THE NEW IMPROVED SILASTIC BAND FOR LIGATION OF FALLOPIAN TUBES

Transcription

1 FERTILITY AND STERILITY Copyright' 1977 The American Fertility Society Vol. 28, No. 12, December 1977 Printed in U.s.A. THE NEW IMPROVED SILASTIC BAND FOR LIGATION OF FALLOPIAN TUBES COY L, LAY, M.s., M.D., F.A.C.S.* Department of Obstetrics and Gynecology, University of South Florida School of Medicine, Tampa, Florida Twelve different sizes of elastic bands were tried in animal experiment~tion for tubal sterilization. Reversible sterilization was not successful in any of the ammals after removal of the various-slzed bands.. A new elastic Silastic band is reported which is larger and wlder than those previously described. Over a 4-year period, no serious complications have been :eported and extremely low pregnancy rates have been achieved by utilizing the new, wlder bands and our applicators for human sterilization. HISTORY The concept of using elastic bands to ligate and thereby defunctionalize an area of tissue has found a variety of applications in the past. Among the earliest applications of this principle was the use of elastic bands to castrate domestic animals l or in tail docking.2 In humans, elastic band ligation of tissues found early application in the clamping of the umbilical cord. Dr. L. Clark Gravlee should be credited with the first widespread use of an elastic band for this purpose. He published articles and patented the Gravlee Gun elastic band applicator in Gravlee's instrument was larger than those used today in laparoscopy but utilized the same basic principle of pulling a loop of tissue into the instrument and discharging an elastic band upon this tissue, effecting a ligation. The second widespread surgical use of elastic bands in humans was for ligation ofhemorrhoids. 4 McGivney5 popularized and modified instruments to ~ake ligation with an elastic band a procedure WIdely used by proctologists for many years. The author was a student of McGivney in 1956 and was therefore, aware of his early work. Later, McGivn~y was contacted regarding the possibility of modifying his hemorrhoid ligation instrument Received May 25, 1977; revised July 25, 1977; accepted July 26, * Reprint requests: Coy L. Lay, M.D., P.O. Box 1429, Watson Clinic Building, Lakeland, Fla so that it could be used in fallopian tube ligation. He was encouraging and helped us to obtain a modification of the elastic band applicator for use in our animal work on the fallopian tube, using the McGivney elastic bands made of butyl rubber. Later, when Silastic materials were recommended by the Food and Drug Administration, the butyl rubber was discontinued in favor of Silastic elastic bands for both animal and human tubal ligation. The preliminary reports of our early work were presented at medical meetings in 1973 and We discovered in 1974 that Y oon et al. lo were also using Silastic bands for sterilization, when they published their first preliminary report on the use of silicone rubber bands in 100 cases. They also were obtaining successful ligation with a low incidence of complications but their patients were experiencing a significant incidence of postoperative abdominal pain. The frequency of this occurrence was reported to be as high as 15% to 200/oY Early Animal Experimentation. During 1972 and 1973 in the animal surgery laboratory, attempts were made to utilize elastic bands through the laparoscope, and many problems were encountered. The modified McGivney instruments were found to be too large to apply through the largest laparoscopy trocars. Also, the oviducts in some animals are extremely difficult to demonstrate through the laparoscope. In order to apply the elastic bands to the fallopian tubes in many of the animals it was necessary to perform lapa- 1301

