHICH MUST REMAIN IN PLACE LONGER THAN  DAYS MAY CAUSE
LOCALIZEDIRRITATIONANDSHOULDBESNIPPEDOFFORREMOVEDASINDICATED
5NDERSOMECIRCUMSTANCES NOTABLYORTHOPAEDICPROCEDURES IMMOBILIZATIONOF
JOINTSBYEXTERNALSUPPORTMAYBEEMPLOYEDATTHEDISCRETIONOFTHESURGEON
#ONSIDERATIONSHOULDBETAKENINTHEUSEOFABSORBABLESUTURESINTISSUESWITH
POORBLOODSUPPLYASSUTUREEXTRUSIONANDDELAYEDABSORPTIONMAYOCCUR
)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
DAMAGEFROMHANDLING!VOIDCRUSHINGORCRIMPINGDAMAGEDUETOAPPLICATION
OF SURGICAL INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS #OATED 6)#29,
SUTURES WHICH ARE TREATED TO ENHANCE HANDLING CHARACTERISTICS REQUIRE THE
ACCEPTED SURGICAL TECHNIQUE OF FLAT AND SQUARE TIES WITH ADDITIONAL THROWS AS
WARRANTEDBYSURGICALCIRCUMSTANCEANDTHEEXPERIENCEOFTHESURGEON
!VOIDPROLONGEDEXPOSURETOELEVATEDTEMPERATURES
4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLEINANAREA
ONE THIRD  TO ONE HALF  OF THE DISTANCE FROM THE SWAGED END TO THE
POINT2ESHAPINGNEEDLESMAYCAUSETHEMTOLOSESTRENGTHANDBELESSRESISTENT
TO BENDING AND BREAKING 5SERS SHOULD EXERCISE CAUTION WHEN HANDLING
SURGICAL NEEDLES TO AVOID INADVERTENT NEEDLE STICKS $ISCARD USED NEEDLES IN
SHARPSCONTAINER

!$6%23%2%!#4)/.3

!#4)/.3
#OATED6)#29, SUTURE ELICITS A MINIMAL ACUTE INFLAMMATORY REACTION IN TISSUE
ANDINGROWTHOFFIBROUSCONNECTIVETISSUE0ROGRESSIVELOSSOFTENSILESTRENGTH
AND EVENTUAL ABSORPTION OF COATED 6)#29, SUTURE OCCURS BY MEANS OF
HYDROLYSIS WHERETHECOPOLYMERDEGRADESTOGLYCOLICANDLACTICACIDSWHICHARE
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LOSSOFTENSILESTRENGTHFOLLOWEDBYALOSSOFMASS)MPLANTATIONSTUDIESINRATS
INDICATETHATCOATED6)#29,SUTURERETAINSAPPROXIMATELYOFTHEORIGI
NALTENSILESTRENGTHATTWOWEEKSPOSTIMPLANTATION!TTHREEWEEKS APPROXI
MATELY  OF THE ORIGINAL STRENGTH IS RETAINED FOR SIZES   AND LARGER AND
APPROXIMATELYOFITSORIGINALSTRENGTHISRETAINEDFORSIZES ANDSMALLER
!TFOURWEEKS APPROXIMATELYOFTHEORIGINALSTRENGTHISRETAINEDFORSIZES
  AND LARGER !LL OF THE ORIGINAL TENSILE STRENGTH IS LOST BY FIVE WEEKS POST
IMPLANTATION !BSORPTION OF COATED 6)#29, SUTURE IS ESSENTIALLY COMPLETE
BETWEENANDDAYS
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$AYS
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#/.42!).$)#!4)/.3

!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND
DEHISCENCE FAILURETOPROVIDEADEQUATEWOUNDSUPPORTINCLOSUREOFTHESITES
WHERE EXPANSION STRETCHING OR DISTENSION OCCUR FAILURE TO PROVIDE ADEQUATE
WOUND SUPPORT IN ELDERLY MALNOURISHED OR DEBILITATED PATIENTS OR IN PATIENTS
SUFFERINGFROMCONDITIONSWHICHMAYDELAYWOUNDHEALING INFECTION MINIMAL
ACUTE INFLAMMATORY TISSUE REACTION LOCALIZED IRRITATION WHEN SKIN SUTURES ARE
LEFTINPLACEFORGREATERTHANDAYS SUTUREEXTRUSIONANDDELAYEDABSORPTIONIN
TISSUE WITH POOR BLOOD SUPPLY CALCULI FORMATION IN URINARY AND BILIARY TRACTS
WHENPROLONGEDCONTACTWITHSALTSOLUTIONSSUCHASURINEANDBILEOCCURS AND
TRANSITORY LOCAL IRRITATION AT THE WOUND SITE "ROKEN NEEDLES MAY RESULT IN
EXTENDEDORADDITIONALSURGERIESORRESIDUALFOREIGNBODIES)NADVERTENTNEEDLE
STICKS WITH CONTAMINATED SURGICAL NEEDLES MAY RESULT IN THE TRANSMISSION OF
BLOODBORNEPATHOGENS

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#OATED 6)#29, SUTURES ARE AVAILABLE STERILE AS BRAIDED DYED VIOLET AND
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DISPENSINGREELS
#OATED6)#29, SUTURES ARE ALSO AVAILABLE IN SIZE   WITH ATTACHED BEADS FOR
USEINOPHTHALMICPROCEDURES#OATED6)#29,SUTURESAREALSOAVAILABLEINSIZES
 THROUGHMETRICSIZES  ATTACHEDTO#/.42/,2%,%!3%
REMOVABLE
NEEDLES #OATED6)#29, SUTURES ARE AVAILABLE IN ONE TWO AND THREE DOZEN
BOXES

4HIS SUTURE BEING ABSORBABLE SHOULD NOT BE USED WHERE EXTENDED
APPROXIMATIONOFTISSUEISREQUIRED


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5SERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING
ABSORBABLE SUTURES BEFORE EMPLOYING COATED 6)#29, SUTURE FOR WOUND
CLOSURE ASRISKOFWOUNDDEHISCENCEMAYVARYWITHTHESITEOFAPPLICATIONAND
THESUTUREMATERIALUSED0HYSICIANSSHOULDCONSIDERTHEINVIVO PERFORMANCE
UNDER!#4)/.3SECTION WHENSELECTINGASUTURE4HEUSEOFTHISSUTUREMAY
BEINAPPROPRIATEINELDERLY MALNOURISHED ORDEBILITATEDPATIENTS ORINPATIENTS
SUFFERING FROM CONDITIONS WHICH MAY DELAY WOUND HEALING !S THIS IS AN
ABSORBABLE SUTURE MATERIAL THE USE OF SUPPLEMENTAL NONABSORBABLE SUTURES
SHOULD BE CONSIDERED BY THE SURGEON IN THE CLOSURE OF THE SITES WHICH
MAY UNDERGO EXPANSION STRETCHING OR DISTENTION OR WHICH MAY REQUIRE
ADDITIONALSUPPORT

4RADEMARK

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SUTURECOMPOSEDOFTHELONG CHAINALIPHATICPOLYMERS.YLONAND.YLON 
%4(),/. SUTURES ARE DYED BLACK OR GREEN TO ENHANCE VISIBILITY IN TISSUE4HE
SUTUREISALSOAVAILABLEUNDYEDCLEAR 



02%#!54)/.3
)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
DAMAGEFROMHANDLING!VOIDCRUSHINGORCRIMPINGDAMAGEDUETOAPPLICATION
OFSURGICALINSTRUMENTSSUCHASFORCEPSORNEEDLEHOLDERS
!SWITHANYSUTUREMATERIAL ADEQUATEKNOTSECURITYREQUIRESTHEACCEPTEDSUR
GICALTECHNIQUEOFFLATANDSQUARETIES WITHADDITIONALTHROWSASWARRANTEDBY
SURGICALCIRCUMSTANCEANDTHEEXPERIENCEOFTHESURGEON4HEUSEOFADDITIONAL
THROWSMAYBEPARTICULARLYAPPROPRIATEWHENKNOTTINGMONOFILAMENTS

).$)#!4)/.3

4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLEINANAREA
ONE THIRD TOONE HALF OFTHEDISTANCE FROMTHESWAGEDENDTOTHEPOINT
2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS RESISTANT TO
BENDINGANDBREAKING5SERSSHOULDEXERCISECAUTIONWHENHANDLINGSURGICAL
NEEDLES TO AVOID INADVERTENT NEEDLE STICKS $ISCARD USED NEEDLES IN SHARPS
CONTAINERS

%4(),/. SUTURE IS INDICATED FOR USE IN GENERAL SOFT TISSUE
APPROXIMATION ANDOR LIGATION INCLUDING USE IN CARDIOVASCULAR
OPHTHALMICANDNEUROLOGICALPROCEDURES

!$6%23%2%!#4)/.3

%4(),/. SUTURE MEETS ALL REQUIREMENTS ESTABLISHED BY THE 5NITED 3TATES
0HARMACOPOEIA530 FORNONABSORBABLESURGICAL SUTURE

!#4)/.3
%4(),/.SUTUREELICITSAMINIMALACUTEINFLAMMATORYREACTIONINTISSUE WHICH
ISFOLLOWEDBYGRADUALENCAPSULATIONOFTHESUTUREBYFIBROUSCONNECTIVETISSUE
7HILENYLONISNOTABSORBED PROGRESSIVEHYDROLYSISOFTHENYLONINVIVO MAY
RESULTINGRADUALLOSSOVERTIMEOFTENSILESTRENGTH

#/.42!).$)#!4)/.3
$UE TO THE GRADUAL LOSS OF TENSILE STRENGTH WHICH MAY OCCUR OVER PROLONGED
PERIODSINVIVO NYLONSUTURESHOULDNOTBEUSEDWHEREPERMANENTRETENTIONOF
TENSILESTRENGTHISREQUIRED

!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND DEHIS
CENCE GRADUAL LOSS OF TENSILE STRENGTH OVER TIME CALCULI FORMATION IN URINARY
ANDBILIARYTRACTSWHENPROLONGEDCONTACTWITHSALTSOLUTIONSSUCHASURINEAND
BILEOCCURS INFECTION MINIMALACUTEINFLAMMATORYTISSUEREACTION ANDTRANSI
TORYLOCALIRRITATIONATTHEWOUNDSITE"ROKENNEEDLESMAYRESULTINEXTENDEDOR
ADDITIONALSURGERIESORRESIDUALFOREIGNBODIES)NADVERTENTNEEDLESTICKSWITH
CONTAMINATED SURGICAL NEEDLES MAY RESULT IN THE TRANSMISSION OF BLOODBORNE
PATHOGENS

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%4(),/.SUTURESAREAVAILABLEASSTERILEMONOFILAMENTSTRANDSIN530SIZES
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THREEDOZENBOXES

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5SERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING
NONABSORBABLESUTURESBEFOREEMPLOYING%4(),/.SUTUREFORWOUNDCLOSURE
ASTHERISKOFWOUNDDEHISCENCEMAYVARYWITHTHESITEOFAPPLICATIONANDTHE
SUTUREMATERIALUSED
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SUCH AS THOSE FOUND IN THE URINARY OR BILIARY TRACTS MAY RESULT IN CALCULUS
FORMATION!CCEPTABLESURGICALPRACTICESHOULDBEFOLLOWEDFORTHEMANAGEMENT
OFCONTAMINATED ORINFECTEDWOUNDS
$ONOTRESTERILIZE$ISCARDOPENPACKAGESANDUNUSEDSUTURES



4RADEMARK

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2!0)$% 0OLYGLACTIN
"RAIDED#OATED3YNTHETIC!BSORBABLE
3UTURE 5NDYED
.ON 530

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ABSORBABLESUTURESBEFOREEMPLOYINGCOATED6)#29,2!0)$% SUTUREFORWOUND
CLOSURE ASARISKOFWOUNDDEHISCENCEMAYVARYWITHTHESITEOFAPPLICATIONAND
THESUTUREMATERIALUSED0HYSICIANSSHOULDCONSIDERTHEINVIVO PERFORMANCE
WHEN SELECTING A SUTURE 4HE USE OF THIS SUTURE MAY BE INAPPROPRIATE IN
ELDERLY MALNOURISHED OR DEBILITATED PATIENTS OR IN PATIENTS SUFFERING FROM
CONDITIONSWHICHMAYDELAYWOUNDHEALING

$%3#2)04)/.

$ONOTRESTERILIZE$ISCARDOPENEDPACKAGESANDUNUSEDSUTURES

#OATED6)#29,
2!0)$%  POLYGLACTIN SUTUREISASYNTHETICABSORBABLESTER
ILESURGICALSUTURECOMPOSEDOF ACOPOLYMERMADEFROM GLYCOLIDEAND
, LACTIDE4HEEMPIRICALFORMULAOFTHECOPOLYMERIS#(/ M#(/ N4HE

!SWITHANYFOREIGNBODY PROLONGEDCONTACTOFANYSUTUREWITHSALTSOLUTIONS
SUCH AS THOSE FOUND IN THE URINARY OR BILIARY TRACTS MAY RESULT IN CALCULUS
FORMATION !S AN ABSORBABLE SUTURE COATED6)#29, 2!0)$% SUTURE MAY ACT
TRANSIENTLYASAFOREIGNBODY

CHARACTERISTICOFRAPIDLOSSOFSTRENGTHISACHIEVEDBYUSEOFAPOLYMERMATERI
ALWITHALOWERMOLECULARWEIGHTTHANCOATED6)#29,
POLYGLACTIN SUTURE
#OATED 6)#29, 2!0)$% SUTURES ARE OBTAINED BY COATING THE BRAIDED SUTURE
MATERIALWITHAMIXTURECOMPOSEDOFEQUALPARTSOFCOPOLYMEROFGLYCOLIDEAND
LACTIDEPOLYGLACTIN ANDCALCIUMSTEARATE0OLYGLACTINCOPOLYMERAND
POLYGLACTIN  WITH CALCIUM STEARATE HAVE BEEN FOUND TO BE NONANTIGENIC
NONPYROGENICANDELICITONLYAMILDTISSUEREACTIONDURINGABSORPTION

!CCEPTABLE SURGICAL PRACTICE SHOULD BE FOLLOWED FOR THE MANAGEMENT OF


CONTAMINATEDORINFECTEDWOUNDS
!S THIS IS AN ABSORBABLE SUTURE MATERIAL THE USE OF SUPPLEMENTAL NONAB
SORBABLESUTURESSHOULDBECONSIDEREDBYTHESURGEONINTHECLOSUREOFSITES
WHICHMAYUNDERGOEXPANSION STRETCHINGORDISTENTION ORWHICHMAYREQUIRE
ADDITIONALSUPPORT

