Gynecology Our Commitment to - Ethicon
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Our Commitment to Gynecology
Contents
Vision and Mission Innovative Products
Gynecology, The next generation • Knowledge and Insight
of care from Ethicon • ENSEAL®
• HARMONIC®
Overview of Gynecology
• HARMONIC ACE®+
Shaping the Future of Surgery • PLUS
Research and Evidence • SURGICEL SNoW™
• SURGIFLO®
Education and Training
• SURGICEL® Powder
• Professional Education Services • STRATAFIX™
• Touch Surgery • INTERCEED®
Access and Reimbursement Summary
Click on the above to navigate to page
Click on lower right of any page to navigate to directory
Our Commitment to
2
Gynecology
Our Vision
Shaping the future of surgery
Our Mission
Our purpose is to advance innovation in
surgery, address the world’s most pressing
health care issues, and help improve and
save more lives
Our Commitment to
FOR INTERNAL USE ONLY
Gynecology
Gynecology, the next generation of
care; the next generation of value
• Changes in health care payment models, along with price
sensitivity among patients with high-deductible health plans,
are shifting gynecology services such as hysterectomies
to the outpatient setting as well as pressuring hospitals to
maximize value1
• Unnecessary variations in care could account for about
30 percent of gynecology health care spending by some
estimates1
• The goal is to use evidence-based medicine to reduce
unnecessary variation to improve care quality and patient
experience, and to lessen the cost of care1
References: 1. The Gynecology Solution Launch Service Line Management Insights. U.S. Health Economics & Market Access.
Our Commitment to
4
Gynecology
The number of hysterectomy and
myomectomy procedures continues
to grow
ANNUAL PROCEDURE GROWTH
13% HYSTERECTOMY AND 29.3% MYOMECTOMY*
1,000,000
900,000
800,000
# of Procedures
700,000
600,000
Hysterectomy
500,000
Myomectomy
400,000
300,000
200,000
100,000
0
2012 2013 2014
Year
Ethicon products provide support for a variety of surgical
approaches for hysterectomy and myomectomy procedures,
including laparoscopic, robotic-assisted laparoscopic, total
vaginal hysterectomy (TVH), and open repair—or total abdominal
hysterectomy (TAH).
*Procedure numbers in this plan are taken from the most recent Procedure spotlight through 2014. To arrive at these numbers the GBI team
used the Truven data from 2013 and the growth rate and calculated out 2 years. Truven Health Analytics is a company that provides healthcare
data and analytics.
Our Commitment to
5
Gynecology
In 2017, it is estimated that there will
be 101,450 new cases diagnosed and
30,450 deaths from gynecologic
cancers1-4
Annual gynecologic cancer diagnoses and deaths – US 1-4
Diagnoses Deaths
Ovarian
Uterine/
22%
endometrial Uterine/
59% endometrial
36%
Cervical
13%
Ovarian
Vaginal
Vaginal 46%
4%
5% Cervical
14%
Ethicon offers innovations to help meet the unique needs of
gynecology oncologists. Our innovations span the variety of
surgical approaches to cancer surgery, including laparoscopic
approaches, robotic-assisted laparoscopic approaches, and open
procedures.
References: 1. Endometrial (Uterine) Cancer. American Cancer Society website. http://www.cancer.org/cancer/endometrialcancer/
detailedguide/endometrial-uterine-cancer-key-statistics. Accessed August 14, 2017. 2. Vaginal Cancer. American Cancer Society website.
http://www.cancer.org/cancer/vaginalcancer/detailedguide/vaginal-cancer-key-statistics. Accessed August 14, 2017. 3. Cervical Cancer.
American Cancer Society website. http://www.cancer.org/cancer/cervicalcanc er/detailedguide/cervical-cancerkey-statistics. Accessed
August 14, 2017.. 4. Ovarian Cancer. American Cancer Society website. http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-
cancer-key-statistics. Accessed August 14, 2017.
Our Commitment to
6
Gynecology
Together, our goal is to enhance
patient care and outcomes
Our comprehensive approach helps achieve the goal
of best outcomes and well-being for patients.
Research Education
and Evidence and Training
Access and Innovative
Reimbursement Products
Our Commitment to
7
Gynecology
Research and Evidence
Our relentless investment in evidence
to support patient care
Our Commitment to
8
Gynecology
Research and evidence specific
to gynecologic surgery
Click on study titles to activate hyperlink
Laparoscopic supracervical hysterectomy (LASH), a retrospective
study of 1,584 cases regarding intra- and perioperative complications
In this retrospective analysis, the rate of complications for LASH was very low in a
hospital of standard care and residency. LASH has to be considered as a minimally
invasive method with a low perioperative morbidity to treat benign uterine
pathologies, even in a teaching setting, and should therefore be the method of
choice if the cervix can be preserved1
Modifications of laparoscopic supracervical hysterectomy (LSH)
technique significantly reduce postoperative spotting
The results of this study indicate that the routine excision of the endocervix is
a quick procedure that allows a significant reduction of postoperative cyclical
bleeding in patients who undergo LSH2
Prevalence and risk factors for mesh erosion after laparoscopic-
assisted sacrocolpopexy
Based on this study, surgeons should consider supracervical hysterectomy over
total vaginal hysterectomy as the procedure of choice in association with MISC,
unless removal of the cervix is otherwise indicated
WHO global guidelines for the prevention of SSI recommend the use
of antimicrobial sutures*,3
“The panel suggests the use of triclosan-coated sutures for the purpose of reducing
the risk of SSI, independent of the type of surgery.”– “Conditional” Recommendation
with “Moderate” Quality of Evidence
CDC guidelines for the prevention of Surgical Site Infections 2017*,4
“Consider the use of triclosan-coated sutures for the prevention of SSI”–Category II
*The CDC, WHO, ACS and SIS guidelines on reducing the risk of surgical site infections are general to triclosan-coated
sutures and are not specific to any one brand.
