2013 gynecology contracting matrices · bleeding in approximately 10% to 25% of procedures. ......

Module 1 Burden of Bleeding

Module 2 Clarifying the confusion in the adjunctive hemostat marketplace

Module 3 Science of Hemostasis

Module 4 Hemostasis Optimization Program

Educational Series

Module 5 Resident Training

Hemostasis Education

FoundationUnderstanding the role of adjunctive hemostats in the appropriate management of surgical bleeding

2

IntroductionWhy are we here?

Presenter

Presentation Notes

Today’s discussion centers on a basic element of any procedure: hemostasis. And more specifically, the role of adjunctive hemostats in the appropriate management of surgical bleeding. We’ll discuss several topics, including: Why this is important Patient factors that put them at greater risk for surgical bleeding Points of intervention along the hemostatic cascade The available options for bleeding management And descriptions of the predominant bleeding situations

Knowledge Check

4

• When does surgical bleeding become a concern?

• What is the impact of uncontrolled surgical bleeding?

• What can be done when primary approaches are not enough to control bleeding efficiently?

Presenter

Presentation Notes

Let’s begin with a knowledge check about bleeding concerns and the potential impact. [capture on flip chart and refer back during the slide presentation]

Surgeon training and education regarding surgical bleeding is highly variable throughout residency and in practice. An opportunity exists to ensure consistent knowledge and practice training is available.

5

Presenter

Presentation Notes

[Based on the responses] As we can see, education and training about bleeding management varies throughout residency and in practice. We believe there’s an opportunity for consistency in knowledge and practice.

Surgical bleeding adversely affects patient outcomes, hospital costs, and resources

6

of cases in open procedures experience disruptive bleeding events1

1Corral M, Hollmann S, Ferko N, Broder MS, Chang E, Sun GH. Health and Economic Consequences of Controlled versus Uncontrolled Surgical Bleeding in Patients Treated with Haemostatic Agents: A Retrospective Analysis of the Premier Perspective Database. SABM, 2014. 2Marietta M, Facchini L, Pedrazzi P, Busani S, Torelli G. Pathophysiology of Bleeding in Surgery. Transplant Proc. 2006; 38(3):812–4. 3Shippert RD. A Study of Time-Dependent Operating Room Fees and How to Save $100 000 by Using Time-Saving Products. Amer Jrnl Cosmetic Surg. 2005; 22. 4Kahn JM, Rubenfeld GD, Rohrbach J, Fuchs BD. Cost Savings Attributable to Reductions in Intensive Care Unit Length of Stay for Mechanically Ventilated Patients. Med Care. 2008; 46: 1226. 5Dasta JF, McLaughlin TP, Mody SH, Piech CT. Daily cost of an intensive care unit day: The contribution of mechanical ventilation, Crit Care Med. 2005; 22: 1266. 6Toner RW, Pizzi L, Leas B, Ballas SK, Quigley A, Goldfarb NI. Costs to Hospitals of Acquiring and Processing Blood in the US. Appl Health Econ Health Policy. 2011; 9: 29. 7Zimlichman E, Henderson D, Tamir O, et al. Health Care–Associated Infections A Meta-analysis of Costs and Financial Impact on the US Health Care System. JAMA Intern Med. 2013; 173.

Challenging and uncontrollable bleeding during surgery is associated with high mortality rates2

Complications related to surgical bleeding may increase resource utilization3-7

Presenter

Presentation Notes

Although managing bleeding during surgery is a basic element in any procedure, patient outcomes, hospital costs, and resources can all be adversely affected by surgical bleeding. In fact, in open procedures that have a high likelihood of bleeding, 32-68% of cases can escalate to a disruptive bleeding event. This data was found in a range of procedures: cholecystectomy, cystectomy, pancreatic surgery, cardiac revascularization, and cardiac valve surgery. Disruptive bleeding events and their related complications are associated with increase hospital resource utilization, including increased rate blood transfusion, longer surgery time and increased length of stay. Managing surgical bleeding appropriately gives surgeons and hospitals an opportunity to improve patient outcomes and reduce overall costs associated with surgical bleeding.