#OATED6)#29,2!0)$% SUTURESAREONLYAVAILABLEUNDYED
!LTHOUGHTHISSUTUREISASYNTHETICABSORBABLESUTURE ITSPERFORMANCECHARAC
TERISTICS ARE INTENDED TO MODEL THE PERFORMANCE OF COLLAGEN SURGICAL GUT
SUTURE4HEKNOTTENSILESTRENGTHOFCOATED6)#29,2!0)$% SUTUREMEETS530
KNOT TENSILE STRENGTH REQUIREMENTS FOR COLLAGEN SUTURES HOWEVER #OATED
6)#29, 2!0)$% SUTURE STRENGTH IS UP TO  LESS THAN KNOT TENSILE STRENGTH
REQUIREMENTSFORSYNTHETICABSORBABLESUTURES
-!8)-5-35452%/6%23):%).$)!-%4%2MM &2/-530
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#OATED6)#29,2!0)$% SYNTHETICABSORBABLESUTUREISINDICATEDONLYFORUSEIN
SUPERFICIALSOFTTISSUEAPPROXIMATIONOFTHESKINANDMUCOSA WHEREONLYSHORT
TERMWOUNDSUPPORT DAYS ISREQUIRED#OATED6)#29,2!0)$% SUTUREIS
NOT INTENDED FOR USE IN LIGATION OPHTHALMIC CARDIOVASCULAR OR NEUROLOGICAL
PROCEDURES

02%#!54)/.3
3KIN SUTURES WHICH REMAIN IN PLACE LONGER THAN  DAYS MAY CAUSE LOCALIZED
IRRITATIONANDSHOULDBESNIPPEDOFFORREMOVEDASINDICATED
5NDERSOMECIRCUMSTANCES NOTABLYORTHOPAEDICPROCEDURES IMMOBILIZATIONOF
JOINTSBYEXTERNALSUPPORTMAYBEEMPLOYEDATTHEDISCRETIONOFTHESURGEON
#ONSIDERATIONSHOULDBETAKENINTHEUSEOFABSORBABLESUTURESINTISSUESWITH
POORBLOODSUPPLYASSUTUREEXTRUSIONANDDELAYEDABSORPTIONMAYOCCUR
)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
DAMAGEFROMHANDLING!VOIDCRUSHINGORCRIMPINGDAMAGEDUETOAPPLICATION
OFSURGICALINSTRUMENTSSUCHASFORCEPSORNEEDLEHOLDERS
#OATED 6)#29, 2!0)$% SUTURE WHICH IS TREATED WITH COATING TO ENHANCE
HANDLING CHARACTERISTICS REQUIRES THE ACCEPTED SURGICAL TECHNIQUE OF FLAT AND
SQUARETIESWITHADDITIONALTHROWSASWARRANTEDBYSURGICALCIRCUMSTANCEAND
THEEXPERIENCEOFTHESURGEON
!VOIDPROLONGEDEXPOSURETOELEVATEDTEMPERATURES
4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLEINANAREA
ONE THIRD  TO ONE HALF  OF THE DISTANCE FROM THE SWAGED END TO THE
POINT 2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS
RESISTANTTOBENDINGANDBREAKING
5SERS SHOULD EXERCISE CAUTION WHEN HANDLING SURGICAL NEEDLES TO AVOID IN
ADVERTENTNEEDLESTICKS$ISCARDUSEDNEEDLESINhSHARPSvCONTAINERS

!#4)/.3
#OATED6)#29,2!0)$% SUTURE WHENUSEDINCLOSUREOFSKINANDMUCOUSMEM
BRANES TYPICALLYBEGINSTOFALLOFF DAYSPOST OPERATIVELYANDCANBEWIPED
OFFSUBSEQUENTLYWITHSTERILEGAUZE.ATURALMECHANICALABRASIONOFTHESUTURES
WHILEINSITUMAYALSOACCELERATETHISDISAPPEARANCERATE2APIDLOSSOFTENSILE
STRENGTHMAYPRECLUDETHENEEDFORSTITCHREMOVAL
#OATED 6)#29, 2!0)$% ELICITS A MINIMAL TO MODERATE ACUTE INFLAMMATORY
REACTIONINTISSUE0ROGRESSIVELOSSOFTENSILESTRENGTHANDEVENTUALABSORPTION
OFCOATED6)#29,2!0)$% OCCURSBYMEANSOFHYDROLYSIS WHERETHECOPOLYMER
DEGRADES TO GLYCOLIC AND LACTIC ACIDS WHICH ARE SUBSEQUENTLY ABSORBED AND
METABOLIZED IN THE BODY !BSORPTION BEGINS AS A LOSS OF TENSILE STRENGTH
FOLLOWEDBYALOSSOFMASS
3UBCUTANEOUSTISSUEIMPLANTATIONSTUDIESOFCOATED6)#29, 2!0)$% SUTURESIN
RATS SHOW THAT  DAYS POST IMPLANTATION APPROXIMATELY  OF THE ORIGINAL
TENSILESTRENGTHREMAINS!LLOFTHEORIGINALTENSILESTRENGTHISLOSTBYAPPROXI
MATELYTODAYSPOST IMPLANTATION)NTRAMUSCULARIMPLANTATIONSTUDIESIN
RATS SHOW THAT THE ABSORPTION OF THESE SUTURES OCCURS THEREAFTER AND IS
ESSENTIALLYCOMPLETEBYDAYS

#/.42!).$)#!4)/.3
$UETOTHERAPIDLOSSOFTENSILESTRENGTH THISSUTURESHOULDNOTBEUSEDWHERE
EXTENDED APPROXIMATION OF TISSUES UNDER STRESS IS REQUIRED OR WHERE WOUND
SUPPORTBEYONDDAYSISREQUIRED

!$6%23%2%!#4)/.3
!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND DEHIS
CENCE FAILURETOPROVIDEADEQUATEWOUNDSUPPORTINCLOSUREOFTHESITESWHERE
EXPANSION STRETCHING ORDISTENSIONOCCUR FAILURETOPROVIDEADEQUATEWOUND
SUPPORTINELDERLY MALNOURISHEDORDEBILITATEDPATIENTSORINPATIENTSSUFFERING
FROM CONDITIONS WHICH MAY DELAY WOUND HEALING INFECTION MINIMAL ACUTE
INFLAMMATORY TISSUE REACTION LOCALIZED IRRITATION WHEN SKIN SUTURES ARE LEFT IN
PLACEFORGREATERTHANDAYS SUTUREEXTRUSIONANDDELAYEDABSORPTIONINTISSUE
WITHPOORBLOODSUPPLY CALCULIFORMATIONINURINARYANDBILIARYTRACTSWHENPRO
LONGEDCONTACTWITHSALTSOLUTIONSSUCHASURINEANDBILEOCCURS ANDTRANSITORY
LOCAL IRRITATION AT THE WOUND SITE "ROKEN NEEDLES MAY RESULT IN EXTENDED OR
ADDITIONALSURGERIESORRESIDUALFOREIGNBODIES)NADVERTENTNEEDLESTICKSWITH
CONTAMINATED SURGICAL NEEDLES MAY RESULT IN THE TRANSMISSION OF BLOODBORNE
PATHOGENS

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#OATED6)#29, 2!0)$% SUTURES ARE AVAILABLE STERILE UNDYED AND ATTACHED TO
STAINLESSSTEELNEEDLESOFVARYINGTYPESANDSIZES
#OATED6)#29,2!0)$% SUTURESAREAVAILABLEINVARIOUSLENGTHSINSIZES TO
TOMETRIC INONEANDTHREEDOZENBOXES



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4RADEMARK

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%8#%, 0/,9%34%235452%

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./.!"3/2"!",%352')#!,35452% 530
%XCEPTFORSIZE DIAMETER

)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
DAMAGEFROMHANDLING!VOIDCRUSHINGORCRIMPINGDAMAGEDUETOAPPLICATION
OFSURGICALINSTRUMENTSSUCHASFORCEPSORNEEDLEHOLDERS

$%3#2)04)/.

!S WITH ANY SUTURE MATERIAL ADEQUATE KNOT SECURITY REQUIRES THE ACCEPTED
SURGICALTECHNIQUEOFFLATANDSQUARETIESWITHADDITIONALTHROWSASWARRANTED
BYSURGICALCIRCUMSTANCEANDTHEEXPERIENCEOFTHESURGEON

%4()"/.$
%8#%, POLYESTER SUTURE IS A NONABSORBABLE BRAIDED STERILE
SURGICALSUTURECOMPOSEDOF0OLYETHYLENETEREPHTHALATE )TISPREPAREDFROM
FIBERSOFHIGHMOLECULARWEIGHT LONG CHAIN LINEARPOLYESTERSHAVINGRECURRENT
AROMATICRINGSASANINTEGRALCOMPONENT%4()"/.$%8#%, SUTUREISUNIFORM
LY COATED WITH POLYBUTILATE OR POLY [OXY   BUTANEDIYLOXY   DIOXO 
 HEXANEDIYL ] 4HE HIGHLY ADHERENT COATING IS A RELATIVELY NONREACTIVE
NONABSORBABLE COMPOUND WHICH ACTS AS A LUBRICANT TO MECHANICALLY IMPROVE
THEPHYSICALPROPERTIESOFTHEUNCOATEDSUTUREBYIMPROVINGEASEOFPASSAGE
THROUGH TISSUES AND BY PROVIDING OVERALL IMPROVED HANDLING QUALITIES AS
CONTRASTEDTOTHEBRAIDED UNCOATEDFIBER
%4()"/.$%8#%, SUTURESAREBRAIDEDFOROPTIMALHANDLINGPROPERTIES ANDFOR
GOODVISIBILITYINTHESURGICALFIELD AREDYEDGREEN
3IZE %4()"/.$ %8#%, SUTURESARE530 EXCEPTFORDIAMETER

-!8)-5-35452%/6%23):%).$)!-%4%2MM &2/-530
53035452%3):%$%3)'.!4)/.
 

4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLEINANAREA
ONE THIRD  TO ONE HALF  OF THE DISTANCE FROM THE SWAGED END TO THE
POINT 2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS
RESISTANT TO BENDING AND BREAKING 5SERS SHOULD EXERCISE CAUTION WHEN
HANDLING SURGICAL NEEDLES TO AVOID INADVERTENT NEEDLE STICKS $ISCARD USED
NEEDLESINSHARPSCONTAINERS

!$6%23%2%!#4)/.3
!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND
DEHISCENCE CALCULI FORMATION IN URINARY AND BILIARY TRACTS WHEN PROLONGED
CONTACT WITH SALT SOLUTIONS SUCH AS URINE AND BILE OCCURS INFECTION MINIMAL
ACUTEINFLAMMATORYTISSUEREACTIONANDTRANSITORYLOCALIRRITATIONATTHEWOUND
SITE"ROKENNEEDLESMAYRESULTINEXTENDEDORADDITIONALSURGERIESORRESIDUAL
FOREIGN BODIES )NADVERTENT NEEDLE STICKS WITH CONTAMINATED SURGICAL NEEDLES
MAYRESULTINTHETRANSMISSIONOFBLOODBORNEPATHOGENS

-!8)-5-/6%23):%MM


).$)#!4)/.3
%4()"/.$ %8#%, SUTURE IS INDICATED FOR USE IN GENERAL SOFT TISSUE
APPROXIMATIONANDORLIGATION INCLUDINGUSEINCARDIOVASCULAR OPHTHALMICAND
NEUROLOGICALPROCEDURES

!#4)/.3
%4()"/.$ %8#%, SUTURE ELICITS A MINIMAL ACUTE INFLAMMATORY REACTION IN
TISSUE FOLLOWEDBYAGRADUALENCAPSULATIONOFTHESUTUREBYFIBROUSCONNECTIVE
TISSUE )MPLANTATION STUDIES IN ANIMALS SHOW NO MEANINGFUL DECLINE IN
POLYESTER SUTURE STRENGTH OVER TIME "OTH POLYESTER FIBER SUTURE MATERIAL AND
THEPOLYBUTILATECOATINGAREPHARMACOLOGICALLYINACTIVE

#/.42!).$)#!4)/.3
.ONEKNOWN

7!2.).'3
5SERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING
NONABSORBABLESUTURESBEFOREEMPLOYING%4()"/.$%8#%, SUTUREFORWOUND
CLOSURE ASRISKOFWOUNDDEHISCENCEMAYVARYWITHTHESITEOFAPPLICATIONAND
THESUTUREMATERIALUSED
$ONOTRESTERILIZE$ISCARDOPENEDPACKAGESANDUNUSEDSUTURES
!SWITHANYFOREIGNBODY PROLONGEDCONTACTOFANYSUTUREWITHSALTSOLUTIONS
SUCH AS THOSE FOUND IN THE URINARY OR BILIARY TRACTS MAY RESULT IN CALCULUS
FORMATION !CCEPTABLE SURGICAL PRACTICE SHOULD BE FOLLOWED FOR THE
MANAGEMENTOFINFECTEDORCONTAMINATEDWOUNDS

(/73500,)%$
%4()"/.$%8#%, SUTURESAREAVAILABLEASSTERILE BRAIDED GREENANDUNDYED
WHITE STRANDSINSIZES THROUGHMETRICSIZES  INAVARIETYOFLENGTHS
WITHANDWITHOUTPERMANENTLYATTACHEDNEEDLES
%4()"/.$%8#%, SUTURES GREEN BRAIDED INSIZES THROUGHMETRICSIZES
  AREALSOAVAILABLEATTACHEDTO#/.42/,2%,%!3%
REMOVABLENEEDLES
%4()"/.$ %8#%, SUTURES GREEN AND UNDYED ARE ALSO AVAILABLE ATTACHED TO
4&%POLYMERPLEDGETSMEASURINGXXMMXMMXMM
XXMMXMMXMM 
%4()"/.$%8#%, SUTURESAREAVAILABLEINONE TWOANDTHREEDOZENBOXES



4RADEMARK

%4()#/. ).#

#(!04%2
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./.!"3/2"!",%352')#!,35452%3 530
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NYLON SUTURE IS A NONABSORBABLE STERILE SURGICAL MONOFILAMENT
SUTURECOMPOSEDOFTHELONG CHAINALIPHATICPOLYMERS.YLONAND.YLON 
%4(),/. SUTURES ARE DYED BLACK OR GREEN TO ENHANCE VISIBILITY IN TISSUE4HE
SUTUREISALSOAVAILABLEUNDYEDCLEAR 