References: 1. Grosse-Drieling, D., Schlutius, J.C., Altgassen, C. et al. Laparoscopic supracervical hysterectomy (LASH), a
retrospective study of 1,584 cases regarding intra- and perioperative complications. Arch Gynecol Obstet (2012) 285: 1391.
2. Schmidt T, Eren Y, Breidenbach M, et al. Modifications of laparoscopic supracervical hysterectomy technique significantly
reduce postoperative spotting. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):81-4. 3. World Health Organization. Global
Guidelines for the Prevention of Surgical Site Infection. www.who.int/gpsc/global-guidelines-web.pdf 4. Centers for Disease
Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. Published online May 3, 2017.
5. Tan-Kim J, Menefee SA, Luber KM, Nager CW, Lukacz ES. Prevalence and risk factors for mesh erosion after laparoscopic-
assisted sacrocolpopexy. International Urogynecology Journal. 2011;22(2):205-212.
Our Commitment to
9
Gynecology
Education and Training
Our commitment provides best-in-class
education throughout every step of the process
Our Commitment to
10
FOR INTERNAL USE ONLY
GynecologyProfessional education services
Minimally invasive and open gynecologic surgery
preceptorships, fellows programs, virtual programs, and
live web stream seminars
• Programs designed to expand awareness and knowledge
of the latest advancements in gynecologic procedures and
surgical skill enhancement
• Discussion around safe and effective use of our products
used in hysterectomies for access, repair, and closure
• Review of surgical techniques for laparoscopic suturing and
ability to apply learnings in a hands-on setting
• Discussion of patient selection considerations for total
laparoscopic hysterectomy approaches
• Highlight unique challenges faced in gynecologic oncology
FOR SURGEONS FOR PATIENTS
Minimally Invasive Gynecologic Shared Decision Making in
Surgery Preceptorship Hysterectomy Program
Virtual Gynecologic Surgery
Preceptorship (Online Program) Smarterpatient.com
Fellows in Minimally Invasive
Gynecologic Surgery Program
Minimally Invasive Gynecologic
Surgery Course
Gynecologic Oncology Fellows
Program
Our Commitment to
11
GynecologyRevolutionizing surgical education
through a virtual training mobile
platform
• Allows surgeons to rehearse simulated surgery anytime, anywhere
• Delivers cognitive training that has the potential to improve outcomes
LAUNCHING IN LATE 2017
• Gynecological anatomy
• Open total hysterectomy
• Laparoscopic total hysterectomy
• Total vaginal hysterectomy
Our Commitment to
12
GynecologyAccess and Reimbursement
Helping patients have access to the care they need
Our Commitment to
13
FOR INTERNAL USE ONLY
GynecologyOur US Health Economics & Market
Access (HEMA) Team
Our team works with payors, providers, and other health
care advocates to provide value-based clinical and economic
decision making to provide access to Ethicon products and
procedures.
US HEMA also offers:
• Evidence-based tools such as economic models
• Medical policy and benefit design advocacy
• Insights on new and emerging payment models
• Reimbursement support: fact sheets and helpline
for Ethicon devices
Our Commitment to
14
GynecologyReimbursement information and
support services
• Our Health Economics and Market Access team works directly
with health plans, employers, hospital systems, brokers,
and coalitions
• They are here to educate and assist with coding, coverage, and
reimbursement inquiries
• Resources available on ethicon.com or by contacting your
health care policy and economics manager
Our Commitment to
15
GynecologyInnovative Products
At the forefront of innovation to help
enable the best surgical outcomes
Our Commitment to
16
GynecologyOur approach to innovation starts
with knowledge and insight
TISSUE
2
• Pneumostasis
• Hemostasis
1
SURGEON AND OR TEAM
3
ANATOMY
• Disease State • Observation
• Access • Experience
• Visibility • Technique
TECHNOLOGY
4
• Stability
• Precision
• Cost
resulting in the development of technology
that meets your surgical needs
Our Commitment to
17
GynecologySurgical innovations that help you meet
the demanding needs of critical steps
of gynecologic surgery
Surgical Goal Surgical Challenge Ethicon Product Innovations
The pelvis has rich arterial blood
supply and complex venous ENSEAL® X1 Large Jaw
Achieve optimal sealing
drainage. Effective bleeding ENSEAL® G2 Articulating Tissue
and hemostasis
management during hysterectomy Sealers
is necessary for optimal visualization (Links to ethicon.com)
and to avoid bleeding complications
Urinary, neural, and vascular
structures encountered during HARMONIC® HD 1000i
Minimize damage to
hysterectomy should be preserved Harmonic ACE® +7 Shears with
surrounding tissues
and injury to surrounding tissues Advanced Hemostasis
kept at a minimum
Infectious complications in
hysterectomy can arise from multiple
Secure wound closure and address Plus Antibacterial Sutures
sources including the surgical site.
