Population Reports

SERIES C NUMBER 7 MAY 1976 STERILIZATION

Department of Medical and Public Affairs, The George Washington University Medical Center, 2001 S Street, N.W.. Washington. D.C. 20009

Tubal Sterilization This report on tubal sterilization methods was prepared by Judith Wortman, R.N., on the basis -Review of Methods- of published reports and articles, unpublished papers, personal interviews, and correspon­ dence.

SUMMARY The assistance of the following reviewers is ap­ preciated: Elizabeth Connell, William Droege­ mueller, Jaroslav Hulka, Theodore King, R. T. Widespread demand for simple, effective, and inexpensive Ravenholt, Ralph Richart, John Sciarra, and J. female sterilization procedures which can be performed Joseph Speidel. Frances G. Conn is Executive on an outpatient basis has encouraged both medical Editor. Comments and additional updated mate­ practitioners and researchers to evaluate existing meth­ rial are welcome. ods of tubal occlusion and to develop new ones. Recent research has concentrated on: • modification and improvement of older methods of ciated with a higher rate of infection than abdominal tubal occlusion, such as ligation and fulguration; approaches. Finally, methods which interrupt (cut • application of clips and bands to the tubes; through) the tubes are associated with higher morbidity • introduction of chemicals and plugs into the tubes. (e.g . bleeding) than those in which tube continuity is Invention of equipment such as endoscopes and spe­ maintained. cially-tailored cannulae which now permit a variety of Potential for reversibility may be a factor in selecting a approaches to the tubes has contributed to the develop­ particular method of tubal occlusion. Experience in both ment of new methods of tubal occlusion. As a result, the developing and developed countries indicates that most tracjitionallarge abdominal incision for sterilization (Iapa­ women desiring sterilization prefer a permanent method, rotqmy) has been replaced by a tiny abdominal incision but many, particularly in the younger age groups, might (mihilaparotomy) or punctu re (Iaparoscopy) and by trans­ welcome a means of sterilization that could be reversed. vaginal (colpotomy, culdoscopy) or transcervical ap­ proaches (hysteroscopy, blind delivery) which require no Although some plugs offer potential for reversibility be­ incision. cause theoretically they may be withdrawn from the tube, reversibility has not been adequately assessed by tests in These approaches permit occlusion of any part of the humans. In animal experiments, the tubal epithelium is fallopian tube. For example, the infundibulum (distal, sometimes destroyed beyond repair when plugs are re­ fimbrial end of the tube) can be excised, buried, plugged, moved. Clips or bands, on the other hand, destroy a or capped; the ampulla or isthmus (middle of the tube) can narrow segment of tube, but there is virtually no expe­ be tied, cut, excised, fulgurated, clipped, banded, or rience with reversibility. Reversal would require a second buried; and the interstitial portion of the tube (near the operation to cut out the crushed section of tube and uterotubal junction) can be coagulated or blocked with chemicals or plugs (see Fig. 1).

The choice of approach and the method of tu bal occlusion CONTENTS often depend upon the physician's prior training, degree of skill, and knowledge regarding the safety and effective­ Ligation ...... C-74 ness of the various methods. Endoscopic approaches, for Fulguration ...... C-78 example, generally require more training and skill than Clips ...... , C-82 other approaches, while most transcervical approaches Bands...... ,. C-84 are still considered experimental and are less effective Chemicals ...... C-86 than those performed by other approaches. Likewise, Solid Plugs...... C-89 cautery and some chemicals are associated with a higher Other Tubal Occlusion Methods ...... C-91 risk of damage to structures adjacent to the tubes Bibliography ...... C-91 than ligation, clips, bands, or plugs. Methods performed through the vaginal cul-de-sac (e.g. colpotomy) are asso-

Part 1 of 2 parts-May 1976 mailing C-73 Ligatic 1 techniques can be classified into one or a comt i­ nation Jf the following categories according to the exte 1t Population Reports is published bi-monthly at of acti n on the fallopian tubes: 2001 S Street NW., Washington, D.C. 20009, USA, by the Population Information Program, Science • sim Ie ligation; Communication Division, Department of Medical • liga on and crushing; and Public Affairs of the George Washington • liga on, division, and burial; University Medical Center and is supported by the • liga on and resection; United States Agency for International Develop­ • liga on, resection, and burial. ment. Helen K. Kolbe, Project Director. Second class postage paid at Washington, D.C. SIMPL : LIGATION. Simple ligation is seldom performf! d today lecause of the high failure rate asso iated with Its use. F rst proposed by Lungren (USA) in 1880 (90), simple ligatio preceded other ligation methods by almost t 10 anastomose (join) the two remaining ends. Ligation is the decad s. In 1895, DLihrssen (The Netherl nds) used a procedure most often reversed successfully, but the same doubl!' ligature on each tube in an effort to prevent t 1e operative procedure for anastomosis is required. The use failure associated with single ligatures (119). Howevl!r, of cautery makes reversibility virtually impossible to subse uent investigations have shown that hydrosalpir1x achieve because a large segment of tube is destroyed. (colle! ion of fluid) frequently develops between the t'tlO Likewise, most chemical methods are not reversible be­ ligatul )S and, as a result, reports of double ligation have cause the epithelium is permanently damaged. disapf eared from the literature. In one of the few recent report on simple ligation, Purandare (India), who p r­ Comparisons of the effectiveness of the various tubal forms colpotomy for interval sterilization and laparotor y occlusion procedures are difficult to make. In many cases, for p erperal sterilization, uses nonabsorbable lin ,n there are insufficient data and investigators do not con­ threac to tie the tubes at the junction of the lateral 0 e­ sider life tables or the Pearl Index' in computing failure th ird 0 ld medial two-thirds of the tubes. Purandare recog­ rates (see Population Reports, Series H, Number 4, Janu­ nizes I Ie possibility of failu re with his tech nique and ac ks ary 1976). Thus, there is no basis for comparison among up tht, procedure by abortion. He has not r ecently p b­ studies and only estimates can be made from published lished ailure rates orthe percentage of abor ions requir ,d information. amon the total number of procedures perf rmed.

While great strides in knowledge about tubal physiology tv ljor Advantages Major Disadvantage and in biomedical engineering have been made, more • sirr )Ie to perform; • high failure rate (up to 20 research is needed to determi ne the practical ity, effective­ • 10'11 morbidity; percent). ness, and applicability of the newer methods of tubal • higll potential for rever­ occlusion, such as use of chemicals. Until then, traditional sibl ity. methods (e.g., ligation) are likely to remain popular. Ligation and Crushing MADl ::: NER TECHNIQUE. This technique, first reported LIGATION in 19 ), is easier to perform and results in less bleedi 19 than I lore extensive ligation procedures (144). However, like si 1ple ligation, the failure rate is higher than forthc se Tubal ligation (tying the fallopian tubes) to prevent pas­ technq ues in which tubal continuity is interrupted. In the sage of sperm and ova is one of the oldest forms of tubal Madl ~ 1er technique, the midsection of the tube is picked occlusion. Nearly a century of experience with this me­ up to )rm a loop, and the base of the loop is crushed wit a thod has eliminated the least effective techniques and the clam~ and ligated with nonabsorbable suture matel ial outcome of most of those remaining is now predictable. (e.g., ;ilk, cotton) (see Fig. 2) . In a modification of t lis Traditionally performed through a large 10 cm (3-4 techn .:Jue adopted by some practitioners, ~ he top of 'he inches) abdominal incision (laparotomy), today the tubes loop i cut off. are ligated through a 2.5 cm abdominal incision (minilapa­ rotomy) or a 3-5 cm vaginal incision (colpotomy). The amount of skill required to perform ligation, the approach ul 'us interstitial isthmic-ampullary used, and effectiveness vary according to the type of ligatio"1 procedure performed (see Table 1).

Major Advantages Major Disadvantage • only average skill is re­ • most effective proce­ infundibLlum quired for most proce­ dures are usually irre­ dures; versible; • only simple instrumen­ • the procedures per­ tation is required ; formed via laparotomy • morbidity is usually low. require hospitalization.

'Failure rates per 100 woman years are computed using the Pearl Fig 1. Anatomy of fallopian tube in relation to the uterus formula: an ovary. No. of pregnancies x 1200 No. of months of exposure

C-74 Like simple ligation, the Madlener technique may be performed by the abdominal or vaginal route. Recently its performance on an outpatient basis was reported in Tai­ wan where Ou uses a "one finger technique" which in­ volves inserting a finger through a minilaparotomy inci­ sion (2 .5 cm) to bring the tube onto the abdomen (102). However, Chen (Taiwan) reports that the tubes are some­ times difficult to locate by this blind technique (12) . The Madlener technique has also been performed via laparo­ scopy using a prolene loop to ligate the tubes, but this procedure requires endoscopic expertise and a high de­ gree of skill to manipulate the instruments (39) .

Failures following Madlener ligation are probably due to the reanastomosis and regeneration of tissue at the crushed portion of tube following penetration by the ligature. Thus tubal patency is restored. For this reason, the International Planned Parenthood Federation Panel of Fig. 2. Often used tubal ligation techniques. Experts on Male and Female Sterilization (Bombay, 1973) recommended that the tube not be crushed and that use of a nonabsorbable ligature alone would yield better results WOOD TECHNIQUE. A microsurgical technique (per­ (67). formed under magnification) of ligation, division, and burial-first reported by Wood (Australia) in 1973-re­ The failure rate varies according to the approach used: It quires above-average skill, but it is highly effective and remains low with laparotomy or culdoscopy, but increases potentially reversible. The procedure, termed "atraumatic with colpotomy (10). The reason for th is difference has not midampullary sterilization," involves division of the am­ been explained. Accounting for all approaches, investiga­ pullary portion of the tube, ligation of the cut ends with tors have reported failure rates ranging from 1-2 percent absorbable suture, and burial of the medial stump in a (43,52,90). pocket cut in the mesosalpinx (portion of the peritoneum Major Advantages Major Disadvantage enclosing the tube). • low morbidity; • variable failure rate (de­ Thus far the technique has only been used in Australia • simple to perform; pending on approach with a few patients. However, there have been no failures • may be performed by a used). among 18 women, most of whom have been followed-up v.ariety of approaches. for two years (151) . Although reversal has not yet been attempted, the Wood technique is potentially reversible Ligation, Division, and Burial because there is: Ligation procedures which involve division of the tube and burial of the stumps are nearly 100 percent effective, but • no excision of the tube; are slightly more difficult to perform than I igation and • minimal interference with the blood and nerve supply division or ligation and resection. In addition, the more to the tube; extensive a tubal occlusion procedure (e .g., those requir­ • treatment of the ampulla (widest part of the tube) . ing burial) is, the higher the rate of morbidity, such as bleeding. Among the techniques in use today are those of Major Advantages Major Disadvantage Irving and Wood. • potentially highly effec­ • above average skill re­ tive (data inadequate to quired. IRVING TECHNIQUE. Although it requires more time to date); perform than most ligation procedures, I rving's technique • potentially reversible. is highly effective. As he reported in 1924, the tubes are divided between two absorbable ligatures and the prox­ Ligation and Resection imal stump is buried in the uterine myometrium (58) (see Procedures involving ligation and resection (removal) of a Fig. 2). segment of tube are easier to perform and, therefore, are In 1950, Irving reported no failures among 814 women more widely used than those that require burial of the sterilized by his ligation procedure (59) . There were also stumps. Many techniq ues have been developed since no failures among 1,056 procedures in a literature review Fritch first proposed ligation and resection in 1898. While by Garb (43), and only one failure (0.5 percent) in 1,966 some techniques have virtually disappeared from current procedures reviewed by Merz (90). practice, among those still reported in the literature are:

Major Advantage Major Disadvantages • salpingectomy; • nearly 100 percent effec­ • performed by laparot­ • Pomeroy; tive. omy requiring abdomi­ • fimbriectomy. nal incision and hospi­ talization; SALPINGECTOMY. Of the ligation and resection tech­ • more complicated than niques, salpingectomy-removal of the tube distal to a many ligation proce­ non absorbable suture placed near the uterus-is least dures; often performed. Because the procedure is extensive, it • poor potential for rever­ offers little chance of reversibility and is associated with sibility. higher morbidity (e.g., bleeding) than many other ligation C-75 Table l-Comparison of Tubal Occlusion Methods Currently Used in Humans*

Part of Done Degree of In Range of Incidence Possible as o Possible Potential for I Method Tube with Standard Skill Experimental Cost Failure of Outpatient --.J Approaches Reversibility 0> Treated Equipment Required Stage Rate Morbidity Procedure

LIGATION Pomeroy isthmus minilaparotomya good yes average no low 0-D.4 low yes laparotomy yes average no high" (higher when low no coipotomy yes above average no high" performed by moderateb no culdoscopy no high no high t culdoscopy) low yes laparoscopy no high yes high t low yes F i mbriectomy fimbria minilaparotomy poor yes average no low nil low yes (distal) laparotomy yes average no high" low no colpotomy yes above average no high" (higher when moderateb no culdoscopy no high no hight performed low yes post-partum) Uchida ampulla minilaparotomy good yes above average no low nil low yes laparotomy yes above average no high" low no Madlener isthmus minilaparotomy moderate yes average no low 0.3-2 low yes laparotomy yes average no high" (higher-30­ low no colpotomy yes above average no high" when performed moderateb no culdoscopy no high no hight by colpotomy) low yes Wood ampulla laparotomy very good no above average yes high" nil low NR Irving ampulla minilaparotomy good yes average no low nil low yes laparotomy yes no high" no Cornual resection cornual laparotomy poor yes average no high" 2.8-3.2 moderate no (proximal) Salpingectomy lateral minilaparotomy poor yes average no low 0-1.9 moderate yes laparotomy poor yes average no high" no

C': _~ I ", l i-~~ .; "'''' ;...... " .. - i "'i l ~f'~Y" "' ''''' ''''''''' unr.. " ""'00 "P'; Q\,,.. r ~np nn Inw 20 low ves laparotomy yes average no hIgh' '. lOW no colpotomy yes above average no high" mOderateb no

FULGURATION coagulate only isthmus laparoscopy moderate no high no hight 1-2 moderate yes coagulate & divide poor no high no hight 0.1-2 high yes coagulate & excise poor no high no hight 0-D_6 high yes interstitial hysteroscopy poor no above average yes hight 10-25 moderate yes (uterotubal junction) isthmus culdoscopy poor no high no high t 30-40 low yes

CLIPS Spring-loaded isthmus laparoscopy very good no high no hight 0.2-D.6 low yes (other routes possible)

Tant:Jlum h cmoc l ip~ i~ t hm u minilaparotOnlY very Qood no a VPfilge no low 5-18 low ves laparotomy no average no high" no colpotomy no above average no high" no culdoscopy no high no hight yes t laparU"';() f'Y nCi hlg" no hlgh ye!

BANDS Falope Ring™ isthmus laparoscopy not tested no high no hight nil low yes (other routes possible) procedures. It is performed via the abdominal or vaginal routes. on on a: '"» '" 2 In 1973, Stoot (The Netherlands) reported combining salpingectomy and cautery via colpotomy. Two linen sutures were tied around the tube close to the uterus. The more distal suture was also tied around the mesosalpinx. The tube was then cut and the remaining stump cauter­ o~ ized. Hysterosalpingograms performed three months fol­ lowing the procedure showed one tube was patent in two (1 .9 percent) of 106 women (140) . However, in a previous review of the literature, Garb (USA) found that investiga­ tors reported no failures following salpingectomy (43).

7o N Major Advantages Major Disadvantage • effective (0-1.9 percent • irreversible. failures); • can be performed by either abdominal or vag­ inal routes.

POMEROY TECHNIQUE. The Pomeroy technique of

on on tubal ligation is the most freq uently performed of all '"» '" ligation techniques. Although Pomeroy developed this technique in the early 20th century, it was not unti I after his death that a description of it was published by his col­ c: o leagues (7). The technique's simplicity and high degree of . '(;; '"OlOl '" 'tl ::J effectiveness have made it popular in all countries. The '" OJ ::"'­ ~ technique requires picking up the tube near the midpor­ ~ ~ .:,[ 0 OJ '" on tion to form a loop, ligating the base of the loop with '"> '" > .8.8 absorbable suture, and cutting off (resecting) the top of OJ OJ the loop. As the suture material is absorbed, the ends of the tube pull apart (128) (see Fig. 2) .

o 0 The IPPF Panel of Experts recommended the Pomeroy c: c: technique for tubal ligation, using traditional abdominal or -5'" vaginal approaches (62) . For many years, the technique has been the procedure of choice in the immediate puer­ perium at which time it is performed via laparotomy. For interval sterilization, Pomeroy ligation is performed via laparotomy, colpotomy, or culdoscopy, and recently by '"c: o minilaparotomy and laparoscopy. a. ::J al .§ Clark, Loeffler, Gre~ne, and Alexander have described Pomeroy ligation via laparoscopy whereby the tube is 0.>'" ...'" either tied within the abdomen or brought out through the ::J_ o '" abdominal puncture site for ligation (2, 14,45,81). How­ 0::;9~ .. '" 1:1 ever, the procedure is complicated, thus making this j:§ & approach less attractive than simpler ones, such as mini­ laparotomy.

Although the usual failure rate for Pomeroy ligation is low (0-0.4 percent) (43,90, 110, 152), some investigators have reported failure rates ranging from 2.5 to 5 percent when the technique is performed at the time of cesarean section (43, 103, 110). No account has been given for the high failure rate when the technique is used at this time. However, in 1970 Husbands reported that, among his en...I '"c: <{ '': patients, the failure rate for the procedure performed at (JU ... OJ cesarean section is comparable to that for interval Pome­ :E .!: <{ LI.I ::J u roy ligation. He reported one failure (0 .2 percent) in 400 ::to :E (J patients, 202 of whom were followed up for three years (57).

C-77 Major Advantages Major Disadvantage wed~ , of surrounding uterine myometrium is excised to previ . t endometriosis and ectopic pregnancy (1 44), the • simple to perform; • none. prox nal end of the distal segment of tube IS buried in the • highly effective (0-0.4 percent failure rate); broa ligament (see Fig. 2). • possible in the imme­ Aajor Advantage Major Disadvantages diate puerperium; • possible by the abdomi­ • or y a small amount of • moderately high fail re nal or vaginal route; tu e is exposed, thus rate (2.8- 3.2 perce-nt) • potentially reversible; pr ducing minimal in­ due to regeneration of • low morbidity. te erence with broad tubal epithelium in the li~ ament or ovarian cornual area; FIMBRIECTOMY. Fimbriectomy, removal of the distal bl od supply. • profuse bleeding, u_,u­ (fimbrial) end of the tube, can be easily performed by the ally from the tube, may vaginal route and is highly effective as an interval proce­ be difficult to control dure. Developed in 1935 by Kroener and reported in 1969 • high risk f postope a­ by his son, the technique involves placement of a double tive adhesions; silk ligature near the distal one-third of tube and excision • reversibility unlikely; of the fimbrial end (see Fig. 2) . Despite treatment of the • requires laparoto y. distal part of the tube, there is no interference with the ovarian blood supply. UCH JA TECHNIQUE. The Uchida technique of tu al occll ion is often performed in Japan where it prove to Fimbriectomy for interval sterilization is associated with a be e1f ective. The technique is also performed in so e low failure rate. For example, Kroener encountered no other ;ountries (e.g., USA), but on a more limited scale. failures among 146 women followed up for a minimum of six years (107). Uchid l (Japan) developed his technique of tubal li gation, reseclion, and burial in the mid-1940s. It requires that he Although fimbriectomy may be performed either through tube e brought out onto the abdomen through a sma I 1 the abdomen or vagina, the IPPF Panel of Experts favored cm or less suprapubic incision (minilaparotomy). Epi­ the vaginal route as an interval procedure or following neph ne-saline solution (1:1,000) is injected beneath he vaginal abortion because only the distal end of the tube seros in the ampulla of the tube which produces lo;al needs to be exposed. However, the Panel stated it should vaSCl ar spasm and ballooning of the mesosalpinx, t us only be performed when a nonreversible method is de­ separ ting the serosal surface from the m cular portion sired (67). of thE tube. The serosa is incised and stripp d back, a 5 ':m segm nt of the proximal tube severed, the short stu np Uchida, well known for his own tubal ligation technique, ligatE I with nonabsorbable suture, and a segment of t be has also developed a modification of the Kroener tech­ remo ed. The ligated stumps automatically bury '!he-m­ nique to prevent failures from recanalization associated selver beneath the serosa. The edge of the s rosal incis on with postpartum fimbriectomy. In the Uchida technique, is the gathered around the distal end of tube and tied i a the cut distal end of the tube is covered with serosa (a thin purSE ' string ligature so that the tube is left projecting irlto membrane), thereby providing an extra block to sperm or the a dominal cavity (145, 146) (see Fig. 2). Usi ng is ova (145,146) . Using this technique, Uchida encountered technique, Uchida claims he has seen no fai lures in 21,00 no failures in 405 postpartum fimbriectomies and no cases though many patients have not bee followed up failures in 120 fimbriectomies performed following cesar­ after Jbal ligation. ean section (175). t\ ajor Advantage Major Disadvantage

Major Advantages Major Disadvantage • hi~ Iyeffective. • more cOrlplicated to • nearly 100 percent effec­ • less effective when per­ perform than most li ga­ tive as interval proce­ formed abdominally tion procedures. dure; postpartum. • easily performed via vaginal route (also pos­ FULGURATION sible via the abdominal route). Fulguration (burning a segment of tube) is tubalocclu­ Ligation, Resection, and Burial sion n ethod used frequently in both developed and devel­ Ligation procedures which require burial of cut ends of oping countries during the past 15 years. 1 some coun­ the tube are more difficult to perform than simple ligation tries, uch as the USA, it has become more prevalent than and division or excision. Two ligation, resection, and ligatic 1 for accomplishing interval sterilization (see Tallie burial techniques still practiced today are cornual resec­ 1). It 13 usually performed via an endoscope (a viewi g tion and the Uchida technique. SCOpE inserted into the abdomen (Iaparosc py) or uter us (hyst! coscoPy), or through the vaginal cul-de-sac (c..l l­ CORNUAL RESECTION. Cornual resection is an exten­ doscc )y). Using a special instrument (e.g., grasping for­ sive procedure requiring laparotomy. First reported by ceps, irobe). burning heat is applied to a small pOint on or Neumann in 1898, cornual resection involves placing an withir the tube by a concentration of electrical current. absorbable ligature near the uterotubal junction, incising Howe er, to date, there is no standardization of kind and the tube proximal to the ligature, dissecting it free from the amou t of current or length of time it must be applied in mesosalpinx, and then removing 1 cm of tube. After a order 0 destroy the tubal lumen.