02%#!54)/.3
)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
DAMAGEFROMHANDLING!VOIDCRUSHINGORCRIMPINGDAMAGEDUETOAPPLICATION
OFSURGICALINSTRUMENTSSUCHASFORCEPSORNEEDLEHOLDERS
!SWITHANYSUTUREMATERIAL ADEQUATEKNOTSECURITYREQUIRESTHEACCEPTEDSUR
GICALTECHNIQUEOFFLATANDSQUARETIES WITHADDITIONALTHROWSASWARRANTEDBY
SURGICALCIRCUMSTANCEANDTHEEXPERIENCEOFTHESURGEON4HEUSEOFADDITIONAL
THROWSMAYBEPARTICULARLYAPPROPRIATEWHENKNOTTINGMONOFILAMENTS

).$)#!4)/.3

4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLEINANAREA
ONE THIRD TOONE HALF OFTHEDISTANCE FROMTHESWAGEDENDTOTHEPOINT
2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS RESISTANT TO
BENDINGANDBREAKING5SERSSHOULDEXERCISECAUTIONWHENHANDLINGSURGICAL
NEEDLES TO AVOID INADVERTENT NEEDLE STICKS $ISCARD USED NEEDLES IN SHARPS
CONTAINERS

%4(),/. SUTURE IS INDICATED FOR USE IN GENERAL SOFT TISSUE
APPROXIMATION ANDOR LIGATION INCLUDING USE IN CARDIOVASCULAR
OPHTHALMICANDNEUROLOGICALPROCEDURES

!$6%23%2%!#4)/.3

%4(),/. SUTURE MEETS ALL REQUIREMENTS ESTABLISHED BY THE 5NITED 3TATES
0HARMACOPOEIA530 FORNONABSORBABLESURGICAL SUTURE

!#4)/.3
%4(),/.SUTUREELICITSAMINIMALACUTEINFLAMMATORYREACTIONINTISSUE WHICH
ISFOLLOWEDBYGRADUALENCAPSULATIONOFTHESUTUREBYFIBROUSCONNECTIVETISSUE
7HILENYLONISNOTABSORBED PROGRESSIVEHYDROLYSISOFTHENYLONINVIVO MAY
RESULTINGRADUALLOSSOVERTIMEOFTENSILESTRENGTH

#/.42!).$)#!4)/.3
$UE TO THE GRADUAL LOSS OF TENSILE STRENGTH WHICH MAY OCCUR OVER PROLONGED
PERIODSINVIVO NYLONSUTURESHOULDNOTBEUSEDWHEREPERMANENTRETENTIONOF
TENSILESTRENGTHISREQUIRED

!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND DEHIS
CENCE GRADUAL LOSS OF TENSILE STRENGTH OVER TIME CALCULI FORMATION IN URINARY
ANDBILIARYTRACTSWHENPROLONGEDCONTACTWITHSALTSOLUTIONSSUCHASURINEAND
BILEOCCURS INFECTION MINIMALACUTEINFLAMMATORYTISSUEREACTION ANDTRANSI
TORYLOCALIRRITATIONATTHEWOUNDSITE"ROKENNEEDLESMAYRESULTINEXTENDEDOR
ADDITIONALSURGERIESORRESIDUALFOREIGNBODIES)NADVERTENTNEEDLESTICKSWITH
CONTAMINATED SURGICAL NEEDLES MAY RESULT IN THE TRANSMISSION OF BLOODBORNE
PATHOGENS

(/73500,)%$
%4(),/.SUTURESAREAVAILABLEASSTERILEMONOFILAMENTSTRANDSIN530SIZES
  THROUGH  METRIC SIZES   IN A VARIETY OF LENGTHS WITH AND WITHOUT
PERMANENTLYATTACHEDNEEDLES%4(),/.SUTURESAREAVAILABLEINONE TWOAND
THREEDOZENBOXES

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5SERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING
NONABSORBABLESUTURESBEFOREEMPLOYING%4(),/.SUTUREFORWOUNDCLOSURE
ASTHERISKOFWOUNDDEHISCENCEMAYVARYWITHTHESITEOFAPPLICATIONANDTHE
SUTUREMATERIALUSED
!SWITHANYFOREIGNBODY PROLONGEDCONTACTOFANYSUTUREWITHSALTSOLUTIONS
SUCH AS THOSE FOUND IN THE URINARY OR BILIARY TRACTS MAY RESULT IN CALCULUS
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OFCONTAMINATED ORINFECTEDWOUNDS
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4RADEMARK

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&AST ABSORBING SURGICAL GUT SUTURES ARE STERILE AND ELICIT ONLY A SLIGHT TO
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&AST ABSORBING SURGICAL GUT SUTURES DIFFER FROM 530 MINIMUM STRENGTH
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&AST ABSORBING SURGICAL GUT SUTURES ARE INTENDED FOR DERMAL SKIN SUTURING
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4HERESULTSOFIMPLANTATIONSTUDIESOFFASTABSORBINGSURGICALGUTSUTURESINTHE
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APPROXIMATELYSEVEN DAYSOFIMPLANTATION
7HENSURGICALGUTSUTUREISPLACEDINTISSUE AMODERATETISSUEINFLAMMATION
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 4YPEOFSUTURE PLAINGUTGENERALLYABSORBSMORERAPIDLYTHANCHROMICGUT
 )NFECTION SURGICAL GUT IS ABSORBED MORE RAPIDLY IN INFECTED TISSUE THAN IN
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 4ISSUESITES SURGICALGUTWILLABSORBMORERAPIDLYINTISSUEWHEREINCREASED
LEVELSOFPROTEOLYTICENZYMESAREPRESENT ASINTHESECRETIONSEXHIBITEDIN
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$ATA OBTAINED FROM IMPLANTATION STUDIES IN RATS SHOW THAT THE ABSORPTION OF
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4HESE SUTURES BEING ABSORBABLE SHOULD NOT BE USED WHERE PROLONGED
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DESIGNED TO ABSORB AT A RAPID RATE AND MUST BE USED ON DERMAL TISSUE ONLY
4HESESUTURESSHOULDNEVER BEUSEDONINTERNALTISSUE4HEUSEOFTHISSUTUREIS
CONTRAINDICATEDINPATIENTSWITHKNOWNSENSITIVITIESORALLERGIESTOCOLLAGEN AS
GUTISACOLLAGENBASEDMATERIAL

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THE RISK OF WOUND DEHISCENCE MAY VARY WITH THE SITE OF APPLICATION AND THE
SUTUREMATERIALUSED0HYSICIANSSHOULDCONSIDERTHEINVIVO PERFORMANCEWHEN
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4HEUSEOFTHISSUTUREMAYBEINAPPROPRIATEINELDERLY MALNOURISHED ORDEBIL
ITATEDPATIENTS ORINPATIENTSSUFFERINGFROMCONDITIONSWHICHMAYDELAYWOUND
HEALING !S THIS IS AN ABSORBABLE MATERIAL THE USE OF SUPPLEMENTAL NONAB
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SIS WOUNDSUPPURATIONANDBLEEDING ASWELLASSINUSFORMATION

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)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
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REQUIRETHEACCEPTEDSURGICALTECHNIQUEOFFLATANDSQUARETIESWITHADDITIONAL
THROWS AS WARRANTED BY SURGICAL CIRCUMSTANCE AND THE EXPERIENCE OF THE
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JOINTSBYEXTERNALSUPPORTMAYBEEMPLOYEDATTHEDISCRETIONOFTHESURGEON
4HESURGEONSHOULDAVOIDUNNECESSARYTENSIONWHENRUNNINGDOWNKNOTS TO
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!VOIDPROLONGEDEXPOSURETOELEVATEDTEMPERATURES
4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLEINANAREA
ONE THIRD  TO ONE HALF  OF THE DISTANCE FROM THE SWAGED END TO
THE POINT 2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS
RESISTANT TO BENDING AND BREAKING 5SERS SHOULD EXERCISE CAUTION WHEN
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NEEDLESINSHARPSCONTAINERS

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!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND
DEHISCENCE VARIABLERATESOFABSORPTIONOVERTIMEDEPENDINGONSUCHFACTORS
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ING IN INFLAMMATION TISSUE GRANULATION OR FIBROSIS WOUND SUPPURATION AND
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RESPONSECHARACTERISTICOFFOREIGNBODYRESPONSE CALCULIFORMATIONINURINARY
ANDBILIARYTRACTSWHENPROLONGEDCONTACTWITHSALTSOLUTIONSSUCHASURINEAND
BILE OCCURS AND TRANSITORY LOCAL IRRITATION AT THE WOUND SITE "ROKEN NEEDLES
MAY RESULT IN EXTENDED OR ADDITIONAL SURGERIES OR RESIDUAL FOREIGN BODIES
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4RADEMARK

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)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
DAMAGEFROMHANDLING!VOIDCRUSHINGORCRIMPINGDAMAGEDUETOAPPLICATION
OFSURGICALINSTRUMENTSSUCHASFORCEPSORNEEDLEHOLDERS4HEUSEOFADDITION
ALTHROWSISPARTICULARLYAPPROPRIATEWHENKNOTTINGMONOFILAMENTSUTURES
!S WITH ANY SUTURE MATERIAL ADEQUATE KNOT SECURITY REQUIRES THE ACCEPTED
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4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLEINANAREA
ONE THIRD  TO ONE HALF  OF THE DISTANCE FROM THE SWAGED END TO
THE POINT 2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS
RESISTANT TO BENDING AND BREAKING 5SERS SHOULD EXERCISE CAUTION WHEN
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ANDOR LIGATION INCLUDING USE IN CARDIOVASCULAR OPHTHALMIC AND NEUROLOGICAL
PROCEDURES

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!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND
DEHISCENCE CALCULI FORMATION IN URINARY AND BILIARY TRACTS WHEN PROLONGED
CONTACT WITH SALT SOLUTIONS SUCH AS URINE AND BILE OCCURS INFECTION MINIMAL
ACUTEINFLAMMATORYTISSUEREACTIONANDTRANSITORYLOCALIRRITATIONATTHEWOUND
SITE"ROKENNEEDLESMAYRESULTINEXTENDEDORADDITIONALSURGERIESORRESIDUAL
FOREIGN BODIES )NADVERTENT NEEDLE STICKS WITH CONTAMINATED SURGICAL NEEDLES
MAYRESULTINTHETRANSMISSIONOFBLOODBORNEPATHOGENS

!#4)/.3
-%23),%.% SUTURE ELICITS A MINIMAL ACUTE INFLAMMATORY REACTION IN TISSUE
FOLLOWED BY A GRADUAL ENCAPSULATION OF THE SUTURE BY FIBROUS CONNECTIVE
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POLYESTER SUTURE STRENGTH OVER TIME4HE POLYESTER FIBER SUTURE MATERIAL IS
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 METRICSIZES  
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5SERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING
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4RADEMARK

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0OLYESTER &IBER -ESH IS CONSTRUCTED FROM POLYETHYLENE
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0OLYESTER &IBER -ESH AFFORDS EXCELLENT STRENGTH DURABILITY AND SURGICAL
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!MINIMUMOFMMINCH OFMESHSHOULDEXTENDBEYONDTHESUTURELINE

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THEMESH

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4RADEMARK

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POLIGLECAPRONE  SUTURE IS A MONOFILAMENT SYNTHETIC
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EPSILON CAPROLACTONE 0OLIGLECAPRONE  COPOLYMER HAS BEEN FOUND TO BE
NONANTIGENIC NONPYROGENIC AND ELICITS ONLY A SLIGHT TISSUE REACTION DURING
ABSORPTION
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3KINSUTURESWHICHMUSTREMAININPLACELONGERTHANDAYSMAYCAUSELOCAL
IZEDIRRITATIONANDSHOULDBESNIPPEDOFFORREMOVEDASINDICATED3UBCUTICULAR
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5NDERSOMECIRCUMSTANCES NOTABLYORTHOPAEDICPROCEDURES IMMOBILIZATIONOF
JOINTSBYEXTERNALSUPPORTMAYBEEMPLOYEDATTHEDISCRETIONOFTHESURGEON
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SECURITY REQUIRES THE ACCEPTED SURGICAL TECHNIQUE OF FLAT AND SQUARE TIES WITH
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THESURGEON4HEUSEOFADDITIONALTHROWSMAYBEPARTICULARLYAPPROPRIATEWHEN
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TORYREACTIONINTISSUESANDINGROWTHOFFIBROUSCONNECTIVETISSUE0ROGRESSIVE
LOSSOFTENSILESTRENGTHANDEVENTUALABSORPTIONOF-/./#29,SUTURESOCCURS
BY MEANS OF HYDROLYSIS !BSORPTION BEGINS AS A LOSS OF TENSILE STRENGTH
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-/./#29, SUTURE RETAINS APPROXIMATELY  TO  OF ITS ORIGINAL STRENGTH
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ESSENTIALLYCOMPLETEBETWEENANDDAYS

!DVERSEEFFECTSASSOCIATEDWITHTHEUSEOFSYNTHETICABSORBABLESUTURESINCLUDE
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FORMATION!SANABSORBABLESUTURE -/./#29,SUTUREMAYACTTRANSIENTLYAS
A FOREIGN BODY !CCEPTABLE SURGICAL PRACTICE SHOULD BE FOLLOWED FOR THE
MANAGEMENTOFCONTAMINATEDORINFECTEDWOUNDS



4RADEMARK

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POLIGLECAPRONE  SUTURE IS A MONOFILAMENT SYNTHETIC
ABSORBABLE SURGICAL SUTURE PREPARED FROM A COPOLYMER OF GLYCOLIDE AND
EPSILON CAPROLACTONE 0OLIGLECAPRONE  COPOLYMER HAS BEEN FOUND TO BE
NONANTIGENIC NONPYROGENIC AND ELICITS ONLY A SLIGHT TISSUE REACTION DURING
ABSORPTION
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3KINSUTURESWHICHMUSTREMAININPLACELONGERTHANDAYSMAYCAUSELOCAL
IZEDIRRITATIONANDSHOULDBESNIPPEDOFFORREMOVEDASINDICATED3UBCUTICULAR
SUTURESSHOULDBEPLACEDASDEEPLYASPOSSIBLETOMINIMIZETHEERYTHEMAAND
INDURATIONNORMALLYASSOCIATEDWITHABSORPTION
5NDERSOMECIRCUMSTANCES NOTABLYORTHOPAEDICPROCEDURES IMMOBILIZATIONOF
JOINTSBYEXTERNALSUPPORTMAYBEEMPLOYEDATTHEDISCRETIONOFTHESURGEON
#ONSIDERATIONSHOULDBETAKENINTHEUSEOFABSORBABLESUTURESINTISSUEWITH
POORBLOODSUPPLYASSUTUREEXTRUSIONANDDELAYEDABSORPTIONMAYOCCUR
)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
DAMAGEFROMHANDLING!VOIDCRUSHINGORCRIMPINGDAMAGEDUETOAPPLICATION
OFSURGICALINSTRUMENTSSUCHASFORCEPSORNEEDLEHOLDERS
-/./#29,SUTUREKNOTSMUSTBEPROPERLYPLACEDTOBESECURE!DEQUATEKNOT
SECURITY REQUIRES THE ACCEPTED SURGICAL TECHNIQUE OF FLAT AND SQUARE TIES WITH
ADDITIONALTHROWSASWARRANTEDBYSURGICALCIRCUMSTANCEANDTHEEXPERIENCEOF
THESURGEON4HEUSEOFADDITIONALTHROWSMAYBEPARTICULARLYAPPROPRIATEWHEN
KNOTTINGMONOFILAMENTS
!VOIDPROLONGEDEXPOSURETOELEVATEDTEMPERATURE
4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLEINANAREA
ONE THIRD  TO ONE HALF  OF THE DISTANCE FROM THE SWAGED END TO THE
POINT 2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS
RESISTANT TO BENDING AND BREAKING 5SERS SHOULD EXERCISE CAUTION WHEN
HANDLING SURGICAL NEEDLES TO AVOID INADVERTENT NEEDLE STICKS $ISCARD USED
NEEDLESINSHARPSCONTAINERS