a known risk factor for surgical site STRATAFIX® Spiral PDS® Plus
Postoperative infections create
infection Knotless Tissue Control Device
additional pain for patients and an
economic burden for hospitals
Ensuring complete hemostasis SURGICEL® SNoWTM Absorbable
Achieve adjunctive hemostasis during procedures and prior to Hemostat
vaginal cuff closure SURGIFLO® Hemostatic Matrix Kit*
Protect the pelvic organs from
Significantly and safely reduce the
adhesion formation over the 5-to-7 GYNECARE INTERCEED® Absorbable
incidence of both new and reformed
-day peritoneal tissue healing Adhesion Barrier
adhesions1,2
process3,4
*The bleeding situations identified reflect customer insights/market research on optimal adjunctive hemostat utilization. The
product solutions should only be used in accordance with their instructions for use. Product recommendations should not
supplant medical judgment. Surgeon preference, experience, and patient needs may dictate alternate technique. Review
all relevant precautions, especially the indications, contraindications, warnings, and information for use. Please see package
inserts for Full Prescribing Information.
The visual does not reflect any sequential order in use.
1. Ten Broek RPG, Stommel MWJ, Strik C, et al. Beneits and harms of adhesion barriers for abdominal surgery: a systematic
review and meta-analysis. The Lancet 2014;383(9911):48-59. 2. Ahmad G, Du y JMN, Farquhar C,et al. Barrier agents for
adhesion prevention after gynecological surgery. Cochrane Database Syst Rev 2008;(2);1-40. 3. Interceed Claims List
INT005709. 4. DiZerega GS. Peritoneum, Peritoneal Healing, and Adhesion Formation.
Peritoneal Surgery. New York, NY: Springer-Verlag; 2000:27-33
Our Commitment to
18
GynecologySeal Better. ENSEAL® X1 Large Jaw
Surgical Goal: Achieve optimal sealing and hemostasis
Surgical Challenge: Effective bleeding management during gynecologic surgeries is necessary
for optimal visualization and to avoid bleeding complications
ENSEAL X1 Large Jaw is an advanced bipolar device designed for use in open surgical
procedures. It offers better sealing compared to LigaSure Impact™, with less bleeding,1 less
thermal spread,2 and better ergonomics.3
Better hemostasis1 Better tissue management2 Better design3
With a larger distal electrode surface Enabled by Adaptive Tissue Technology, ENSEAL X1 Large Jaw offers an overall
area,4 ENSEAL X1 Large Jaw had 88% ENSEAL X1 Large Jaw had 41% less better design compared to LigaSure
less bleeding in thick tissue compared thermal spread compared to LigaSure Impact3
to LigaSure Impact1 Impact2
Convenient control placement is
designed for less hand movement4
360° shaft rotation is designed to
improve access to targeted tissue5
References: 1. Preclinical test of distal tip bleeding (ENSEAL® vs Impact-LF4318) in thick porcine mesentery base (pHARMONIC® HD 1000i Shears: Unmatched
precision, unparalleled strength, and
optimized efficiency
Surgical Goal: Minimize damage to surrounding tissues
Surgical Challenge: Pelvic vessels and structures encountered during hysterectomies should be
preserved and injury to surrounding tissues kept at a minimum
Unmatched Precision Unparalleled Strength Optimized Efficiency
Unique shape mimics a mechanical Unique blade design delivers more Simple energy activation using one
dissector,1 which may reduce the need secure seals, even in the most energy button provides the reliable
to use a separate dedicated dissecting challenging conditions sealing of the HARMONIC® MIN button
instrument2 with faster cutting than HARMONIC®
Exceptional sealing strength as MAX button for vessels up to 5 mm in
More tapered jaw is designed to enable evidenced by burst pressures of 150% diameter6
more precise access to tissue planes. relative to both small and large jaw
Curved, tapered blade geometry devices4,5 Strong tip grasping is designed to
delivers superior dissection among minimize tissue slippage and may aid in
advanced energy devices.3 tissue manipulation and control7
References: 1. Design Validation Study with surgeons (n=33) operating in simulated procedures in an animate porcine laboratory model. 2. In a design vali-
dation study with surgeons (n=33) operating in simulated procedures in an animate porcine laboratory model (26/33) 3. Based on a pre-clinical study 4. In
a benchtop study with 5-7 mm porcine carotid arteries that compared median burst pressure, HARMONIC® HD 1000i (1878 mmHg) vs. LigaSure Impact™
(1224 mmHg) (pWorld-class precision: HARMONIC ACE® +7
Shears with Advanced Hemostasis
For use in soft tissue incisions when bleeding control and minimal thermal injury are desired.
