ETHICON, INC.

Somerville, NJ

2/22/99

RE:             INTERCEED* (TC7) Absorbable Adhesion Barrier in Laparoscopic Use

 

Dear Customer,

 

This letter is to report important new clinical research findings based on a recent prospective randomized clinical trial conducted by ETHICON, INC. for laparoscopic use of INTERCEED Barrier. In addition the proper use and application of INTERCEED Barrier will be highlighted.

INTERCEED 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. The safety and effectiveness of the device for reducing the incidence of postoperative pelvic adhesions in other than open (laparotomy) gynecologic microsurgical procedures have not been established through clinical studies.

A recent company sponsored, US, multi-center, randomized, parallel group, controlled clinical trial of INTERCEED Barrier in laparoscopic surgery in patients with extensive adhesions due to endometriosis, showed a statistically significant (p-value < 0.05) increase in adhesion formation at 2nd look laparoscopy for the intent-to-treat INTERCEED Barrier group, in which 100% of subjects (19/19) had adhesions compared to the surgical control group (no-barrier treatment) in which 76% of subjects (16/21) had adhesions. Also, the primary end-point of percent adhesion-free sites score at 2nd look laparoscopy was statistically significantly (p-value < 0.05) lower for the INTERCEED Barrier group (27%) than for the no-barrier treatment surgical control group (44%). Therefore, the safety and effectiveness of INTERCEED Barrier in laparoscopic surgery have not been established. Possible contributing factors for the increase in adhesions were conjoining and coaptation of adjacent surgically traumatized structures (e.g. ovary with fallopian tube). Limited clinical experience overseas had previously shown potential benefit when INTERCEED Barrier was used in laparoscopic surgery (1,2,3,4).

Postoperative adhesions may be caused by application of INTERCEED Barrier if adjacent structures (e.g. ovary and tube) are coapted or conjoined by the device. Care must be taken to apply INTERCEED Barrier in single layers, interposed between tissues at risk for adhesion formation.

Attached is an illustration showing the proper application of INTERCEED Barrier to the ovary and fallopian tube in laparotomy procedures. Also attached is a copy of the revised Package Insert that will accompany INTERCEED Barrier product in May, 1999. Please review the Directions for Use in the product Package Insert for complete information.

If you have any questions, or require further information or clarifications, please contact your Gynecare sales representative or call 1-877-384-4266.

References

1.   Keckstein I, Karageorgieva E, Sasse V, Roth A, Tuttlies F, Ulrich U.

Reduction of Postoperative Adhesion Formation after Laparoscopic Ovarian Cystectomy. Hum Reprod 1996;11:579-582.

2.   Wallwiener D, Meyer A, Bastert G. Adhesion formation of the parietal and visceral peritoneum: an explanation for the controversy on the use of autologous and alloplastic  barriers? Fertil Steril 1998; 69:132-7.

3.   Mais V, Ajossa S, Peiretti RF, Guerriero S, Melis GB. Reduction of adhesion reformation after laparoscopic endometriosis surgery: a randomized trial with an oxidized regenerated cellulose absorbable barrier. Obstet Gynecol 1995;86:512-515.

4.   Mais V, Ajossa S, Piras B, Guerriero S, Marongiu G, Melis GB. Prevention of de novo adhesion formation after laparoscopic myomectomy: a randomized trial to evaluate the effectiveness of an oxidized regenerated cellulose absorbable barrier. Hum Reprod 1995;10:3133-3135.

 

* Trademark