C-78 Table 2-Failures Following Laparoscopic Fulguration of the Fallopian Tubes in Selected Studies, 1973-1976

Author Reference Number of Technique of Failures & Date Number Patients Tubal Occlusion Number Percent Comments

Edgerton 27 2,018 coagulation, division, 12 0.6 9 luteal phase pregnancies* 1974 and excision 3 operator errors EI-Serour 28 82 coagulation and divi­ 1975 sion 3 2.0 operator error 70 coagulation only \IV!leeless 149,150 1,000 coagulation only 11 1.1 recanalization 1973 & 1976 1,600 coagulation, division 0.1 luteal phase pregnancy* and recoagulation of the cut ends Yuzpe 158 335 coagulation only 0*· 0 1974 I · ,Procedure performed during luteal rather than proliferative phase of the menstrual cycle at which time patient was pregnant. **No failures occurred following use of bipolar equipment.

Major Advantages Major Disadvantages also result in bleeding from the cut ends of the tube (37 . 124,130). Edgerton, an experienced laparoscopist, uses a • effective; • risk of burns and perfo­ mixed current for both electrocoagulation and cutting. • outpatient procedure; ration injury to adjacent This produces blanching, hemostasis, and cutting with • does not require large structures; very little charring and without the sparking which causes abdominal incision. • special equipment re­ quired (elect r ical burns (27). source, fulguration equipment); Because burns of the bowel or other adjacent structures • equipment difficult to have been reported following laparoscopic fulguration, maintain. many investigators now prefer to use bipolar instruments (current passes only between two closely placed elec­ trodes) or equipment employing only low voltage current. Laparoscopic Fulguration both of which reduce the hazard. Although laparoscopic fulgu ration is highly effective (0.1-2.0 percent failure rate) Of all fulguration approaches, laparoscopy is the most work is being done to eliminate failures and reduce mor­ popular because in the hands of a properly trained physi­ bidity. I n this respect, practitioners using the laparoscopic cian, it is not only quick but also highly effective. Laparo­ approach to tubal occlusion have been most concerned scopy was first proposed as an approach to tubal occlu­ with the number of times a tube must be burned and sion by ET Anderson (USA) in 1937 (4) and described whether the tube should be transected and/or a piece by Power and Barnes (USA) in 1941 (111). Although the removed (see Table 2). The debate over which method is technique was improved by Palmer (France) during the best still continues because the most effective procedures 1940s, it was not until the 1960s, following development of are often associated with high morbidity rates and the modern laparoscopes which use fiberoptic light bundles safest procedures with high failure rates. In 1975, 1,000 to transmit cold light from an external source directly into physicians from around the world were asked by the the abdomen. that laparoscopic fulgu ration of the fallo­ American Association of Gynecological Laparoscopists pian tubes became widely used. to state the tubal procedures they preferred (108). Results follow: Once the abdomen is insufflated with 2-4 liters of gas (pneumoperitoneum) and the tip of the laparoscope is Number Percent introduced into the abdomen through a small puncture, Coagulation only 214 21.4 the fulgurating instrument can either be inserted through Coagulation and division 404 40.4 a speCial channel in the scope or through a second tiny Coagulation and excision of puncture (see Fig. 3) . The tube is then picked up and either a segment 306 30.6 coagulating or cutting current. applied. The choice of Other procedures 27 2.7 current depends upon whether or not the practitioner Not answered 6 0.6 intends to divide the tube. Coagulation current causes No sterilization performed 43 --4.3 cellular dehydration and charring without division while 1,000 100.0 the intense heat of cutting current causes the tube to divide. Both kinds of current are potentially dangerous: coagulating current may produce sparks which burn The AAGL survey data must be interpreted cautiously adjacent structures (37 , 124, 130) and cutting current may since results of the different procedures chosen by the

C-79 respondents are subject to varying interpretation. How­ ever, the survey did indicate that failure rates (in terms of pregnancy) are about the same for all three procedures, but morbidity (e .g., mesosalpingeal tears with subsequent bleeding) was higher when a segment of tubewas excised (108) . The survey also revealed that the percentage of laparoscopists performing coagulation alone increased from 15.3 in 1974 to 21.4 in 1975-an increase probably due to the lower morbidity associated with this technique. Although early reports of coagulation alone revealed high failure rates, some practitioners now claim that if a seg­ ment of tube is adequately fulgurated (i.e., blanching is visible on each side of the fulguration instrument), failure is unlikely and there is thus no advantage in dividing the tubes.

Fig. 3. During laparoscopic fulguration, th operating Studies conducted in 1974 reveal that electrocoagulation lapE oscope (for single puncture laparoscopy) is inse ed without division using the new bipolar instruments may be thro IJgh lower rim of umbilicus. The fallopian tube is as effective as dividing the tube. Performing coagulation grat ed by the fulgurating instrument, inserted through a spe· ial channel in the scope. alone with a bipolar instrument, Yuzpe encountered no pregnancies in 335 women, many of whom had been fOllowed up for 10 months after sterilization (158). Broader experience is needed to determine the true efficacy of this destre l ed, potential exists for future reversal by surgi al technique. reana tomosis of the remaining ends (137) . The fact It at only \I w voltage is required-the amount supplied by a car batter -suggests that this procedure mi ght be used in Wheeless (USA) tested the effectiveness of coagulation areas where sophisticated electrical equipment is u nav ail­ alone versus coagulation and division with conventional able ( 29) . equipment. Among 1,000 women who were sterilized by coagulation alone, there were 11 failures (1.1 percent), Becal :;e excision of a segment of tube is the most compli­ most of which were due to recanalization of the fallopian cated of the fulguration procedures and associated with tube in the area of el ectrocoagulation (149) . In contrast, highel morbidity from mesosalpingeal tears which ca LI se the three-burn technique-where a portion of tube is bleed g, Soderstrom (USA) indicates it should only be excised and the two remaining ends coag ulated-resulted under aken by a surgeon experienced in operative lapa­ in no recanalization failures (150) . The failure rate re­ roscopy (132). Most practitioners who use this techni ue mained low (0.25 percent) in Nepal where this technique remo .e a segment of tube to confirm histo logically t 1at was used in 2,000 women, but 35 patients (1.7 percent) they ave fulgurated the tube and not an adjacent str c­ experienced tubal hemorrhage. All but two of the bleeding ture ~ . g . , round ligament). However, in n April 1!)75 complications were controlled by recoagulation through meet g in London, the IPPF Panel of Experts on Steriliza­ the laparoscope; the remaining two required laparotomy tion r ade the following statement regardi ng excision of a to control the bleeding (149). segrn lmt of tube:

Tt ) panel does not recommend the removal of parts of th:l Safer and equally effective sterilization by the coagulation ut rine tube for biopsy and histological examination as and division technique has been achieved by a few practi­ ct ,ck on the success of the operation. Su ch a procedur'! tioners using low thermal current (74, 129, 137). Prior to m y add an otherwise avoidable risk of hemorrhage, mak insertion of the fulguration instrument which is heated re ersibility more difficult, burden the pathological serv - Cf ,and increase the cost of the operation to the patie t c r from the inside by a wire, the operator selects the amount th service. Even when established practice in the com­ of heat and length of time it is to be applied. Because low m nity is to remove tissue for biopsy, the panel doe ~; not voltage (6 volts) and low temperatures (usually under C( lsider this an essential part of female ste ri lization. (68 1 140°C) are used, the risk of burns to nearby structures, such as the bowel, during fulguration is reduced. When OncE experience is gained in identifying the tube, mis­ the maximum temperature is reached and applied to the takef rarely occur. Thus, most physicians now si mply tube for the selected time, the coagulating forceps cools coag late and divide the tube without obtaining a sp o:l ci­ automatically. Thus, there is also little danger of burns men tsee Fig. 4) . from inadvertent contact with nearby structures following fulguration. One millimeter of the tube is burned on each Acce di ng to the 1975 AAGL su rvey, over 40 percent of side of the fulguration instrument; then, the tube is divided phys ians coagulate and divide the tu be, while 30.6 and hemostasis ascertained for the remaining ends. Only perc'7/l t (down from 50 percent in 1971) excise a segment those vessels in the mesosalpinx immediately adjacent to of tu e (108). The coagulation and division procedure is the segment of tube treated are coagulated. Therefore, the not ( I Iy less complicated to perform than excision, but risk of bleeding is also minimized. Using this technique, also rasults in a low failure rate if transection is complete Semm has performed over 270 sterilizations without acci­ and cludes a segment of the mesosalpinx. In Soder­ dents (129), but the technique is still experimental and stror 's opinion one adequate transection is superior to only limited experience with low thermal coagulation has mult pie partial or incomplete ones because it more fully been reported. Because only a small section of tube is prev nts recanalization (132).

C-80 Major Advantages Major Disadvantages • riighly effective (0.1-2.0 • requires light source, in­ percent failure rate); sufflation, and fulgura­ • permits visualization of tion equipment; the pelvic cavity for pa­ • equipment expensive thology at the same time and difficult to maintain. sterilization is per­ • successful reversal un­ formed; likely; • quick (requires 15-20 • high risk of burn morbid­ minutes); ity (0.2-1.3 percent); • outpatient procedure; requiresa high degreeof • does not require an ab­ physician skill. dominal incision.

Hysteroscopic Fulguration Fig.5. A hysteroscope is introduced into the uterine cavity which has been distended by gas or liquid. Under direct Although most physicians consider hysteroscopy easier vision, an electrode inserted through a channel in the to perform than laparoscopy because it requires less scope is guided toward the uterotubal junction for subse­ equipment, tubal fulguration by hysteroscopy has been quent electrocoagulation. (Source: Pauerstein, C.J., (106), generally unsatisfactory because of the high incidence of p. 166.) failure and morbidity. To occlude the tubes, a hystero­ scope (fiberoptic scope) is inserted via the cervix into the uterus, and an electrode inserted through a channel in the hysteroscope is passed into the tubal orifices at the coagulation using a hysteroscope. Subsequent improve­ uterotubal junction. An electrical coagulating current is ment in instrumentation and experiments with media (e.g., then applied (see Fig. 5). nitrous oxide or dextran) to distend the uterus made it easier to locate and place an electrode directly into the Early attempts at cornual occlusion involved the blind tubal orifices under direct vision, thus increasing the insertion of a cautery sound into the upper angle of each safety and effectiveness of fulguration. uterine horn. Although first attempted by Kocks (Ger­ many) in 1878, it was not until 1929 that the first patient Failures may be caused by technical difficulties. Uterine series of any size was reported. At that time, Dickinson anomalies such as polyps, deep uterine horns, or a uterine stated he had performed "cautery stricture of the uterine septum can prevent passage of the electrode into the tubal ends of the tubes" in 65 women . Current was passed for 10 orifices (114). Another technical difficulty occurs after to 30 seconds-the longer period of time used for women cauterization of one tube if tissue adheres around the with more vascular uterine linings. If the tubal vestibules probe, insulating it so that fulguration of the second tube were difficult to locate, X-rays were used to visualize the is less effective. To increase the effectiveness of the cornua (25). Dickinson reported the "new hysteroscopes" second fulguration, Lindemann uses a different probe on would permit direct visualization of the uterotubal junc­ the second tube (78) . tion and might improve the transcervical route to steriliza­ tion (25). Gauss and Mikulica-Radecki (Germany) and In a review of 10 hysteroscopiC sterilization studies involv­ Freund (Germany) in 1928 and Schroder (Germany) in ing a total of 524 women, Darabi reports a failure rate 1 . noted some difficulty in attempting tubal electro­ ranging from 12.5 to 82.8 percent. I n the total series, there I were 186 fail ures (35.5 percent), 175 of which were disco­ vered during postoperative tubal occlusion tests. Eleven pregnancies occurred following tests for tubal occlusion. A 23.7 percent failure rate was noted among women who were not tested postoperatively (19) .