Type of bleeding: - Capillary, Venous, Small Arterial, or Arterial - Mild, Moderate, or Brisk

Is blood or smoke from cautery obstructing the operative field?

What is the condition of the tissue – is it friable? Healthy? Distorted? Calcified bone?Do patient comorbidities factor in?

Can you reach the source of bleeding?1

Intensity

Intra-operative bleeding concerns and considerations

7

1

Visualization2

Tissue Surface and Condition3

Accessibility4

Concern Key Considerations

1S-Factors Insight Research and Next Steps Meeting, dated 06/30/2014.

Presenter

Presentation Notes

There are four main concerns when it comes to intra-operative bleeding, each with key considerations.

Knowledge Check

8

• How do patient factors contribute to uncontrolled surgical bleeding?

Presenter

Presentation Notes

Now’s let’s talk about any patient factors that play a role in uncontrolled surgical bleeding. [capture on flip chart and refer back during the slide presentation]

Patient factors contribute to the increased risk of surgical bleeding

9

The “new normal”

• Patients suffer from a growing number of comorbidities, which increases surgical bleeding risk1,2

• Comorbidities such as uncontrolled diabetes and obesity can affect the natural clotting process2

• Aging demographics have led to increasingly complex and extensive surgeries2,3,4

1Parekh AH, Barton MB. The Challenge of Multiple Comorbidity for the US Health Care System. JAMA. 2010; 303: 1303. 2 Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017. MedMarket Diligence. Report #S190. 2012; 3World Population Ageing 2015. United Nations Department of Economic and Social Affairs ǀ Population Division. 4Levy JH, Dutton RP, Hemphill JC, et al. Multidisciplinary Approach to the Challenge of Hemostasis. Anesth Analg. 2010; 110: 354.

Presenter

Presentation Notes

This is increasingly important because “new” normal is emerging in patients that are presenting for surgery every day. These patients suffer from a growing number of comorbidities such as uncontrolled diabetes and obesity – all of which can increase surgical bleeding risk and negatively affect the body’s natural clotting process. At the same time, the number of older patients undergoing surgery are leading to more extensive and complex procedures.

Patient medications and conditions increase the risk for surgical bleeding

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• Several patient medications and conditions may lead to surgical bleeding in approximately 10% to 25% of procedures1,2,3

• Growing incidence of cardiovascular disease increases use of anticoagulants and antiplatelets4,5,6

1Shander A. Financial and clinical outcomes associated with surgical bleeding complications. Surgery. 2007; 142: S20. 2Voils S. Thrombin Products: Economic Impact of Immune-Mediated Coagulopathies and Practical Formulary Considerations. Pharmacotherapy. 2009; 29: 18S. 3Marietta M, Facchini L, Pedrazzi P, Busani S, Torelli G. Pathophysiology of Bleeding in Surgery. Transplant Proc. 2006; 38(3):812–4. 4US Markets for Surgical Hemostats, Internal Tissue sealants, and adhesion Barriers 2012. Millenium Research Group. 2011. 5Shireman TI, Howard PA, Kresowik TF, Ellerbeck EF. Combined Anticoagulant–Antiplatelet Use and Major Bleeding Events in Elderly Atrial Fibrillation Patients. Stroke. 2004; 35: 2362-2367. 6Anderson FA, White K. Prolonged Prophylaxis in Orthopedic Surgery: Insights from the United States. Seminars Thrombosis Hemostasis. 2002; 28: 43.

Patient medications: • Aspirin• Warfarin (COUMADIN)• Clopidogrel (PLAVIX)• Novel oral anticoagulants

Presenter

Presentation Notes

In addition to patient factors in terms of their general health conditions and demographics, the medications surgical patients are taking can also increase the risk for bleeding. Of particular importance, the increase in cardiovascular disease is associated with increased use of a variety of anticoagulants medications, such as Coumadin and NOACs (Novel Oral Anticoagulants), and antiplatelet medications including Plavix and Aspirin. Both classes may lead to bleeding in 10-25% of procedures. It’s a new generation of patients and what we have found is that many hospitals have not updated their game plans to get ahead of the complexity.

