Provider Content
Focus On: One Method for Reducing Pelvic Adhesions
Overview: GYNECARE INTERCEED® Absorbable Adhesion Barrier
If you're preparing for a C-section or another pelvic surgery, your attention is probably most concerned with the procedure itself. You may not realize, however, that your doctor can take steps before the surgery to prevent painful postsurgical issues, like pelvic adhesions.
Pelvic adhesions are abnormal bands of scar tissue that form after gynecological surgeries and bind organs that are usually not connected.
Most patients develop adhesions after pelvic surgery. In fact, one study shows that adhesions formed in 55-100% of patients who had reproductive pelvic surgery. However, surgical adhesion barriers are effective at reducing adhesion formation after surgery.
GYNECARE INTERCEED® Absorbable Adhesion Barrier 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%.
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
*Learn more about C-sections
*Hysterectomy
*Surgical treatment of endometriosis
*Myomectomy
* Ovarian surgery
*Reconstructive tubal surgery
GYNECARE INTERCEED® may not be used in the presence of infection.
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®.
Read more articles about C-Sections and Pelvic Surgery:
- About C-Sections & Pelvic Surgery
- Why Are C-Sections Necessary?
- About Pelvic Adhesions
For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse.
Click here to download questions to ask your doctor: http://www.pelvichealthsolutions.com/c-sections-talk-to-doctor
Click here to download questions to ask your doctor about adhesions:
http://www.pelvichealthsolutions.com/interceed-talk-to-doctor
Click here to learn more about Gynecare Interceed and Absorbable Adhesion Barrier:
http://www.pelvichealthsolutions.com/gynecare-interceed
GYNECARE INTERCEED® is a registered trademark of ETHICON Women's Health & Urology, a division of ETHICON, INC., a Johnson & Johnson Company.
