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Dr. Sonia Ramamoorthy discusses improving patient outcomes related to anastomotic leaks and how engineers listened to surgeons to design ECHELON CIRCULAR™ Powered Stapler.
Shaping the Future of Surgery
Delivering Meaningful Innovation
VISTASEAL™ Fibrin Sealant (Human) mimics the clot formation process and forms a rapid, adherent, and durable clot regardless of the patient’s coagulation profile.1,2 No other fibrin sealant preps faster.3*
Transforming Business Models
Smoke Evacuation Case Study – 7 Keys to a Smoke-Free Operating Room
Responding With a Caring Spirit
Sonya’s journey to a healthier lifestyle. Learn how bariatric surgery changed her life.
Over a Century of Meaningful Innovation
At Ethicon, weʼre focused on improving health outcomes for patients and helping solve the greatest health challenges… with only meaningful innovation. The kind that led to the creation of the first sutures, that helped revolutionize surgery with minimally invasive procedures, and that elevates standards of care around the world.
1887 — Sterile Sutures
Johnson & Johnson’s mass production of sterile sutures and other products ushered in the widespread practice of modern antiseptic surgery that dramatically raised survival rates.
1960 — SURGICEL® Original
SURGICEL® made history as the first oxidized regenerated cellulose hemostat and set a new standard for managing surgical bleeding.
1969 — PROLENE® Polypropylene Suture
The first synthetic sterile suture, PROLENE® Polypropylene Suture is used in cardiac bypass surgery for its strength, secure knotting and biocompatibility.
1978 — PROXIMATE® Disposable Skin Stapler
This game-changing skin stapler introduced disposable instruments to the OR. The success of disposable PROXIMATE opened the door to new innovations for open and minimally invasive procedures.
1979 — Coated VICRYL® (polyglactin 910) Suture
Used by surgeons around the world today for general surgery use, Coated VICRYL® (polyglactin 910) Suture balances the surgeon’s need for slide with knot security in achieving reliable approximation and closure.
1988 —Laparoscopic Cholecystectomy
First Laparoscopic Cholecystectomy and development of Minimally Invasive solutions
1993 — Ethicon Endo-Surgery
Founded in Ohio, Ethicon Endo-Surgery brought surgical technologies and solutions including staplers, energy devices and trocars.
1995 — Telesurgery
Our pioneering live telesurgery, Dr. J. Barry McKernan performed a laparoscopic cholecystectomy at the American College of Surgeons’ annual meeting introduced clinicians to the possibilities of distance learning.
1998 — DERMABOND® Topical Skin Adhesive
The first FDA-approved topical skin adhesive in the U.S., DERMABOND® Topical Skin Adhesive paved the way for replacing sutures with a new generation of skin closure solutions.4,5
1998 — HARMONIC® Shears
Our launch of the first 5mm HARMONIC® shears allowed surgeons for the first time to dissect, cut and coagulate with one ultrasonic energy device with minimal lateral thermal damage.
2000 — Fighting Obesity
Committed to shaping the future of surgery in the fight against obesity and metabolic diseases and helping to elevate the standard of care through research and evidence, best-in-class education and training, innovative products and expanding patient access to care.
2003 — PLUS Sutures
The first commercially available antibacterial suture, Coated VICRYL® Plus Antibacterial (polyglactin 910) Suture broke new ground in addressing a known risk factor for surgical-site infections (SSI), bacterial colonization of the suture.6
2011 — ECHELON FLEX™ Powered ENDOPATH® Stapler
This first powered endocutter with system-wide compression and stability helped to fuel the revolution to minimally invasive approaches. Less unwanted movement of the tip offered the potential for reduced trauma to vital structures, even in thick tissue and at awkward angles.
2015 — VERB Surgical Partnership
Verb Surgical, founded in 2015, is developing a digital surgery platform built with technology from Verily (formerly Google Life Sciences) and Ethicon Endo-Surgery, Inc. Verb’s platform will include robotics, visualization, advanced instrumentation, data analytics, and connectivity.
2016 — NEUWAVE Medical Acquisition
Ethicon acquires NeuWave Medical, Inc., a company that manufactures and markets minimally invasive soft-tissue microwave ablation systems. This acquisition is consistent with the strategy of advancing innovation and investing in areas of unmet medical needs such as surgical oncology.