Failures in the form of interstitial (within the interstitium of the tube) or cornual (withi n the myometrium of the uterine cornua) pregnancies have occurred following hystero­ scopic fulguration . Israngkun reported eight such preg­ nancies (3.1 percent) among 251 women sterilized by this procedure (61). Because these pregnancies may rupture and lead to severe hemorrhage and are thus hazardous to the patient's life, he determined that hysteroscopic fulgu­ ration should not be done in rural areas of developing countries where backup medical facilities are not available (61) .

Lindemann, who discovered interstitial pregnancies in Fig. 4. Steps in laparoscopic fulguration of fallopian tube two patients two months after fulguration, hypothesized on a surgical specimen: 1) approaching tube, 2) grasping that high frequency current does not destroy enough tube tube with coagulating forceps, 3) fulguration and cutting, and its deep penetration into tissue causes necrosis and and 4) final appearance of tube (whitened with chalk for clarity). (Courtesy of Dr. William Brenner, University of enlargement of the tubal openings which can lead to North Carolina, Chapel Hill, USA (9).) failure of the sterilization (79). Subsequently, he used a

C-81 low-voltage-current thermoprobe* (a sound heated from the inside) in which temperature can be predetermined CLIPS and accurately controlled, thus minimizing the risk of burns to other than tubal tissue. No ectopic pregnancies resulted, but the overall effectiveness rate (88 percent) in Since lips to occlude the fallopian tubes a e associated terms of tubal occlusion had not improved (79, 129). with Ie N morbidity, are easy to apply by the bdominal r vagina l route, and may result in a potentially reversible Most investigators now recognize that timing the passage tubal ( 'clusion, their use in female sterilization is gaini g of cu rrent and regulating voltage are important to provide wider ttention. However, clips are not use as often s sufficient damage to the tubal ostium without spreading ligatio or laparoscopic fulguration methods because of current beyond the uterine muscles and tubes. Neverthe­ the PI walence of reported failures, inclu ing ectopic less, use of controlled temperatures and of time durations pregn ·ncies, with some models. has not greatly improved the effectiveness of hystero­ scopic fulguration (133, 134). Although investigations are continuing in an effort to find the optimal procedure (see In 195 ,Evans (USA) suggested that clips were a simple, Table 3), many physicians have abandoned hysteroscopic safe, c ld quick way to occlude the fallopian tubes (33). In fulguration in favor of introducing chemicals or trying the H 'Os when the use of cautery for tubal occlusi n different approaches to tubal occlusion. becan '3 popular and reports of burns to structures near the tu e began appearing in the literature, a number f Major Advantages Major Disadvantages physi( ans began experimenting with clips s a less haz­ ardou method of tubal occlusion. no incision required; risk of uterine perfora­ • quick outpatient proce­ tion and burns; dure. high failure rate (11 ­ 35 Despi ! the simplicity of clip application, a imal experi­ percent); ments ;onducted in the 1960s showed that lips often are risk of ectopic or cornual less e ective than conventional methods, either becau .3 e pregnancies; they e pand after application renewing tu b I patency or • frequent technical diffi­ becau e they become dislodged from the tube (83,100). culties in locating tubal Despi- 1 failures, researchers were encouraged by til e orifices; minim I damage to the tissues which makes t e proced ure • may not be immediately poten ally reversible. In one of the first a imal experi­ effective. ments reported by Neumann and Frick in 1961 , paten y was ru tored in 50 percent of the fallopian tubes of ba­ *NTC thermoprobe, F.M. W iest, K.G ., Reic hpietschufer 20, Berlin boom after clips were removed (96) . However, in 19 74 30, Federal Republic of Germany. exper rnents by Ma and Wong (Hong Kong), only 2 (9

Table 3-Female Sterilization by Hysteroscopic Fulguri ion in Selected Studies, 1974-1976

Number Co.. ula­ Refer­ Failures Failures Total Effect- Author Number of Kind of of t i n ence Current Indicated by Indicated by Failures ivene:lS & Date Patients Fulguration Seconds Terri era- Number Tubal Patency Pregnancy (Percent) (Percentl Applied t l e

Israngkun 61 251 high 30 watts at 45-60 1\ I NR 48 (8 ectopic 19 81 1976 frequency 2-3 volts or cornual pregs.)

Lindemann 79 48 low 2 watts at 60-90 95- 40°C 10 unilateral} 1976 thermal 6 volts 48 52 12 bilateral

360(314)* high 25-30 watts 30-90 9( C 21 unilatera'} frequency 9 (2 ectopic) 11 89 13 bi lateral

260(216)* high 2-3 watts at 60 9( C 17 unilatera} frequency 5 volts 7 (1 ectopic) 11 89 6 bilateral March 87 27(23)* high 30 watts 12 1\ I 2 1975 frequency Quinones 113 800(70)* high 27 .8 watts 4 1\ I 26 74 1976 frequency 18 } 5 (3 cornual) (179)* high 27.8 watts 6 1\ I 30 17 83 frequency Sugimoto 141 38(16)* high 30 watts or 3-4 1\ I 0 0 0 100 1974 frequency 40 watts 2

* Number of patients followed up appears in parenthesis. **Of 16 patients, 11 had sinus tracts which could lead to later recanalization fi lure. NR = Not Reported

C-82 percent) of 22 rabbits became pregnant following clip There is also danger of subsequent ectopic pregnancy removal and nine months of breeding (83). The investiga­ when a clip opens wide enough to permit passage of tors hypothesized that interruption of the blood supply to sperm but not a fertilized ovum (49, 97 , 106). ln an effort to the tube may have caused permanent injury making rever­ reduce this hazard and increase effectiveness, Wheeless sal impossible (83). and other investigators applied two clips to the tubes, but the fai lure rate remained unacceptably high (11.2 percent) Realizing that tubal physiology and fertility rates in ani­ (148). The highest effectiveness rate (0 .9 percent failure mals are different from those in humans, several investiga­ rate) was achieved by Gutierrez-Najar who applied two tors began applying clips to human fallopian tubes. Re­ clips and then cut between them. However, as with all searchers used the approach to the tubes most familiar to procedures where the tube is transected, there is greater them-laparotomy, laparoscopy, colpotomy, or culdo­ risk of bleeding from the cut ends of tube. scopy. Particular consideration was given to the number of clips applied to the tube, where they were applied, and Major Advantages Major Disadvantages the material used to make them (132) (see Table 4) . • simple in design and ap- • high failure rate (0.0-11 Tantalum Clips plication; percent; potentially reversible; Most of the clips used by investigators in the last two • risk of ectopic pregnancy. decades have been made of tantalum, a non-tissue­ inexpensive; • application possible by a reactive metal. The most frequently used model is simple number of approaches. in design with grooves on the inner surface to secure its grip on the tube. It is applied to the tube via a specially designed pliers or applicator (see Fig. 6) . Reports of failure with tantalum hemoclips have led a few investigators to develop new designs to improve the Previously, the clip was used to provide hemostasis (stop efficacy of clips. One of the most recent designs is being bleeding) during surgery and was highly effective when developed by Filshie (Great Britain) in cooperation with used for that purpose. However, the clip is less effective the Simon Population Trust. The clip has an outer surface when used for tubal occlusion. Failure rates of more than of tantalum and a soft-ridged inner core of Silastic. It has 10 percent, particularly among puerperal patients, have been tested successfully in animals and human trials are been recorded (49). Failures usually result when a clip: to begin soon (11) . migrates off the tube; Spring-loaded Clips • opens slightly, renewing tubal patency (may be caused by normal buildup of intraluminal secretions); In extensive clinical trials a spring-loaded clip designed in • cuts through the tube leading to recanalization; the 1970s by Hulka and Clemens (USA) has been judged • opens subsequent to the pressure produced by a more effective than the tantalum clip. The clip has two hysterosalpingogram or injection of dye used to test plastic-toothed jaws which are hinged by a metal pin and tubal occlusion. are locked closed around the tubes by a stainless steel

Table 4-Tubal Occlusion by the Application of Clips in Selected Studies, 1971-1975 l I Number of Effect­ Reference Number of Approach Part of Tube Failures* Author & Oate Kind of Clip Clips Applied iveness Number Patients Used Treated Number Percent to Each Tube (Percent)

Davidson 20 9 tantalum laparoscopy 2 NR 2 22 78 1972 hemoclip Gutierrez-Najar 47 1112 tantalum culdoscopy 2 isthmus (cut 9 99 1971 hemoclip between clips) Haskins 49 100 tantalum laparotomy isthmus 11 11 89 1972 (puerperal) hemoclip 250 tantalum colpotomy isthmus 3 99 (nonpuerperal) hemoclip Huang 52 64 tantalum culdoscopy isthmus 3 7 93 1975 hemoclip

Hulka 53 907 spring- laparoscopy isthmus 24 2 98 1975 loaded Mroueh 94 150 tantalum culdoscopy isthmus 1(ectopic 18 82 1976 hemoclip preg.) 600 tantalum culdoscopy 2 isthmus 3(1 ecto­ 5 95 hemoclip pic preg.) Wheeless 149 52 tantalum laparoscopy 2 1 & 2 cm from 14 27 73 1976 hemoclip cornua

* For recorded failures, no differentiation is made between tubal patency and pregnancy. NR = Not Reported

C-83 spring (see Fig . 7). Although the clip may be placed on the isthmus of the tube by any route, its applicator was originally designed for laparoscopic use (see Population Reports, Series C, NUf11ber 4, March 1974).

As of March 1974, the spring clip had been applied in over 1,000 women at nine different locations with a minimum one-year follow-up (56). The majority of clip applications was done as interval sterilization. A few procedures were done following a first or second trimester abortion, but because the tubes are edematous after second trimester abortion, two clips were applied.

In a follow-up study of 907 patients, 24 failures occurred : 11 were due to operator error; 3 were luteal phase preg­ nancies; 3 occurred in early experiments using a proto­ type clip with incorrect spring tension; and in 7 the cause of pregnancy was unknown. On reexamination of 2 of these 7 patients, clips had been properly applied (56). Hulka reports that if properly manufactured clips are Fig , 7. A spring-loaded clip in its laparoscopic applicator correctly applied to the tube, the pregnancy rate will be pri r to closing on fallopian tube. (Courtesy of Dr. Jaroslav Hu a, University of North Carolina, Chapel Hill, USA.) about 2/ 1000 or less (53). He suggests that the failure rate is likely to be slightly higher than that for fulguration because the tube must be caught properly in the jaws of joinec To date, reversal by reanastomosis with Dexon !') ' the clip. Thus, there is greater chance of operator error. sutUrE has only been attempted in 8 pigs, six months folio", ng clip application. Six of the eight pigs became Only minor morbidity has occurred following spring-clip preg n nt. Therefore, a 75 percent restored fertility n te application. Although a vagal reflex (nausea, faintness, occur1ed which compares favorably to an 80 percent bradycardia, hypotension) occurred in 8 percent of Uni­ fertilil rate for pigs under normal husbandry conditions versity of North Carolina patients, the most often reported (55). side effects during or following clip application were abdominal pain and cramps (26 percent of patients). In ~ ajor Advantages Major Disadvantages countries where more sedation and local anesthesia are 10\ morbidity; high cost of clip a d used, operative pain has not been a reported problem. In OL patient application appl icator; other series, the application of local anesthesia to the tube pc sible; technically difficult. has eliminated operative pain . Cramps lasting up to 48 pc entially reversible; hours following the procedure are thought due to the • ef 1J ctive (0.2-1.5 per­ pressure of the clip on nerve endings in the tube and ce t failure rate). mesosalpinx and are treated with analgesics. Plastic Clip To reverse occlusion produced by the spring-clip, the Use 0 a plastic clip to occlude the fallopian 1ubes is bei ,lg section of tube under the clip which has undergone invest i gated by Bleier in Germany. The clip IS 10m IIO.1g necrosis is cut out and the two remaining ends of tube and 4 mm wide. Between 1970 and 1973, the cli p v.as appliE. i to the fallopian tubes of 600 women via colpotomy, lapan. omy, or minilaparotomy. No mortality was reported and t e only morbidity was slight bleeding from t e fallop In tube and ovary. It is possible that bleeding res Its from ' )ars of the vessels in the mesosalpinx which occur as thE clip's latch snaps shut (53). No adh sions formed folio'll ng clip application. Technical diffi ulty was en­ count red in a few cases (number unreported) in which the cl , ) broke at its joint during application. In 1975, two failun .3 (pregnancies) were reported as resulting from operalor error in which the clip was placed on to the meso alpinx instead of the fallopian tub . Reversal of sterili ation following clip application has not yet been attem lted (8).