Surgical Goal: Minimize damage to surrounding tissues
Surgical Challenge: Pelvic vessels and structures encountered during hysterectomies should be
preserved and injury to surrounding tissues kept at a minimum
Advanced Hemostasis Superior heat Unmatched precision and
with stronger large management multi-functionality
vessel sealing
HARMONIC ACE+7 is indicated for HARMONIC devices use heat to Adaptive Tissue Technology uses a
vessels up to and including 7 mm effectively seal and divide vessels while proprietary algorithm that actively
in diameter using the Advanced delivering minimal lateral thermal monitors the instrument during use,
Hemostasis hand activation button1 spread. Harmonic ACE +7 Shears deliver and enables the system to sense and
less tissue damage and a significantly respond appropriately to changes in
smaller thermal footprint compared to patient tissue conditions
other devices2-4
Multi-functionality is enabled through
simultaneous sealing and cutting, back-
scoring, grasping, and dissecting5
References: 1. Internal market analysis as of 1/31/2014. Data on file, Ethicon Endo-Surgery (SCN034259). 2. In a preclinical study on 5-7mm goat carotids (n=76) that compared the mean
thermal damage via histology of HARMONIC ACE® + 7 in Advanced Hemostasis mode vs LigaSure™ Blunt Tip (LF1537) (2.54 [0.48] mm vs. 3.08 [0.67] mm, respectively, p=0.003). Data on
file, Ethicon Endo-Surgery (PSP003910, PSP003620, PCS0000215). (C1647). 3. In a preclinical study on 5-7mm goat carotids (n=38) that compared the mean thermal footprint via histology
of HARMONIC ACE®+7 in Advanced Hemostasis mode vs LigaSure™ Blunt Tip (LF1537) (6.48 [–0.81] mm vs. 10.07 [–1.12] mm, respectively, pTake greater control of key risk factors
related to SSIs
Surgical Goal: Secure wound closure
Surgical Challenge: Suture as a site for infection. Each tissue layer has a different wound
healing process.
The antibacterial component of all Plus Sutures–IRGACARE®† MP–represents the purest
form of triclosan. Ethicon Plus Sutures have been shown in vitro to inhibit colonization
of the suture for 7 days or more, including bacteria commonly associated with surgical
site infection (SSI)1,2
STRATAFIX™ Spiral PDS™
Plus Knotless Tissue Triclosan-coated sutures are supported by the
World Health Organization (WHO).
Control Device
Plus Antibacterial Sutures
“The panel suggests the use of triclosan-
With significantly more points of fixation coated sutures for the purpose of reducing
than traditional sutures, STRATAFIX the risk of SSI, independent of the type of
Proven in vitro to inhibit bacterial Knotless Tissue Control Devices provide surgery.”– “Conditional” Recommendation
colonization of the suture1,2 a combination of more security, more with “Moderate” Quality of Evidence
consistency, and more efficiency3
The only globally available suture
Triclosan-coated sutures are supported by the
that addresses a known, controllable Devices provide the wound-holding Centers for Disease Control and Prevention
risk factor for infection–bacterial strength of interrupted suturing, with (CDC):
colonization of the suture1,2 greater security and efficiency than
continuous suturing4 “Consider the use of triclosan-coated sutures
for the prevention of SSI. (Category II–weak
recommendation; moderate-quality evidence
suggesting a trade-off between clinical
benefits and harms.).”*
*The CDC, WHO, ACS and SIS guidelines on reducing the risk of
surgical site infections are general to Triclosan-coated sutures
and are not specific to any one brand.
†Trademark of BASF SE.
References: 1. Ming X, Rothenburger S, Yang D. In vitro antibacterial efficacy of Monocryl Plus Antibacterial Suture (poliglecaprone 25 with triclosan). Surg
Infect (Larchmt). 2007;8(2):201-207. 2. Ming X, Rothenburger S, Nichols MM. In vivo and in vitroantibacterial efficacy of PDS Plus (polidioxanone with
triclosan) suture. Surg Infect (Larchmt). 2008;9(4):451-457. 3. STRATAFIX™ Plus Knotless Tissue Control Device Consolidated Claims Matrix SFX 052321-
160429. 4. STRATAFIX™ Plus Knotless Tissue Control Device Consolidated Claims Matrix SFX 052359-160502.
Our Commitment to
22
GynecologyFaster time to hemostasis,*† so you can focus
on the procedure, not the bleed‡
Surgical Goal: Achieve adjunctive hemostasis
Surgical Challenge: Ensuring complete hemostasis during procedures and prior to
vaginal cuff closure
Our biosurgery portfolio helps you act fast to manage bleeding complications.
The SURGICEL® Family of Absorbable Hemostats are the first and only absorbable
hemostats that are proven bactericidal in vitro against a broad range of gram-positive
and gram-negative organisms during surgical procedures.1
Also available in the Adjunctive
Hemostasis Portfolio of products:
SURGIFLO®
Hemostatic Matrix Kit
SURGIFLO® stops bleeding in less than
2 minutes when mixed with thrombin.
Its applicator allows for precise
placement to address bleeding in tight
and difficult-to-access sites4
SURGICEL SNoW™
Absorbable Hemostat
With enhanced comfortability and superior handling vs. SURGICEL® Original, SURGICEL
SNoW is easy to deploy and manipulate–its non-woven structure increases surface
contact to bleeding site.2-3
*Compared to SURGICEL® Original Absorbable Hemostat.