2 1302 LAY rotomies. Following surgery, the animals were mated over a 6-month period and no pregnancies resulted. Later, a second operation was performed for removal of the oviducts and uterus for study. No undue foreign body reaction, abscesses, hemorrhage, or other adverse effects were found to have occurred as a result of ligating the fallopian tubes with either butyl elastic bands or Silastic elastic bands. The absence of adverse tissue reaction encouraged us to attempt a second project to determine whether reversible sterilization could be achieved simply by removing the elastic bands many months after application and remating the animals. Through the cooperation of Dow Chemical Co., Midland, Mich.; Dyonics Inc., Woodburn, Mass.; and the Richard Wolf Medical Instrument Corporation, Rosemont, Ill., 12 sizes of Silastic bands were obtained. Over a period of 1 % years, progressively larger Silastic bands were placed on the fallopian tubes of animals, including dogs, monkeys, and pigs. The bands were removed 4 to 6 months later in an effort to obtain a reversible sterilization procedure. In our hands this method was not successful for two important reasons: 1. When elastic bands the size developed by McGivney were used, contracture and fibrosis of a small segment of fallopian tube resulted, completely blocking the oviduct. Therefore, simple removal of the band did not re-establish patency or tubal function. 2. When a much larger band was used to avoid the fibrosis and contracture, the bands occasionally slipped off the loop of fallopian tube and some of the animals became pregnant. Peristalsis of the fallopian tube will apparently dislodge a band that is too loose. We did not achieve a reversible sterilization by simply removing the bands, but we did gain a great deal of information regarding the advantages and disadvantages of the various sizes of Silas tic elastic bands. In our search for an elastic band specifically adapted for ligating fallopian tubes, we found that by doubling the width of the McGivney band and enlarging the size of the hole of the ring by 50% we achieved the following advantages as shown in both animal and human experiments (Fig. 1): 1. The wider band, being stronger, has less tendency to break when stretched onto the applicator and it stays on the tube better, since to December 1977 O=2.lmm t03.3mm d'= 1.8mm t02.2mm d"=i.4mm to 1.8mm j =2t03.5mm FIG. 1. Dimensions of the modified band. dislodge it from the fallopian tube much more pressure is required. 2. Reduced postoperative pain is being reported with the larger band, possibly because the larger opening in the band and the broader band surface result in a diminished cutting edge and less pressure applied to the tube-thus less pain postoperatively. 3. The larger internal diameter of the elastic band avoids cutting through the tube in most cases. This may explain the extremely low pregnancy rates by reducing the occurrence of tubal fistulas and minimizing reanastomoses of the cut ends of the oviduct (Fig. 2). Development of the Silastic Band Applicator. After experimenting with modifications of Mc Givney's applicator, we concluded that a satisfactory instrument having the qualities necessary for use in laparoscopic surgery would (1) be safe, to eliminate as many complications as possible, including electrical burns; (2) apply the band securely to at least 1 cm of oviduct and be rapid and easy to use in the vast majority of patients, including those with larger fallopian tubes; (3) be of simple structural design, easily dismantled for proper cleansing and sterilization; (4) be sturdily and reliably constructed to require a minimum of repair and to ensure against untimely malfunction during surgery. A plicotor Silastic elastic band / ~I""~ ~ 1 metric FIG. 2. Silastic elastic band before and after application to the end of the applicator.

3 Vol. 28, No. 12 IMPROVED SILASTIC BAND FOR TUBAL LIGATION 1303 The two Silastic band applicators developed over a period of years were laboriously and carefully refined to achieve as nearly as possible these idealistic goals. The first is referred to as the "manual applicator" and is of extremely simple construction of three basic parts: a long thumb forceps; two pieces of hollow stainless steel tubing, one being slightly smaller; and a loading cone (Fig. 3). The slightly larger hollow steel tube is slipped over the smaller tube, leaving a cuff of the smaller tube extending from the end. The Silastic band is applied onto the end of the instrument, utilizing a loading-cone technique described by Gravlee. With standard laparoscopic techniques the midportion of the oviduct is grasped by the thumb forceps and a loop of tube pulled inside the instrument. The Silastic band is then pushed off the end of the instrument onto the loop of fallopian tube. The "automatic model" is more sophisticated and faster to use, since simply pulling the trigger back will pull a portion of oviduct into the instrument, and further pulling on the trigger applies the elastic band in one movement of the finger (Fig. 4). Attempts were made to utilize instruments small enough to go through a 5-mm trocar, commonly used for the secondary puncture site. Experimenting with fresh hysterectomy specimens with normal fallopian tubes, we tried smaller applicators, but concluded that the desirable internal diameter of the instrument is 7 mm or more, otherwise there was a tendency in some cases to cut the fallopian tube inadvertently. This may result in mesosalpingeal hemorrhage, which is reported to be the most frequent complication when smaller applicators and bands are used. 12 RESULTS AND PREGNANCY RATE In Williams' Obstetrics l3 the failure rate for the Pomeroy sterilization technique is reported to be 0.5%, or 5/1000 sterilizations. For the Hulka Clip l4 a pregnancy rate recently reported is 25/1000, with a rate of unexplained pregnancies of 6/1000 women with a follow-up of 1 year, or 0.6% in 1 year. For the Falope-Ring, Yoon l4 reported a pregnancy rate in February 1977 of 2.32 pregnancies/1000 women, or 0.23%. Tietze and Lewit l5 and others have recommended reporting pregnancy rates for various methods of contraception as the number of pregnancies occurring per 100 woman-years of usage of the method. This rate is usually referred to as "pregnancies per 100 woman-years." With our wider Silastic band, follow-up studies now show in a small group of women the very low pregnancy rate of 0.1 pregnancy/100 woman-years, or 1 pregnancy/1000 woman-years. Eight different laparoscopists, each of whom was selected because of his wide experience in sterilization techniques, applied the bands in 370 patients. All of the years of the study have been included in the woman-years figure. A 90% follow-up rate is being attained for the Manual applicator / Loading cone Hollow stainless steel tubing c=====~ec===============~~~~~~~~~~ Long thumb forceps FIG. 3. Simple Silastic band applicator-manual model. I

