Laparoscopy Implant and Long Term Efficacy of the GORE-TEX Surgical Membrane: Preliminary Report

A prospective clinical study to determine the ease of use of the GORE-TEX Surgical Membrane in laparoscopic surgery to enhance fertility was undertaken. A secondary aim of the study was to report on short and long-term safety of the product and its effectiveness when implanted laparoscopically. Ten centers enrolled 36 patients to date in this preliminary report. During the initial operation, the time to accomplish the operative procedure, time necessary to implant the surgical membrane, and a subjective rating of the ease of implant were evaluated. If an adhesion was lysed at the implant site, the adhesion was scored using a standard system. The time spent in implantation was calculated for each implant site. The uterine sites had a smaller time spent in implantation than either the pelvic sidewall or cul-de-sac. Less time was spent in implanting the surgical membrane with staples than clips or sutures. There have been no reports of immediate or long-term postoperative complications attributable to the surgical membrane. Most patients were implanted with the intention of keeping the surgical membrane in place long-term. Five patients had second-looks; one had a filmy, avascular adhesion, while the remaining patients had no adhesion formation to the implant site, the surgical membrane and its edges or the anchoring devices. There were no postoperative complications in the latter patients. In conclusion, the surgical membrane is easily used at laparoscopy, with the most rapid fixation accomplished through the use of laparoscopic staples. Short and long term complications have been nil, while efficacy after laparoscopic implantation has been good in a limited second-look series.