GYNECARE INTERCEED™ | Absorbable Adhesion Barrier

GYNECARE INTERCEED™ Absorbable Adhesion Barrier is the safe, effective and site specific solution for adhesion prevention. When a woman undergoes surgery, such as a cesarean section there is a high risk of developing post-surgical adhesions, also known as pelvic adhesions. Adhesions occur when bands of scar tissue in the abdominal cavity get “stuck” to pelvic or abdominal organs, similar to how plastic wrap clings to itself, thus restricting motion. Adhesions are common and can potentially lead to serious complications. Adhesions that form after surgery in the pelvic area are often the cause of post-operative pelvic pain, small bowel obstruction, and even infertility.

The use of a barrier during surgery to protect raw tissue surfaces as they heal has been shown to be one of the most effective methods of reducing adhesions. GYNECARE INTERCEED™ is a lightweight fabric that can be placed at the surgical site thus creating a physical barrier to prevent these areas from adhering to adjacent surfaces. The film helps prevent post-operative adhesions by protecting and separating the surfaces where adhesions are likely to form. GYNECARE INTERCEED™ barrier is then absorbed by the body as the healing process occurs. The risk of adhesions after gynaecologic surgery is up to 97% and is a common occurrence. The likelihood of adhesion formation and the seriousness of their consequences are based on multiple factors (e.g., type of surgery, number of previous surgeries, surgical technique, and the predisposition of individual patients). However, studies have consistently shown that a majority of women who have gynaecologic surgery will experience some degree of adhesion formation, as this surgery is the most common cause of adhesions.

GYNECARE INTERCEED™ can also be used to prevent adhesions after c-section by positioning it between the uterine incision and bladder flap, as well as between the bladder flap and anterior peritoneum, if the bladder flap is closed.

Click here to see an Illustrated Guide to Adhesion Prevention in Pelvic Surgery

RISK INFORMATION

GYNACARE INTERCEED™ Barrier is not indicated as a hemostatic agent. Appropriate means of achieving hemostasis must be employed.

WARNINGS: Postoperative adhesions may be induced by GYNACARE INTERCEED™ Barrier application if adjacent tissues (e.g., ovary and tube) and structures are coapted or conjoined by the device, or if GYNACARE INTERCEED™ Barrier is folded, wadded or layered. Care must be taken to apply GYNACARE INTERCEED™ Barrier in single layers, interposed between adjacent anatomic structures at risk for adhesion formation. Postoperative adhesions may occur in the presence of GYNACARE INTERCEED™ Barrier if meticulous hemostasis is not achieved prior to application. GYNACARE INTERCEED™ Barrier must not be used if meticulous hemostasis has not been achieved or if blood contacts the product prior to its application. As with all foreign substances, GYNACARE INTERCEED™ Barrier should not be placed in a contaminated surgical site. The performance of INTERCEED Barrier at such a site has not been determined.

PRECAUTIONS: Use only a single layer of GYNACARE INTERCEED™ Barrier, since multiple layers of packing or folding will not enhance the adhesion barrier characteristics and may interfere with the absorption rate of GYNACARE INTERCEED™ Barrier. Care should be exercised in applying GYNACARE INTERCEED™ 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 adequate and well controlled studies have been conducted in women who have become pregnant within the first month after exposure to GYNACARE INTERCEED™ Barrier. No data exist to establish the effect, if any, of GYNACARE INTERCEED™ Barrier on the occurrence of ectopic pregnancies. No teratogenic studies have been performed. Therefore, an avoidance of conception should be considered during the first complete menstrual cycle after use of GYNACARE INTERCEED™ Barrier. The safety and effectiveness of using GYNACARE INTERCEED™ Barrier in combination with other adhesion prevention treatments have not been clinically established. GYNACARE INTERCEED™ Barrier is supplied sterile. As the material is not compatible with autoclaving or ethylene oxide sterilization, GYNACARE INTERCEED™ Barrier must not be resterilized. Foreign body reactions may occur in some patients. Interactions may occur between GYNACARE INTERCEED™ Barrier and some drugs used at the surgical site. Pathologists examining sites of GYNACARE INTERCEED™ Barrier placement should be made aware of its usage and of the normal cellular response to GYNACARE INTERCEED™ Barrier2 to facilitate proper evaluation of specimens3.

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 GYNACARE INTERCEED™ Barrier. Possible reasons for adhesion formation include failure to achieve meticulous hemostasis, or conjoining or coapting adjacent structures with GYNACARE INTERCEED™ Barrier.

