ETHICON LAUNCHES COMPREHENSIVE SOLUTION FOR BARIATRIC REVISION SURGERY 

Portfolio of Products, Education and Training to Help Surgeons Handle Challenging Reoperations

DUBAI – Sept. 26, 2018 – Ethicon,* part of Johnson & Johnson Medical Devices Companies**, and a global leader in bariatric surgery, announced the launch of a new comprehensive surgical solution for bariatric revision surgery that encompasses a portfolio of products and professional education and training for managing the challenges of reoperations. Ethicon’s Bariatric Revision Surgical Solution is being featured here this week at 23rd World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO 2018). 

Bariatric surgery has been shown to be the most effective long-term treatment for the disease of severe obesity,[1] but in certain instances, patients may require revision surgery or a new treatment modality due to weight recidivism, changes in anatomy, inadequate weight loss or co-morbidity reduction or complications.[2] Due to the nature and chronicity of the disease of obesity, lifelong management is required.

“When reoperations are required, they can be challenging due to the unpredictable nature and complexity of variables to which the surgeon may be confronted during surgery. These include such issues as adhesions, tissue type and thickness, unexpected or disruptive bleeding, and difficult access to the patient’s anatomy. This new portfolio of products and education from Ethicon helps the surgeon manage this unpredictability to the benefit of the patient,” said Alan Wittgrove+ MD, FACS, FASMBS, Medical Director at the Wittgrove Bariatric Center in Del Mar, CA. 

Ethicon’s Bariatric Revision Surgical Solution includes a product portfolio designed to help surgeons perform bariatric revision surgery with precision, efficiency and consistency. It includes the HARMONIC HD 1000i Shears, an advanced energy device for precise dissection and secure sealing of tissue, the ECHELON FLEX™ GST System for exceptional staple line integrity across a wide range of tissue thickness,[3] STRATAFIX™ Knotless Tissue Control Devices for suturing with consistent tension control, and SURGICEL SNoW™ Absorbable Hemostat for enhanced hemostatic performance, conformability and tissue adherence.[4] 

Education and training also play a critical role in preparing bariatric surgeons for revision surgery and Ethicon is filling this important need with bariatric revision courses, symposia and interactive learning experiences offered through the Johnson & Johnson Institute, which brings together 26 professional education facilities and a network of online education and collaborative partnerships across multiple specialties. The company is also sponsoring a symposium at 1 p.m. on September 28, 2018 at IFSO 2018 entitled, “How Do You Get Prepared to Tackle the Challenges You Face with Revision?” featuring leading experts from around the world. 

“Over the last 20 years, Ethicon has invested significantly in the treatment of obesity and related diseases,” said Michael del Prado, Ethicon Company Group Chairman. “Based on this legacy of leadership and collaboration, bariatric surgeons, healthcare professionals and patients can rely on Ethicon to provide comprehensive solutions that help them effectively manage the challenges of primary bariatric surgery and revision surgery, and the disease of obesity, both inside and outside the operating room.”  

About the Johnson & Johnson Medical Devices Companies

The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

About Ethicon 

From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing healthcare issues and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter and LinkedIn.

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* Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates.

** The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment. 

# All surgery presents risk. Please consult with your doctor.

+ Dr. Alan Wittgrove is a consultant for Ethicon.

[1] Weiner R. (2010). Indications and principles of metabolic surgery. Der Chirug. 81(4):379-394.  https://www.ncbi.nlm.nih.gov/pubmed/20361370

[2] Brethauer S, Kothari S, Sudan R, et al. (2014). Systematic review on reoperative bariatric surgery, American Society for Metabolic and Bariatric Surgery Revision Task Force. Surg Obes Relat Dis. 10(5):952-972. https://asmbs.org/resources/systematic-review-on-reoperative

[3] The ECHELON FLEX GST System was designed and tested to meet rigorous design requirements for staple line integrity. The GST System accommodates a tissue thickness range of 1.0mm to 4.0mm (measured at 8g/mm2, tissue comfortably compressed to closed staple height during firing per IFU) while the Medtronic Tri-StapleTM portfolio is intended for a tissue thickness range of 0.75mm to 3.0mm (per IFU & materials downloaded from Medtronic website on Nov 16, 2016).

[4] https://www.ethicon.com/na/products/adjunctive-hemostasis/absorbable-hemostats/surgicel-snow-absorbable-hemostat

SURGICEL 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™, SURGICEL® NU-KNIT®, and SURGICEL® SNoW™ Absorbable 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 section of the complete product package insert).

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.  For complete product information including indications, contraindications, warnings, precautions, and adverse reactions, please reference the individual product package inserts.

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