Arterial• Spurting, pulsating flow

Types of Bleeding

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There are different types of bleeding (eg, capillary, venous, or arterial). Each type may require different methods to achieve hemostasis.

Capillary• Slow-flow• Broad or diffuse oozing

Bright-redDark-red

Primary Methods and Adjunctive Hemostats Primary Methods

Venous• Slow-steady flow• Broad or diffuse oozing Small Artery Large Artery

Hemostasis Primary methods of hemostasis may not always allow achievement of complete hemostasis. Using an adjunctive hemostat may result in faster time to achieve and sustain hemostasis.

Different bleeding situations require different solutions

12

Primary Methods

Mechanical• Sutures• Ligating clips• Staples• Clamps• Manual compression

Energy• Monopolar and

Bipolar Electrosurgery

• Ultrasonic• Advanced Bipolar

Adjunctive Methods

Topical Hemostats and Sealants• Oxidized regenerated cellulose• Flowable gelatin• Fibrin sealants• Fibrin patches• Bone wax• Collagen based

Primary Hemostasis Methods Alone May Be Ineffective or Impractical in Some Bleeding Situations

13

Surgical Situations• Uneven tissue

topography in bone or tumor bed

• Difficult to control compression at sites of diffuse bleeding

• Obstructed visualization by blood or anatomic structures

• Difficult to access to bleeding source

• Bleeding near critical structures (ureters, nerves, and blood vessels)

• Minimizing charring from monopolar energy

Patient Groups• Comorbidities, such as

uncontrolled diabetes, obesity, and certain chemotherapies

• Anticoagulant and antiplatelet therapies source

• Aging population with more complex surgeries and comorbidities

Knowledge Check

14

• How does understanding the hemostatic cascade influence surgical bleeding management?

Presenter

Presentation Notes

As we continue to build strengthen our knowledge, understanding the hemostatic cascade is instrumental managing surgical bleeding. [capture on flip chart and refer back during the slide presentation]

There are multiple points of intervention along the coagulation cascade

15

Presenter

Presentation Notes

There are multiple points of intervention along the coagulation cascade The coagulation cascade is comprised of the following steps: Vessel injury Vasoconstriction Platelet plug formation Fibrin clot formation Fibrinolysis

There are multiple points of intervention along the hemostatic cascade

Vessel Injury

Red Blood Cell

Platelet

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Disrupted endothelium

Presenter

Presentation Notes

Damage to the vessel wall triggers physiologic mechanisms that initiate the hemostatic cascade


Vasoconstriction

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Presenter

Presentation Notes

Damaged blood vessels immediately contract to narrow the diameter and decrease blood loss


Platelet Plug Formation

ActivatedPlatelet

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Presenter

Presentation Notes

Platelets bind to damaged blood vessels, which causes the platelets to change shape and aggregate to forma plug at the damaged site. The next step is the formation of a platelet plug. Circulating platelets adhere to exposed collagen and von Willebrand’s factor (VWF) and undergo platelet activation. These activated platelets will then release other signaling molecules (such as adenosine diphosphate (ADP) and thromboxane A2) that will induce the activation and aggregation of other platelets This cascade of platelet activation and aggregation results in the formation of the platelet plug. DETAILED description Under normal conditions, endothelial cells produce molecules including nitric oxide and prostacyclin to prevent platelet stasis and maintaining vessel dilation. This is to prevent abnormal clot formation. These molecules are no longer produced when the vascular endothelium is disrupted. In response to the disrupted endothelium, platelets adhere to the damaged intima (collagen) and form aggregates. Initial platelet adhesion is to von Willebrand’s factor (VWF), previously secreted by endothelial cells into the subendothelium. VWF binds to receptors on the platelet surface membrane (glycoprotein Ib/IX). These platelets that are anchored to the vessel wall undergo activation and release signaling molecules, including adenosine diphosphate (ADP) and thromboxane A 2 ADP, thromboxane A 2 , and other mediators induce activation and aggregation of additional platelets on the injured endothelium. Another receptor is assembled on the platelet surface membrane from glycoproteins IIb and IIIa. Fibrinogen binds to the glycoprotein IIb/IIIa complexes of adjacent platelets, connecting them into aggregates.


