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Wed, 03/25/2009 - 21:12 — admin

A Solution: GYNECARE INTERCEED® Absorbable Adhesion Barrier

GYNECARE INTERCEED® is a lightweight, tissue-like "fabric" adhesion barrier that your doctor can apply to organs to protect and separate them during the healing process. The fabric eventually dissolves as your body heals.

GYNECARE INTERCEED® is clinically proven effective to reduce adhesion formation by 50%.1

How GYNECARE INTERCEED® Works

Most pelvic organs are at least partially wrapped in a clear membrane called the peritoneum (per-i-TOE-nee-um). When this delicate membrane is damaged during surgery, it becomes inflamed. Inflammation is normal and part of the healing process, but inflammation also encourages fibrous bands of scar tissue to develop, which can lead to adhesions.

Your doctor places GYNECARE INTERCEED® over your pelvic organs during your C-section or pelvic surgery.
GYNECARE INTERCEED® acts as a barrier between healing tissue surfaces, preventing them from adhering or "sticking" together. The fabric eventually dissolves as your body heals.

Who is a candidate for GYNECARE INTERCEED®?

You may be a candidate for GYNECARE INTERCEED® if you are preparing to undergo one of these common gynecologic procedures:

  • Cesarean section

  • Hysterectomy

  • Surgical treatment of endometriosis

  • Myomectomy

  • Ovarian surgery

  • Reconstructive tubal surgery

GYNECARE INTERCEED® may not be used in the presence of infection.

What are the risks of GYNECARE INTERCEED®?

All surgical procedures present some risks, so be sure to talk to a doctor about whether GYNECARE INTERCEED® is right for you.

For a complete description of risks related to this treatment, please see the Adverse Reactions section of the Risk Information.

This information represents no statement, promise or guarantee by Ethicon, Inc., concerning insurance coverage, levels of reimbursement, payment, or charge. Please consult your payor organization with regard to local or actual coverage determination processes.

Talk to your doctor before the surgery

Since adhesions can recur once you have them, it's important to talk to your doctor about what can be done to reduce the risk of them forming in the first place.

Click here for a Free Discussion Guide: "Talk to a Doctor About Gynecological Surgeries" (4 MB)



Reference:
1. 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. Fertil Steril. 1995; (suppl 227): S19.

 

Next: Talk to a Doctor About Adhesions

Risk Information

GYNECARE INTERCEED®
ABSORBABLE ADHESION BARRIER PATIENT EPI

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® Absorbable Adhesion Barrier 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® 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®.

For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse

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