2017 — MEGADYNE Acquisition
The acquisition of Megadyne’s innovative portfolio of electrosurgical tools represents a major step forward in Ethicon’s goal to deliver the most comprehensive suite of intelligent energy solutions that enhance precision and efficiency in the operating room.
ECHELON CIRCULAR™ Powered Stapler
The ECHELON CIRCULAR Powered Stapler is designed to reduce leaks without compromising perfusion—resulting in 61% fewer leaks at the staple line compared to the Medtronic DST Series™ EEA™ Stapler.‡
ENSEAL® X1 Large Jaw Tissue Sealer
Designed for use in open surgical procedures, ENSEAL X1 Large Jaw Tissue Sealer is an advanced bipolar device that provides better hemostasis, less thermal spread, and improved ergonomics compared to LigaSure Impact™.
LINX® Reflux Management System
The LINX® Reflux Management System is a laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD).
ENSEAL® G2 Articulating Tissue Sealer
Offers secure sealing of vessels up to and including 7mm diameter, as well as lymphatics,§ while also providing versatility driven by its articulating shaft
* Based on number of set-up steps and thawing time required for VISTASEAL™ Dual Applicator vs competition.
† Individual results may vary
‡ Benchtop testing in porcine tissue ≤30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon ECHELON CIRCULAR™ Powered Stapler CDH25P to Medtronic DST Series™ EEA™ Stapler EEA2535 (p<0.001) and preclinical perfusion model, in which perfusion was not significantly different between devices.
§ Studies conducted on porcine mesentery. (C157)
1. Bjelovic M, Ayguasonosa J, Kim RD, et al. A prospective, randomized, phase III study to evaluate the eicacy and safety of fibrin sealant Grifols as an adjunct to hemostasis as compared to cellulose sheets in hepatic surgery resections. J Gastrointest Surg. 2018. 22:1939-1949.
2. VISTASEAL™ Fibrin Sealant (Human). [Highlights of Prescribing Information] Instituto Grifols, S.A. 2018.
3. Thawing time and set-up steps comparison between VISTASEAL, EVICEL, and TISSEEL. Report 100708726-Rev 2. August 28, 2019. Ethicon, Inc.
4. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. doi:10.1001/jamasurg.2017.0904.
5. WHO Global Guidelines for the Prevention of Surgical Site Infection, 2016.
6. Rothenburger S, Spangler D, Bhende S, Burkley D. In vitro antimicrobialevaluation of coated Vicryl Plus Antibacterial Suture (coated polyglactin 910 with triclosan) using zone of inhibition assays. Surg Infect (Larchmt). 2002;3 (suppl):S79-S87.
7. Ban KA, Minei JP, Laronga C, et al. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2016;224:59-74.
8. US Market Share Report, October 2016. Ethicon, Inc.
9. SURGICEL® Technical Report, 2018. Ethicon, Inc.
10. Hong YM, Loughlin KR. The use of hemostatic agents and sealants in urology. J Urol. 2006;176(6 Pt 1):2367-2374.
11. SURGICEL® Absorbable Hemostat. Full Prescribing Information. Ethicon, Inc.
12. Sissener T. Suture patterns. Com Anim. 2006;11:14-19.
13. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178.
14. Vakil JJ, O'Reilly MP, Sutter EG, Mears SC, Belko SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713.
15. Nonnenman H. 100326296: Time zero tissue holding - Competitive claims comparisons for STRATAFIX Knotless Tissue Control Devices vs various products. 2015. Ethicon, Inc.
16. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi: 10.3928/01477447-20110714-35.
17. Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety, and efficacy. J Minim Invasive Gynecol. 2011;18(1): 92-95.
18. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167.
19. 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.
20. Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial efficacy of PDS Plus (polidioxanone with triclosan) suture. Surg Infect (Larchmt). 2008;9(4):451-457.
21. Ethicon retrospective analysis of economic and clinical outcomes comparing the use of Echelon Powered vs. Medtronic non-powered endoscopic surgical staplers to treat patients undergoing video-assisted thoracoscopic surgery lobectomy.Review of 3,006 cases between 2012 and 2015 from the Premier Perspective® Hospital Database. Data assessed included length of stay, total hospital cost, supply cost, room & board cost, incidence of transfusion, and incidence of hemostasis-related complications; all p ≤ 0.05.
