Jaroslav F. Hulka M.D.
University of North Carolina
School of Medicine
Chapel Hill, N.C., U.S.A
Assia Stepanian M.D.
Russian Academy of Medical Sciences
Scientific Center for Obstetrics, Gynecology an Perinatolgy
Moscow 117815, Russia
In 1994, the WHO in Geneva convened current investigators in sterilization to assess research developments1. The following are excerpts from the summary report as concerns laparoscopy:
"The most appropriate method of female sterilization in a particular family planning programme often is determined by local situations and constraints. The ideal female sterilization method would involve a simple, easily learned, one-time procedure that could be accomplished under local anesthesia and involve a tubal occlusion technique that caused minimum damage. The procedure would be safe, have high efficacy, be readily accessible, and be personally and culturally acceptable. The cost for each procedure would be low and there would be minimal costs for the maintenance of equipment. No currently available procedure meets all of these criteria, although minilaparotomy and laparoscopy come close.
Training, to ensure adequate surgical skills, and counseling to ensure that women accepting the method understand fully the possibility of both pregnancy and ectopic pregnancy should the method fail and the highly permanent nature of the procedure, are of major importance in sterilization programmes.
The potential reversibility of sterilization was touched on by several speakers. It was agreed that where procedures used in a programme have a high potential for reversibility there should be centres established where the necessary surgical skills are available. It also was agreed that sterilization methods should be presented to potential acceptors as being permanent methods of fertility regulation
The abdominal procedures that have been developed, namely minilaparotomy (postpartum and interval), and laparoscopy, meet the essential requirements of efficacy, safety, and can be carried out under local anesthesia with a minimum use of sedatives. Training in technical skills should put emphasis on the use of local anesthesia and correct site for placement of clips or rings. Accurate placement of clips and rings on the tube is critical to ensure high rates of efficacy 1."
World-wide development of laparoscopic sterilization
The following are excerpts pertaining to laparoscopy from a recent WHO overview of the evolution of female sterilization. 2
"Sterilization of women, by surgical occlusion of the Fallopian tubes, is the most widely accepted of all modern family planning measures, being currently used by an estimated 140 million eligible couples worldwide (United Nations 1992), and is the most commonly used modern contraceptive method in many developing countries3.
The re-emergence of laparoscopy in the 1960s, made possible by the development of fibre-optics, resulted in a rapid adaptation of this approach to the tubes for sterilization. Initially the technique was employed under general anesthesia, with carbon dioxide being used to provide abdominal distention. Early instrumentation required a two-puncture technique, but refinement of the instruments soon led to procedures being carried out through a single, sub-umbilical puncture. The use of local anaesthesia and alternative gases, such as nitrous oxide or operating room air, were further simplifications.
The wider introduction of laparoscopy in the 1970s was a major contributor throughout the world to women's acceptance of sterilization as a method of family planning. The original unipolar electrocoagulation technique by Steptoe in 1967, described in his classic text book of laparoscopy4, paved the way for worldwide use of the laparoscope and development of simpler and safer techniques.
The training required, the cost of the instruments and the skilled maintenance needed meant that laparoscopy was principally confined to hospital settings where there were established surgical facilities. This was challenged by some. In (the Phillippines and) India many saw the potential of laparoscopy for accomplishing large numbers of procedures in a short time. Camp sterilization programs were set up with some spectacular claims being made for the numbers of sterilization that could be done in a day5.
Sterilization, other than postpartum, was infrequent before the acceptance of laparoscopy. Many vaginal surgeons were performing a vaginal fimbriectomy as described by Kroener6 in 1969. Other vaginal approaches incorporated the use of tantalum clips. Compared to laparoscopic approaches, however, the vaginal methods have been associated with a higher morbidity from postoperative infection, as well as higher pregnancy rates due to incomplete removal of the fimbriae or incomplete closure of the tantalum clips.