Fibrin Clot Formation

Fibrin

19

Presenter

Presentation Notes

Blood vessel damage initiates a series of enzyme activations leading to the generation of thrombin, the enzyme which catalyzes the conversion of soluble fibrinogen into fibrin monomers, which assemble into an insoluble fibrin polymer network that entraps cells, anchors to tissue, and stabilizes the platelet plug. Occurring in parallel with platelet plug formation is the formation of a fibrin clot. Tissue factor interacts with blood, trigger a series of biochemical events that produces thrombin, which converts soluble fibrinogen in the blood to insoluble fibrin Fibrin then polymerizes into a mesh that traps cells and anchors the clot to the tissue. DETAILED description Fibrin clot formation occurs through an intrinsic and extrinsic pathway. For the purposes of vessel injury, we will focus on the extrinsic pathway. The extrinsic pathway occurs when injury to the vessel exposes tissue factor to blood. This results in the interaction of plasma factor VII/VIIa and tissue factor (TF) to form a complex that activates factor X and IX. After vascular injury, clotting is initiated by the binding of plasma FVII/FVIIa to tissue factor (TF) (also known as coagulation factor III or tissue thromboplastin). The TF:FVIIa complex of the extrinsic pathway initiates blood coagulation by converting factor X to factor Xa. Factor Xa participates in the prothrombinase complex (FVa:FXa). This complex activates prothrombin to thrombin. Thrombin cleaves fibrinogen to monomers, which are cross-linked and form a fibrin clot.


Fibrinolysis

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Presenter

Presentation Notes

Clot formation and dissolution are balanced for normal healing to take place. Clot dissolution occurs predominately via the removal of fibrin in a process called “fibrinolysis”, which will disrupt the clot and cause it to break away. Hemostasis is restored to the vessel. DETAILED description The fibrinolytic system dissolves fibrin by means of plasmin, a proteolytic enzyme. Fibrinolysis is activated by plasminogen activators released from vascular endothelial cells. Plasminogen activators and plasminogen (from plasma) bind to fibrin, and plasminogen activators cleave plasminogen into plasmin Plasmin then proteolyzes fibrin into soluble fibrin degradation products that are swept away in the circulation.

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Antithrombotic medications disrupt the body’s ability to form a clot

22


SYNTHETIC SEALANT

Knowledge Check

23

• With many options and approaches available, what are the appropriate adjunctive hemostats to use and when?

The Confusion in the Marketplace

24

Number of choices & lack of standardization has led to suboptimal use of adjunctive hemostats

FlowableGelatin

VascularSealantFibrin

Patch

ORC*

FibrinSealant

The third-party trademarks used herein are trademarks of their respective owners.

Presenter

Presentation Notes

The sheer number of choices, combined with the lack of standardization in use, presents us with an unclear picture. This subsequently may lead to suboptimal use of adjunctive hemostats.

Published evidence offers conflicting or contradictory guidance to decision-makers

25

33 reviews/guidelines yield limited clinical or economic proof to optimize hemostat use1

• 28 had product information only

• 5 publications contained decision trees2-6

• Inconsistent terminology• “Minimal, Mild, Moderate” • “Anticipated, Active Bleeding”

• Multiple products recommended for each category of bleeding

1Literature Search 06/02/15. 2Barkun AN, Moosavi S, Martel M. Topical hemostatic agents: a systematic review with particular emphasis on endoscopic application in GI bleeding. Gastrointest Endosc. 2013; 77: 692. 3Forcillo J, Perrault LP. Armentarium of topical hemostatic products in cardiovascular surgery: An update. Transfus Apher Sci. 2014; 50: 26. 4Shander A, Kaplan LJ, Harris MT, et al. Topical Hemostatic Therapy in Surgery: Bridging the Knowledge and Practice Gap. J Am Coll Surg. 2014; 219: 570. 5Sileshi B, Achneck H, Ma L, Lawson JH. Application of Energy-Based Technologies and Topical Hemostatic Agents in the Management of Surgical Hemostasis. Vascular. 2010; 18: 197. 6Spotnitz WD, Burks S. Hemostats, sealants, and adhesives III: a new update as well as cost and regulatory considerations for components of the surgical toolbox. 2012; 52: 2243-2255.