† SURGICEL® Consolidated Claims Matrix 057092-160726
‡The bleeding situations identified reflect customer insights/market research on optimal adjunctive hemostat utilization. The product solutions should
only be used in accordance with their instructions for use. Product recommendations should not supplant medical judgment. Surgeon preference,
experience, and patient needs may dictate alternate technique. Review all relevant precautions, especially the indications, contraindications, warnings, and
information for use. Please see package inserts for Full Prescribing Information.
The visual does not reflect any sequential order in use.
1. 057059-160725. 2. 057091-160726. 3. 057096-160726. 4. 048494-160304.
Our Commitment to
23
GynecologySURGICEL® Powder Absorbable Hemostat: built
to stop continuous, broad-surface oozing—fast
For use adjunctively in surgical procedures to assist in the control of capillary, venous,
and small arterial hemorrhage when ligation or other conventional methods of control
are impractical or ineffective.
Surgical Goal: Achieve adjunctive hemostasis
Surgical Challenge: Ensuring complete hemostasis during procedures and prior to
vaginal cuff closure
Our biosurgery portfolio helps you act fast to manage bleeding complications. The
SURGICEL® Family of Absorbable Hemostats is the first and only absorbable hemostat
that is proven bactericidal in vitro against a broad range of gram-positive and gram-
negative organisms during surgical procedures.1
Built on a legacy of Get to the source May not require manual
performance of the bleed compression
Fully absorbable within 7 to 14 days3 Unique structure of the powder SURGICEL Powder provides effective,
penetrates the surface of the blood to broad surface coverage to vertical
Contains an aggregate of ORC fiber get to the source of bleeding5,6 planes like the pelvic sidewall7
fragments that help control capillary,
venous, and small arterial hemorrhages4,8 Blood saturates the material, providing Penetrates blood to get to the source
a surface for platelet adhesion and of the bleed, for efficient control of
ORC technology helps control capillary, aggregation, and initiating clot continuous oozing bleeding8,9
venous, and small arterial hemorrhage formation5.6
SURGICEL Powder Absorbable
Bactericidal activity in vitro against all Forms a durable clot that did not wash Hemostat has been demonstrated to
five of the hospital-acquired pathogens away or rebleed when irrigated4 sustain hemostasis even when it is
(MRSA, MRSE, VRE, PRSP, E Coli)1,2 irrigated10
References: 1. SURGICEL Master Claims List. Consolidated Claims Matrix 057081-160725. 2.SURGICEL Master Claims List. Consolidated Claims Matrix
057056-160725 3. SURGICEL Master Claims List. Consolidated Claims Matrix 057062-160725. 4. Data on file, Ethicon. Final Report, PSE Accession No.
16-0006. Project No. 16438. 5. Data on file, Ethicon. Powder TTH vs Original Final Report. 2015. 6. Data on file, Ethicon. METHOD, Surface Energy/Tension
Analysis. 7. Poon RT. Current techniques of liver transection. HPB. 2007;9:166-73. 8. SURGICEL® Powder Absorbable Hemostat, Instructions for Use.
Ethicon, Inc. 9. Data on file. 036971-150714_S-Factors Wall Cling_FINAL. 10. Data on file. Ethicon, Inc. MacDonald MH. PSE Accession No. 16-0006. Study
Comparing Performance of SURGICEL® Powder Absorbable Hemostatic Powder to Marketed Competitive Powdered Topical Hemostats in a Swine
Acute Liver Abrasion Model. 2016. Our Commitment to
24
GynecologyINTERCEED® Absorbable Adhesion Barrier: the
adhesion barrier that conforms for control you
can count on
Indicated as an adjuvant in open (laparotomy) gynecologic
pelvic surgery for reducing the incidence of postoperative
pelvic adhesions after meticulous hemostasis is achieved. This
is consistent with microsurgical principles.
Surgical Goal: Reduce the incidence of both new and reformed
adhesions in open gynecologic cases
Surgical Challenge: Adhesions are thought to adversely affect
fertility, and potentially lead to the development of chronic
abdominal pain, dyspareunia and intestinal obstruction.1
Proven safe and Easy to handle, and
Designed for optimal
effective in gynecologic conforms to pelvic
healing
procedures organs
Significantly and safely reduce the Forms a continuous protective coating Does not crack, tear, or stick to gloves
incidence of both new and reformed during the critical 5-7 day peritoneal
adhesions2,3 healing period5 May be rolled or folded to aid in
placement. Final placement should be
Clinically effective across multiple Chemically composed of oxidized flat (not folded or rolled)
gynecological procedures2 regenerated cellulose, which has
been shown in an in vitro study not to Pliability allows it to contour to organs
Up to 2 times more effective than good enhance bacterial growth6 of varying shapes and sizes for full
surgical technique alone in achieving an coverage
adhesion-free outcome4
References: 1. Farquhar, C., Vandekerckhove, P., Watson, A., Vail, A., & Wiseman, D. (1999). Barrier agents for preventing adhesions after surgery for
subfertility. Cochrane Database of Systematic Reviews. 2. Ten Broek RPG, Stommel MWJ, Strik C, et al. Beneits and harms of adhesion barriers for
abdominal surgery: a systematic review and meta-analysis. The Lancet 2014;383(9911):48-59. 3. Ahmad G, Du y JMN, Farquhar C,et al. Barrier agents for
adhesion prevention after gynecological surgery. Cochrane Database Syst Rev 2008;(2);1-40.4. Franklin RR, Trout R, Marks MG, et al. Interceed barrier in
the prevention of post-operative adhesions following laparotomy: meta-analysis of its efficacy and safety. Poster Presentation: 1995 ASRM. 5. Interceed
Claims List INT005709. 6. Dineen, P.: Surgery, Gynecology and Obstetrics 142:481, 1976.
