GYNECARE INTERCEED™ Absorbable Adhesion Barrier

GYNECARE INTERCEED™ Absorbable Adhesion Barrier Essential Product Information

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™ Absorbable Adhesion Barrier is not indicated as a hemostatic agent.

Appropriate means of achieving hemostasis must be employed.

WARNINGS

Postoperative adhesions may be induced by GYNECARE INTERCEED™ Absorbable Adhesion Barrier application if adjacent tissues (eg, ovary and tube) and structures are coapted or conjoined by the device, or if GYNECARE INTERCEED™ Absorbable Adhesion Barrier is folded, wadded or layered. Care must be taken to apply GYNECARE INTERCEED™ Absorbable Adhesion Barrier in single layers, interposed between adjacent anatomic structures at risk for adhesion formation.

Postoperative adhesions may occur in the presence of GYNECARE INTERCEED™ Absorbable Adhesion Barrier if meticulous hemostasis is not achieved prior to application. GYNECARE INTERCEED™ Absorbable Adhesion 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, GYNECARE INTERCEED™ Absorbable Adhesion Barrier should not be placed in a contaminated surgical site. Potentially contaminated surgical sites include hysterotomy following labor and/or prolonged rupture of membranes. The performance of GYNECARE INTERCEED™ Absorbable Adhesion Barrier at potentially contaminated surgical sites has not been determined.

PRECAUTIONS

Use only a single layer of GYNECARE INTERCEED™ Absorbable Adhesion Barrier, since multiple layers of packing or folding will not enhance the adhesion barrier characteristics and may interfere with the absorption rate of GYNECARE INTERCEED™ Absorbable Adhesion Barrier. Care should be exercised in applying GYNECARE INTERCEED™ Absorbable Adhesion 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 GYNECARE INTERCEED™ Absorbable Adhesion Barrier. No data exist to establish the effect, if any, of GYNECARE INTERCEED™ Absorbable Adhesion 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 GYNECARE INTERCEED™ Absorbable Adhesion Barrier.

The safety and effectiveness of using GYNECARE INTERCEED™ Absorbable Adhesion Barrier in combination with other adhesion prevention treatments have not been clinically established.

GYNECARE INTERCEED™ Absorbable Adhesion Barrier is supplied sterile. As the material is not compatible with autoclaving or ethylene oxide sterilization, GYNECARE INTERCEED™ Absorbable Adhesion Barrier must not be resterilized.

Foreign body reactions may occur in some patients.

Interactions may occur between GYNECARE INTERCEED™ Absorbable Adhesion Barrier and some drugs used at the surgical site.

Pathologists examining sites of GYNECARE INTERCEED™ Absorbable Adhesion Barrier placement should be made aware of its usage and of the normal cellular response to GYNECARE INTERCEED™ Absorbable Adhesion Barrier ‘to facilitate proper evaluation of specimens'. The safety and effectiveness of GYNECARE INTERCEED™ Absorbable Adhesion Barrier has not been evaluated in clinical studies for the following involving:

• Patients undergoing laparotomy/laparoscopy for gastrointestinal surgery
• Patients with abdominopelvic malignance
• Device use in the presence of other implants (e.g., surgical mesh)

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™ Absorbable Adhesion Barrier.  Possible reasons for adhesion formation include failure to achieve meticulous hemostasis, or conjoining or coapting adjacent structures with GYNECARE INTERCEED™ Absorbable Adhesion Barrier.For more information and technical questions, call 1-800-795-0012. For complete information including indications, contraindications, warnings, precautions, and adverse reactions, and directions for use, consult the product package insert

A. Care should be exercised in applying GYNECARE INTERCEED™ Barrier to a pelvic organ not to constrict or restrict it.

B. The safety and effectiveness of GYNECARE INTERCEED® in laparoscopic surgery or any procedures other than open (laparotomy) gynecologic microsurgical procedures have not been established. The reduced incidence of de novo adhesions had an odds ratio of 0.50, 95% CI 0.30 to 0.83, three RCTs, 360 participants, I2 = 75%, very low-quality evidence. The re-formed adhesions had an odds ratio of 0.17, 95% CI 0.07 to 0.41, three RCTs, 100 participants, I2 = 36%, low quality evidence.

