Human Reproduction, Vol. 14, No. 4, 925-927,
April 1999
© 1999 European Society of Human Reproduction and Embryology
Permanent implantation of expanded polytetrafluoroethylene is safe for pelvic surgery*
Department of Obstetrics and Gynecology, University of Colorado Health Sciences Center, Denver, Colorado, USA
Clinical trials have shown the expanded polytetrafluoroethylene (ePTFE) membrane to be a highly effective adhesion barrier in gynaecological reconstructive surgery, but the material has not gained wide acceptance because of uncertainty about long-term safety. We conducted a prospective, observational multicentre study to determine if permanent implantation of the ePTFE membrane in the pelvis caused any adverse effects. The subjects were 146 women in whom the membrane was implanted permanently during peritoneal reconstruction in 1991–1996. Postoperatively, patients were examined at regular intervals. The mean postoperative observation time was 3.5 years. No long-term complications occurred. There were 10 births by Caesarean section and 12 by vaginal delivery. All of the pregnancies before these 22 births were uneventful, including 10 in which the women had uterine implantation sites. There were two ectopic pregnancies and three spontaneous abortions. Since the primary purpose of the study was to evaluate the long-term safety of ePTFE, early second-look laparoscopy was not performed routinely. Nevertheless, 24 women had a subsequent operation. Adhesions were present at 8/21 of the membrane sites in these women, a significant decrease compared with adhesions at 17/21 sites during the initial procedure (P = 0.005). This large, multicentre study confirmed the long-term safety of the ePTFE membrane in pelvic reconstruction. Removal of the barrier is not necessary.
Key words: adhesions/expanded polytetrafluoroethylene/pelvis/reproductive surgery/surgical barriers
*Paper previously presented at the XV FIGO World Congress of Gynecology and Obstetrics, Copenhagen, Denmark, August 3-8, 1997.
1 To whom correspondence should be addressed at: Department of Obstetrics and Gynecology, University of Kentucky Medical Center, 800 Rose Street, Lexington, Kentucky 40536, USA
§ J.Crain, Women's Specialty Center, Charlotte, NC; D.Curole, Ochsner Clinic, New Orleans, LA; G.Hill, Nashville Fertility Center, Nashville, TN; D.A.Metzger, Reproductive Medical Institute of Connecticut, Hartford, CT; A.A.Murphy, Department of Obstetrics and Gynecology, Emory University School of Medicine, Atlanta, GA; M.Perloe, Atlanta Reproductive Health Center, Atlanta, GA; H.Reich, Wyoming Valley Health Care System, Wilkes-Barre, PA; G.Rowe, Baylor College of Medicine, Houston, TX; J.S.Sanfilippo, University of Louisville School of Medicine, Louisville, KY; W.D.Schlaff, Department of Obstetrics and Gynecology, University of Colorado, Denver, CO; S.Taylor, The Fertility Institute, New Orleans, LA; and R.Wing, Women's Specialty Center, Charlotte, NC, USA.