Similarly, the concept of minilaparotomy has been introduced in developing countries as a means of avoiding the expensive equipment necessary for laparoscopy. In trained hands, and under general anesthesia, a minilaparotomy is an effective and comfortable method of accomplishing sterilization with the simple Pomeroy technique. Under local anesthesia, the abdominal invasion is usually sufficiently uncomfortable to make this procedure less acceptable by patients, particularly if laparoscopy is available as an alternative. A large, multicentre study comparing minilaparotomy and laparoscopy has shown few differences between the two approaches, as well as very low short-term complication rates7. For these reasons, minilaparotomy has also been abandoned except by a few skilled practitioners.
From the mid 1960s and extending to about 1983, when the last extensive review of the field was undertaken, the period was characterized by the development of new ways of approaching the tubes, such as by laparoscopy and hysteroscopy, and the use of new materials, both plastic and metal, to achieve tubal occlusion. Electrocoagulation was refined during this period."2
1. Unipolar coagulation and division
This technique was the first described by Steptoe and used by gynaecologists learning both laparoscopy and electrocoagulation techniques. The tube is grasped, and current is passed through the tube (and body) to a base plate. The method produced considerable destruction of tube with electric current but was also associated with hemorrhage from incompletely coagulated vessels severed at the time of tubal division. Deaths were associated with unipolar coagulation8, perhaps as much because of complications of trocar entry as electrocoagulation of bowel. This method was abandoned by most laparoscopists in favor of the less destructive techniques described below.
2. Bipolar coagulation
This technique was developed simultaneously and independently in the early 1970s by Rioux in Canada, Kleppinger in the United States, and Hirsch in Germany. The Kleppinger technique emerged as the most popular method of laparoscopic sterilization in the United States. The bipolar technique is the simplest to perform technically and is the most common method of laparoscopic sterilization today. The poles of the forceps conduct the electricity between them, with no current flow beyond the forceps, so the patient is not part of the circuit. Failures after bipolar coagulation have been due to incomplete coagulation, sometimes using inappropriate generators9.
The end point of successful coagulation is indicated by a current flow meter on the appropriate or matched generator. When the flow diminishes and ceases, the tubal tissue has been desiccated to the point that it no longer conducts electricity and the forceps can be moved to the next area for coagulation. Kleppinger stresses that three contiguous areas are to be coagulated. This results in at least 3 cm of tube being destroyed and prevents spontaneous recanalisation occurring as a result of the healing process bringing the two stumps closely together10. Recent reports of a high incidence of ectopic pregnancy following bipolar coagulation11 (see Table 1) may be the result of fistula formation between the uterus and peritoneum when the tube is destroyed too close to the uterus12. Sperm can travel through these utero-peritoneal fistulas, reach the egg in the distal tube segment, and cause an ectopic pregnancy by this route. This has led to the recommendation that the tube be grasped at least 2 to 3 cm away from the utero-cornual junction at the time of sterilization so that a stump of isthmus remains to absorb the intrauterine fluid under pressure and minimize fistula formation.
3. Silastic band application
The Silastic band for sterilization was developed simultaneously by In Bae Yoon and Coy Lay in the early 1970s. Widely distributed by the U.S. Agency for International Development, the band was offered as a non-electric (and presumably therefore safer) method of tubal occlusion. A loop of the fallopian tube is drawn 1.5 cm into a 0.5 cm diameter metal cylinder, destroying 3 cm of tube. A Silastic ring stretched on the outside of the cylinder is released to form an occlusion at the base of this knuckle. Over time, about 3 cm of constricted tube undergoes necrosis and the tubes separate. Similar to the Pomeroy technique in theory, the laparoscopic application of band is associated with a 2-3% incidence of haemorrhage from stretching the vessels underneath the tube or tearing the tube itself. For this reason, Yoon and associates13 have recommended that bipolar coagulation be available to manage this complication. Post operatively, patients experience pain arising from hypoxic necrosis of the tube in the band. This pain has led to a high incidence of readmission to hospitals (see table 1). This subsides in 48 to 96 hours and can be diminished somewhat by topical application of anaesthesia at the time of band application.