Our Commitment to
25
GynecologyTogether, our goal is to enhance
patient care and outcomes
Our comprehensive approach helps achieve the goal
of best outcomes and well-being for patients.
Research Education
and Evidence and Training
Access and Innovative
Reimbursement Products
Our Commitment to
26
GynecologyINTERCEED® Essential Product Information
Indications
GYNECARE INTERCEED® Absorbable Adhesion Barrier is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of
postoperative pelvic adhesions after meticulous hemostasis is achieved consistent with microsurgical principles.
Contraindications
The use of GYNECARE INTERCEED®> (TC7) Absorbable Adhesion Barrier is contraindicated in the presence of frank infection. GYNECARE INTERCEED® is not
indicated as a hemostatic agent. Appropriate means of achieving hemostasis must be employed.
Warnings
The safety and effectiveness of GYNECARE INTERCEED® in laparoscopic surgery or any procedures other than open (laparotomy) gynecologic microsurgical
procedures have not been established.
Postoperative adhesions may be induced by GYNECARE INTERCEED® application if adjacent tissues (eg, ovary and tube) and structures are coapted or conjoined by
the device, or if GYNECARE INTERCEED® is folded, wadded or layered. Postoperative adhesions may occur in the presence of GYNECARE INTERCEED® if meticulous
hemostasis is not achieved prior to application. As with all foreign substances, GYNECARE INTERCEED® should not be placed in a contaminated surgical site.
Precautions
Use only a single layer of GYNECARE INTERCEED®, since multiple layers of packing or folding will not enhance the adhesion barrier characteristics and may interfere
with the absorption rate of GYNECARE INTERCEED®. Care should be exercised in applying GYNECARE INTERCEED® to a pelvic organ not to constrict or restrict it.
If the product comes in contact with blood prior to completing the procedure, it should be discarded, as fibrin deposition cannot be removed by irrigation and may
promote adhesions formation. Ectopic pregnancies have been associated with fertility surgery of the female reproductive tract. No data exist to establish the effect, if
any, of GYNECARE INTERCEED® on the occurrence of ectopic pregnancies. No adequate studies have been conducted in women who have become pregnant within
the first month after exposure to GYNECARE INTERCEED®. No teratogenic studies have been performed. Therefore, avoidance of conception should be considered
during the first complete menstrual cycle after use of GYNECARE INTERCEED®. The safety and effectiveness of using GYNECARE INTERCEED® in combination
with other adhesion prevention treatments have not been clinically established. GYNECARE INTERCEED® is supplied sterile. As the material is not compatible with
autoclaving or ethylene oxide sterilization, GYNECARE INTERCEED® must not be resterilized. Foreign body reactions may occur in some patients. Interactions may
occur between GYNECARE INTERCEED®and some drugs used at the surgical site. Pathologists examining sites of GYNECARE INTERCEED®placement should be
made aware of its usage and of the normal cellular response to GYNECARE INTERCEED® ‘to facilitate proper evaluation of specimens’.
Adverse Reactions
The type and frequency of adverse events reported are consistent with events typically seen following surgery. Postsurgical adhesions may occur in the presence of
GYNECARE INTERCEED®.
For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse
Our Commitment to
27
GynecologySURGICEL® Powder Absorbable Hemostat
Essential Product Information
Indications Precautions
SURGICEL® Powder (oxidized regenerated cellulose) is used adjunctively in • SURGICEL® Powder should not be used in conjunction with autologous
surgical procedures to assist in the control of capillary, venous, and small arterial blood salvage circuits, because its fragments may pass through the
hemorrhage when ligation or other conventional methods of control are transfusion filters of blood-scavenging systems.
impractical or ineffective. • Use only as much SURGICEL® Powder (oxidized regenerated cellulose)
as is necessary and apply only where needed for hemostasis. Remove
Contraindications any excess before surgical closure in order to facilitate absorption and to
• Do not inject or place SURGICEL® Powder into an open blood vessel. minimize the possibility of foreign body reaction.
• SURGICEL® Powder should not be used to control hemorrhage from large • In urological procedures, minimal amounts of SURGICEL® Powder should be
arteries. used and care must be exercised to prevent plugging of the urethra, ureter,
• When SURGICEL® Powder is used to help achieve hemostasis in, around, or or a catheter by dislodged portions of the product.
in proximity to foramina in bone, areas of bony confine, the spinal cord, or • Since absorption of SURGICEL® Powder could be prevented in chemically
the optic nerve and chiasm, it must always be removed after hemostasis is cauterized areas, its use should not be preceded by application of silver
achieved since it will swell and could exert unwanted pressure. nitrate or any other escharotic chemicals.