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-/./#29,SUTURESAREINDICATEDFORUSEINGENERALSOFTTISSUEAPPROXIMATION
ANDOR LIGATION BUT NOT FOR USE IN CARDIOVASCULAR OR NEUROLOGICAL TISSUES
MICROSURGERYOROPHTHALMICSURGERY

!#4)/.3
-/./#29,SUTUREISAMONOFILAMENTWHICHELICITSAMINIMALACUTEINFLAMMA
TORYREACTIONINTISSUESANDINGROWTHOFFIBROUSCONNECTIVETISSUE0ROGRESSIVE
LOSSOFTENSILESTRENGTHANDEVENTUALABSORPTIONOF-/./#29,SUTURESOCCURS
BY MEANS OF HYDROLYSIS !BSORPTION BEGINS AS A LOSS OF TENSILE STRENGTH
FOLLOWED BY A LOSS OF MASS )MPLANTATION STUDIES IN RATS INDICATE THAT
-/./#29, SUTURE RETAINS APPROXIMATELY  TO  OF ITS ORIGINAL STRENGTH
 DAYS POST IMPLANTATION AND APPROXIMATELY  TO  OF ITS ORIGINAL TENSILE
STRENGTH AT  DAYS POST IMPLANTATION %SSENTIALLY ALL OF THE ORIGINAL TENSILE
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ABSORBABLE SUTURES BEFORE EMPLOYING -/./#29, SUTURE FOR WOUND CLOSURE
AS RISK OF WOUND DEHISCENCE MAY VARY WITH THE SITE OF APPLICATION AND THE
SUTURE MATERIAL USED 0HYSICIANS SHOULD CONSIDER THE IN VIVO PERFORMANCE
UNDER !#4)/.3 SECTION WHEN SELECTING A SUTURE FOR USE IN PATIENTS4HE
USEOFTHISSUTUREMAYBEINAPPROPRIATEINELDERLY MALNOURISHED ORDEBILITATED
PATIENTS OR IN PATIENTS SUFFERING FROM CONDITIONS WHICH MAY DELAY WOUND
HEALING
$ONOTRESTERILIZE$ISCARDOPENEDPACKAGESANDUNUSEDSUTURES
!SWITHANYFOREIGNBODY PROLONGEDCONTACTOFANYSUTUREWITHSALTSOLUTIONS
SUCH AS THOSE FOUND IN THE URINARY OR BILIARY TRACTS MAY RESULT IN CALCULUS
FORMATION!SANABSORBABLESUTURE -/./#29,SUTUREMAYACTTRANSIENTLYAS
A FOREIGN BODY !CCEPTABLE SURGICAL PRACTICE SHOULD BE FOLLOWED FOR THE
MANAGEMENTOFCONTAMINATEDORINFECTEDWOUNDS
!S THIS IS AN ABSORBABLE SUTURE MATERIAL THE USE OF SUPPLEMENTAL
NONABSORBABLESUTURESSHOULDBECONSIDEREDBYTHESURGEONINTHECLOSUREOF
THESITESWHICHMAYUNDERGOEXPANSION STRETCHINGORDISTENTION ORWHICHMAY
REQUIREADDITIONALSUPPORT

!DVERSEEFFECTSASSOCIATEDWITHTHEUSEOFSYNTHETICABSORBABLESUTURESINCLUDE
WOUNDDEHISCENCE FAILURETOPROVIDEADEQUATEWOUNDSUPPORTINCLOSUREOFTHE
SITES WHERE EXPANSION STRETCHING OR DISTENSION OCCUR FAILURE TO PROVIDE
ADEQUATEWOUNDSUPPORTINELDERLY MALNOURISHEDORDEBILITATEDPATIENTSORIN
PATIENTSSUFFERINGFROMCONDITIONSWHICHMAYDELAYWOUNDHEALING INFECTION
MINIMAL ACUTE INFLAMMATORY TISSUE REACTION LOCALIZED IRRITATION WHEN SKIN
SUTURESARELEFTINPLACEFORGREATERTHANDAYS SUTUREEXTRUSIONANDDELAYED
ABSORPTION IN TISSUE WITH POOR BLOOD SUPPLY CALCULI FORMATION IN URINARY AND
BILIARYTRACTSWHENPROLONGEDCONTACTWITHSALTSOLUTIONSSUCHASURINEANDBILE
OCCURS ANDTRANSITORYLOCALIRRITATIONATTHEWOUNDSITE"ROKENNEEDLESMAY
RESULT IN EXTENDED OR ADDITIONAL SURGERIES OR RESIDUAL FOREIGN BODIES
)NADVERTENTNEEDLESTICKSWITHCONTAMINATEDSURGICALNEEDLESMAYRESULTINTHE
TRANSMISSIONOFBLOODBORNEPATHOGENS

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-/./#29, SUTURES ARE AVAILABLE AS STERILE MONOFILAMENT DYED VIOLET
STRANDSINSIZES THROUGHMETRICSIZES  INAVARIETYOFLENGTHS WITH
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METRICSIZES  ATTACHEDTO#/.42/,2%,%!3%
REMOVABLENEEDLES
-/./#29,SUTURESAREAVAILABLEINONEANDTHREEDOZENBOXES



4RADEMARK

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NYLON SUTURE IS A NONABSORBABLE STERILE SURGICAL BRAIDED SUTURE
COMPOSED OF THE LONG CHAIN ALIPHATIC POLYMERS .YLON  OR .YLON  
.52/,/.SUTURESAREDYEDBLACKTOENHANCEVISIBILITYINTISSUE4HESUTUREIS
ALSOAVAILABLEUNDYEDCLEAR 
.52/,/. SUTURE MEETS ALL REQUIREMENTS ESTABLISHED BY THE 5NITED 3TATES
0HARMACOPOEIA530 FORNONABSORBABLESURGICALSUTURE



02%#!54)/.3
)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
DAMAGEFROMHANDLING!VOIDCRUSHINGORCRIMPINGDAMAGEDUETOAPPLICATION
OFSURGICALINSTRUMENTSSUCHASFORCEPSORNEEDLEHOLDERS
!S WITH ANY SUTURE MATERIAL ADEQUATE KNOT SECURITY REQUIRES THE ACCEPTED
SURGICALTECHNIQUEOFFLATANDSQUARETIESWITHADDITIONALTHROWSASWARRANTED
BYSURGICALCIRCUMSTANCEANDTHEEXPERIENCEOFTHESURGEON
4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLE INANAREA
ONE THIRD  TO ONE HALF  OF THE DISTANCE FROM THE SWAGED END TO THE
POINT 2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS
RESISTANT TO BENDING AND BREAKING 5SERS SHOULD EXERCISE CAUTION WHEN
HANDLING SURGICAL NEEDLES TO AVOID INADVERTENT NEEDLE STICKS $ISCARD USED
NEEDLESINSHARPSCONTAINERS

).$)#!4)/.3
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APPROXIMATION ANDOR LIGATION INCLUDING USE IN CARDIOVASCULAR
OPHTHALMICANDNEUROLOGICALPROCEDURES

!#4)/.3
.52/,/. SUTURE ELICITS A MINIMAL ACUTE INFLAMMATORY REACTION IN
TISSUE WHICHISFOLLOWEDBY A GRADUAL ENCAPSULATION OF THESUTUREBY FIBROUS
CONNECTIVETISSUE7HILENYLONISNOTABSORBED PROGRESSIVEHYDROLYSISOFTHE
NYLONINVIVO MAYRESULTINGRADUALLOSSOFTENSILESTRENGTHOVERTIME

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$UE TO THE GRADUAL LOSS OF TENSILE STRENGTH WHICH MAY OCCUR OVER PROLONGED
PERIODSINVIVO NYLONSUTURESHOULDNOTBEUSEDWHEREPERMANENTRETENTIONOF
TENSILESTRENGTHISREQUIRED

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5SERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING
NONABSORBABLESUTURESBEFOREEMPLOYING.52/,/.SUTUREFORWOUNDCLOSURE
AS RISK OF WOUND DEHISCENCE MAY VARY WITH THE SITE OF APPLICATION AND THE
SUTUREMATERIALUSED
!SWITHANYFOREIGNBODY PROLONGEDCONTACTOFANYSUTUREWITHSALTSOLUTIONS
SUCHASTHOSEFOUNDINTHEURINARYORBILIARYTRACTS MAYRESULTINCALCULUSFOR
MATION!CCEPTABLESURGICALPRACTICESSHOULDBEFOLLOWEDFORTHEMANAGEMENT
OFINFECTEDORCONTAMINATEDWOUNDS
$ONOTRESTERILIZE$ISCARDOPENEDPACKAGESANDUNUSEDSUTURES

!$6%23%2%!#4)/.3
!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND
DEHISCENCE GRADUAL LOSS OF TENSILE STRENGTH OVER TIME CALCULI FORMATION IN
URINARY AND BILIARY TRACTS WHEN PROLONGED CONTACT WITH SALT SOLUTIONS SUCH AS
URINE AND BILE OCCURS INFECTION MINIMAL ACUTE INFLAMMATORY TISSUE REACTION
ANDTRANSITORYLOCALIRRITATIONATTHEWOUNDSITE"ROKENNEEDLESMAYRESULTIN
EXTENDEDORADDITIONALSURGERIESORRESIDUALFOREIGNBODIES)NADVERTENTNEEDLE
STICKS WITH CONTAMINATED SURGICAL NEEDLES MAY RESULT IN THE TRANSMISSION OF
BLOODBORNEPATHOGENS

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.52/,/. SUTURES ARE AVAILABLE IN 530 SIZES   THROUGH  METRIC SIZES
  INAVARIETYOFLENGTHSWITHANDWITHOUTPERMANENTLYATTACHEDNEEDLES
.52/,/. SUTURES ARE AVAILABLE IN 530 SIZES   THROUGH  METRIC SIZES
  ATTACHEDTO#/.42/,2%,%!3%
REMOVABLENEEDLES
.52/,/.SUTURESAREAVAILABLEINONE TWOANDTHREEDOZENBOXES



4RADEMARK

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02/$5#4).&/2-!4)/.



0$3
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))POLYDIOXANONE MONOFILAMENTSYNTHETICABSORBABLESUTUREISPREPARED
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POLYMERIS#( X
0OLYDIOXANONEPOLYMERHASBEENFOUNDTOBENONANTIGENIC NONPYROGENICAND
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0$3))SUTURESARE530 EXCEPTFORDIAMETER
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4WOIMPORTANTCHARACTERISTICSDESCRIBETHEINVIVO PERFORMANCEOFABSORBABLE
SUTURESFIRST TENSILESTRENGTHRETENTION ANDSECOND THEABSORPTIONRATELOSS
OFMASS 0$3))SYNTHETICABSORBABLESUTUREHASBEENFORMULATEDTOMINIMIZE
THEVARIABILITYOFTHESECHARACTERISTICSANDTOPROVIDEWOUNDSUPPORTTHROUGH
ANEXTENDEDHEALINGPERIOD
4HERESULTSOFIMPLANTATIONSTUDIESOF0$3))MONOFILAMENTSUTUREINANIMALS
INDICATE THAT APPROXIMATELY  OF ITS ORIGINAL STRENGTH REMAINS TWO WEEKS
AFTERIMPLANTATION!TFOURWEEKSPOST IMPLANTATION APPROXIMATELYOFITS
ORIGINALSTRENGTHISRETAINED ANDATSIXWEEKS APPROXIMATELYOFTHEORIGI
NALSTRENGTHISRETAINED

7!2.).'3
4HESAFETYANDEFFECTIVENESSOF0$3 ))POLYDIOXANONE SUTURESHAVENOTBEEN
ESTABLISHED IN NEURAL TISSUE ADULT CARDIOVASCULAR TISSUE OR FOR USE IN MICRO
SURGERY
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BYEXTERNALSUPPORTMAYBEEMPLOYEDATTHEDISCRETIONOFTHESURGEON
$ONOTRESTERILIZE

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4HE 0$3 )) SUTURE KNOTS MUST BE PROPERLY PLACED TO BE SECURE!S WITH OTHER
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ANDTHEEXPERIENCEOFTHEOPERATOR
!S WITH ANY SUTURE CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING
!VOID THE CRUSHING OR CRIMPING APPLICATION OF SURGICAL INSTRUMENTS SUCH AS
NEEDLEHOLDERSANDFORCEPS TOTHESTRANDEXCEPTWHENGRASPINGTHEFREEENDOF
THESUTUREDURINGANINSTRUMENTTIE
#ONJUNCTIVAL AND VAGINAL MUCOSAL SUTURES REMAINING IN PLACE FOR EXTENDED
PERIODSMAYBEASSOCIATEDWITHLOCALIZEDIRRITATIONANDSHOULDBEREMOVEDAS
INDICATED
3UBCUTICULAR SUTURES SHOULD BE PLACED AS DEEPLY AS POSSIBLE IN ORDER TO
MINIMIZETHEERYTHEMAANDINDURATIONNORMALLYASSOCIATEDWITHABSORPTION
!CCEPTABLESURGICALPRACTICESHOULDBEFOLLOWEDWITHRESPECTTODRAINAGEAND
CLOSUREOFINFECTEDWOUNDS

!$6%23%2%!#4)/.3
$UE TO PROLONGED SUTURE ABSORPTION SOME IRRITATION AND BLEEDING HAS BEEN
OBSERVED IN THE CONJUNCTIVA AND MILD IRRITATION HAS BEEN OBSERVED IN THE
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5SEASREQUIREDPERSURGICALPROCEDURE

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$ATA OBTAINED FROM IMPLANTATION STUDIES IN RATS SHOW THAT THE ABSORPTION OF
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ISESSENTIALLYCOMPLETEWITHINSIXMONTHS