C.Studies include adhesiolysis, endometriosis, ovarian, tubal, and fimbria procedures.

D. The clinical benefit of these bactericidal claims has not been studied or demonstrated.

1. diZerega GS. Peritoneum, Peritoneal Healing, and Adhesion Formation. Peritoneal Surgery. New York, NY: Springer- Verlag; 2000:27-33
2. Awonuga, A. O., Fletcher, N. M., Saed, G. M., & Diamond, M. P. (2011). Postoperative adhesion development following cesarean and open intra-abdominal gynecological operations: a review. Reproductive sciences (Thousand Oaks, Calif.), 18(12), 1166–1185.
3. Ghobrial, S., Ott, J., & Parry, J. P. (2023). An Overview of Postoperative Intraabdominal Adhesions and Their Role on Female Infertility: A Narrative Review. Journal of clinical medicine, 12(6), 2263..
4. Baakdah MD, et al Adhesion in Gynecology Complication, Cost and Prevention: A Review. Surgical Technology International XIV, 185-190
5. Howard FM, et al Conscious Pain Mapping by Laparoscopy in Women with Chronic Pelvic Pain. Obstetrics & Gynecology, 2000:96:6:934-939
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7. Schick MA, Kashyap S, Collier SA, et al. Small Bowel Obstruction. [Updated 2025 Jan 19]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-.
8. Franklin RR. Ovarian Adhesion Study Group. Reduction of ovarian adhesions by the use of Interceed. Obstet Gynecol. 1995;86:335- 340
9. Gynecare INTERCEED [instructions for use]. Somerville, NJ: Ethicon, Inc.; 2022.
10. Azziz R and The INTERCEED (TC7) Adhesion Barrier Study Group II. Microsurgery alone or with INTERCEED Absorbable Adhesion Barrier for pelvic sidewall adhesion reformation. Surg Gynecol Obstet. 1993 Aug;177(2):135-9
11. Sawada T, Nishizawa H, Nishio E, Kadowaki M. Postoperative adhesion prevention with an oxidized regenerated cellulose adhesion barrier in infertile women. J Reprod Med. 2000;45:387-389
12. Wiseman DM, Trout JR, Franklin RR, Diamond MP. Meta-analysis of the safety and efficacy of an adhesion barrier (INTERCEED) in Laparotomy. J Repro Med. 1999;44: 325-331.
13. Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society of Reproductive Surgeons. Electronic address: asrm@asrm.org; Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society of Reproductive Surgeons. Postoperative adhesions in gynecologic surgery: a committee opinion. Fertil Steril. 2019;112(3):458-463. doi:10.1016/j.fertnstert.2019.06.027
14. FDA Market Approval
15. Roy S, Carlton R, Weisberg M, Clark R, Migliaccio-Walle K, Chapa H. Economic impact of the use of an absorbable adhesion barrier in preventing adhesions following open gynecologic surgeries. J Long Term Eff Med Implants. 2015;25(3):245-252. doi:10.1615/jlongtermeffmedimplants.201501214.
16. Ahmad G, O’Flynn H, Hindocha A, Watson A. Barrier agents for adhesion prevention after gynecological surgery; Cochrane Database of Systematic Reviews. 2015
17. Sekiba K. Use of INTERCEED (TC7) absorbable adhesion barrier to reduce postoperative adhesion reformation in infertility and endometriosis surgery. Obstet Gynecol. 1992;79(4):518-522. 
18. Nordic Adhesion Prevention Study Group. The efficacy of INTERCEED (TC7) for prevention of reformation of postoperative adhesions on ovaries, fallopian tubes, and fimbriae in microsurgical operations for fertility: a multicenter study. Fertil Steril. 1995 Apr;63(4):709-14.
19. Wiseman DM, Trout JR, Franklin RR, Diamond MP. Meta-analysis of the safety and efficacy of an adhesion barrier (INTERCEED) in Laparotomy. J Repro Med. 1999;44: 325-331
20. Hou, M., Bhende, S., McGill, M. (2019). Definitive bactericidal study comparing INTERCEED and Seprafilm® using a log reduction assay. Ethicon, Inc.
    

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
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