Presenter

Presentation Notes

The published literature, though vast, offers conflicting or sometimes contradictory guidance to surgeons. A literature search was performed, and 33 reviews/guidelines from the past 10 years were evaluated. 28 of these had product information only, describing the mechanism of action of the particular hemostats and summarizing clinical evidence. 5 publications offered decision trees for determining the optimal product for different types of bleeding. However, the terminology was inconsistent across these publications, and their recommendations differed, or even multiple products were recommended for each category of bleeding.

Ethicon initiated a robust quantitative study to clarify the optimized use of adjunctive hemostats

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11 Specialties

450Surgeons

7,864 Bleeding occasions

CV

Uro

OBGYN

Ortho(Joint)

Gen

Neuro(Spine)

Bari

Ortho(Spine)

Neuro(Cranial)

Vasc Plast

S-Factors Insight Research and Next Steps Meeting, dated 06/30/2014.

Presenter

Presentation Notes

To better understand the surgeon mindset, a landmark study was undertaken by Ethicon that involved surveying 450 surgeons across 11 surgical specialties; and reviewing almost 8,000 surgical bleeding events

Surgeons choose adjunctive hemostats predominantly by site and situation

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Site

Situation

Product Characteristics

Years of Practice

Bleeding Intensity

Primary Insurance

Patient’s Age

Risk Factors

Comorbidities

% Importance450 Surgeons; 7,864 Bleeding Occasions


Presenter

Presentation Notes

This study found that, when confronted with bleeding, surgeons consider the site and the situation as the primary factors in choosing which adjunctive hemostat to use.

What did surgeons mean by “site” and “situation?”

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Presenter

Presentation Notes

What is actually meant by “site” and “situation?” Site means the following: The anatomy and critical surrounding anatomic structures that could be impacted The condition of the anatomy, for example thin, friable, calcified, or irregular bone Situation is multifactorial Intra-operative vs Post-operative Bleeding Risk Type of Access and Visualization - Direct: Able to see the site - Indirect: Not easily visible or accessible Type of Tissue Surface - Smooth or rough/raw? How big is the surface area? Bleeding Intensity - Think of this as a scale; on one end you have oozing and the other, brisk bleeding.

Continuous oozing. Bleeding that will not stop with compression/simple packing. The solution for this bleeding is more time consuming than it is difficult.

Five bleeding situations emerge from the sites and situations that surgeons encounter

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Difficult-to-access. Bleeding occurs in tight and irregular spaces and you cannot see the exact source of the bleed. You are concerned accessing in a tight space will cause more harm.

Problematic. Even though the bleeding is accessible, it could be trouble. It is more than routine and likely to be resistant to conventional means, and requires immediate attention, causing disruption to the normal progression of surgery.

Potential re-bleeding risk. Bleeding may be addressed intraoperatively, but could later develop into more serious complications, especially in high-risk patients.

High-pressure vessel bleeding. A leak in a high-pressure vessel (aortic or peripheral vascular suture line) that has been stopped, but if it leaks post-op, it could be catastrophic.

*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 indications, contraindications, warnings, and information for use. The visual does not reflect any sequential order in use.

Important Risk Information: Adjunctive hemostats (shown above) are not intended for use on nonbleeding tissue or for prophylactic use. 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.