• SURGICEL® Powder should not be used for implantation in bone defects, • If SURGICEL® Powder is used temporarily to line the cavity of open wounds,
such as fractures, since there is a possibility of interference with callus it should be removed by irrigation with sterile water or saline solution after
formation and a theoretical chance of cyst formation. bleeding has stopped.
• Precautions should be taken in otorhinolaryngologic surgery to ensure that
Warnings none of the material is aspirated by the patient (e.g., controlling hemorrhage
• Closing with SURGICEL® Powder in a contaminated wound without after tonsillectomy and controlling epistaxis).
drainage may lead to complications and should be avoided. • This applicator tip is not intended for laparoscopic or other endoscopic use.
• SURGICEL® Powder should not be impregnated with anti-infective agents or
Adverse Events
with other materials such as buffering or hemostatic substances.
• Paralysis and nerve damage have been reported when other SURGICEL®
• SURGICEL® Powder is dry and there may be difficulties in precise delivery
products were used around, in, or in proximity to foramina in bone, areas of
under certain circumstances. Unintentional device placement may result
bony confine, the spinal cord, and/or the optic nerve and chiasm.
in powder scattering and device migration that may increase the risk of
adhesion formation. • Blindness has been reported in connection with surgical repair of a
lacerated left frontal lobe when other SURGICEL® products were placed in
• Although SURGICEL® Powder is bactericidal against a wide range
the anterior cranial fossa (see WARNINGS and PRECAUTIONS).
of pathogenic microorganisms, it is not intended as a substitute for
systemically administered therapeutic or prophylactic antimicrobial agents • Foreign body reactions have been reported with other products from the
to control or to prevent postoperative infections. SURGICEL® Family of Absorbable Hemostats.
• Do not attempt to trim the applicator tip. • Burning has been reported when other SURGICEL® products were applied
after nasal polyp removal. Headache, burning, stinging, and sneezing
in epistaxis and other rhinological procedures, and stinging when
SURGICEL® product was applied on surface wounds (varicose ulcerations,
dermabrasions, and donor sites) have also been reported.
For more information and technical questions, call 1-800-795-0012.
Our Commitment to
28
GynecologySURGICEL® SNoW Essential Product Information
Indications
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small
arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL® ORIGINAL, SURGICEL® FIBRILLAR™ and
SURGICEL® NU-KNIT® Hemostats can be cut to size for use in endoscopic procedures.
Precautions
• Use only as much SURGICEL® Absorbable Hemostat as is necessary for hemostasis, holding it firmly in place until bleeding stops. Remove any excess before
surgical closure in order to facilitate absorption and minimize the possibility of foreign body reaction.
• In urological procedures, minimal amounts of SURGICEL® Absorbable Hemostat should be used and care must be exercised to prevent plugging of the urethra,
ureter, or a catheter by dislodged portions of the product.
• Since absorption of SURGICEL® Absorbable Hemostat could be prevented in chemically cauterized areas, its use should not be preceded by application of silver
nitrate or any other escharotic chemicals.
• If SURGICEL® Absorbable Hemostat is used temporarily to line the cavity of large open wounds, it should be placed so as not to overlap the skin edges. It should
also be removed from open wounds by forceps or by irrigation with sterile water or saline solution after bleeding has stopped.
• Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient. (Examples: controlling hemorrhage
after tonsillectomy and controlling epistaxis.)
• Care should be taken not to apply SURGICEL® Absorbable Hemostat too tightly when it is used as a wrap during vascular surgery (see Adverse Reactions).
Adverse Events
• “Encapsulation” of fluid and foreign body reactions have been reported.
• There have been reports of stenotic effect when SURGICEL® Absorbable Hemostat has been applied as a wrap during vascular surgery.
• Paralysis and nerve damage have been reported when SURGICEL® Absorbable Hemostat was used around, in, or in proximity to foramina in bone, areas of bony
confine, the spinal cord, and/or the optic nerve and chiasm.
• Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when SURGICEL® Absorbable Hemostat was placed in the anterior
cranial fossa.
• Possible prolongation of drainage in cholecystectomies and difficulty passing urine per urethra after prostatectomy have been reported.
• For more information, please consult your doctor or for product quality and technical questions, call 1-800-795-0012.
Our Commitment to
29
GynecologySURGIFLO® Hemostatic Matrix Kit Essential Product Information
(Made from Absorbable Gelatin Sponge, USP) with Thrombin
Description • The safety and effectiveness of SURGIFLO® for use in ophthalmic procedures
SURGIFLO® with Thrombin (SURGIFLO® Hemostatic Matrix Kit) is intended for has not been established.
hemostatic use by applying to a bleeding surface. • SURGIFLO® should not be used for controlling post-partum intrauterine
bleeding or menorrhagia.
Actions • The safety and effectiveness of SURGIFLO® has not been established in
children and pregnant women.