0$3 )) SUTURES ARE AVAILABLE AS STERILE MONOFILAMENT DYED VIOLET STRANDS IN
SIZES   THRU  METRIC SIZES   AND STERILE MONOFILAMENT DYED BLUE
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0$3))MONOFILAMENTDYEDVIOLET SUTURES SIZES THRUMETRICSIZE  ARE


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0$3))MONOFILAMENTSYNTHETICABSORBABLESUTURESAREINDICATEDFORUSEINALL
TYPESOFSOFTTISSUEAPPROXIMATION INCLUDINGUSEINPEDIATRICCARDIOVASCULARTIS
SUEWHEREGROWTHISEXPECTEDTOOCCURANDOPTHALMICSURGERY0$3))SUTUREIS
NOT INDICATED IN ADULT CARDIOVASCULAR TISSUE MICROSURGERY AND NEURAL TISSUE
4HESESUTURESAREPARTICULARLYUSEFULWHERETHECOMBINATIONOFANABSORBABLE
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4HESESUTURES BEINGABSORBABLE ARENOTTOBEUSEDWHEREPROLONGEDBEYOND
SIXWEEKS APPROXIMATIONOFTISSUESUNDERSTRESSISREQUIREDARENOTTOBEUSED
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0$3))#LEARSUTURESTRANDSAREAVAILABLEINSIZES THRUMETRICSIZE  IN


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4RADEMARK

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SILK SUTURE IS A NONABSORBABLE STERILE SURGICAL SUTURE
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0%2-! (!.$SUTURESAREPROCESSEDTOREMOVETHENATURALWAXESANDGUMS
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0%2-! (!.$SUTUREISALSOAVAILABLEINITSNATURALCOLOR0%2-! (!.$6IRGIN
SILKSUTUREISAVAILABLEINWHICHTHESERICINGUMISNOTREMOVEDANDSERVESTO
HOLDTHEFILAMENTSTOGETHER
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0%2-! (!.$SUTUREISINDICATEDFORUSEINGENERALSOFTTISSUEAPPROXIMATION
ANDOR LIGATION INCLUDING USE IN CARDIOVASCULAR OPHTHALMIC AND NEUROLOGICAL
PROCEDURES

!#4)/.3



02%#!54)/.3
)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
DAMAGEFROMHANDLING!VOIDCRUSHINGORCRIMPINGDAMAGEDUETOAPPLICATION
OFSURGICALINSTRUMENTSSUCHASFORCEPSORNEEDLEHOLDERS
!S WITH ANY SUTURE MATERIAL ADEQUATE KNOT SECURITY REQUIRES THE ACCEPTED
SURGICALTECHNIQUEOFFLATANDSQUARETIESWITHADDITIONALTHROWSASWARRANTED
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4O AVOID DAMAGING NEEDLES POINTS AND SWAGE AREAS GRASP THE NEEDLE IN AN
AREAONE THIRD TOONE HALF OFTHEDISTANCEFROMTHESWAGEDENDTOTHE
POINT 2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS
RESISTANT TO BENDING AND BREAKING G 5SERS SHOULD EXERCISE CAUTION WHEN
HANDLING SURGICAL NEEDLES TO AVOID INADVERTENT NEEDLE STICKS $ISCARD USED
NEEDLESINSHARPSCONTAINERS

!$6%23%2%!#4)/.3
!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND
DEHISCENCE GRADUALLOSSOFALLTENSILESTRENGTHOVERTIME ALLERGICRESPONSEIN
PATIENTSTHATAREKNOWTOBESENSITIVETOSILK CALCULIFORMATIONINURINARYAND
BILIARYTRACTSWHENPROLONGEDCONTACTWITHSALTSOLUTIONSSUCHASURINEANDBILE
OCCURS INFECTION ACUTE INFLAMMATORY TISSUE REACTION AND TRANSITORY LOCAL
IRRITATION AT THE WOUND SITE "ROKEN NEEDLES MAY RESULT IN EXTENDED OR
ADDITIONALSURGERIESORRESIDUALFOREIGNBODIES)NADVERTENTNEEDLESTICKSWITH
CONTAMINATED SURGICAL NEEDLES MAY RESULT IN THE TRANSMISSION OF BLOODBORNE
PATHOGENS

0%2-! (!.$SUTUREELICITSANACUTEINFLAMMATORYREACTIONINTISSUE WHICHIS


FOLLOWEDBYAGRADUALENCAPSULATIONOFTHESUTUREBYFIBROUSCONNECTIVETISSUE
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STRENGTHOVERTIME

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0%2-! (!.$ SUTURES ARE ALSO AVAILABLE IN 530 SIZES   THROUGH  METRIC
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REMOVABLENEEDLES

4HEUSEOFTHISSUTUREISCONTRAINDICATEDINPATIENTSWITHKNOWNSENSITIVITIESOR
ALLERGIESTOSILK

0%2-! (!.$SUTURESAREAVAILABLEIN530SIZES THROUGHMETRICSIZES


  INAVARIETYOFLENGTHSWITHANDWITHOUTPERMANENTLYATTACHEDNEEDLES
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DISPENSINGREELS

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$UE TO THE GRADUAL LOSS OF TENSILE STRENGTH WHICH MAY OCCUR OVER PROLONGED
PERIODSINVIVO SILKSHOULDNOTBEUSEDWHEREPERMANENTRETENTIONOFTENSILE
STRENGTHISREQUIRED


7!2.).'3
5SERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING
NONABSORBABLE SUTURES BEFORE EMPLOYING 0%2-! (!.$ SUTURE FOR WOUND
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SUCHASTHOSEFOUNDINTHEURINARYORBILIARYTRACTS MAYRESULTINCALCULUSFOR
MATION!CCEPTABLESURGICALPRACTICESHOULDBEFOLLOWEDFORTHEMANAGEMENT
OFINFECTEDORCONTAMINATEDWOUNDS
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4RADEMARK

%4()#/. ).#

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02/,%.%
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02/,%.%
POLYPROPYLENE SUTURE CLEAR OR PIGMENTED IS A NONABSORBABLE
STERILE SURGICAL SUTURE COMPOSED OF AN ISOTACTIC CRYSTALLINE STEREOISOMER OF
POLYPROPYLENE A SYNTHETIC LINEAR POLYOLEFIN4HE SUTURE IS PIGMENTED BLUE TO
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02/,%.%SUTURE AVAILABLEAS(%-/ 3%!,


NEEDLESUTURE ISANEEDLESUTURE
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TO FACILITATE ATTACHMENT OF FINER WIRE DIAMETER NEEDLES4HE DIAMETER OF THE
SUTURESTRANDANDTHENEEDLEWIREHAVEBEENMORECLOSELYALIGNEDTOREDUCETHE
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02/,%.% SUTURE IS INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION
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02/,%.%SUTUREELICITSAMINIMALACUTEINFLAMMATORYREACTIONINTISSUE WHICH
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RESISTS INVOLVEMENT IN INFECTION AND HAS BEEN SUCCESSFULLY EMPLOYED IN CON
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ANDSUTUREEXTRUSION4HELACKOFADHERENCETOTISSUESHASFACILITATEDTHEUSEOF
02/,%.%SUTUREASAPULL OUTSUTURE

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INFECTEDORCONTAMINATEDWOUNDS

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)N HANDLING THIS SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID DAMAGE FROM
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!DEQUATEKNOTSECURITYREQUIRESTHEACCEPTEDSURGICALTECHNIQUEOFFLAT SQUARE
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ONE THIRD  TO ONE HALF  OF THE DISTANCE FROM THE SWAGED END TO THE
POINT2ESHAPINGNEEDLESMAYCAUSETHEMTOLOSESTRENGTHANDBELESSRESIST
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GICAL NEEDLES TO AVOID INADVERTENT NEEDLE STICKS $ISCARD USED NEEDLES IN
SHARPSCONTAINERS

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!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND
DEHISCENCE CALCULI FORMATION IN URINARY AND BILIARY TRACTS WHEN PROLONGED
CONTACT WITH SALT SOLUTIONS SUCH AS URINE AND BILE OCCURS INFECTION MINIMAL
ACUTEINFLAMMATORYTISSUEREACTION ANDTRANSITORYLOCALIRRITATIONATTHEWOUND
SITE"ROKENNEEDLESMAYRESULTINEXTENDEDORADDITIONALSURGERIESORRESIDUAL
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02/,%.% SUTURES PIGMENTED ARE AVAILABLE AS STERILE STRANDS IN 530 SIZES
 THROUGH METRICSIZES  AND THROUGHMETRICSIZES  
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THROUGHMETRICSIZES  3IZE METRICSIZE 02/,%.%SUTURES PIG
MENTEDANDCLEARARE530EXCEPTFORDIAMETER!LL02/,%.%SUTURESAREAVAIL
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0OLYPROPYLENE (ERNIA 3YSTEM IS A STERILE PRE SHAPED THREE
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CYLINDER TO A CIRCULAR UNDERLAY PATCH 4HE MATERIAL IS UNDYED 02/,%.%

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FILAMENTS

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4HE 02/,%.% (ERNIA 3YSTEM IS A NONABSORBABLE MESH USED TO REINFORCE OR
BRIDGE INGUINAL HERNIA DEFICIENCIES TO PROVIDE EXTENDED SUPPORT DURING AND
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-ESHELICITSAMINIMUMTOSLIGHTINFLAMMATORYREACTION WHICHISTRANSIENTANDIS
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THEINTERSTICESOFTHEMESH THUSINCORPORATINGTHEMESHINTOADJACENTTISSUE
4HEMESHREMAINSSOFTANDPLIABLE ANDNORMALWOUNDHEALINGISNOTNOTICEABLY
IMPAIRED4HEMATERIALISNEITHERABSORBEDNORISITSUBJECTTODEGRADATIONOR
WEAKENINGBYTHEACTIONOFTISSUEENZYMES



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&ORINDIRECTHERNIA AHIGHDISSECTIONOFTHENECKOFTHEHERNIASACTOUTILIZETHE
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(ERNIA3YSTEM4HECIRCULARORBOTTOMUNDERLAYPORTIONOFTHE02/,%.%(ERNIA
3YSTEMISFOLDEDANDISINSERTEDTHROUGHTHEINTERNALRINGALLOWINGTHEMESHTO
EXPAND TO THE UNDERLAY POSITION 3URGICAL MANIPULATION MAY BE USED TO
FACILITATETHEEXPANSIONOFTHEDEVICETOTHEUNDERLAYPOSITION.OSUTURESARE
NECESSARYINTHEBOTTOMUNDERLAYPATCH4HETOPONLAYPATCH WHICHISDESIGNED
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THAN THE OTHER THE 02/,%.% (ERNIA 3YSTEM IS POSITIONED SO THAT THE LONGER
ENDCOVERSTHEPOSTERIORWALLFLOOROFTHECANAL ANDOVERLAPSTHEPUBLIC
TUBERCLE
&OR DIRECT HERNIA THE DEFECT IS CIRCUMSCRIBED AT ITS BASE THE CONTENTS FULLY
REDUCED ANDTHEPREPERITONEALSPACEISACTUALIZEDPRIORTOTHEINSERTIONOFTHE
02/,%.% (ERNIA 3YSTEM 4HE CIRCULAR OR BOTTOM UNDERLAY PORTION OF THE
02/,%.% (ERNIA 3YSTEM IS FOLDED AND IS INSERTED THROUGH THE DEFECT OR THE
INTERNAL RING ALLOWING THE MESH TO EXPAND TO THE UNDERLAY POSITION 4HE
UNDERLAY PORTION SHOULD EXPAND UNDER THE DEFECT IN THE FLOOR OF THE CANAL
3URGICALMANIPULATIONMAYBEUSEDTOFACILITATETHEEXPANSIONOFTHEDEVICETO
THE UNDERLAY POSITION 3UTURES OR CLIPS MAY BE USED TO SECURE THE TOP ONLAY
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34%2),)49
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4HIS PRODUCT IS INDICATED FOR THE REPAIR OF INDIRECT AND DIRECT INGUINAL HERNIA
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34/2!'%
2ECOMMENDEDSTORAGECONDITIONSBELOW# & AWAYFROMMOISTUREAND
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3UTURESORCLIPS IFNECESSARY SHOULDBEPLACEDSUCHTHATAMINIMUMOFMM
 OFMESHSHOULDEXTENDBEYONDTHESUTURELINE

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0OTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY
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ADHESIONFORMATION FISTULAFORMATIONAND EXTRUSION

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4HE02/,%.%(ERNIA3YSTEMISAVAILABLESTERILE UNDYEDINSEVERALSIZES

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&EDERAL 53! ,AW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN

4RADEMARK

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!$6%23%2%!#4)/.3
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02/,%.%
POLYPROPYLENEMESHISCONSTRUCTEDOFKNITTEDFILAMENTSOFEXTRUDED
POLYPROPYLENE IDENTICAL IN COMPOSITION TO THAT USED IN 02/,%.%

0OLYPROPYLENE 3UTURE .ONABSORBABLE 3URGICAL 3UTURES 530 %4()#/.