4. Spring clip application
Devised in the 1970s to offer a mechanical alternative to electrocoagulation, the spring clip (Hulka Clip) occludes the isthmus of the tube by 2 plastic jaws, compressing the tube by a gold-plated stainless steel spring pressing the jaws together14. This is the only clip that does not rely on a latch which can potentially tear through a meso-salpingeal vein. Spring clip application by laparoscopy requires careful surgical technique to assure that the clip is completely across the isthmus of the tube. Although the initial pregnancy rates were high as a result of misapplication, the current pregnancy rates for clip, coagulation, and band are comparable. The spring clip is the most reversible of the techniques15 (see table 1) since less than 5mm of tube is destroyed between the jaws of the clip. For this reason, it should be considered when one is selecting a method for a woman under 30.
5. Cautery techniques
True cautery is the direct application of heat to tissue, in contrast to electrocoagulation and desiccation, where electrical energy flows through tissue and heats it. In Germany, the Semm Endotherm forceps is placed across the tube and one prong of the forceps is heated to 100c, cauterizing the tube. The time (30 to 60 seconds) required for each cautery, as well as the high postoperative ectopic pregnancy rate, has limited the popularity of this method.
Techniques under investigation
The laser has been tried for tubal division at laparoscopy but offers no advantage over standard techniques. Burying the fimbriae in a pouch of broad ligament peritoneum, and burying the ovary in an artificial plastic pouch, has been evaluated in animals but have not been used with humans because of the increased morbidity compared to standard techniques. Various other clips have been devised (Bleier and Filshie clips). The Bleier clip has been discontinued because of a high pregnancy rate due to the tube slipping into spaces within the jaws of the clip. The Filshie clip is heavier and more expensive than the Spring clip and is associated with occasional hemorrhage on application due to the latch going through meso-salpingeal vessels. It received approval by the FDA in 1996, but comparative efficacy data are lacking.
A number of hysteroscopic approaches have reached the human trial stage only to prove less cost-effective than the standard laparoscopic techniques. In Europe, plastic tubal plugs developed by Steptoe in England and Hamou in France were abandoned after ectopic pregnancies developed. In the United States, the Silastic plug16 was extensively evaluated17 and found to be efficacious in about 85% to 90% of candidates, but technical failures persisted despite two or three hysteroscopic re-applications. The technique is intended to be reversible, but reversibility has not been demonstrated. Other hysteroscopic approaches have included destroying the endometrium by freezing or coagulation by heat or chemicals, but these approaches have been abandoned or are still in pre-clinical evaluation stages. Similarly, the introduction of methyl cyanoacrylate (crazy glue) into the tube has been clinically tested overseas but is not ready for clinical use. The Chinese have experimented with formalin injection into the tube, but reports of the efficacy and safety of this approach are incomplete. Although there are still active research projects concerning alternative sterilization techniques, the existing laparoscopic approaches of mechanical or electrocoagulation tubal occlusion remain the standard against which these alternatives must be measured in terms of cost, efficacy, and safety.
A large number of patients (over 1000) must be followed for a 2 to 3 year period with a high rate (over 85%) of follow-up to study the pregnancy rate following sterilization techniques,. This enormously difficult task has been accomplished very few times: by Johns Hopkins University in the early days of electrocoagulation and by the University of North Carolina in the development of the spring clip. Currently, the CREST study of the Centers for Disease Control (CDC) is following several thousand patients sterilized by a variety of techniques. This prospective 10 year national study has recently been concluded18 and is revealing a much higher pregnancy rate than was first appreciated for all methods of sterilization - approaching 1 pregnancy per 100 sterilizations within 3 years, and 2-3 per 100 over 10 years. The latest education pamphlet on sterilization by the American College of Obstetricians and Gynecologists (ACOG 1991) states, "More than 99 out of every 100 women who have this procedure will not become pregnant, but you should be aware that the procedure does not guarantee sterility. Although the risk of failure is low, sometimes the procedure does not work."
Ectopic pregnancy is a rare but life threatening form of pregnancy failure requiring early intervention for safe management. The CDC study has revealed that the late pregnancies after bipolar coagulation are mostly ectopic in nature. For this reason, we strongly recommend that when this technique is used a segment of isthmic tube next to the uterus be left to minimize the risks of fistula formation. Women with less tissue damage (from Pomeroy, band, and spring clip sterilization) have relatively less risk of ectopic pregnancy.