Comprehensive Bleeding Management Solution

PRIMARY Methods of Hemostasis

GOAL: Prevent/minimize bleeding

Dissection/Transection

Mechanical

Sutures/Ligatures

Staplers

Energy

• Ultrasonic• Advanced bipolar

Ligating Clips

Monopolar and bipolarelectrosurgery





PRIMARY Methods of Hemostasis

GOAL: Prevent/minimize bleeding

Dissection/Transection

Mechanical

Sutures/Ligatures

Staplers

Energy

• Ultrasonic• Advanced bipolar

Ligating Clips

Monopolar and bipolarelectrosurgery

Were Primarymethods of hemostasiseffective or practical in achieving complete hemostasis?

No

ADJUNCTIVE Methods of Hemostasis

GOAL: To achieve complete intra-operative hemostasis & reduce risk of post-operative bleeding

HemostasisAchieved

Yes





Can you see the source of bleeding and apply an adjunctive hemostat?

Is there intraoperative bleeding with a concern of postoperative re-bleeding?







Continuous oozingWill not stop with compression/simple packing. The solution for this bleeding is more time consuming than it is difficult.1

ProblematicEven though the bleeding is accessible, it could be trouble. It is more than routine and likely to be resistant to conventional means, and requires immediate attention causing disruption to the normal progression of surgery.1

Potential rebleeding riskBleeding may be addressedintraoperatively, but could later develop into more serious complications,especially in high-risk patients.1

High-pressure vessel bleedingA leak in high-pressure vessel (aortic orperipheral vascular suture line) that has been stopped, but if it leaks post-op, could be catastrophic.1

Difficult to accessBleeding that occurs in tight andirregularspaces and you cannot see the exact source of the bleed. You are concerned accessing a tight space will cause more harm.1





No

Yes

Yes



Oxidized regenerated

cellulose(ORC)

Fibrinpatch

Fibrinsealant

Vascularsealant

Flowablegelatin










No

Yes

Yes


The visual does not reflect any sequential order in use. S-Factors Insight Research and Next Steps Meeting, dated 06/30/2014.

SURGICEL®Absorbable Hemostats

SURGIFLO®Hemostatic Matrix

EVICEL®Fibrin Sealant (Human)


Oxidized regenerated

cellulose(ORC)

Fibrinpatch

Fibrinsealant

Vascularsealant

Flowablegelatin










No

Yes

Yes

EVARREST®Fibrin Patch


The visual does not reflect any sequential order in use. S-Factors Insight Research and Next Steps Meeting, dated 06/30/2014.

>350-Bed Teaching Hospital

>30 ORs1-year study

>100 HCPs trained

Validation of HOP

A systematic approach to surgical hemostat use supports standardization and cost efficienciesby: Nicole Ferko MSc, Cornerstone Research Group, Burlington, ON, CanadaWalt Danker III PhD and Gaurav Gangoli PharmD, Ethicon Inc., Somerville, NJ, USA, Healthcare Purchasing News, November, 2017

Not including contractual

savings

Results

Results

A systematic approach to surgical hemostat use supports standardization and cost efficienciesby: Nicole Ferko MSc, Cornerstone Research Group, Burlington, ON, CanadaWalt Danker III PhD and Gaurav Gangoli PharmD, Ethicon Inc., Somerville, NJ, USA, Healthcare Purchasing News, November, 2017

EVARREST® Fibrin Sealant PatchImportant Safety Information

Indications and UsageEVARREST® is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

Limitations for Use• Cannot be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding.• Not for use in children under one month of age • Laparoscopic and other minimally invasive surgeries where manual compression would be difficult to achieve.

Important Safety Information• For topical use only. Apply immediate manual compression over the entire surface of the patch and maintain contact pressure for 3 minutes to control

the bleeding.• Do not apply intravascularly. This can result in life threatening thromboembolic events.• Do not use to treat bleeding from large defects in arteries or veins where the injured vascular wall requires conventional surgical repair and

maintenance of vessel patency or where there would be persistent exposure of EVARREST® to blood flow and/or pressure during absorption of the product. Thrombosis can occur if absorbed systemically.

• Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. EVARREST ® can cause hypersensitivity reactions including anaphylaxis.