GYNECARE INTERCEED™ Absorbable Adhesion Barrier:

• Is proven to safely and effectively reduce the formation of adhesions in a range of open gynecologic procedures
• Reduces adhesion formation by forming a continuous protective coating over raw tissue surfaces within 8 hours of surgery
• Maintains its integrity as a barrier during the period of peritoneal healing and is absorbed from the tissue site within 28 days

GYNECARE INTERCEED™ reduces the extent and severity of adhesions. Studies demonstrate that the GYNECARE INTERCEED™ barrier significantly enhances good surgical technique and its use reduces adhesion formation by 50% when compared to the use of good technique alone. Studies also demonstrate that GYNECARE INTERCEED™ is between 1.6 to 2.5 times more effective than good surgical technique alone in achieving adhesion free outcome¹. The GYNECARE INTERCEED™ barrier improves the reduction in serosal surface area involved in adhesions by over 50%². Statistically and clinically this confirms the effectiveness of the GYNECARE INTERCEED™ barrier in reducing the incidence of adhesions after gynaecologic surgery.

References
1.Franklin, R.R., er al. 1995. GYNECARE INTERCEED Barrier in the prevention of post-operative adhesions following laparotomy: meta-analysis of its efficacy and safety. Fertility and Sterility (Program supplement): S227, 19. ion surgery. Gynecology and Obstretics. 1993;177:135-139.
2.Assiz et al. Microsurgery alone or with GYNECARE INTERCEED absorbable adhesion barrier for pelvic sidewall adhesion re-format

Patients can be directed to the following sites for more information:

Patients in the UK - www.womenshealthsolutions.co.uk
Patients in Ireland - www.womenshealthsolutions.ie
Patients in Switzerland - www.womenhealth.ch
Patients in Germany - www.gynecare.de
Patients in Austria - www.gynecare.at
Patients in Portugal - www.saudedamulher.com.pt
 

RISK INFORMATION

GYNACARE INTERCEED™ Barrier is not indicated as a hemostatic agent. Appropriate means of achieving hemostasis must be employed.

WARNINGS: Postoperative adhesions may be induced by GYNACARE INTERCEED™ Barrier application if adjacent tissues (e.g., ovary and tube) and structures are coapted or conjoined by the device, or if GYNACARE INTERCEED™ Barrier is folded, wadded or layered. Care must be taken to apply GYNACARE INTERCEED™ Barrier in single layers, interposed between adjacent anatomic structures at risk for adhesion formation. Postoperative adhesions may occur in the presence of GYNACARE INTERCEED™ Barrier if meticulous hemostasis is not achieved prior to application. GYNACARE INTERCEED™ Barrier must not be used if meticulous hemostasis has not been achieved or if blood contacts the product prior to its application. As with all foreign substances, GYNACARE INTERCEED™ Barrier should not be placed in a contaminated surgical site. The performance of INTERCEED Barrier at such a site has not been determined.

PRECAUTIONS: Use only a single layer of GYNACARE INTERCEED™ Barrier, since multiple layers of packing or folding will not enhance the adhesion barrier characteristics and may interfere with the absorption rate of GYNACARE INTERCEED™ Barrier. Care should be exercised in applying GYNACARE INTERCEED™ 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 adequate and well controlled studies have been conducted in women who have become pregnant within the first month after exposure to GYNACARE INTERCEED™ Barrier. No data exist to establish the effect, if any, of GYNACARE INTERCEED™ Barrier on the occurrence of ectopic pregnancies. No teratogenic studies have been performed. Therefore, an avoidance of conception should be considered during the first complete menstrual cycle after use of GYNACARE INTERCEED™ Barrier. The safety and effectiveness of using GYNACARE INTERCEED™ Barrier in combination with other adhesion prevention treatments have not been clinically established. GYNACARE INTERCEED™ Barrier is supplied sterile. As the material is not compatible with autoclaving or ethylene oxide sterilization, GYNACARE INTERCEED™ Barrier must not be resterilized. Foreign body reactions may occur in some patients. Interactions may occur between GYNACARE INTERCEED™ Barrier and some drugs used at the surgical site. Pathologists examining sites of GYNACARE INTERCEED™ Barrier placement should be made aware of its usage and of the normal cellular response to GYNACARE INTERCEED™ Barrier2 to facilitate proper evaluation of specimens3.

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 GYNACARE INTERCEED™ Barrier. Possible reasons for adhesion formation include failure to achieve meticulous hemostasis, or conjoining or coapting adjacent structures with GYNACARE INTERCEED™ Barrier.