gynecare interceed

GYNECARE INTERCEED® “XL”
NOW AVAILABLE 5in X 6in
CONTROL
COVERAGE
CONFIDENCE
Maintain control beyond
closure over large
tissue surfaces with NEW
EXTRA-LARGE GYNECARE INTERCEED®
Absorbable Adhesion Barrier
CONTROL
Maintain control over postsurgical healing with safe and effective pelvic adhesion prevention from GYNECARE INTERCEED®
that protects damaged peritoneal tissue during the 5-7 day healing process
COVERAGE
Extra-large surface coverage for gynecologic surgeries requiring broader continuous protection
Standard pelvic size adhesion risk area
OVARIAN
SURGERY
TUBAL
SURGERY
ADHESIOLYSIS
Extra-large pelvic adhesion risk area
MYOMECTOMY
SURGICAL
TREATMENT OF
ENDOMETRIOSIS
CESAREAN
SECTION
HYSTERECTOMY
CONFIDENCE
The absorbable adhesion prevention barrier with conclusive evidence showing effective reduction of pelvic adhesions1
Cochrane Review:
Systematic Review of
Randomized Clinical Trials
for Adhesion Prevention
in Women Undergoing
Gynecologic Surgery1
ABSORBABLE
ADHESION BARRIER
NUMBER
OF TRIALS
RESULTS
GYNECARE INTERCEED®
12 studies vs
control
Reduced incidence of pelvic adhesion
formation and reformation following
gynecologic surgery
Seprafilm®
1 study vs
control
According to the 2008 Cochrane Review Conclusion:
“there was no evidence of effectiveness of
Seprafilm®... in preventing adhesion formation”
With over 20 years of clinical use, GYNECARE INTERCEED® is a
preferred pelvic adhesion prevention barrier in gynecologic surgery2
Close with Confidence.
GYNECARE INTERCEED®
Absorbable Adhesion Barrier – 5 in x 6 in:
An effective solution that provides
control, coverage, and confidence
PROVEN
Ordering Information
GYNECARE INTERCEED is proven with over
20 years’ experience.
®
SAFE
GYNECARE INTERCEED® in combination with
meticulous surgical technique has been safely used
to prevent pelvic adhesions.
To order, call 1-800-255-2500.
For more information, visit
www.gynecareinterceed.com
To locate your local representative,
call 1-877-ETHICON.
Product
Ordering
Code
EFFECTIVE
GYNECARE INTERCEED®
Absorbable Adhesion Barrier 3x4
4350
GYNECARE INTERCEED®
is clinically effective across multiple
gynecological procedures.1
GYNECARE INTERCEED®
Absorbable Adhesion Barrier 5x6
4350XL
How
Supplied
10 sheets per box
(3 in. x 4 in.)
(7.6 cm. x 10.2 cm.)
10 sheets per box
(5 in. x 6 in.)
(12.7 cm. x 15.2 cm.)
References:
1. Ahmad G, Duffy JMN, Farquhar C, et al. Barrier agents for adhesion prevention after gynecological surgery. Cochrane Database of Syst Rev. 2008; (2):1-40.
2. Data on file, Ethicon, Inc.
GYNECARE INTERCEED® ABSORBABLE ADHESION BARRIER
INDICATIONS:
GYNECARE INTERCEED® Absorbable Adhesion Barrier is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved
consistent with microsurgical principles.
CONTRAINDICATIONS:
The use of GYNECARE INTERCEED® is contraindicated in the presence of frank infection. GYNECARE INTERCEED® is not indicated as a hemostatic agent. Appropriate means of achieving hemostasis must be employed.
WARNINGS:
The safety and effectiveness of GYNECARE INTERCEED® 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® application if adjacent tissues (eg, ovary and tube) and structures are coapted or conjoined by the device, or if GYNECARE INTERCEED® is folded, wadded or layered.
Postoperative adhesions may occur in the presence of GYNECARE INTERCEED® if meticulous hemostasis is not achieved prior to application. As with all foreign substances, GYNECARE INTERCEED® should not be placed in a contaminated
surgical site.
PRECAUTIONS:
Use only a single layer of GYNECARE INTERCEED®, since multiple layers of packing or folding will not enhance the adhesion barrier characteristics and may interfere with the absorption rate of GYNECARE INTERCEED®.
Care should be exercised in applying GYNECARE INTERCEED® to a pelvic organ not to constrict or restrict it. If the product comes in contact with blood prior to completing the procedure, it should be discarded, as fibrin
deposition cannot be removed by irrigation and may promote adhesions formation. Ectopic pregnancies have been associated with fertility surgery of the female reproductive tract. No data exist to establish the effect, if
any, of GYNECARE INTERCEED® on the occurrence of ectopic pregnancies. No adequate studies have been conducted in women who have become pregnant within the first month after exposure to GYNECARE INTERCEED®.
No teratogenic studies have been performed. Therefore, avoidance of conception should be considered during the first complete menstrual cycle after use of GYNECARE INTERCEED®. The safety and effectiveness of using
GYNECARE INTERCEED® in combination with other adhesion prevention treatments have not been clinically established. GYNECARE INTERCEED® is supplied sterile. As the material is not compatible with autoclaving or ethylene
oxide sterilization, GYNECARE INTERCEED® must not be resterilized. Foreign body reactions may occur in some patients. Interactions may occur between GYNECARE INTERCEED® and some drugs used at the surgical site. Pathologists
examining sites of GYNECARE INTERCEED® placement should be made aware of its usage and of the normal cellular response to GYNECARE INTERCEED® to facilitate proper evaluation of specimens.
ADVERSE REACTIONS:
The type and frequency of adverse events reported are consistent with events typically seen following surgery.
Postsurgical adhesions may occur in the presence of GYNECARE INTERCEED®.
Refer to package for complete instructions for use, warnings and precautions.
Ethicon Women’s Health & Urology. A Division of Ethicon, Inc., a Johnson & Johnson Company © Ethicon, Inc. 2011. Seprafilm® is a registered trademark of Genzyme Corp
Close with Confidence.
The third-party trademarks used herein are trademarks of their respective owners
INT-322-11-11/13

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