• Avoid application to contaminated areas of the body or in the presence of active infection. Infection can occur.• EVARREST contains oxidized regenerated cellulose which adheres to bleeding surfaces. Inadvertent adhesions can occur. • Avoid use in, around, or in proximity to, foramina in bone or areas of bony confines where swelling may cause compression. • Use the least number of patches required to cover the entire bleeding area. Portions of excess patch material can become dislodged and migrate to

other areas of the body. • Do not use more than eight 2x4 inch (5.1 x 10.2 cm) or more than four 4x4 inch (10.2 x 10.2 cm) patches. • Use in patients who have been previously exposed to EVARREST® has not been studied.• May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-

Jakob disease (CJD) agent. • The adverse reactions reported during clinical trials occurred in less than 1% of all cases and included deep venous thrombosis, pulmonary embolism,

blood fibrinogen increase, anastomotic hemorrhage, post procedural and intra-abdominal hemorrhage, abdominal distension, anemia, gastrointestinal hemorrhage, thoracic cavity drainage, pleural effusion, abdominal abscess, ascites, localized intra-abdominal fluid collection, cardiac failure, operative hemorrhage, and ischemic bowel.

• Pediatrics: Safety and effectiveness in pediatric patients have not been established. Use in children under the age of one month may be unsafe or ineffective due to small size and limited ability to apply the patch as recommended.

Please see package insert for EVARREST® Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact ETHICON Customer Support Center at 1-877-384-4266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

http://www.fda.gov/medwatch

EVICEL® Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION

Indication EVICEL® Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

Contraindications • Do not inject directly into the circulatory system. Intravascular application of EVICEL® may result in life-threatening thromboembolic events. • Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. • Do not use for the treatment of severe or brisk arterial bleeding. • Do not use EVICEL® for spraying in endoscopic or laparoscopic procedures where the minimum recommended distance from the applicator

tip to the target site cannot be ensured.

Warnings and Precautions • Life-threatening air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer EVICEL®. This

event appears to be related to the use of the spray device at pressures higher than recommended and/or at distances closer than recommended to the surface of the tissue.

• Monitor changes in blood pressure, pulse, oxygen saturation, and end-tidal CO2 when spraying EVICEL® because of the possibility of gas embolism.

• To reduce the risk of potentially life-threatening gas embolism, spray EVICEL® using only pressurized CO2 gas at the pressures and distances recommended for the specific tips.

• Use EVICEL® spray application only if it is possible to accurately judge the spray distance, especially during endoscopic or laparoscopic procedures.

• Prior to applying EVICEL®, dry surface areas of the wound by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). Prepare and administer EVICEL® according to the instructions and with only devices recommended for this product.

• May carry a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most common adverse reactions reported in clinical trials are peripheral edema, abdominal abscess, infection, hematoma, incision site hemorrhage, vascular graft occlusion, postoperative wound complication and decreased hemoglobin.

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

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SURGICEL Essential Product Information

INDICATIONSSURGICEL® 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.

45

SURGICEL® Powder Absorbable Hemostat Essential Product Information

INDICATIONSSURGICEL® Powder (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.

CONTRAINDICATIONS• Do not inject or place SURGICEL® Powder into an open blood vessel.• SURGICEL® Powder should not be used to control hemorrhage from large arteries.• When SURGICEL® Powder is used to help achieve hemostasis in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, or

the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted pressure.• SURGICEL® Powder should not be used for implantation in bone defects, such as fractures, since there is a possibility of interference with callus

formation and a theoretical chance of cyst formation.

WARNINGS• Closing with SURGICEL® Powder in a contaminated wound without drainage may lead to complications and should be avoided.• SURGICEL® Powder should not be impregnated with anti-infective agents or with other materials such as buffering or hemostatic substances. • SURGICEL® Powder is dry and there may be difficulties in precise delivery under certain circumstances. Unintentional device placement may result in

powder scattering and device migration that may increase the risk of adhesion formation. • Although SURGICEL® Powder is bactericidal against a wide range of pathogenic microorganisms, it is not intended as a substitute for systemically

administered therapeutic or prophylactic antimicrobial agents to control or to prevent postoperative infections.• Do not attempt to trim the applicator tip.