4 1304 LAY December 1977 FIG. 4. Automatic model Lay Loop applicator. private patients through two follow-up letters and telephone follow-up when the letters fail to contact the patients. The follow-up period varies from 1 to 4 years, the average being 2.7 years. The information being obtained from follow-up at this time also confirms our clinical impression that increased lower abdominal pain is not a problem, as oral analgesics have given satisfactory postoperative pain relief with rare indications. The incidence of minor postoperative complications was reported by all eight laparoscopists to be the same as or less than that with the coagulation techniques previously used. No reports of major postoperative complications or ectopic pregnancies have been received. The only pregnancy thus far reported occurred 3 months after laparoscopy. A repeat surgical sterilization was later performed on the same patient and examination of the tube revealed no breaking of the band, cutting through the tubes by the band, tubal recanalization, or tuboperitoneal fistula. The surgeon believed that he had not placed the band properly at the time of the original application or that it had partially slipped off the tube after application. DISCUSSION Although this is a small group of patients, our objective was to follow a smaller number of patients closely and to utilize only experienced laparoscopists until the safety and effectiveness documented in our animal studies could be. verified. The number of patients and the number of doctors using this method are now being rapidly expanded as the method is proving to be safer than electrical burning and apparently nearly equally. effective. We limited the first 1000 woman-years of experience to eight surgeons for two reasons: (1) In order to achieve the desired 90% follow-up rate, too many doctors and patients could not be included. (2) In order to achieve a realistic and accurate evaluation of the new, wider Silas tic bands, it was believed that surgeons with experience in diagnosing and treating problems inherent in pelvic endoscopy could accurately identify new problems whic4 might be attributable to the band. They could also compare the convenience and patient acceptance of the band with those of previous techniques they had used. As less experienced operators begin to use the Silastic loop the pregnancy rate may increase as a result of improper placement of the band. The most serious complication, sometimes fatal to the patient of the pelvic endoscopist, is unrecognized intestinal burn from the electrosurgical coagulation. It now appears this danger can be effectively and safely eliminated by these newer techniques as well as by those described by Y oon et al. 10 and others. Acknowledgments. The author acknowledges assistance and advice from the following in the preparation of this paper: G. T. Jim Foust, M.D., Denver; Col.; Charles H. Hockberg, M.D., Tampa, Fla.; James M. Ingram, M.D., Tampa, Fla.; Gordon Jackson, M.D., Macon, Ga.;. Raymond C. Lackore, M.D., Rochester, Minn.; Anthony M. Messina, M.D., Tampa,

5 \ Vol. 28, No. 12 Fla.; Glenn I. Moore and Associates, Lexington, Ky.; Barry S. Verkauf, M.D., Tampa, Fla.; and Robert L. Vermillion, M.D., Roanoke, Va. REFERENCES 1. US Patent Office: Device for applying expanded elastic rings, by WM Alexander et al. Patent No 2,764,160, September 25, US Patent Office: Applicator for ligatures, by Max W Thaete. Patent No 2,619,964, December 2, US Patent Office: Apparatus for applying an elastic tie, by Leland C Gravlee, MD. Patent No 2,942,604, June 28, Blaisdell PC: Prevention of massive hemorrhage secondary to hemorrhoidectomy. Surg Gynecol Obstet 106:485, McGivney J: Ligation treatment of internal hemorrhoids. Texas Med Vol 63:59, Lay CL: Preliminary report on use of Silastic band in laparoscopy. Presented at The American Fertility Society Endoscopy Course, San Francisco, Calif, April 4, Lay CL: Laparoscopy-technique and complications. Presented at the American College of Obstetricians and Gynecologists' Conference, Bal Harbour, Fla, May 22,1973 IMPROVED SILASTIC BAND FOR TUBAL LIGATION Lay CL: Tubal sterilization with the Lay Lasso. Presented at the Mayo Clinic Alumni Association Meeting, Rochester, Minn, June 9, Lay CL: Experimental use of elastic bands for tubal sterilization. Presented at the South Atlantic Association of Obstetricians and Gynecologists' Meeting, Miami Beach, Fla, January 30, Yoon IB, Wheeless CF Jr, King TM: A preliminary report on a new laparoscopic sterilization approach: the silicone rubber band technique. Am J Obstet Gynecol 120:132, Queenan JT: The ring: new technique for laparoscopic tubal sterilization. Contemp Obstet Gynecol 5:36, Phillips J, Hulka B, Hulka J, Keith D, Keith L: Laparoscopic procedures: American Association of Gynecologic Laparoscopists' membership survey for Presented at the American Association of Gynecologic Laparoscopists' Meeting, Atlanta, Ga, November 17, Hellman LM, Pritchard JA: Sterilization. In Williams' Obstetrics, 14th Edition, Edited by LM Hellman. New York, Appleton-Century-Crofts, 1971, p Hulka JF, Richard RM; Lubell I, Neuwirth RS, Yoon IB: Sterilization: five experts compare the techniques. Contemp Obstet Gynecol 9:119, Tietze C, Lewit S: Statistical evaluation of contraceptive methods. Clin Obstet Gynecol17:121, 1974