SURGICEL Essential Product Information
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™, SURGICEL® NU-KNIT®, and SURGICEL® SNoW™ Absorbable Hemostats can be cut to size for use in endoscopic procedures.
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 section of the complete product package insert).
“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. For complete product information including indications, contraindications, warnings, precautions, and adverse reactions, please reference the individual product package inserts.
SURGICEL® Powder Absorbable Hemostat Essential Product Information
SURGICEL® 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. SURGICEL® Powder can also be applied in laparoscopic or other endoscopic procedures when used with the SURGICEL™ Endoscopic Applicator.
The SURGICEL™ Endoscopic Applicator is intended for use in delivering SURGICEL® Powder absorbable hemostat to bleeding surgical sites through a 5 mm or larger trocar.
• Do not inject or place SURGICEL® Powder into an open blood vessel. Do not use to treat bleeding from large defects in arteries or veins.
• SURGICEL® Powder should not be used to control hemorrhage from large arteries or veins.
• The SURGICEL® Powder and the SURGICEL™ Endoscopic Applicator devices were not designed for intraluminal procedures.
• 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.
• SURGICEL® Powder is not intended for use on dry (non-bleeding) surfaces or for prevention of bleeding.
• 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. In preclinical in vivo animal studies it was demonstrated that SURGICEL® Powder does not increase the incidence of remote adhesions in laparoscopic procedures.
• 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.
• To prevent clogging with the SURGICEL™ Endoscopic Applicator Tip, do not touch the tip to wet surface. Be careful to avoid damaging tissue with the rigid tip.
• Do not attempt to trim the applicator tip. Replace the tip if it becomes clogged.
• SURGICEL® 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.
• Use minimal amount of SURGICEL® Powder required to achieve hemostasis, and remove excess powder in the area of drains to prevent clogging. 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.
• 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).
• The applicator tip provided on the SURGICEL® Powder device is not intended for laparoscopic or other endoscopic use. If laparoscopic or other endoscopic use is desired, remove the existing applicator tip from the SURGICEL® Powder device, and replace with the SURGICEL™ Endoscopic Applicator tip (supplied separately). In laparoscopic or other endoscopic procedures, SURGICEL® Powder should only be applied using the SURGICEL™ Endoscopic Applicator. Consult the SURGICEL™ Endoscopic Applicator Instructions for Use (IFU) for proper assembly and directions for use with the SURGICEL® Powder device.
• The SURGICEL Endoscopic Applicator is supplied with a flexible inner tip inside a rigid cannula. The rigid cannula cannot be used independently.
• The SURGICEL Endoscopic Applicator should only be used by persons having adequate training and familiarity with endoscopic techniques. Consult medical literature relative to techniques, complications, and hazards prior to performance of any endoscopic procedure.
• To prevent inadvertent device spillage, or unintended contact with tissue, organs, or blood, maintain visualization of the SURGICEL™ Endoscopic Applicator tip at all times.
• Do not compress or excessively bend the flexible inner tip of the SURGICEL Endoscopic Applicator which could obstruct the application of the powder. It is possible that the powder accumulated in the applicator could disperse beyond the target bleeding site upon compression of the bellows, which may require additional irrigation and aspiration.
• Paralysis 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 donor sites) have also been reported.
For more information and technical questions, call 1-800-795-0012. For complete information including indications, contraindications, warnings, precautions, adverse reactions, and directions for use, consult the product package insert.
VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION
VISTASEAL™ is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.
Do not inject directly into the circulatory system.
Do not use for the treatment of severe or brisk arterial bleeding.
Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products.
Do not use VISTASEAL for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved.
WARNINGS AND PRECAUTIONS
Thromboembolic events may occur if VISTASEAL is administered intravascularly.
Only spray VISTASEAL if it is possible to accurately judge the distance from the spray tip to the tissue surface.
Hypersensitivity reactions can occur.
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 >1% of clinical trial subjects) were nausea and procedural pain.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
EVITHROM® 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.