Laparoscopic sterilization in Russia
At a conference held in Moscow in November 199520, the Program for Family Planning, the ways of development of modern gynaecology in Russia and the current acceptability and utilization of laparoscopic sterilization were analyzed . The data presented at the conference reflect the medical and social aspects of introducing a sterilization programme in Russia where sterilization has not been a part of the culture and medical tradition.
A. Legal background
In the beginning of the century abortion was prohibited by law. In the 1920s, in order to reduce the complication and death rate from illegally performed abortions, the government proclaimed abortion to be legal, providing free hospitalization and doctors to provide these services. Since the 1920s this program has been the main method of birth control in the country. Currently 65% of all pregnancies in Russia are terminated by abortion21.
Before 1990 sterilization as a method of birth control was under the restriction of Regulation 303 of the USSR People’s Health Committee which, in 1939, proclaimed ligation or excision of healthy fallopian tubes illegal20. From 1939 to 1990 these operations were pre-formed only in the presence of medical indications.
The USSR Ministry of Health revised regulation 30323 and in 1990 they issued Regulation 48424, The main reasons for these revisions were high rates of gynaecological diseases connected with incorrect family planning, including abortions, as frequent reasons for inflammatory diseases and mortality. These Regulations determined indications and contraindications for surgical sterilization and defined the instruction of patients prior to the procedure. It also called on the chiefs of all health providing organizations and medical institutions to organize committees to implement surgical sterilization services and to designate the medical institutions or centres responsible for providing these services. It specified that these centres must have the appropriate equipment and trained specialists, especially for laparoscopic sterilization. This regulation stimulated the First Advanced Operative Laparoscopy Symposium held in 1991 in Moscow. Over 400 gynaecologists from all over Russia attended and continue to attend the annual Symposium of live televised surgery and lectures by world leaders in endoscopy and sterilization.
The most recent New Regulation 30325 in 1993 by the Russian Federation Ministry of Health was proclaimed "with the object of protecting the health of citizens, realization of their rights for specialized medical help, and for the decrease of the number of abortions and mortality related to them." Unlike the regulation of 1990, the new one includes instructions "for the process of obtaining permission for surgical sterilization procedure" and for male sterilization. It also expanded the list of medical and social indications for female sterilization.
The problems of family planning, as well as protecting the reproductive health of women under Russian conditions, involve not just medical but also social problems. The Russian Federal Program for Family Planning was created by the Ministry of Health and approved by the Government of the Russian Federation, and by Regulation #1696 of the President on August 18, 1994. Again, this regulation stimulated the November 1995 meeting20.
B. Current status, 1995
1. Indications for sterilization:
The new Regulation 303 lists 57 medical and 3 social indications for sterilization. Female sterilization is allowed:
- after a written request
- and/or 35 years and over
- and/or with 2 or more children
- or with medical indications unrelated to age or number of children
- or during repeat cesarean section when children are already in the family.
2. Potential interest.
Sixty five percent of all pregnancies in 1993 in Russia were terminated by abortions, and only 21.3% progressed to delivery (Frolova, 1995). Many abortions (estimated 30%) are obtained by women who have completed their desired family size. In a survey of urban women held in 1994, 70% of women wanted no more than one child in the family, and 15% chose no children at all21.
In the context of reproductive health care, "...the current demographic situation in Russia resembles one during the postwar period 1945-1950"22. Maternal mortality in Russia is 15 time higher than in highly developed countries, child mortality continues to increase (19.9 deaths per 1,000 children in 1993) and legal abortions in 1994 totaled approximately 2.8 million compared to 1 million births. Sterilization must be viewed in the context of this overview of reproductive problems.
3. Current use.
Combined reports from 89 centers for reproduction and family planning indicate that the number of laparoscopic sterilizations in 1995 is expected to be about 14,000. Almost all of these were with bipolar sterilization. About 300 cases were with mechanical devices (clips or rings). This low utilization is due to lack of funds for the purchase of devices.
The intra-uterine device has been the leading method of contraception in Russia for many years26. Oral contraceptives have been expensive to obtain, and condoms are not widely available. It is estimated that 75% of young women starting thir sexual life do not have enough information about contraception and are not ready for safe sexual relationships. This is particularly true in lower socio-economic and educational levels.