When used in appropriate amounts SURGIFLO® is absorbed completely within 4 to
6 weeks. • The blue flexible applicator tip should not be trimmed to avoid exposing
internal guidewire.
• The white straight applicator tip should be trimmed away from the surgical
Intended Use/Indications
area. Cut a square angle to avoid creating a sharp tip.
SURGIFLO®, mixed with thrombin solution, is indicated in surgical procedures (other
than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature
or other conventional methods is ineffective or impractical. Precautions
• Safe and effective use of SURGIFOAM® Sponge has been reported in a
published neurologic retrospective study involving 1700 cases in Europe. Safe
Contraindications
and effective use in neurosurgery has not been proven through randomized,
• Do not use SURGIFLO® in intravascular compartments because of the risk of controlled clinical studies in the United States.
embolization.
• SURGIFLO® is supplied as a sterile product and cannot be resterilized.
• Do not use SURGIFLO® in patients with known allergies to porcine gelatin.
• SURGIFLO® should not be used for packing unless excess product that is not
• Do not use SURGIFLO® in closure of skin incisions because it may interfere with needed to maintain hemostasis is removed. SURGIFLO® may swell up to 20%
the healing of skin edges. This interference is due to mechanical interposition upon contact with additional fluid.
of gelatin and is not secondary to intrinsic interference with wound healing.
• SURGIFLO® should not be used in conjunction with autologous blood salvage
circuits.
Warnings • SURGIFLO® should not be used in conjunction with methylmethacrylate
• SURGIFLO® should not be used in the presence of infection and should be adhesives.
used with caution in contaminated areas of the body• SURGIFLO® should not • In urological procedures, SURGIFLO® should not be left in the renal pelvis or
be used in instances of pumping arterial hemorrhage. SURGIFLO® will not act ureters to eliminate the potential foci for calculus formation.
as a tampon or plug in a bleeding site.
• SURGIFLO® should be removed from the site of application when used in,
around, or in proximity to foramina in bone, areas of bony confine, the spinal
cord, and/or the optic nerve and chiasm because it may swell resulting in
nerve damage.
• Excess SURGIFLO® should be removed once hemostasis has been achieved.
Our Commitment to
30
GynecologySURGIFLO® Hemostatic Matrix Kit Essential Product Information
(Made from Absorbable Gelatin Sponge, USP) with Thrombin (cont’d)
Adverse Events
A total of 142 patients received SURGIFOAM® Sponge during a clinical trial comparing SURGIFOAM® Sponge to another absorbable gelatin sponge. In general, the following
adverse events have been reported with the use of absorbable porcine gelatin-based hemostatic agents:
• Gelatin-based hemostatic agents may serve as a nidus for infection and abscess formation and have been reported to potentiate bacterial growth.
• Giant cell granulomas have been observed at implant sites when used in the brain.
• Compression of the brain and spinal cord resulting from the accumulation of sterile fluid have been observed.
• Multiple neurologic events were reported when absorbable gelatin-based hemostatic agents were used in laminectomy operations, including cauda equina syndrome,
spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and impotence.
• The use of absorbable gelatin-based hemostatic agents during the repair of dural defects associated with laminectomy and craniotomy operations, has been associated
with fever, infection, leg paresthesias, neck and back pain, bladder and bowel incontinence, cauda equina syndrome, neurogenic bladder, impotence, and paresis.
• The use of absorbable gelatin-based hemostatic agents has been associated with paralysis, due to device migration into foramina in the bone around the spinal cord, and
blindness, due to device migration in the orbit of the eye, during lobectomy, laminectomy, and repair of a frontal skull fracture and lacerated lobe.
• Foreign body reactions, “encapsulation” of fluid, and hematoma have been observed at implant sites.
• Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatinbased sponges were used in severed tendon repair.
• Toxic shock syndrome was reported in association with the use of absorbable gelatin-based hemostats in nasal surgery.
• Fever, failure of absorption, and hearing loss have been observed when absorbable hemostatic agents were used during tympanoplasty.
Our Commitment to
31
GynecologyEVITHROM® Thrombin, Topical (Human) for Topical Use Only
Lyophilized Powder for Solution
EVITHROM® is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and
control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
EVITHROM® may be used in conjunction with an Absorbable Gelatin Sponge, USP.
Important Safety Information
• For topical use only.
• Do not inject.
• Apply EVITHROM® on the surface of bleeding tissue only.
• The amount of EVITHROM® required depends upon the area of tissue to be treated and the method of application. In clinical studies, volumes up to 10 ml were
used in conjunction with Absorbable Gelatin Sponge.
• Do not use for the treatment of severe or brisk arterial bleeding.
• Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. Hypersensitivity reactions, including anaphylaxis,
may occur.
• There is a potential risk of thrombosis if absorbed systemically.
• May carry a risk of transmitting infectious agents such as viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps
designed to reduce the risk of viral transmission.
• The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM®) were prolonged activated partial
thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count.
• None of the patients treated with EVITHROM developed antibodies to human thrombin or to human Factor V/Va. The clinical significance of these findings is
unknown.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
021328-140912
Our Commitment to
32 ©2017 Ethicon US, LLC. All rights reserved. 032633-170814
GynecologyYou can also read