SURGIFLO® Hemostatic Matrix Kit Essential Product Information (Made from Absorbable Gelatin Sponge, USP) with Thrombin
SURGIFLO® with Thrombin (SURGIFLO® Hemostatic Matrix Kit) is intended for hemostatic use by applying to a bleeding surface.
When used in appropriate amounts SURGIFLO® is absorbed completely within 4 to 6 weeks.
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.
• 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.
• 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.
• 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.
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 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.
LINX® Reflux Management System Important Safety Information
The LINX® Reflux Management System is a laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
Contraindications: Do not implant the LINX Reflux Management System in patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
Warnings: The LINX device is considered MR Conditional in a magnetic resonance imaging (MRI) system up to either 0.7 Tesla (0.7T) or 1.5 Tesla (1.5T), depending on the LINX model implanted. Scanning under different conditions may result in serious injury to you and/or interfere with the magnetic strength and the function of the device. In the event alternative diagnostic procedures cannot be used and MRI is required, the LINX device can be safely removed utilizing a laparoscopic technique that does not compromise the option for traditional anti-reflux procedures. It is recommended that patients receiving the LINX device register their implant with the MedicAlert Foundation (www.medicalert.org) or equivalent organization.
Failure to secure the LINX device properly may result in its subsequent displacement and necessitate a second operation.
Laparoscopic placement of the LINX device is major surgery and death can occur.
General Precautions: The LINX device is a long-term implant. Explant (removal) and replacement surgery may be indicated at any time. Management of adverse reactions may include explantation and/or replacement.
The use of the LINX device in patients with a hiatal hernia larger than 3 cm should include hiatal hernia repair to reduce the hernia to less than 3 cm. The LINX device has not been evaluated in patients with an unrepaired hiatal hernia greater than 3 cm.
The safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's esophagus or Grade C or D (LA classification) esophagitis.
The safety and effectiveness of the LINX device has not been evaluated in patients with electrical implants such as pacemakers and defibrillators, or other metallic, abdominal implants.
The safety and effectiveness of the LINX Reflux Management System has not been established for the following conditions:
• Suspected or confirmed esophageal or gastric cancer
• Prior esophageal or gastric surgery or endoscopic intervention
• Distal esophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or High Resolution Manometry equivalent, and/or a known motility disorder such as Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive LES
• Symptoms of dysphagia more than once per week within the last 3 months
• Esophageal stricture or gross esophageal anatomic abnormalities (Schatzki’s ring, obstructive lesions, etc.)
• Esophageal or gastric varices
• Lactating, pregnant or plan to become pregnant
• Morbid obesity (BMI >35)
• Age < 21
Potential Side Effects: Potential adverse events associated with laparoscopic surgery and anesthesia include adverse reaction to anesthesia (headache, muscle pain, nausea), anaphylaxis (severe allergic reaction), cardiac arrest, death, diarrhea, fever, hypotension (low blood pressure), hypoxemia (low oxygen levels in the blood), infection, myocardial infarction, perforation, pneumonia, pulmonary embolism (blood clot in the lung), respiratory distress, and thrombophlebitis (blood clot). Other risks reported after anti-reflux surgery procedures include bloating, nausea, dysphagia (difficulty swallowing), odynophagia (painful swallowing), retching, and vomiting.
Potential risks associated specifically with the LINX Reflux Management System include achalasia (lower part of esophagus does not relax), bleeding, cough, death, decreased appetite, device erosion, device explant/re-operation, device failure, device migration (device does not appear to be at implant site), diarrhea, dyspepsia (indigestion), dysphagia (difficulty swallowing), early satiety (feeling full after eating a small amount of food), esophageal spasms, esophageal stricture, flatulence, food impaction, globus sensation (sensation of a lump in the throat), hiccups, inability to belch or vomit, increased belching, infection, impaired gastric motility, injury to the esophagus, spleen, or stomach, nausea, odynophagia (painful swallowing), organ damage caused by device migration, pain, peritonitis (inflammation of the peritoneum), pneumothorax (collapsed lung), regurgitation, saliva/mucus build-up, stomach bloating, ulcer, vomiting, weight loss, and worsening of preoperative symptoms (including but not limited to dysphagia or heartburn).
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