GYNECARE INTERCEED^® Absorbable Adhesion Barrier

GYNECARE INTERCEED^® Absorbable Adhesion Barrier

• Is proven to safely and effectively reduce the formation of adhesions in a range of open gynecologic pelvic procedures¹
• Reduces adhesion formation by forming a continuous protective coating over raw tissue surfaces
• Maintains its integrity as a barrier during the period of peritoneal healing and is absorbed from the tissue site within 4 weeks

Use of GYNECARE INTERCEED® Adhesion Barrier in C-section Multiple studies have shown that a majority of adhesions post-cesarean form between the anterior uterine wall and the abdominal wall. Based on the locations where adhesions are most likely to occur, the suggested application of GYNECARE INTERCEED® Adhesion Barrier is an inverted T placement2,3,4. GYNECARE INTERCEED® Adhesion Barrier is cut into two pieces. One layer is placed over the uterine incision and the other is placed perpendicular to the uterine incision, over the anterior uterine serosa.

name: GYNECARE INTERCEED® C-Section Brochure

http://www.ethicon360.com/sites/default/files/INT-005-10_INTERCEEDc-sectionbrocureFINAL.pdf

name: GYNECARE INTERCEED® Operating Room Poster

http://www.ethicon360.com/sites/default/files/INTERCEEDplacementInCsectionPoster_DermabondSkinClosure.pdf

name: GYNECARE INTERCEED® In C-Section Animation Video

http://prod.360.ethicon.edgesuite.net/ethicon360/Intrceed_HCP_Procedure_FINAL_4_12_10.wmv

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.

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.

C-section protection starts deep with an absorbable adhesion barrier

Multiple studies have shown that a majority of adhesions post-cesarean form between the anterior uterine wall and the abdominal wall (see chart below). Based on the locations where adhesions are most likely to occur, the suggested application of GYNECARE INTERCEED® Adhesion Barrier is an inverted T placement. GYNECARE INTERCEED® Adhesion Barrier is cut into two pieces. One layer is placed over the uterine incision and the other is placed perpendicular to the uterine incision, over the anterior uterine serosa.

Inverted T Placement

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.

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.

The current GYNECARE INTERCEED^® reimbursement information is available via the link below:

Reimbursement Information: GYNECARE INTERCEED^®

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.

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.

The following brochure provides information for patients about adhesion reduction for C-sections.

Patient Brochure: “What you should know about pelvic adhesions and C-sections”

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.

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.

For additional information about this product and related female pelvic health conditions and solutions, click on the links below:

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.

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.