BANDS

Fig. 6. A tantalum Weck Hemoclip® being applied to The L ;e of bands is a recent addition to tubal oCc;usiDn fallopian tube by means of a special laparoscopic clip meth( :Is. To date, they are utilized in only a few clini :al applicator. (Photo courtesy of Dr. Hans Frangenheim, cente 3 around the world. The best known ~f the C;Jrrtmt Chief of the Womens' Clinic, Kostanz, Federal Republic of Germany. Weck Hemoclips are manufactured by: Edward Weck & Company, Inc., 49-33 31st Place, Long Island City, 'Davis Jnd Geck. American Cyanamid Co., Pearl River, New Y'Jrk New York 11101, USA.) 10965, JSA.

C-84 designs-the Falope Ring'· (also known as the Yoon Falope Ring cases and a lower failure rate for fulguration band)-has been tested clinically only within the past cases (0.4 percent) than for spring-loaded clip cases (1 .5 three years. Like clips, bands may be applied by any percent). The incidence of technical difficulties was also approach, except the transcervical, to occlude the fallo­ lower for the Falope Ring, but operative and postoperative pian tubes by the external application of pressure. The complication rates were slightly higher than for the other amount of continuing pressure which will allow bands to two procedures: adapt to tubal changes without expanding too widely or cutting through the tube is an important factor in deter­ Falope Ring Fulguration Spring-Loaded Clip mining their effectiveness. (N=312) (N=967) (N=976) No. % No. % No. % Falope Ring'·' Technical Difficulties 9 2.9 34 3.5 66 6.8 Experiments using a silicone rubber band developed by Operative Yoon (USA) began in 1973. The Falope Ring is a small (1 Complications 5 1.6 9 0.9 12 1.2 mm inner diameter) silicone circle which exerts 0.3-0.4 Postoperative pounds per square inch. It will revert to 90-100 percent its Complications 10 3.2 18 1.8 15 1.5 normal size and shape after application if not stretched beyond 6 mm (156) . The only operative complication reported for the Falope Ring was bleeding from the tube or mesosalpinx requiring The Ring can be applied to the tube by a variety of cautery or the application of another Ring. Early postoper­ routes-laparotomy, minilaparotomy, culdoscopy, col­ ative complications were due to pelvic orwound infections potomy, or laparoscopy. To date, however, most have (9). been applied by one- or two-puncture laparoscopy (see Since doctors from the USA, Korea, the Philippines, India, Fig. 8). The Ring was developed to eliminate the hazards of Thailand, Egypt, Iran, and Mexico are receiving training in electrocautery during laparoscopy and, at the same time, the Falope Ring procedure, data based upon broader provide a simple tubal occlusion method surpassing the experience are now being collected (1,65). For example, effectiveness of tantalum hemoclips. After the Ring is the International Fertility Research Program (Research slipped onto the base of a loop of the tube via a special Triangle Park, North Carolina) has analyzed data from applicator, the loop blanches white as the blood supply is Bangkok, Singapore, Seoul, San Salvador, and the USA. cut off and eventually undergoes fi brosis (154, 156) . Pregnancy failure rates using the life-table method were computed for those women who were not pregnant at the When the Ring is applied via laparoscopy, there is no time of a completed sterilization that was successful danger of burns since electrocautery is not required. In according to the operator. Pregnancy rates per 100 addition, only a small amount of insufflation gas (1.5-2 women followed up at 12 months wereO.3 for the Ring (480 liters) is needed. women followed up), 0.2 for fulguration (1,576 women followed up), and 2.1 for spring-loaded clip (949 women Nearly 4,000 women have been sterilized by the Falope followed up) (65). Although both operative and postopera­ Ring since 1973. Over 900 procedures were performed at tive complications appeared lower for the Ring than for the Johns Hopkins University; the rest were carried out in fulguration or spring-loaded clip, a larger series of pa­ Seoul (Korea) and Manila (the Philippines). Whenever the tients with Ring-occluded tubes is needed to provide an Ring was properly applied, there were no failures. Of the 3 adequate basis for comparison with other methods. reported failures among the 500 cases evaluated, 1 was caused by operator error when two Rings were applied to the same tube; 1 resulted from an uncompleted procedure due to adhesions; and the third was a luteal phase preg­ nancy. Tubal transection (10 in 370 cases) was most likely to occur when pelvic inflammatory disease or adhesions were present (156). Transection of the tube can also result from pulling it too strongly toward the applicator rather than lowering the tip of the instrument toward the tube to lessen tension. If the tube is transected, a Ring can be applied to the end of each segment, or the ends can be electrocoagulated. Lower abdominal cramping lasting up to 48 hours occurred in 32 of 567 cases and may be due to avascular ischemia of the treated knuckle of tube. Applica­ tion of an anesthetic jelly to the tube during the application procedure has eliminated pain. In 8 cases the Ring was dropped into the abdomen by the operator. Because the Ring is non-tissue-reactive, it is not essential that it be retrieved (156). Fig. 8. Steps in application of Falope Ring'· to tube of In a comparison of the Falope Ring, fulguration, and the a surgical specimen: 1) approaching tube with Ring resting spring-loaded clip methods of tubal occlusion performed at end of applicator, 2) grasping tube with tongs 2-3 cm via laparoscopy, Brenner reported no fai lures among from uterine cornu, 3) retracting loop of tube, and 4) final appearance of tube with Ring applied. (Courtesy of Dr. William Brenner, University of North Carolina, Chapel Hill, 'KL!, 65 Industrial Drive, Ivyland, Pennsylvania 18974, USA. USA (9).)

C-85 Major Advantages Major Disadvantage tube, t us forming a plug (e .g., tissue adhesive), or by • outpatient procedure • special applicator re­ destro ng the inner lining of the tube with subseque t (discharge in 3-6hours) ; quired. fibrosil (sclerosing agent) (see Table 5) . I vestigat ions • low morbidity; are un erway to determine which substances are mo t • low failure rate; effectil l, the proper dosage, and the best in strumentatio • potentially reversible for de very. Advantages and disadvanta g ~ s of some (only a small segment of chemic lis have not yet been fully determined. tube is damaged). Chemi als may be introduced through the cervix and CHEMICALS instiller into the tubes at the uterotubal junction und r direct sion via a hysteroscope or blindly VI a catheter. They n ay also be introduced into the fimbri I end of t e Several chemicals are now being used experimentally to tube u der direct vision via the abdominal or vaginal occlude the fallopian tubes. While many chemicals have routes. rhe transcervical route to the uterot bal junctio n been tested in animals, only a few are being used in is used most often because it is simplest to tJerform and humans. These chemicals either act by solidifying in the requirE no incision.

Table 5-Tubal Occlusion by Chemicals in Selected E perimental Studies, 1971-1976

Refer­ Number of Number .ind of Effect­ Author ence Formulation Failures of Sub­ Chemical Used C. emical Where Applied iveness & Date Num­ & Dosage Indicated by jectsa Agent (Percent ) ber Patency

Alvarado 3 30(16)b quinacrine NR 5 lerosing uterine cornua 10 (6 unilateral 37 1974 & 4 bilateral)

Benoit 6 30 quinacrine & 1 gm in 6 ml H2O 5 lerosing uterus 17" 43" 1975 atropine 0.4 mg 11 " " 77"" 83t

Dafoe 18 8(4)b paraldehyde 0.5cc of 16 molar 5 lerosing uterine cornua 1 (unilateral) 75 1976 suspension of 4.8 gm paraldehyde in 10 ml ethanol Davidson 21 60(48)b quinacrine 5-6 ml suspension of s [erosing uterus 47 (of 96 tubes) 0 1976 1 gm quinacrine in (6 pregnancies) 7 ml H2O 50135)b quinacrine (same as above; im­ s lerosing uterine cornua 12 (1 pregnancy' 76 proved instrumenta­ tion) Erb 29,31 19 silastic 80 part medical tis­ t sue 95 1974 S-382 sue elastomer & 20 a hesive & 1976 parts 360 medical fluid + 1 % stannous octoate

Isranghkun 62 60 quinacrine 60 gr in 7 ml H2O 5 lerosing uterine cornua 26 44 1976 Lindemann 79 50(16)b methyl-2-cyano­ 0.5 ml t sue interstitial 3 (unilateral) 81 1976 acrylate (MCA) a hesive Rakshit 118 6 silastic NR t sue uterus 6 0 1972 S-5392 a hesive 21 silastic NR sue uterus 3 86 S-521 a hesive Richart 121 14 silver nitrate 0 .2 ml of 10% hydro­ s erosing fimbria 0 100 1971 philic ointment Stevenson 139 41 methyl-2-cyano­ 1 ml t sue uterus 13 (11 unilateral 66" 1975 acrylate a hesive & 2 bilateral)" 3 - ­ 92 -­ Zipper 161 638 quinacrine 1.5 gr (various s erosing uterus 241 (50 preg­ 69 1975 & potentiating dosages) nancies) agents

"after one instillation ""after two instillations t after three i nsti lIat ions aA11 studies involved human subjects except Erb who use d rabbits. bNumber of cases followed up appears in parenthesis. NR = Not Reported