).# 4HEMESHISAPPROXIMATELYINCHESTHICK4HISMATERIAL WHENUSED
AS A SUTURE HAS BEEN REPORTED TO BE NON REACTIVE AND TO RETAIN ITS STRENGTH
INDEFINITELYINCLINICALUSE
02/,%.%MESHISKNITTEDBYAPROCESSWHICHINTERLINKSEACHFIBERJUNCTIONAND
WHICH PROVIDES FOR ELASTICITY IN BOTH DIRECTIONS4HIS CONSTRUCTION PERMITS THE
MESHTOBECUTINTOANYDESIREDSHAPEORSIZEWITHOUTUNRAVELING4HEFIBERJUNC
TIONSARENOTSUBJECTTOTHESAMEWORKFATIGUEEXHIBITEDBYMORERIGIDMETALLIC
MESHES4HISBI DIRECTIONALELASTICPROPERTYALLOWSADAPTIONTOVARIOUSSTRESSES
ENCOUNTEREDINTHEBODY

0OTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY


IMPLANTABLE MATERIALS WHICH INCLUDE INFECTION POTENTIATION INFLAMMATION
ADHESIONFORMATION FISTULAFORMATIONANDEXTRUSION

).3425#4)/.3&/253%
)T IS RECOMMENDED THAT NONABSORBABLE SUTURES BE PLACED MM TO MM
TO APARTATADISTANCEAPPROXIMATELYMM FROMEDGEOFTHE
MESH 3OME SURGEONS PREFER TO SUTURE AN UNCUT SECTION OF MESH THAT IS
CONSIDERABLYLARGERTHANTHEDEFECTINTOPOSITIONOVERTHEWOUND4HEOPPOSITE
SIDES ARE THEN SUTURED TO ASSURE PROPER CLOSURE UNDER CORRECT TENSION7HEN
THEMARGINSUTURESHAVEALLBEENPLACED THEEXTRAMESHISTRIMMEDAWAY

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02/,%.%MESHISANONABSORBABLEMESHUSEDTOSPANANDREINFORCETRAUMAT
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HEALING!NIMALSTUDIESSHOWTHATIMPLANTATIONOF02/,%.%MESHELICITSAMIN
IMUMTOSLIGHTINFLAMMATORYREACTION WHICHISTRANSIENTANDISFOLLOWEDBYTHE
DEPOSITIONOFATHINFIBROUSLAYEROFTISSUEWHICHCANGROWTHROUGHTHEINTER
STICESOFTHEMESH THUSINCORPORATINGTHEMESHINTOADJACENTTISSUE4HEMESH
REMAINSSOFTANDPLIABLE ANDNORMALWOUNDHEALINGISNOTNOTICEABLYIMPAIRED
4HEMATERIALISNOTABSORBEDNORISITSUBJECTTODEGRADATIONORWEAKENINGBY
THEACTIONOFTISSUEENZYMES

).$)#!4)/.3
4HISMESHMAYBEUSEDFORTHEREPAIROFHERNIAANDOTHERFASCIALDEFICIENCIES
THAT REQUIRE THE ADDITION OF A REINFORCING OR BRIDGING MATERIAL TO OBTAIN THE
DESIREDSURGICALRESULT

#/.42!).$)#!4)/.3
7HENTHISMESHISUSEDININFANTSORCHILDRENWITHFUTUREGROWTHPOTENTIAL THE
SURGEONSHOULDBEAWARETHATTHISPRODUCTWILLNOTSTRETCHSIGNIFICANTLYASTHE
PATIENTGROWS
02/,%.%MESHINCONTAMINATEDWOUNDSSHOULDBEUSEDWITHTHEUNDERSTAND
INGTHATSUBSEQUENTINFECTIONMAYREQUIREREMOVALOFTHEMATERIAL

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02/,%.% MESH IS PROVIDED BY %4()#/. ).# AS A STERILE PRODUCT
2ESTERILIZATION OF THE DEVICE IS ./4 RECOMMENDED (OWEVER TESTING HAS
DEMONSTRATED THAT REPROCESSING OF UNUSED 02/,%.% MESH WHICH HAS BEEN
REMOVED FROM THE PACKAGE WILL NOT BE ADVERSELY AFFECTED WHEN EXPOSED NOT
MORE THAN ONE TIME TO CONVENTIONAL STEAM AUTOCLAVE CONDITIONS OF  &
 # FOR  MINUTES 2EPROCESSING UNDER ANY OTHER CONDITION OR BY ANY
OTHER MEANS IS NEITHER RECOMMENDED NOR ENDORSED BY %4()#/. ).#
02/,%.%MESHSHOULDNOT BEFLASHAUTOCLAVED
)F THIS PRODUCT SHOULD BECOME STAINED WITH BLOOD OR SOILED IT SHOULD NOT BE
RESTERILIZEDFORREUSE
7HENREPROCESSEDASOUTLINEDABOVE ITISTHERESPONSIBILITYOFTHEEND USERTO
ASSURESTERILITYOFTHEPRODUCTVIAAVALIDATEDSTERILIZATIONPROCESSAS%4()#/.
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PRIORTO DURING ORAFTERREPROCESSING

02/,%.%MESHISAVAILABLEINSINGLEPACKETSASSTERILE UNDYEDCLEAR SHEETS


INSEVENSIZES4HESIZESAVAILABLEARECMXCMX CMXCM
X CMXCMX CMXCMX CMXCM
 X  CM X CM  X  AND CM X CM  X   %ACH SHEET IS
APPROXIMATELYMM THICK

2

4RADEMARK

%4()#/. ).#

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02/./6!
SUTURE CLEAR OR PIGMENTED IS A NONABSORBABLE STERILE SURGICAL
SUTURE MADE FROM A POLYMER BLEND OF POLYVINYLIDENE FLUORIDE AND POLY
VINYLIDENEFLUORIDE CO HEXAFLUOROPROPYLENE 4HESUTUREISPIGMENTEDBLUETO
ENHANCEVISIBILITY
3IZE 02/./6!SUTURESARE530 EXCEPTFORDIAMETER
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ANDOR LIGATION INCLUDING USE IN CARDIOVASCULAR OPHTHALMIC AND NEUROLOGICAL
PROCEDURES



02%#!54)/.3
)N HANDLING THIS SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID DAMAGE FROM
HANDLING!VOID CRUSHING OR CRIMPING DAMAGE DUE TO APPLICATION OF SURGICAL
INSTRUMENTSSUCHASFORCEPSORNEEDLEHOLDERS
!DEQUATEKNOTSECURITYREQUIRESTHEACCEPTEDSURGICALTECHNIQUEOFFLAT SQUARE
TIES OF SINGLE SUTURE STRANDS 4HE USE OF ADDITIONAL THROWS IS PARTICULARLY
APPROPRIATEWHENKNOTTINGMONOFILAMENTSUTURES
4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLEINANAREA
ONE THIRD  TO ONE HALF  OF THE DISTANCE FROM THE SWAGED END TO THE
POINT 2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS
RESISTANT TO BENDING AND BREAKING 5SERS SHOULD EXERCISE CAUTION WHEN
HANDLING SURGICAL NEEDLES TO AVOID INADVERTENT NEEDLE STICKS $ISCARD USED
NEEDLESINSHARPSCONTAINERS

!$6%23%2%!#4)/.3
!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND DEHIS
CENCE CALCULI FORMATION IN URINARY AND BILIARY TRACTS WHEN PROLONGED CONTACT
WITH SALT SOLUTIONS SUCH AS URINE AND BILE OCCURS INFECTION MINIMAL TO MILD
INFLAMMATORYTISSUEREACTION ANDTRANSITORYLOCALIRRITATIONATTHEWOUNDSITE
"ROKENNEEDLESMAYRESULTINEXTENDEDORADDITIONALSURGERIESORRESIDUALFOR
EIGNBODIES)NADVERTENTNEEDLESTICKSWITHCONTAMINATEDSURGICALNEEDLESMAY
RESULTINTHETRANSMISSIONOFBLOODBORNEPATHOGENS

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02/./6! SUTURE ELICITS A MINIMAL TO MILD INFLAMMATORY REACTION IN TISSUE
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TISSUE 02/./6! SUTURE IS NOT ABSORBED NOR IS IT SUBJECT TO DEGRADATION OR
WEAKENING BY THE ACTION OF TISSUE ENZYMES !S A MONOFILAMENT 02/./6!
SUTURE 530 RESISTS INVOLVEMENT IN INFECTION AND HAS BEEN SUCCESSFULLY
EMPLOYEDINCONTAMINATEDANDINFECTEDWOUNDSTOELIMINATEORMINIMIZELATER
SINUS FORMATION AND SUTURE EXTRUSION &URTHERMORE THE LACK OF ADHERENCE TO
TISSUESHASFACILITATEDTHEUSEOF02/./6!SUTUREASAPULL OUTSUTURE

#/.42!).$)#!4)/.3

02/./6!SUTURES PIGMENTED AREAVAILABLEASSTERILESTRANDSIN530SIZES


THROUGH METRICSIZES  AND THROUGHMETRICSIZES  
02/./6! SUTURES CLEAR ARE AVAILABLE AS STERILE STRANDS IN 530 SIZES  
THROUGHMETRICSIZES  3IZE METRICSIZE 02/./6!SUTURES PIG
MENTED AND CLEAR ARE 530 EXCEPT FOR DIAMETER !LL 02/./6! SUTURES ARE
AVAILABLEINAVARIETYOFLENGTHS WITHPERMANENTLYATTACHEDNEEDLES
02/./6!SUTURES PIGMENTEDANDCLEARAREALSOAVAILABLEASSTERILESTRANDSIN
530SIZESTHROUGHMETRICSIZES  ATTACHEDTO#/.42/,2%,%!3%

REMOVABLENEEDLES
02/./6!SUTURESAREAVAILABLEINONE TWO ANDTHREEDOZENBOXES

.ONEKNOWN

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5SERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING
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SUTUREMATERIALUSED
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!SWITHANYFOREIGNBODY PROLONGEDCONTACTOFANYSUTUREWITHSALTSOLUTIONS
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MATION!CCEPTABLESURGICALPRACTICEMUSTBEFOLLOWEDFORTHEMANAGEMENTOF
INFECTEDORCONTAMINATEDWOUNDS



4RADEMARK

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7HENITISNOTPOSSIBLETOMAINTAINATLEASTAMMDISTANCEFROMTHESTAPLED
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CLOSUREISCONTRAINDICATED

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6ERIFY COMPATIBILITY OF ALL INSTRUMENTS AND ACCESSORIES PRIOR TO USING THE
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5SING STERILE TECHNIQUE REMOVE THE INSTRUMENT FROM THE PACKAGE


4OAVOIDDAMAGE DONOTFLIPTHEINSTRUMENTINTOTHESTERILEFIELD

3UGGESTED %VERSION4ECHNIQUES 7ITH TWO TISSUE FORCEPS PICK UP EACH


WOUNDEDGEINDIVIDUALLYANDAPPROXIMATETHEEDGES)LLUSTRATION 
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/R APPLYTENSIONTOEITHERENDOFTHEINCISION SUCHTHATTHETISSUEEDGES
BEGINTOAPPROXIMATETHEMSELVES/NEFORCEPSCANBEUSEDTOENSURETHAT
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0OSITION THE INSTRUMENT WITH MODERATE PRESSURE OVER THE EVERTED SKIN
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3QUEEZE THE TRIGGER UNTIL THE TRIGGER MOTION IS HALTED THEN RELEASE THE
TRIGGER AND MOVE THE INSTRUMENT OFF THE INCISION IN ANY DIRECTION
)LLUSTRATION 
!LTERNATE 2ELEASE )F DESIRED BEFORE RELEASING THE TRIGGER LIFT UP ON THE
INSTRUMENT4HISWILLHELPTOEVERTTHESKINEDGES WHICHCANTHENBEMORE
EASILY GRASPED WITH THE TISSUE FORCEPS 2ELEASE THE TRIGGER AFTER THE
FORCEPS ARE IN PLACE AND REPEAT THE SEQUENCE TO FIRE THE NEXT STAPLE
)LLUSTRATION
!LTERNATE4ECHNIQUE4HEINSTRUMENTCANALSOBEPRECOCKEDPARTIALLYFIRED
SOTHATTHESTAPLEPOINTSAREVISIBLEATTHENOSEOFTHEINSTRUMENT4HISFEA
TURE INCONJUNCTIONWITHTHECLEARNOSEANDALIGNMENTARROW ENSURESPRE
CISESTAPLEPLACEMENTINTHESKIN)LLUSTRATION 
.OTE)FDESIRED AFTERTHEINSTRUMENTHASBEENPRECOCKED ONELEGOFTHE
STAPLECANBEHOOKEDONTOONESIDEOFTHETISSUE4HISWILLAIDINDRAWING
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UNDERMODERATETENSION)LLUSTRATION 

7!2.).'3!.$02%#!54)/.3
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$ISPOSE OF ALL OPENED PRODUCTS WHETHER USED OR UNUSED $O .OT
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THEINSTRUMENTWHICHMAYRESULTINUNINTENDEDINJURY

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4RADEMARK

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4HE FUNCTION OF THE 3KIN 3TAPLE %XTRACTOR IS TO REMOVE 0ROXIMATE 2EGULAR OR
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6ERIFYCOMPATIBILITYOFALLINSTRUMENTSANDACCESSORIESPRIORTOUSINGTHE DEVICE


5SING STERILE TECHNIQUE REMOVE THE DEVICE FROM THE PACKAGE4O AVOID
DAMAGE DONOTFLIPTHEDEVICEINTOTHESTERILEFIELD

2EMOVETHESAFETYCAPFROMTHEDEVICE

3LIDE LOWER JAW OF EXTRACTOR UNDER REGULAR OR WIDE STAPLE UNTIL STAPLE IS
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3QUEEZE DOWN WITH THUMB TO OPEN STAPLE UNTIL HANDLES ARE FIRMLY
TOUCHING)LLUSTRATION

%NSURE STAPLE IS COMPLETELY OPENED BEFORE LIFTING EXTRACTOR FROM SKIN
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7ARNINGSAND0RECAUTIONS
s

$ISPOSE OF ALL OPENED PRODUCTS WHETHER USED OR UNUSED $O .OT
2ESTERILIZETHEDEVICE2ESTERILIZATIONMAYCOMPROMISETHEINTEGRITYOFTHE
DEVICEWHICHMAYRESULTINUNINTENDEDINJURY

)NSTRUMENTS OR DEVICES WHICH COME INTO CONTACT WITH BODILY FLUIDS MAY
REQUIRESPECIALDISPOSALHANDLINGTOPREVENTBIOLOGICALCONTAMINATION

(/73500,)%$
4HE02/8)-!4%3KIN3TAPLE%XTRACTORISSUPPLIEDSTERILEFORSINGLEPATIENTUSE
$ISCARDAFTERUSE

00
4RADEMARK

%4()#/.%.$/ 352'%29 ).#





02/$5#4).&/2-!4)/.