PRECAUTIONSSURGICEL® Powder should not be used in conjunction with autologous blood salvage circuits, because its fragments may pass through the transfusion filters of blood-scavenging systems.

Use only as much SURGICEL® Powder (oxidized regenerated cellulose) as is necessary and apply only where needed for hemostasis. Remove any excess before surgical closure in order to facilitate absorption and to minimize the possibility of foreign body reaction.

In urological procedures, minimal amounts of SURGICEL® Powder should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product.

46

SURGICEL® Powder Absorbable Hemostat Essential Product Information (continued)

PRECAUTIONS (continued)Since absorption of SURGICEL® Powder 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® Powder is used temporarily to line the cavity of open wounds, it should be removed by irrigation with sterile water or saline solution after bleeding has stopped.

Precautions should be taken in otorhinolaryngologic surgery to ensure that none of the material is aspirated by the patient (e.g., controlling hemorrhage after tonsillectomy and controlling epistaxis).

This applicator tip is not intended for laparoscopic or other endoscopic use.

ADVERSE EVENTSParalysis and nerve damage have been reported when other SURGICEL® products were 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 other SURGICEL® products were placed in the anterior cranial fossa (see WARNINGS and PRECAUTIONS).

Foreign body reactions have been reported with other products from the SURGICEL® Family of Absorbable Hemostats.

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 donorsites) have also been reported.

For more information and technical questions, call 1-800-795-0012.

47

SURGIFLO® Hemostatic Matrix Kit Essential Product Information(Made from Absorbable Gelatin Sponge, USP) with Thrombin

DESCRIPTIONSURGIFLO® with Thrombin (SURGIFLO® Hemostatic Matrix Kit) is intended for hemostatic use by applying to a bleeding surface.

ACTIONSWhen used in appropriate amounts SURGIFLO® is absorbed completely within 4 to 6 weeks.

INTENDED USE/INDICATIONSSURGIFLO®, 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.

CONTRAINDICATIONS• Do not use SURGIFLO® in intravascular compartments because of the risk of embolization.• Do not use SURGIFLO® in patients with known allergies to porcine gelatin.• Do not use SURGIFLO® in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to mechanical

interposition of gelatin and is not secondary to intrinsic interference with wound healing.

WARNINGS• SURGIFLO® should not be used in the presence of infection and should be used with caution in contaminated areas of the body• SURGIFLO®

should not be used in instances of pumping arterial hemorrhage. SURGIFLO® will not act 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.• The safety and effectiveness of SURGIFLO® for use in ophthalmic procedures has not been established.• SURGIFLO® should not be used for controlling post-partum intrauterine bleeding or menorrhagia.• The safety and effectiveness of SURGIFLO® has not been established in children and pregnant women.• 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 area. Cut a square angle to avoid creating a sharp tip.

48

SURGIFLO® Hemostatic Matrix Kit Essential Product Information(Made from Absorbable Gelatin Sponge, USP) with Thrombin (CONTINUED)

PRECAUTIONS• Safe and effective use of SURGIFOAM® Sponge has been reported in a published neurologic retrospective study involving 1700 cases in

Europe. Safe and effective use in neurosurgery has not been proven through randomized, controlled clinical studies in the United States.• SURGIFLO® is supplied as a sterile product and cannot be resterilized. • SURGIFLO® should not be used for packing unless excess product that is not needed to maintain hemostasis is removed. SURGIFLO® may

swell up to 20% upon contact with additional fluid.• SURGIFLO® should not be used in conjunction with autologous blood salvage circuits. • SURGIFLO® should not be used in conjunction with methylmethacrylate adhesives. • In urological procedures, SURGIFLO® should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.

ADVERSE EVENTSA 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 equinasyndrome, 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 gelatin-based 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.

EVITHROM® Thrombin, Topical (Human) for Topical Use OnlyLyophilized 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.

© 2018 Ethicon US, LLC 048029-180109

2013 gynecology contracting matrices · bleeding in approximately 10% to 25% of procedures. ......

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