C-86 Ideally, chemicals should be: In a 1974 report, Moulding (USA) suggested that failure of • delivered by a single instillation; a quinacrine suspension to enter the oviducts may be the • 100 percent effective; cause of the high failure rate. He recommended additional experiments using a more viscous preparation and a • nontoxic; cannula without an occlusive tip (93). • inexpensive; • readily available; • confined to the tubes (no intraperitoneal spillage); A number of investigators have attempted to improve the • painless to the patient; effectiveness of quinacrine by using instillation equip­ • stable, with unlimited shelf-life. ment which prevents reflux (drainage) of the chemical from the uterus. Despite the use of an indwelling catheter to prevent reflux and the administration of atropi ne sulfate Chemicals which are toxic enough to cause tubal fibrosis to prevent spasm of the uterotubal junction, Benoit (Can­ may also damage peritoneum or viscera upon contact. If ada) achieved only a 77 percent tubal occlusion rate in 30 they enter the vascular system, they may end up in the women after two instillations. Davidson (USA) obtained lungs or elsewhere causing tissue damage. Therefore bilateral occlusion in 6 women following only one instilla­ toxic chemicals require a delivery system which prevents tion of 680 mg of quinacrine using a flexible polyethelene intraperitoneal spillage (134). cannula to prevent reflux. Only a 44 percent tubal closure rate , tested by hysterosalpingogram, was obtained by Major Advantages Major Disadvantages Israngkun and associates (Columbia University, New • simple to administer; • most are ineffective after York, USA) who instilled 60 grof quinacrine hydrochloride • outpatient proced ure. a single administration, in 7 ml of water into 60 women via a Kahn cannula fitted requiring the women to with a device to prevent influx (62). return for further treat­ ment; While instruments are still being developed to refine the • some are highly toxic to tissue, thus carrying the blind (not under direct vision) instillation of quinacrine, Alvarado and Quinones (Mexico) tried instilling the chem­ risk of damage to nearby ical into 30 women under direct vision via hysteroscopy. structures; However, the subsequent high failure rate (62 percent) • many require special in­ caused the investigators to abandon th is route for delivery struments for adminis­ of the chemical (3, 114). tration; • the action of many chemicals is irreversible; Animal experiments to reverse the effects of quinacrine • dosage required is not have been conducted by Zipper and his associates. Tubal always predictable. patency was restored in formerly obstructed tubes of rats by administration of an estrogen (estradiol benzoate) or progesterone between 1 and 28 days after instillation of quinacrine (159, 160). Similar results in monkeys were Quinacrine obtained by Malaviya (India) who injected estrogen (estra­ Quinacrine is the chemical most often used to occlude diol dipropionate) from days 16 to 20 following instilla­ human fallopian tubes. It is a sclerosing agent, which was tion. These investigators conclude that estrogen antagon­ first used by Zipper (Chile) in 1961, and is usually deliv­ izes the tubal occlusion action of quinacrine and is ered to the tubes through the cervix via a catheter or capable of reversing an already established occlusion cannula (see Fig. 9). (85). Major Advantages Major Disadvantages In 1975, Zipper reported on studies conducted between inexpensive; high failure rate (6-30 August 1961 and September 1973 during which quina­ • easily instilled by a sin­ percent) ; crine was instilled into the fallopian tubes of 800 women. gle instrument; usually more than one Of these women, 638 were observed for a total of 14,677 • outpatient procedure; instillation required; woman-months. Five different dosages or combinations requires little or no local • needs improved instru­ of quinacrine with other pharmacological agents were anesthesia. mentation for delivery studied. Considering all instillations, tubal occlusion was into the tubes. observed in 437 (68.4 percent) of the 638 women. The most effective combination for occluding the tubes was quina­ Silver Nitrate crine plus xylocaine with or without epinephrine instilled in two successive cycles of the menstrual cycle. This Although si Iver nitrate was one of the fi rst chemicals combination of chemicals yielded a 94 percent tubal investigated to achieve tubal occlusion, it is seldom used obstruction rate after two instillations (161). In the entire today. As early as 1849, silver nitrate was instilled into the series, 2 patients experienced excitation of the central uterine cornua of cesarean section patients via a sound nervous system and were treated with barbiturates given (42). In 1971, more than a century later, Richart (USA) intravenously. Sixteen other women experienced minor instilled 0.2 ml of 10 percent silver nitrate in hydrophilic complications: 7 women had amenorrhea lasting three ointment into the isthmus via the fimbria of 12 women by months; 4, intrauterine adhesions; 4, chemical vaginitis; culdoscopy. Hysterography conducted 8 to 12 weeks and 1, a skin rash (161) . following the procedure disclosed bilateral tubal occlu­

C-87 Tests n animals have shown that while th silastic pi g confo TlS to the tubal lumen and resists deformation a d expul ~ . on, its high tensile strength permit removal by pullin itoutofthetube(29,30,31).However,becauset e huma fallopian tube is more tortuous, re lOval may e more ifficult if not impossible (120).

To de e, Erb has conducted only animal experiments. There was 1 failure (S.3 percent) among 19 rabbits in which the silastic was instilled. The failure Nas probat Iy - __---vaginal speculum due tl poor instillation since no plug wa s found in the uterin horn where two fetuses were discovered. Fo urte en Fig. 9. Quinacrine is delivered without direct vision high in of eig l teen plugs were successfully removed in 9 rabbits, uterine cavity near tubal ostium via a catheter or cannula. but fe tility was restored in only 29 percent fthe rabbi es. Erb sl lggests that the low fertility rate after reversal W3S due te the tem porary loss of functioning by those ciliat-e d sion in all patients (121). Despite its effectiveness, experi­ cells il the endosalpinx which came in contact with the ments using silver nitrate were discontinued because the plug. Thirty days following instillation there was no e li­ chemical was difficult to deliver into the tubes and it dencE )f tissue damage or alteration and no inflammati ~ n tended to spill out the ends of the tubes into the pelvis. In of the ube (23). Tests conducted 56 days following ins il­ addition all patients experienced abdominal pain for two lation '-evealed that there was no expulsion of the pluGs. to five days postoperatively (120) . An im rument to deliver the silastic plug in humans is n(lW being Jeveloped (31) (see Fig. 10). Silastic· A number of adhesive substances-silastic (a silicone r.. ajor Advantages Major Disadvantages polymer), methyl-2-cyanoacrylate (MCA) , and gelatin­ • po ~ntially reversible; • effectiveness in huma s resorcinol-formaldehyde (GRF)-have been instilled no -tissue-reactive not investi gated suffi­ experimentally into the uterotubal junction to form a plug. (m limal side effects) ; ciently; These compounds are highly viscous (sticky) when in­ no ncision required . requires sophisticat ~d stilled and polymerize (solidify) in place. equipment; plug may reak d ri g Silastic, first suggested in 1965 by Cortman and Taylor removal. (USA) (1S), is one of the most promising tissue adhesives in terms of effectiveness and reversibi I ity. In 1967, Hefnawi investigated its effectiveness in animals. He instilled a MeA highly diluted, low viscosity silicone (SO parts medical grade elastomer/ SO parts medical fluid) into the oviducts Resul ; from animal and human experimentation invo v­ of 37 rabbits. When the plug was retained, the procedure ing IT lthyl-2-cyanoacrylate (MCA) monomer, a ti ssJe was 100 percent effective, prod uced no inflammatory adhes Ie, indicate that it can be an effectiv . but irrever" i­ reaction, and was reversible (SO). However, many of the ble m! thod of tubal occlusion. Experiments sing MCA to plugs did not remain in place, but were ejected from the occluf e the fallopian tubes began in 1965 when Corfm il n distal end of the tube into the peritoneal cavity. instill! j the chemical into the uterotubal junction 01 9 rabbit. The resulting tubal occlusion was d emons ~ rat l d by inj! ~tion of saline containing methylene blue one to ~ ; ix Rakshit in India was thefirst investigator to instill silastic in humans. Blind transcervical instillation of the silicone polymer S-S21 into the uterine cavity of 30 women resulted in tubal occlusion in 21 (70 percent), doubtful occlusion in 6, and failure in 3. There was one failure among 10women in whom S-S21 was instilled transabdominally. In no case did tissue reaction occur. Rakshit observed that tubal peristalsis gave the silastic a segmented appearance as it solidified. This suggested the need for a catalyst that would promote rapid solidification and prevent intraperi­ toneal spillage of the silastic (116).

Erb (USA) found a means of preventing intraperitoneal spillage by mixing 1 percent stannous octoate with 80 parts medical elastomer (S-382) and 20 parts 360 medical fluid. Stannous octoate, a catalyst, transforms the viscous silastic liquid to a rubbery solid in about four minutes.

Fig . 10. A Silaslic plug introduced into uterine cornua to bioI k tubal ostia. (Courtesy of Dr. Robert Erb, Franklin Insl ute Research Laboratories, Philadelphia, Pennsylva­ 'Dow-Corning Corporation, Midland, Michigan 48640, USA. nia, SA (29).)

C-88 weeks after instillation and confirmed histologically. By GRF six weeks the tubal epithelium was destroyed and exten­ Animal experiments with gelatin-resorcinol-formalde­ sive fibrosis had taken place (16) . hyde (GRF). a biodegradeable tissue adhesive. reveal that it may prove effective in blocking the fallopian tubes in In 1975. Stevenson (USA) reported the results following humans. Resorcinol promotes adhesive strength and pre­ transcervical instillation of MCA into the tubes of 41 vents immediate breakdown. while formaldehyde acts to women via an intrauterine catheter with a balloon (to solidify the gelatin-resorcinol solution and to promote prevent endometrial contact) on the seventh day following adhesion between the glue and tissue. menstruation. Ten to fourteen weeks following instilla­ tion. the tubal lumen was obliterated by fibrosis. and by 24 The route for delivery of GRF is still under investigation. weeks. no polymer was evident in the occluded tube. On Although Falb (USA) acknowledged that GRF could be follow-up tests 27 (66 percent) of the 41 women had delivered by hysteroscopy. he expected this approach to bilateral occlusion following one instillation of MCA. The eliminate its simplicity and the possi bil ity of its delivery by 14 other women who had one tube patent were given a nonphysicians. Therefore. investigations have begun to second instillation and 10 of these had subsequent block­ improve a cannulation device with a silicone tip for blind ing. Two patients (5 percent) had bilateral tubal patency introduction of GRF (35). after the first attempt: 1 withdrew from the study. and in the Clinical trials of GRF in humans have not yet been con­ other patient. only one tube was blocked following a ducted. However. use of the chemical to block the right repeat instillation. Therefore. the effectiveness rate was 92 fallopian tubes-the left tubes were untouched-and pro­ percent (38 patients) after the second instillation of MCA. mote tissue ingrowth in rabbits was reported by Grode in The women were followed-up from six months to one year 1971. None of the 4 animals subsequently bred became with no subsequent pregnancies or major morbidity. Six pregnant on the treated side (46). women experienced irregular blood loss for 48 hours and 3 complained of pelvic discomfort (1 was treated with Falb also conducted rabbit experiments using various antibiotics for pelvic sepsis) . A transient gritty discharge adhesive formulas. The most effective contained 54 per­ appeared in 13 women (139). cent gelatin solids and 37 percent formaldehyde concen­ tration and resorcinol which. after mixing. form a water According to Stevenson. women with endometrial irregu­ insoluble mass. (Experiments adding quinacrine did not larities should not receive MCA because polyps and other enhance the effectiveness of GRF.) The formaldehyde and anomalies will deflect the chemical and prevent it from resorcinol dissipate so that they are of low concentration entering both tubes. In his study. instillation was confined in the final product. The compound was 100 percent to times when the endometrium was thin and the tubal effective in preventing pregnancy both initially and after ostia were at their widest (i.e .. days 6-10 of the menstrual subsequent breeding of the rabbits. A few months after cycle) . Experiments are now underway involving the instil­ application. GRF completely disappears from the tubes lation of saline prior to MCA to further distend the tubal with no visual damage to the tubal lumen (34). Becausethe ostia. but it is too soon to draw conclusions about this tubes are not occluded. the action of GRF in preventing procedure (139). pregnancy is not understood. Toxicity studies show that lesions form at the site of contact between GRF and Using a catheter filled with paraffin oil as a "push­ various organs. Therefore. like MCA. it must be confined transport medium." Lindemann and Mohr (West Ger­ to the tubes to prevent injury to other structures. many) injected 0.05 ml MCA monomer into 50 women via hysteroscopy. They suggested that carbon dioxide. rather than dextran. should be used as the uterine distention medium because contact with a liquid medium would SOLID PLUGS result in polymerization of the MCA before it reached the tubes (77) . The investigators observed that MCA des­ Many investigators are optimistic about the potential of troyed 3-4 cm of epithelium. It took 5-10 seconds to solid plugs for reversible sterilization. The consistency of polymerize and no spilling occurred. Of the 16 patients plugs varies from soft to hard. but because they are SOlid . followed up for four to six weeks. 9 had bilateral occlusion they may be directly inserted into or removed from the at four weeks. while 4 additional patients showed bilateral uterine or fimbrial end of the tube (see Table 6) . However. occlusion at eight weeks. By 1976. Lindemann had instrumentation for their insertion needs to be simplified instilled MCA into the tubes of 150 women . Bilateral tubal and reduced in cost. Because there has been less exten­ occlusion was achieved after 14 weeks in those cases sive clinical experience with solid plugs than with most where the solution was easily injected into the tubes other tubal occlusion methods. their advantages and without reflux into the uterus (77). Because tubal occlu­ disadvantages have not been fully ascertained. sion may take eight or more weeks to occur following treatment. patients must be maintained on contraceptives Aside from possessing the ideal properties common to all until occlusion is ascertained (79). tubal occlusion agents. plugs should: • be compatible with tissue (nontoxic); Major Advantage Major Disadvantages • possess properties for complete retention; • effective when reflux • not immediately effec­ • be removable for the restoration of fertility; prevented. tive; • be inserted by a simple delivery system. • highly toxic (risk of in­ jury to nearby structures Solid Silastic Intratubal Device on contact); The only solid plug which has received clinical trials is a • irreversible. silastic device with a nylon thread core designed by