02/8)-!4% 0,53-$

-5,4) $)-%.4)/.!,2%,%!3%3+).34!0,%2
).$)#!4)/.3
4HE02/8)-!4%0,53-$3KIN3TAPLERHASAPPLICATIONFORROUTINESKINCLOSURE
INAWIDEVARIETYOFSURGICALPROCEDURES

#/.42!).$)#!4)/.3
7HENITISNOTPOSSIBLETOMAINTAINATLEASTAMMDISTANCEFROMTHESTAPLED
SKINTOUNDERLYINGBONES VESSELS ORINTERNALORGANS THEUSEOFSTAPLESFORSKIN
CLOSUREISCONTRAINDICATED

$%6)#%$%3#2)04)/.
4HE 02/8)-!4% 0,53 -$ 3KIN 3TAPLER IS A STERILE SINGLE PATIENT USE
INSTRUMENTDESIGNEDTODELIVERRECTANGULAR STAINLESSSTEELSTAPLESFORROUTINE
WOUNDCLOSURE

).3425#4)/.3&/253%
6ERIFYCOMPATIBILITYOFALLINSTRUMENTSANDACCESSORIESPRIORTOUSINGTHEINSTRU
MENTREFERTO7ARNINGSAND0RECAUTIONS 


5SING STERILE TECHNIQUE REMOVE THE INSTRUMENT FROM THE PACKAGE


4OAVOIDDAMAGE DONOTFLIPTHEINSTRUMENTINTOTHESTERILEFIELD

%VERT AND APPROXIMATE SKIN EDGES AS DESIRED 3EVERAL TECHNIQUES ARE
SUGGESTED
A 7ITH ONE TISSUE FORCEP PULL SKIN EDGES TOGETHER UNTIL EDGES EVERT
)LLUSTRATION
/2
B 7ITHTWOTISSUEFORCEPS PICKUPEACHWOUNDEDGEINDIVIDUALLYAND
APPROXIMATETHEEDGES)LLUSTRATION
/2
C !PPLYTENSIONTOEITHERENDOFTHEINCISION SUCHTHATTHETISSUEEDGES
BEGINTOAPPROXIMATETHEMSELVES/NEFORCEPCANBEUSEDTOENSURETHAT
THEEDGESAREEVERTED

0OSITION THE INSTRUMENT OVER THE EVERTED SKIN EDGES ALIGNING THE
INSTRUMENTARROWWITHTHEINCISION)LLUSTRATION

3QUEEZETHETRIGGERUNTILTHETRIGGERMOTIONISHALTED2ELEASETHETRIGGER
ANDREMOVETHEINSTRUMENTFROMTHEFIREDSTAPLE)LLUSTRATION

7!2.).'3!.$02%#!54)/.3
s

$ISPOSE OF ALL OPENED INSTRUMENTS WHETHER USED OR UNUSED $O .OT
2ESTERILIZETHEINSTRUMENT2ESTERILIZATIONMAYCOMPROMISETHEINTEGRITYOF
THESTAPLERWHICHMAYRESULTINUNINTENDEDINJURY

(/73500,)%$
4HE 02/8)-!4% 0,53 -$ 3KIN 3TAPLER IS SUPPLIED STERILE AND PRELOADED FOR
SINGLEPATIENTUSE$ISCARDAFTERUSE

&/2-%$34!0,%$)-%.3)/.3
2EGULARSTAPLESHAVEADIAMETEROFMM ASPANOFMM ANDALEGLENGTH
OFMM
7IDESTAPLESHAVEADIAMETEROFMM ASPANOFMM ANDALEGLENGTH
OFMM
#AUTION &EDERAL 53! LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER
OFAPHYSICIAN

00
4RADEMARK

%4()#/.%.$/ 352'%29 ).#

#(!04%2
352')#!,'5435452%
!"3/2"!",%352')#!,35452%3 530
$%3#2)04)/.
3URGICAL GUT SUTURE IS AN ABSORBABLE STERILE SURGICAL SUTURE COMPOSED OF
PURIFIED CONNECTIVE TISSUE MOSTLY COLLAGEN DERIVED FROM EITHER THE SEROSAL
LAYER OF BEEF BOVINE OR THE SUBMUCOSAL FIBROUS LAYER OF SHEEP OVINE
INTESTINES3URGICALGUTSUTURESAREAVAILABLEINPLAINORCHROMIC#HROMICGUT
IS PROCESSED TO PROVIDE GREATER RESISTANCE TO ABSORPTION 3URGICAL GUT IS
PACKAGEDINTUBINGFLUID"LUEDYEDCHROMICGUTSUTUREISALSOAVAILABLE
3URGICAL GUT SUTURE MEETS ALL REQUIREMENTS ESTABLISHED BY THE 5NITED 3TATES
0HARMACOPOEIA530 FORABSORBABLESURGICALSUTURES

).$)#!4)/.3
3URGICAL GUT SUTURE IS INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION
ANDOR LIGATION INCLUDING USE IN OPHTHALMIC PROCEDURES BUT NOT FOR USE IN
CARDIOVASCULARANDNEUROLOGICALTISSUES

!#4)/.3
7HEN SURGICAL GUT SUTURE IS PLACED IN TISSUE A MODERATE TISSUE INFLAMMATION
OCCURSWHICHISCHARACTERISTICOFFOREIGNBODYRESPONSETOASUBSTANCE4HISIS
FOLLOWEDBYALOSSOFTENSILESTRENGTHANDALOSSOFSUTUREMASS ASTHEPROTE
OLYTIC ENZYMATIC DIGESTIVE PROCESS DISSOLVES THE SURGICAL GUT4HIS PROCESS
CONTINUESUNTILTHESUTUREISCOMPLETELYABSORBED-ANYVARIABLEFACTORSMAY
AFFECTTHERATEOFABSORPTION3OMEOFTHEMAJORFACTORS WHICHCANAFFECTTENSILE
STRENGTHLOSSANDABSORPTIONRATESARE
4YPEOFSUTURE PLAINGUTGENERALLYABSORBSMORERAPIDLYTHANCHROMICGUT
)NFECTION SURGICALGUTISABSORBEDMORERAPIDLYININFECTEDTISSUE
THANINNON INFECTEDTISSUE
4ISSUESITES SURGICALGUTWILLABSORBMORERAPIDLYINTISSUEWHERE
INCREASEDLEVELSOFPROTEOLYTICENZYMESAREPRESENT ASINTHESECRE
TIONS EXHIBITEDINTHESTOMACH CERVIXANDVAGINA

#/.42!).$)#!4)/.3
4HIS SUTURE BEING ABSORBABLE SHOULD NOT BE USED WHERE EXTENDED APPROXI
MATIONOFTISSUEISREQUIRED
4HEUSEOFTHISSUTUREISCONTRAINDICATEDINPATIENTSWITHKNOWNSENSITIVITIESOR
ALLERGIES TO COLLAGEN OR CHROMIUM AS GUT IS A COLLAGEN BASED MATERIAL AND
CHROMICGUTISTREATEDWITHCHROMICSALTSOLUTIONS

7!2.).'3
5SERSSHOULDBEFAMILIARWITHSURGICALPROCEDURESANDTECHNIQUESINVOLVINGGUT
SUTUREBEFOREUSINGSURGICALGUTSUTUREFORWOUNDCLOSURE ASTHERISKOFWOUND
DEHISCENCEMAYVARYWITHTHESITEOFAPPLICATIONANDTHESUTUREMATERIALUSED
0HYSICIANSSHOULDCONSIDERTHEINVIVO PERFORMANCEWHENSELECTINGASUTURE
4HEUSEOFTHISSUTUREMAYBEINAPPROPRIATEINELDERLY MALNOURISHED ORDEBIL
ITATEDPATIENTS ORINPATIENTSSUFFERINGFROMCONDITIONSWHICHMAYDELAYWOUND
HEALING !S THIS IS AN ABSORBABLE MATERIAL THE USE OF SUPPLEMENTAL NONAB
SORBABLESUTURESSHOULDBECONSIDEREDBYTHESURGEONINTHECLOSUREOFSITES
WHICHMAYUNDERGOEXPANSION STRETCHINGORDISTENTIONORWHICHMAYREQUIRE
ADDITIONALSUPPORT
!SWITHANYFOREIGNBODY PROLONGEDCONTACTOFANYSUTUREWITHSALTSOLUTIONS
SUCHASTHOSEFOUNDINTHEURINARYORBILIARYTRACTS MAYRESULTINCALCULUSFOR
MATION!SANABSORBABLESUTURE SURGICALGUTMAYACTTRANSIENTLYASAFOREIGN
BODY!CCEPTABLESURGICALPRACTICESHOULDBEFOLLOWEDFORTHEMANAGEMENTOF
CONTAMINATEDORINFECTEDWOUNDS
$ONOTRESTERILIZE$ISCARDOPENPACKAGESANDUNUSEDSUTURES
#ERTAIN PATIENTS MAY BE HYPERSENSITIVE TO COLLAGEN OR CHROMIUM AND MIGHT
EXHIBITANIMMUNOLOGICALREACTIONRESULTINGININFLAMMATION TISSUEGRANULATIONOR
FIBROSIS WOUNDSUPPURATIONANDBLEEDING ASWELLASSINUSFORMATION



02%#!54)/.3
)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
DAMAGEFROMHANDLING!VOIDCRUSHINGORCRIMPINGDAMAGEDUETOAPPLICATION
OFSURGICALINSTRUMENTSSUCHASFORCEPSORNEEDLEHOLDERS3URGICALGUTSUTURES
REQUIRE THE ACCEPTED SURGICAL TECHNIQUE OF FLAT AND SQUARE TIES WITH
ADDITIONALTHROWSASWARRANTEDBYSURGICALCIRCUMSTANCEANDTHEEXPERIENCEOF
THESURGEON
5NDERSOMECIRCUMSTANCES NOTABLYORTHOPAEDICPROCEDURES IMMOBILIZATIONOF
JOINTSBYEXTERNALSUPPORTMAYBEEMPLOYEDATTHEDISCRETIONOFTHESURGEON
4HESURGEONSHOULDAVOIDUNNECESSARYTENSIONWHENRUNNINGDOWNKNOTS TO
REDUCETHEOCCURRENCEOFSURFACEFRAYINGANDWEAKENINGOFTHESTRAND
!VOIDPROLONGEDEXPOSURETOELEVATEDTEMPERATURES
4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLEINANAREA
ONE THIRD  TO ONE HALF  OF THE DISTANCE FROM THE SWAGED END TO THE
POINT 2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS
RESISTANT TO BENDING AND BREAKING 5SERS SHOULD EXERCISE CAUTION WHEN
HANDLING SURGICAL NEEDLES TO AVOID INADVERTENT NEEDLE STICKS $ISCARD USED
NEEDLESINSHARPSCONTAINERS

!$6%23%2%!#4)/.3
!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND DEHIS
CENCE VARIABLERATESOFABSORPTIONOVERTIMEDEPENDINGONSUCHFACTORSASTHE
TYPEOFSUTUREUSED THEPRESENCEOFINFECTIONANDTHETISSUESITE FAILURETOPRO
VIDEADEQUATEWOUNDSUPPORTINCLOSUREOFSITESWHEREEXPANSION STRETCHING
ORDISTENSIONOCCUR ETC UNLESSADDITIONALSUPPORTISSUPPLIEDTHROUGHTHEUSE
OFNONABSORBABLESUTUREMATERIAL FAILURETOPROVIDEADEQUATEWOUNDSUPPORT
IN ELDERLY MALNOURISHED OR DEBILITATED PATIENTS OR IN PATIENTS SUFFERING FROM
CANCER ANEMIA OBESITY DIABETES INFECTION OR OTHER CONDITIONS WHICH MAY
DELAYWOUNDHEALING ALLERGICRESPONSEINPATIENTSWITHKNOWNSENSITIVITIESTO
COLLAGENORCHROMIUMWHICHMAYRESULTINANIMMUNOLOGICALREACTIONRESULTING
ININFLAMMATION TISSUEGRANULATIONORFIBROSIS WOUNDSUPPURATIONANDBLEED
ING AS WELL AS SINUS FORMATION INFECTION MODERATE TISSUE INFLAMMATORY
RESPONSECHARACTERISTICOFFOREIGNBODYRESPONSE CALCULIFORMATIONINURINARY
ANDBILIARYTRACTSWHENPROLONGEDCONTACTWITHSALTSOLUTIONSSUCHASURINEAND
BILE OCCURS AND TRANSITORY LOCAL IRRITATION AT THE WOUND SITE "ROKEN NEEDLES
MAY RESULT IN EXTENDED OR ADDITIONAL SURGERIES OR RESIDUAL FOREIGN BODIES
)NADVERTENTNEEDLESTICKSWITHCONTAMINATEDSURGICALNEEDLESMAYRESULTINTHE
TRANSMISSIONOFBLOODBORNEPATHOGENS

(/73500,)%$
3URGICAL GUT SUTURES ARE AVAILABLE IN 530 SIZES   THROUGH  METRIC SIZES
  INAVARIETYOFLENGTHSWITHANDWITHOUTPERMANENTLYATTACHEDNEEDLES
ANDON,)'!0!+
DISPENSINGREELS3URGICALGUTSUTURESAREALSOAVAILABLEIN
530SIZESTHROUGHMETRICSIZES  ATTACHEDTO#/.42/,2%,%!3%

REMOVABLE NEEDLES 4HE SUTURE IS SUPPLIED STERILE IN ONE TWO AND THREE
DOZENBOXES



4RADEMARK

%4()#/. ).#



02/$5#4).&/2-!4)/.

352')#!,34!).,%3334%%,35452%
./.!"3/2"!",%352')#!,35452%3 530
$%3#2)04)/.
3URGICAL STAINLESS STEEL SUTURE IS A NONABSORBABLE STERILE SURGICAL SUTURE
COMPOSEDOF,STAINLESSSTEEL3URGICALSTAINLESSSTEELSUTUREISAVAILABLEAS
AMONOFILAMENTANDMULTIFILAMENTSUTURE
3URGICALSTAINLESSSTEELSUTUREMEETSALLREQUIREMENTSESTABLISHEDBYTHE5NITED
3TATES 0HARMACOPOEIA 530 FOR NONABSORBABLE SURGICAL SUTURES 3URGICAL
STAINLESSSTEELSUTUREISALSOLABELEDWITHTHE"3GAUGECLASSIFICATIONS

02%#!54)/.3
)N HANDLING THIS OR ANY OTHER SUTURE MATERIAL CARE SHOULD BE TAKEN TO AVOID
DAMAGEFROMHANDLING SUCH ASKINKINGOR EXCESSIVETWISTING
4OAVOIDDAMAGINGNEEDLEPOINTSANDSWAGEAREAS GRASPTHENEEDLEINANAREA
ONE THIRD  TO ONE HALF  OF THE DISTANCE FROM THE SWAGED END TO THE
POINT 2ESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS
RESISTANT TO BENDING AND BREAKING 5SERS SHOULD EXERCISE CAUTION WHEN
HANDLING SURGICAL NEEDLES TO AVOID INADVERTENT NEEDLE STICKS $ISCARD USED
NEEDLESINSHARPSCONTAINERS

!$6%23%2%!#4)/.3

3URGICALSTAINLESSSTEELSUTUREISINDICATEDFORUSEINABDOMINALWOUNDCLOSURE
HERNIA REPAIR STERNAL CLOSURE AND ORTHOPAEDIC PROCEDURES INCLUDING CERCLAGE
ANDTENDONREPAIR

!DVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDE WOUND DEHIS
CENCE ALLERGICRESPONSEINPATIENTSWITHKNOWNSENSITIVITIESTO,STAINLESS
STEEL OR CONSTITUENT METALS SUCH AS CHROMIUM AND NICKEL INFECTION MINIMAL
ACUTE INFLAMMATORY TISSUE REACTION PAIN EDEMA AND LOCAL IRRITATION AT THE
WOUNDSITE"ROKENNEEDLESMAYRESULTINEXTENDEDORADDITIONALSURGERIESOR
RESIDUAL FOREIGN BODIES )NADVERTENT NEEDLE STICKS WITH CONTAMINATED SURGICAL
NEEDLESMAYRESULTINTHETRANSMISSIONOFBLOODBORNEPATHOGENS

