GYNECARE INTERCEED® Absorbable Adhesion Barrier

Provides an extra layer of assurance against the risk of adhesions. It does not crack, tear, or stick to gloves. Its pliability allows it to contour to organs of varying sizes for full coverage.

INTERCEED® Prevenção de Aderência

Features & Benefits

  • Effective in gynecologic procedures

    Effective in Gynecologic Procedures1

    Safely reduce the incidence of both new and reformed adhesions.1,2 GYNECARE INTERCEED Adhesion Barrier has been shown in various gynecologic studies to be up to 2 times more effective than good surgical technique alone in achieving an adhesion-free outcome.3

  • Easy to use right out of the box

    Easy to Use Right out of the Box

    Adhesion barrier that conforms for control you can count on. Must be applied dry to traumatized tissues, after meticulous hemostasis has been achieved.6 GYNECARE INTERCEED Adhesion Barrier forms a continuous protective coating during the critical 5-7 day peritoneal healing period.7

Product Specifications

Product Code

Product Code

 
4350 4350  

Product Code

Product Code

 
4350XL 4350XL  

Resources

Reducing the Risk of Adhesions in Complex Gynecology

Supporting Documentation

Product Support

GYNECARE INTERCEED Brochure

GYNECARE INTERCEED Patient Brochure

References

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1. Ten Broek RPG, Stommel MWJ, Strik C, et al. Benefits and harms of adhesion barriers for abdominal surgery: a systematic review and meta-analysis. The Lancet 2014;383(9911):48-59.

2. Ahmad G, Duy JMN, Farquhar C, et al v. Cochrane Database Syst Rev 2008;(2);1-40.

3. 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.

4. Azziz R. Microsurgery alone or with INTERCEED Absorbable Adhesion Barrier for pelvic sidewall adhesion reformation. The INTERCEED (TC7) Adhesion Barrier Study Group II. Surg Gynecol Obstet. 1993;177:135-139.

5. Nordic Adhesion Prevention Study Group. The efficacy of INTERCEED (TC7) for prevention of reformation of postoperative adhesions on ovaries, fallopian tubes, and fimbriae in microsurgicaloperations for fertility: a multicenter study. Fertil Steril. 1995;63:709-714.

6. Sawada T, Nishizawa H, Nisho E, et al. Postoperative adhesion prevention with an oxidized regenerated cellulose adhesion barrier in infertile women. J Reprod Med. 2000;45(5):387-389.

7. Sekiba K. Use of INTERCEED (TC7) absorbable adhesion barrier to reduce postoperative adhesion reformation in infertility and endometriosis surgery. Obstet Gynecol. 1992;79:518-522.

8. GYNECARE INTERCEED® Absorbable Adhesion Barrier. Instructions for Use. Ethicon Inc.

9. Interceed Claims List INT-0057-09, Claim # 7.

 

GYNECARE INTERCEED® ABSORBABLE ADHESION BARRIER 
Essential Product Information


INDICATIONS
GYNECARE INTERCEED 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 Adhesion Barrier is contraindicated in the presence of frank infection. GYNECARE INTERCEED Adhesion Barrier is not indicated as a hemostatic agent. Appropriate means of achieving hemostasis must be employed.

WARNINGS
The safety and effectiveness of GYNECARE INTERCEED Adhesion Barrier 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 Adhesion Barrier application if adjacent tissues (eg, ovary and tube) and structures are coapted or conjoined by the device, or if GYNECARE INTERCEED Adhesion Barrier is folded, wadded or layered. Care must be taken to apply GYNECARE INTERCEED Adhesion Barrier in single layers, interposed between adjacent anatomic structures at risk for adhesion formation. 


Postoperative adhesions may occur in the presence of GYNECARE INTERCEED Adhesion Barrier if meticulous hemostasis is not achieved prior to application. As with all foreign substances, GYNECARE INTERCEED Adhesion Barrier should not be placed in a contaminated surgical site. Potentially contaminated surgical sites include hysterotomy following labor and/or prolonged rupture of membranes. The performance of GYNECARE INTERCEED Adhesion Barrier at potentially contaminated surgical sites has not been determined.


PRECAUTIONS
Use only a single layer of GYNECARE INTERCEED Adhesion Barrier, since multiple layers of packing or folding will not enhance the adhesion barrier characteristics and may interfere with the absorption rate of GYNECARE INTERCEED Adhesion Barrier. Care should be exercised in applying GYNECARE INTERCEED Adhesion Barrier 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 Adhesion Barrier 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 Adhesion Barrier. No teratogenic studies have been performed. Therefore, avoidance of conception should be considered during the first complete menstrual cycle after use of GYNECARE INTERCEED Adhesion Barrier. The safety and effectiveness of using GYNECARE INTERCEED Adhesion Barrier in combination with other adhesion prevention treatments have not been clinically established. 
GYNECARE INTERCEED Adhesion Barrier is supplied sterile. As the material is not compatible with autoclaving or ethylene oxide sterilization, GYNECARE INTERCEED Adhesion Barrier must not be resterilized. 


Foreign body reactions may occur in some patients. 


Interactions may occur between GYNECARE INTERCEED Adhesion Barrier and some drugs used at the surgical site. 
Pathologists examining sites of GYNECARE INTERCEED Adhesion Barrier placement should be made aware of its usage and of the normal cellular response to GYNECARE INTERCEED Adhesion Barrier ‘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 Adhesion Barrier.

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

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