C-89 Table 6-Experimental Use of Solid Plugs for Tubal ( cclusion in Selected Studies, 1976 r------..­

Author Reference Point of Number of Numbet of Kind of Plug Approach Be Date Number Insertion Subjects" Failur~ s

Craft 17 porous ceramic uterotubal hysteroscopy 15 NR 1976 iunction Hosseinian 51 polyethylene uterotubal hysteroscopy 7 1976 iunction Malinak 86 aloplastic mid-tube laparotomy 4 o 1976 Steptoe 138 silastic ampulla laparoscopy 40 1976 via fimbria

'Craft and Steptoe used human subjects; Hosseinian and Malinak used baboon NR = Not Reported

Steptoe (Great Britain) and intended for insertion into the desiglled hysteroscope. Hosseinian (USA) has tested t le ampulla of the tube via the fimbria. The plug is available in plug i 7 baboons, with one tubal patencydl covered f( ur either 4 or 6 cm lengths, is 1 mm in diameter, and has 1.5 montl :; following insertion. One device appeared out of mm protuberances located at 1 cm intervals. Tantalum positi n although both uterotubal junctions in that animal clips are applied between the protuberances to hold the were locked. Although reversibility has not been testod, device in place (see Fig. 11). investigators indicate that teeth on the end f the inser er can b used to grasp the base of the device and removn it A number of approaches-minilaparotomy, laparotomy, from letube(51). colpotomy, culdoscopy, or laparoscopy-may be used to insert the plug into the ampulla through the fimbrial end of Ceramic and Proplast®* Plugs the tube. Steptoe has described a quick, 15-minute lapa­ roscopic approach for insertion of the device. The major Two lugs, one made of ceramic and one made of Pro­ disadvantages of this approach are the need for a great plast, lave been tested for their tubal occ sion prop ,r­ deal of instrumentation (a special trocar and cannula to ties. raft (Great Britain) has inserted a ceramic plug, introduce the device and a special clip applicator with its made )f alpha alumina, through the uterotubal junctior of own trocar and cannula) and for three punctures in the rabbi ; and hysterectomy patients. This pl ug has a solid abdomen to insert these instruments. core nd porous head. Technical proble s (e.g., mis­ place lent) were encountered in 5 of 15 women duri g insertl :m of the plug, making modification o f the inserti.::>n The Silastic device has been placed in 40 women. The procE lure necessary. To date, only the insertion proce­ longest period of observation has been 2% years during dure as been tested. Evaluation of the plug's fit or effl1c­ which no pain or menstrual disturbances have been re­ tiven! 3S in preventing pregnancy will be ex p ored in future ported. The device slipped out of one tube in one woman studil:3 (17). leading to failure (3 percent failure rate) as diagnosed by the presence of a normal intrauterine pregnancy. The The F' 'oplast plug has only been investigated in animals. normal pregnancy indicates the device does not injure the The I lug is saturated with autogenous blood. injected tube. Thus tubal occlusion is potentially reversible by throu h a needle into the mid portion of the tube and removal of the device from the tube with a grasping secu r' d by suturing it in place. Follow-up tests on 4 forceps (137). To date, no attempts have been made to babo, IlS in which the plug had been introd ced via lapa­ reverse the procedure (136, 138). rotorTll indicated that all oviducts were complet.ly block d. No adhesions or inflammatory reactions an d no Major Advantages Major Disadvantages effect on the fallopian tubes other than ob&truction wnre • potential reversibility; • specially designed • application possible by instrumentation re­ abdominal or vaginal quired; routes. • above average skill re­ quired for insertion via laparoscopy.

Polyethylene Plug Experiments are just beginning on a polyethylene plug which is inserted into the tube at the uterotubal junction. The plug is 10 mm long and 1 mm in diameter. Projecting Fig 11. Diagram 01 solid Silastic intratubal device in s itu. from its base are spines made of elgiloy (a biocompatible De ' ce is held in place by application 01 8 clip placed metal) which penetrate the myometrium and fix the device bet een protuberances on the plug. (Courtesy 01 Dr. Patrick C. Steptoe, Oldham, Lancashire, Great Britain.) in place. The plug is placed in the tubal lumen with a stainless steel inserter having a 37° angled flexible tip which fits through the operating channel of a specially­ 'Bitek nc.. P.O. Box 6893, Houston, Texas 77025, USA.

C-90 observed. Results have not yet been reported for animal Lopez-Escobar (Colombia) reported that application of a studies in which the Proplast was inserted into the tube via laser beam to the uterotubal junction in rabbits via laparot­ the uterotubal junction (86). omy resulted in later recanalization (142). Therefore, effectiveness, reversibility, and standards for length of Dacron®* and Teflon ®* Plugs time the beam must be applied to obtain the desired result Among the tubal occlusion methods tested by Hulka and need to be determined (38, 142) . The use of smaller Omran (USA) in 1970 was a Dacron® plug which was instruments and ways to reduce cost are also currently inserted into the tubes of 17 pigs. The plug was used alone under study (104). or in combination with silver nitrate or electrocautery. Major Advantages Major Disadvantages Although the Dacron® plug was 100 percent effective in preventing pregnancies, there were a high incidence of • damage to tube re- • requires cumbersome infection, adhesions, and the development of cystic ovar­ stricted; and expensive equip­ ian structures (54) . • low morbidity; ment; • may be applied via lapar- • requires special train­ More recently, a notched Teflon® plug, developed by oscope, hysteroscope, ing; Meeker (USA), has produced minimal tissue reaction in or laparotomy. • no standards of treat­ baboons and rabbits and has been withdrawn from the ment yet established; tube to restore patency. The plug is inserted through the • potential for reversibility fimbrial end of the tube and anchored in place by sutures. unknown. Fertility was restored in 3 of 9 rabbits in which the plug was inserted for three months and then removed (89) . BIBLIOGRAPHY

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101 . OU, Y-Y. A device of technique of vaginal tubal sterilization 120. tlCHART, R. [Tubal occlusion.] Personal communicction through posterior colpoceliotomy. In: Association for Voluntary to J. /ortman, April 8, 1976. 2 p. Sterilization of the Republic of China. Proceedings of the Asian Regional Conference on Voluntary Steri lization. May 10-12,1975. 121. ICHART, R. M., GUTIERREZ-NAJAR, A. J., and f'\EU­ Taipei, Taiwan. July 1975. p. 139. WI Rl ~, R S. Transvaginal human sterilizatio : a prel imi lary repol l American Journal of Obstetrics and Gynecology 11 ( 1): 102. OU, Y-Y ., HSU, C-T. "Onefingermethod"-asimpleabdom­ 108-1 O. September 1, 1971 . inal tubal sterilization through a small incision. I n: Association for Voluntary Sterilization of the Republic of China. Proceedings of 122. lIMKUS, V. and SEMM, K. Sterilization by carbon dio(ide the Asian Regional Conference on Voluntary Sterilization, May hyStE oscopy. In: Sciarra, J. J., Butler, J . C. and Speide l, . J., 10-12, 1975. Taipei, Taiwan, July 1975. p. 138. eds. ysteroscopic sterilization. Proceedings o f a works hop on hYStE oscopic sterilization. Minneapolis, June 22-24, 1973. ew 103. OVERSTREET, E. W. Techniques of sterilization. Obstetrics York 3tratton Intercontinental, 1974. p. 75-84. and Gynecology 7: 109-125. March 1964. 123. I IiNGROSE, C . A. D. Office tubal steriliz tion. Obsteu ics 104. PALMER, R. and GOLD, E. M. Female sterilization-clinical and ( ynecology 42(1): 151-155. July 1973. aspects. In: Schima, M. E., Lubell, I., Davis, J. E., and Conne" , E., eds. Advances in voluntary sterilization. (Proceedings of the 124. , 1I0UX, J-E. and YUZPE, A. A. Electrosurgery untan!j led. Second International Conference, Geneva, February 25-March 1, Cont mporary Ob/ Gyn 4(3): 118-1 24. Septem r 1974. 1973). Amsterdam, Excerpta Medica, 1974. p. 249-254. 125. ";AMI, G, EL-SHAMMAH, S. S. , BADWAY, S, and LAU­ 105. PATEL, D. N., PARIKH, M. N., and SUNDARAM, T . A. Lapa­ REN E, K. A. An animal model for the development an d ev, lua­ roscopic sterilization. In: Talwalkar, C .V. Medical termination of tion f chemical tubal sterilization. In: Fathalla M. F. and S aa­ pregnancy and sterilization. Bombay, C. V. Talwalkar, 1974. p. ban, 1. M., eds. Surgical methods in fertility control. Proceea ings 65-69. of th First Egyptian Meeting, Assuit, February 7-8, 1974. C airo, Gen al Organization for Government Printing Offices, 1975. p. 106. PAUERSTEIN, C. J . Methods. In: Pauerstein, C . J. The 57-60 fallopian tube: a reappraisal. Philadelphia, Leaand Febiger, 1974. p.159-187. 126. 'CHROEDER, C. Uber den Abbau und Leistungen der Hyst roskopie. [Advantages and disadvantages of hystf ros­ 107. PAUERSTEIN, C. J. Tubal sterilization. In : Pauerstein, C. J . copy [GE] Archives fuer Gynaekologie 156: 407-419. 1934 The fallopian tube: a reappraisal. Philadelphia, Lea and Febiger, 1974. p. 121 -140. 127. ;CHWIMMER, W. B. Laparoscopy in famifv planning. " our­ nal 0 1 Reproductive Medicine 13(6): 218-222. D cember 1974. 108. PHILLIPS, J ., KEITH, D. , HULKA, J ., HULKA, B., and KEITH, L. Gynecological laparoscopy in 1975. Paper presented at the 128. ;CIARRA, J. J ., Jr. Sterilization of women ' a review of new Second International Congress of Gynecological Laparoscopy, and I Jtentially reversible techniques. In: Schima, M. E., l ubell, I. , Las Vegas, Nevada, November 20-23, 1975. 29 p. Davi. J. E. , and Connell, E., eds. Advances in vo luntary ster liza­ tion. ! Proceedings of the Second International Conferenc.e, '3 en­ 109. PHILLIPS, J ., KEITH, D., KEITH, L., HULKA, J , and HULKA, eva, ebruary 25-March 1, 1973) Amsterdam, Excerpta MeJ ica, B. Survey of gynecologic laparoscopy for 1974. Journal of Repro­ 1974 p. 62-69.