!#4)/.3

(/73500,)%$

3URGICALSTAINLESSSTEELSUTUREELICITSAMINIMALACUTEINFLAMMATORYREACTIONIN
TISSUEANDISNOTABSORBED

3URGICAL STAINLESS STEEL SUTURES ARE AVAILABLE IN SIZES  THROUGH   METRIC
SIZES  INAVARIETYOFLENGTHSWITHANDWITHOUTPERMANENTLYATTACHEDNEE
DLESINONE TWOANDTHREEDOZENBOXES

).$)#!4)/.3

#/.42!).$)#!4)/.3
4HEUSEOFTHISSUTUREISCONTRAINDICATEDINPATIENTSWITHKNOWNSENSITIVITIESOR
ALLERGIESTO,STAINLESSSTEEL ORCONSTITUENTMETALSSUCHASCHROMIUMAND
NICKEL

7!2.).'3
5SERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING
NONABSORBABLE STAINLESSSTEELSUTURESBEFOREEMPLOYINGFORWOUNDCLOSURE AS
THE RISK OF WOUND DEHISCENCE MAY VARY WITH THE SITE OF APPLICATION AND THE
SUTUREMATERIALUSED
!CCEPTABLESURGICALPRACTICEMUSTBEFOLLOWEDFORTHEMANAGEMENTOFCONTAM
INATEDORINFECTEDWOUNDS



4RADEMARK

%4()#/. ).#

#(!04%2
6)#29,
+NITTED-ESH
$%3#2)04)/.
6)#29,
POLYGLACTIN KNITTEDMESHISPREPAREDFROMASYNTHETICABSORBABLE
COPOLYMEROFGLYCOLIDEANDLACTIDE DERIVEDRESPECTIVELYFROMGLYCOLICANDLAC
TICACIDS4HISKNITTEDMESHISPREPAREDFROMUNCOATED UNDYEDFIBERIDENTICALIN
COMPOSITION TO THAT USED IN 6)#29, POLYGLACTIN  SYNTHETIC ABSORBABLE
SUTURE WHICH HAS BEEN FOUND TO BE INERT NONANTIGENIC NONPYROGENIC AND TO
ELICITONLYAMILDTISSUEREACTIONDURINGABSORPTION
6)#29,KNITTEDMESHISINTENDEDFORUSEASABUTTRESSTOPROVIDETEMPORARYSUP
PORTDURINGTHEHEALINGPROCESS

!#4)/.3
4WO IMPORTANT CHARACTERISTICS DESCRIBE THE IN VIVO FUNCTION AND BEHAVIOR OF
6)#29, KNITTED MESH REINFORCED WOUND STRENGTH AND THE RATE OF ABSORPTION
LOSSOFMASS 
4HEDEHISCENCEFORCEOFHEALINGABDOMINALWOUNDSINRATSCLOSEDWITHSIZE 
ABSORBABLESUTURESWASCOMPAREDWITHCORRESPONDINGWOUNDSCLOSEDWITHSIZE
 ABSORBABLESUTURESANDREINFORCEDWITH6)#29,KNITTEDMESH)NTHISANIMAL
MODEL THESTRENGTHOFTHEINCISION WHENSUPPORTEDBYTHEMESH WASSIGNIFI
CANTLY GREATER THAN THE SUTURED INCISIONAL WOUND %XPLANTED6)#29, KNITTED
MESH WHICH BEFORE IMPLANTATION HAD AN INITIAL AVERAGE BURST STRENGTH OF 
LBS WAS FOUND TO HAVE  OF ITS ORIGINAL BURST STRENGTH REMAINING AFTER
FOURTEENDAYSINVIVO
3UBCUTANEOUS IMPLANTATION STUDIES IN RATS INDICATE THAT THE ABSORPTION OF
6)#29,MESHMATERIALISMINIMALUNTILABOUTSIXWEEKSPOSTIMPLANTATIONAND
ESSENTIALLYCOMPLETEBETWEENANDDAYS

7!2.).'3
$/./42%34%2),):%
4HESAFETYANDEFFECTIVENESSOF6)#29,KNITTEDMESHINNEURALTISSUEANDINCAR
DIOVASCULARTISSUEHASNOTBEENESTABLISHED

02%#!54)/.3
.ONE

!$6%23%2%!#4)/.3
.OSIGNIFICANTCLINICALADVERSEREACTIONSTOTHEMESHHAVEBEENREPORTED

$)2%#4)/.3&/253%
)TISRECOMMENDEDTHATABSORBABLEORNONABSORBABLESUTURESBYPLACEDTO
INCHTOMM APARTATADISTANCEAPPROXIMATELYINCHMM FORMTHE
EDGE OF THE MESH 3OME SURGEONS PREFER TO SUTURE A MESH LARGER THAN THE
DEFECT INTO POSITION OVER THE DEFECT 4HE EDGES ARE THEN SUTURED TO ASSURE A
PROPER CLOSURE UNDER CORRECT TENSION 7HEN ALL MARGIN SUTURES HAVE BEEN
PLACED THE EXCESS MESH IS TRIMMED AWAY LEAVING AT LEAST  INCH OF MESH
EXTENDINGBEYONDTHESUTURELINE
(/73500,)%$
6)#29, KNITTED MESH IS AVAILABLE IN SINGLE PACKETS AS A STERILE UNDYED FABRIC
MESH IN SINGLE SHEET SIZES OF APPROXIMATELY  X  INCHES AND  X  INCHES
XCENTIMETERSANDXCENTIMETERS 



).$)#!4)/.3
6)#29,KNITTEDMESHMAYBEUSEDWHEREVERTEMPORARYWOUNDORORGANSUPPORT
ISREQUIRED PARTICULARLYININSTANCESINWHICHCOMPLIANTANDSTRETCHABLESUPPORT
MATERIAL IS DESIRED AND CONTAINMENT OF WOUND TRANSUDATE IS NOT REQUIRED
6)#29,KNITTEDMESHMAYBECUTTOTHESHAPEORSIZEDESIREDFOREACHSPECIFIC
APPLICATION

#/.42!).$)#!4)/.3
"ECAUSE 6)#29, KNITTED MESH IS ABSORBABLE IT SHOULD NOT BE USED WHERE
EXTENDEDWOUNDORORGANSUPPORTISREQUIRED



4RADEMARK

%4()#/. ).#



02/$5#4).&/2-!4)/.

6)#29,
7OVEN-ESH

7!2.).'3

$%3#2)04)/.

4HESAFETYANDEFFECTIVENESSOF6)#29,WOVENMESHINNEURALTISSUEANDINCAR
DIOVASCULARTISSUEHASNOTBEENESTABLISHED

6)#29,
POLYGLACTIN WOVENMESHISPREPAREDFROMASYNTHETICABSORBABLE
COPOLYMEROFGLYCOLIDEANDLACTIDE DERIVEDRESPECTIVELYFROMGLYCOLICANDLAC
TIC ACIDS 4HIS TIGHTLY WOVEN MESH IS PREPARED FROM UNCOATED UNDYED FIBER
IDENTICAL IN COMPOSITION TO THAT USED IN 6)#29,
POLYGLACTIN  SYNTHETIC
ABSORBABLE SUTURE WHICH HAS BEEN FOUND TO BE INERT NONANTIGENIC NONPYRO
GENICANDTOELICITONLYAMILDTISSUEREACTIONDURINGABSORPTION

$/./42%34%2),):%

02%#!54)/.3
.ONE

6)#29,WOVENMESHISINTENDEDFORUSEASABUTTRESSTOPROVIDETEMPORARYSUP
PORTDURINGTHEHEALINGPROCESS

!$6%23%2%!#4)/.3

!#4)/.3

$)2%#4)/.3&/253%

4WO IMPORTANT CHARACTERISTICS DESCRIBE THE IN VIVO FUNCTION AND BEHAVIOR OF
6)#29, WOVEN MESH REINFORCED WOUND STRENGTH AND THE RATE OF ABSORPTION
LOSSOFMASS 
4HEDEHISCENCEFORCEOFHEALINGABDOMINALWOUNDSINRATSCLOSEDWITHSIZE 
ABSORBABLESUTURESWASCOMPAREDWITHCORRESPONDINGWOUNDSCLOSEDWITHSIZE
 ABSORBABLESUTURESANDREINFORCEDWITH6)#29,WOVENMESH)NTHISANIMAL
MODEL THESTRENGTHOFTHEINCISION WHENSUPPORTEDBYTHEMESH WASSIGNIFI
CANTLY GREATER THAN THE SUTURED INCISIONAL WOUND %XPLANTED6)#29, WOVEN
MESH WHICH BEFORE IMPLANTATION HAD AN INITIAL AVERAGE BURST STRENGTH OF
APPROXIMATELY  LBS WAS FOUND TO HAVE APPROXIMATELY  OF ITS ORIGINAL
BURSTSTRENGTHREMAININGAFTERFOURTEENDAYSINVIVO
3UBCUTANEOUS IMPLANTATION STUDIES IN RATS INDICATE THAT THE ABSORPTION OF
6)#29,MESHMATERIALISMINIMALUNTILABOUTSIXWEEKSPOSTIMPLANTATIONAND
ESSENTIALLYCOMPLETEBETWEENANDDAYS

).$)#!4)/.3
6)#29,WOVENMESHMAYBEUSEDWHEREVERTEMPORARYWOUNDORORGANSUPPORT
ISREQUIRED4HEWOVENMESHSTRUCTUREISLESSPOROUSTHAN6)#29,KNITTEDMESH
)TISINDICATEDININSTANCESINWHICHCONTAINMENTOFWOUNDTRANSUDATEISDESIR
ABLE6)#29,WOVENMESHMAYBECUTTOTHESHAPEORSIZEDESIREDFOREACHSPE
CIFICAPPLICATION

#/.42!).$)#!4)/.3
"ECAUSE 6)#29, WOVEN MESH IS ABSORBABLE IT SHOULD NOT BE USED WHERE
EXTENDEDWOUNDORORGANSUPPORTISREQUIRED

.ONEKNOWN

)TISRECOMMENDEDTHATABSORBABLEORNONABSORBABLESUTURESBEPLACEDTO
INCHTOMM APARTATADISTANCEATLEASTINCHMM FROMTHEEDGEOF
THEMESH3OMESURGEONSPREFERTOSUTUREAMESHLARGERTHANTHEDEFECTINTO
POSITIONOVERTHEDEFECT4HEEDGESARETHENSUTUREDTOASSUREPROPERCLOSURE
UNDERCORRECTTENSION7HENALLMARGINSUTURESHAVEBEENPLACED THEEXCESS
MESHISTRIMMEDAWAY LEAVINGATLEASTINCHOFMESHEXTENDINGBEYONDTHE
SUTURELINE

(/73500,)%$
6)#29, WOVEN MESH IS AVAILABLE IN SINGLE PACKETS AS A STERILE UNDYED FABRIC
MESH IN SINGLE SHEET SIZES OF APPROXIMATELY  X  INCHES AND  X  INCHES
XCENTIMETERSANDXCENTIMETERS 



4RADEMARK

%4()#/. ).#

CHAPTER 9

INDEX



).$%8
!"$/-%.    
ABDOMINALCAVITY    
 
ABDOMINALWALL    
      
FASCIA        
      
MUSCLETISSUE  
PERITONEUM     
   
SKIN   
SUBCUTANEOUSFAT    
SUBCUTICULARTISSUE 
TRANSVERSALISFASCIA 

#/!4%$6)#29,2!0)$%

0/,9',!#4). 35452% 
   

!,)-%.4!2942!#4 
ESOPHAGUS 
ORALCAVITY      
PHARYNX   
UPPERALIMENTARYTRACT 

"

"),)!2942!#4     


GALLBLADDER 
"/.%     
ANCHOR   
STERNUM 
"2!). 
CEREBROSPINALFLUID 
DURAMATER  
GALEA  
PERIPHERALNERVEREPAIR 
SKULL 
#!2$)/6!3#5,!2352'%29  
  
HEARTVALVES   
PLEDGETS     
STERNUM    
#/!4%$6)#29,

0/,9',!#4). 35452%  
 
#/!4%$6)#29,
0,53
0/,9',!#4). 35452%  
     

&
'

(
)

$%!$30!#%    


$%2-!"/.$

4/0)#!,3+).!$(%3)6%
 /#49,#9!./!#29,!4%  
  
$)33%#4)/.   
%4()"/.$
%8#%, 0/,9%34%2
35452%        
    
%4(),/.
.9,/.35452%   
      
%9%  
CONJUNCTIVA   
CORNEA   
OCULARMUSCLES  
SCLERA  
&%-!,%'%.)4!,42!#4 

'!342/).4%34).!,42!#4   
 
COLON   
RECTUM 
SMALLINTESTINE    
STOMACH       
()'(6)3#/3)49 $%2-!"/.$

4/0)#!,3+).!$(%3)6%
 /#49,#9!./!#29,!4% 
 
).#)3)/.         

).&,!--!4/292%30/.3%   
 

#(!04%2

,
-

+./43%#52)49      


  
+./44%.3),%342%.'4(  
+./449).'      
ENDOSCOPIC    
MONOFILAMENTSUTURES  
      

MULTIFILAMENTSUTURES   
  
TECHNIQUES   
DEEPTIE  
INSTRUMENTTIE  
SQUAREKNOT  
SURGEONSKNOT  
,)'!452%3      
FREETIE   
,)'!0!+
DISPENSINGREEL 
    
STICKTIE   
-%23),%.%

0/,9%34%2&)"%2-%3(  
-%23),%.%

0/,9%34%2&)"%2342)0  
-%23),%.%

0/,9%34%2&)"%235452%   
      
-%3(      
3EEALSO -%23),%.%
POLYESTER
FIBERMESH02/,%.%

0OLYPROPYLENE(ERNIA3YSTEM
02/,%.%
POLYPROPYLENEMESH
6)#29,
POLYGLACTIN
KNITTEDMESH6)#29,

POLYGLACTIN PERIODONTAL
MESH6)#29,
POLYGLACTIN
WOVENMESH
-)#2/352'%29      
    
-/./#29,
0/,)',%#!02/.%
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TO
NEEDLES

V I E W T H E E - C ATA L O G G O T O T H E

H E A LT H C A R E P R O F E S S I O N A L

SECTION OF

W W W. E T H I C O N . C O M
ADHESIVES

SURGICAL MESH

ETHICON, INC. , PO BOX 151, SOMERVILLE, NJ 08876-0151


* TRADEMARK
SM
ETHICON, INC.

2005, ETHICON, INC.

WOUND C LOSURE M ANUAL

SUTURES

WOUND HEALING

W O U N D C L O S U R E M A N UA L

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