C-94 129. SEMM, K. Tubal sterilization finally with cauterization or 144. TSUEI, J. J. Female sterilization: post-partum and interpar­ temporary with ligation via pelviscopy. In: Phillips, J. M. and tum program-acceptability, effectiveness, technology and com­ Keith, L., eds. Gynecological laparoscopy: principles and tech­ plications. In: Thambu, J. A. M., ed. Seminar on voluntary sterili­ niques. New York, Stratton Intercontinental, 1974. p. 337-359. zation and post-conceptive regulation, Bangkok, January 30­ 130. SHAABAN, M. Reversibility of female sterilization. In: Fa­ February 2,1974. Singapore, Eurasia Press [1974J . p. 58-70. thalia, M. F. and Shaaban, M. M., eds. Surgical methods in fertility 145. UCHIDA, H. Uchida tubal sterilization . American Journal of control. Proceedings of the First Egyptian Meeting, Assuit, Febru­ Obstetrics and Gynecology 121 (2): 153-158. January 15, 1975. ary 7-8,1974. Cairo, General Organization for Government Print­ 146. UCHIDA, H. Uchida tubal sterilization. Kanazawa, Japan, ing Offices, 1975. p. 128-133. Hashimoto Kakubundo Co., 1975. 75 p. 131 . SIVANESARATNAM, V. and NG, K. H. Tubal pregnancies 147. WHEELESS, C. R. , Jr. An inexpensive system for female following postpartum sterilization. Fertility and Sterility 26(9): sterilization. American Journal of Obstetrics and Gynecology 945-946. September 1975. 123(7): 727-733. December 1, 1975. 132. SODERSTROM, R. M. Laparoscopic sterilization: a com­ 148. WHEELESS, C. R., Jr. Laparoscopically applied hemoclips prehensive review-1973. In: Phillips, J . M. and Keith, L., eds. for tubal sterilization. Obstetrics and Gynecology 44(5): 752-756. Gynecological laparoscopy: principles and techniques. New November 1974. York, Stratton Intercontinental, 1974. p. 209-212. 149. WHEELESS, C. R. , Jr. Where we've been, what we've tried 133. SPEIDEL, J. J. The future of female sterilization technology. and where we are going in the use of laparoscope in female International Journal of Gynaecology and Obstetrics, Spring, sterilization. In: Sciarra, J. J., Droegemueller, W., and Speidel, 1976. 16 p. (In press) J. J., eds. Advances in female sterilization technology. Hager­ 134. SPEIDEL, J. J. and PERRY , M. I. Needed research to im­ stown, Maryland, Harper and Row, 1976.6 p. (In press) prove female sterilization technology. In: Sciarra, J. J., Droege­ 150. WHEELESS, C. R., Jr. and THOMPSON, B. H. Laparoscopic mueller, W., and Speidel, J . J ., eds. Advances in female steriliza­ sterilization-review of 3600 cases. Obstetrics and Gynecology tion technology. Hagerstown, Maryland, Harper and Row, 1976.6 42(5): 751-758. November 1973. p. (In press) 135. STEPTOE, P. C. Assessment of the potential of hysteros­ 151 . WOOD, C. [Tuballigation.J Personal communication to J. copic sterilization. In: Sciarra, J. J., Butler, J. C., and Speidel, Wortman, March 20, 1976. 1 p. J. J., eds. Hysteroscopic sterilization. (Proceedings of a work­ 152. WORLD HEALTH ORGANIZATION [WHO). SCIENTIFIC shop, Minneapolis, June 22-24, 1975) New York, Stratton Inter­ GROUP. Advances in methods of fertility regulation. Geneva, continental, 1974. p. 153-158. WHO, 1974. (Technical Report Series No. 527) p. 30-34. 136. STEPTOE, P. C. Intratubal devices for reversible steriliza­ 153. YOON, I. B. and KING, T. M. A preliminary and intermediate tion. In: Phillips, J. M. and Keith, L., eds. Gynecologicallaparos­ report on a new laparoscopic tubal ring procedure. Journal of copy prinCiples and techniques. New York, Stratton Intercontin­ Reproductive Medicine 15(2): 54-56. August 1975. ental, 1974. p. 309-314 154. YOON, I. B. and KING, T. M. [Falope Ring'·J Personal 137. STEPTOE, P. C. [Intratubal silastic device and low current communication to J. Wortman, February 7, 1975. 1 p. coagulation.J Personal communication to J. Wortman, April 5, 155. YOON, I.B. and KING, T.M. The laparoscope falope ring 1976. 1 p. technique. Advances in Planned Parenthood 10(3): 154-159. 138. STEPTOE, P. C. The potential uses of intratubal stents. In: 1975. Sciarra, J. J., Droegemueller, W., and Speidel, J . J., eds. Advan­ 156. YOON, I. B. and KING, T.M. The laparoscopic Falope­ ces in female sterilization technology. Hagerstown, Maryland, Ring'· procedure. In: Sciarra, J. J., Droegemueller, W., and Spei­ Harper and Row, 1976. 4 p. (In press) del, J. J., eds. Advances in female sterilization technology. Ha­ 139. STEVENSON, T. C. Methyl cyanoacrylate (MCA) for tubal gerstown, Maryland, Harper and Row, 1976.4 p. (In press) occlusion. In: Sciarra, J. J., Droegemueller, W. , and Speidel, J. J., 157. YOON, I. B., WHEELESS, C. R. , and KING, T. M. A prelimi­ eds. Advances in female sterilization technology. Hagerstown, nary report on a new laparoscopic sterilization approach: the Maryland, Harper and Row, 1976. 4 p. (In press) silicone rubber band technique. American Journal of Obstetrics 140. STOOT, J. E. G. M. and UBACHS, J. M. H. Sterilization by and Gynecology 120(1): 132-136. September 1, 1974. salpingectomy through posterior colpotomy. Contraception 8(6) : 577-582. December 1973. 158. YUZPE, A A., ANDERSON, R. J., COHEN, N. P., and WEST, J. L. A review of 1,035 tubal sterilizations by posterior 141 . SUGIMOTO, O. Hysteroscopic sterilization by electrocoag­ colpotomy under local anesthesia or by laparoscopy. Journal of ulation. In: Sciarra, J. J ., Butler, J. C. , and Speidel, J. J., eds. Reproductive Medicine 13(3): 106-109. September 1974. Hysteroscopic sterilization. (Proceedings of a workshop, Min­ neapolis, June 22-24, 1975) New York , Stratton Intercontinental, 159. ZIPPER, J., MEDEL, M., and PRAGER, R. Alterations in 1974. p. 107-120. fertility induced by unilateral intrauterine instillation of cytotoxic compounds in rats. American Journal of Obstetrics and Gynecol­ 142. TATUM, H. and ANSBACHER, R. Female sterilization ­ ogy 101 (7) : 971 -978. August 1, 1968. basic science aspects. In: Schima, M. E., Lubell, I. , Davis, J. E, and Connell, E., eds. Advances in voluntary sterilization (Pro­ 160. ZIPPER , J., PRAGER, R., and MEDEL, M. Biological ceedings of the Second International Conference, Geneva, Feb­ changes induced by unilateral intrauterine instillation of quina­ ruary 25-March 1, 1973) Amsterdam, Excerpta Medica, 1974. p. crine in the rat: reversion through use of estrogen and progeste­ 260-266. rone. Fertility and Sterility 24(1) : 48-53. January 1973. 143. THORSTEINSSON, V. T. and PRATT, J. H. Gynecologic 161 . ZIPPER, J., STACCHETTI, E., and MEDEL, M. Transvaginal operations for sterilization. Minnesota Medicine 55: 204-210. chemical sterilization: clinical use of quinacrine plus potentiating March 1972. adjuvants. Contraception 12(1): 11-21 . July 1975.

GWU-SCD-76-4P

C-95 PUBLICATIONS OF THE POPULATION i\lFORMATION PROGRAM (Copies are available to health personne in developing countries.)

ORAL CONTRACEPTIVES - Series A __A-1, Oral Contraceptives-50 Million Users (F, S) _ _ G-3, A Review: Modulation of Autonomic T ransmis ~ ion Jy __A-2, Advantages of Orals Outweigh Oisadvantages (F) Prostaglandins (F, S) _ _ A-3, Minipill-A Limited Alternative for Certain Women __ _G-4, "Prostaglandin Impact" for Menstrual Induction V) __ .G-5, Physiology and Pharmacology of PG . in Parturitio 1 INTRAUTERINE DEVICES - Series B ___G-6, Prostaglandins Promise More Effectill Fertilit', Cc ntrol __ B-1, Copper IUOs- Performance to Oate (F, S, p) __ B-2, IUOs Reassessed-A Oecade of Experience BAF RIER METHODS - Series H _ _H-1, Condom-An Old Method Meets a Ne , ~ Social Jeee STERILIZATION, Female - Series C (F, P, S) __,C-1, Laparoscopic Sterilization-A New Technique (F, S, P) __ H-2, The Modern Condom-A Quality ProDuct for __--C-2, Laparoscopic Sterilization II; What Are the Problems? Effect'ive Contraception (F, S, p) _ _H-3, Vag ina I Contraceptives-Reappraisal __C-3, COlpotomy-The Vaginal Approach (F, S, p) __ H-4, Oiaphragm & Other Intravaginal Barriers __C-4, Laparoscopic Sterilization with Clips (F) __ C-5, Female Sterilization by Mini-Laparotomy (F) PEF ODIC ABSTINENCE - Series I __C-6, Female Sterilization Using the Culdoscope __1-1, Birth Control Without Contraceptives (F, S) __C-7, Tubal Sterilization-Review of Methods __1-2, Sex Preselection-Not Yet Practical

STERILIZATION, Male - Series D FA I ILY PLANNING PROGRAMS - Series J __0-1, Vasectomy-Old & New Techniques (F, S, P) __J-1 , Family Planning Programs & Fertilit Patterns (F, ), P) __0-2, Vasectomy-What Are the Problems? (F) __J-2, World Fertility Trends, 1974 (F, S) _ _ 0-3, Vasectomy Reversibility-A Status Report _ _ _J-3, Advanced Training in Fertility Mana ement (F, S, P) _ _J-4, Breast-feeding-Aid to Infant Health Fertili l'{ Cmtrol LAW AND POLICY - Series E (F, S, p) ~E-1, Eighteen Months of Legal Change (F, S) __ J-5, Contraceptive Oistribution-Taking SUPplies to __E-2, World Plan of Action & Health Strategy Approved Villages and Households (F, S, P) __E-3, Abortion Law & Pract ice : A Status Report __ J-6, Training Nonphysicians in Family Pla nning Se rvice!, _ _ E-4, Recent Law and Policy Changes in Fertility Control & a Oirectory of Training Programs (F, P, S,I __ J-7, Pregnancy Tests, The Current Status ( F, P) PREGNANCY TERMINATION - Series F __J-B, Effects of Childbearing on Maternal Health __ F-1, Five Largest Countries Allow Legal Abortion on __J-9, Postcoital Contraception, An Appraisal Broad Grounds (F, S, P) __ F-2, Menstrual Regulation-What Is It? (F, S, p) IN. :CTABLES AND IMPLANTS - Series K __F-3, Uterine Aspiration Techniques (F, S, P) _ K-1, Injectable Progestogens-Officials Oehate but Use __- F-4, Menstrual Regu lation Update (F, S) Increases (S)

PROSTAGLANDINS - Series G IN[ EXES __ G-l, Clinical Use of PGs in Fertility Control (F, S) _Index 1972-1973 __ G-2, Fertility Control Research Maps & Oirectory (F, S) __Index 1974

All publications are available in English , Many are avai lable in French, Spa ish and Portuguese as indicated d irectly after each t i tle. Check preferred language: English 0, French 0, Spanish 0, Portuguese 0 , Indicate lumber of copies desired, cut along dash and mail to: Population Informatio Program Department of M edical an, Public Affairs The George Washington Univel ity Medical Center 2001 S Street, N .W., Washingtor D.C. 20009 U .S.A.

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