5. The future.
"The Family Planning Program" of 1994 is new and is designed to improve the current situation through the development of a system of wide-spread information concerning family planning including contraception and laparoscopic sterilization. It is entirely possible that modern intra-uterine devices will be more acceptable that laparoscopic sterilization as a means of maintaining low family size as is the case in Russia’s Scandinavian neighbours. At the same time, the introduction of insurance systems as well as private practice of medicine should create wider possibilities for appropriate financial support for laparoscopic equipment, particularly for the purchase and use of more safe, effective and reversible methods such as the mechanical methods. The Russian industry is working on the development of national devices for laparoscopic sterilization. All these factors should lead to the continuing growth of laparoscopic sterilization as an important part of Russian family planning.
Sterilization was the procedure responsible in the 1970s for the widespread utilization of laparoscopy in gynaecology throughout the world. The recent expansion of laparoscopy into operative techniques in surgery and gynaecology was based on intense analysis worldwide of laparoscopy for sterilization revealing the remarkable safety of the technique. The acceptance by governments, physicians and patients of this useful method of fertility regulation is dependent on cultural and economic aspects in the countries of the world, as the current developments in Russia illustrate. The medical aspects of safety and efficacy can no longer be questioned .
"Since 1983, there have been few, if indeed any, advances made that can seriously claim to have improved, except in a minor way, the safety or efficacy of female sterilization techniques. In most developing country settings, minilaparotomy and Pomeroy tubal ligation under local anesthesia remains the best option. In better equipped situations, laparoscopy and electrocoagulation or clip or ring application are the most common methods2."
Table 1 summarizes the comparative safety and efficacy data of the three most common laparoscopic techniques.
TABLE 1 Safety and efficacy: Comparison of sterilization methods*
|Days re-admission for complication||10.5||5.5||2.1|
|Late ectopic rate (% of failures)||29-40||15.0||4.0|
|Term pregnancies following reversal (%)||41||72||84|
|1 year method failure (rate per 1000)||1.9-2.6||3.3-4.7||1.8-5.9|
*From Chi I, Potts M, and Wilkens L: Rare events associated with tubal sterilization: An international experience. Obstet Gynecol Surv 41: 7-19, 1986. and Siegler AM, Hulka JF, and Peretz A: Reversibility of female sterilization. Fertil Steril 43: 499-510, 1985.
- UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction: Consultation on the Development of new Technologies for Female Sterilization. July 25-27 Report. WHO Geneva 1994.
- Wilson, E.W. The Evolution of Methods for Female Sterilization, in UNDP..1994 above.
- Church CA, Geller JS: Voluntary female sterilization: number one and growing. Population Reports Series C 10: 1, 1990.
- Steptoe PC: Laparoscopy in gynecology, Edinburgh, 1967, Livingstone.
- Mehta PV: A total of 250136 laparoscopic sterilizations by a single operator. Br J Obstet Gynaecol 96: 1024, 1989.
- Kroener WF Jr: Surgical sterilization by fimbriectomy, Am J Obstet Gynecol 104: 247, 1969.
- World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction: Minilaparotomy or laparoscopy for sterilization: a multi center, multinational randomized study. Am J Obstet Gynecol 143: 645, 1982.
- Peterson HB et al: Deaths attributable to tubal sterilization in the United States, 1977 to 1981, Am J Obstet Gynecol 146: 131, 1983.
- Soderstrom RM et al: Reducing bipolar sterilization failures, Obstet Gynecol 74: 60, 1989.
- Fishburne JL JR, Hulka JF: Tubal healing following laparoscopic electrocoagulation, J Reprod Med 16: 129, 1976.
- Makar AP et al: Female sterilization failure after bipolar electrocoagulation: a 6 year retrospective study, Eur J Obstet Gynecol Reprod Biol 37: 237, 1990.
- Stock RJ: Histopathologic changes in tubal pregnancy, J Reprod Med 30: 923, 1985.
- Yoon IB et al: A two year experience with the falope ring sterilization procedure, Am J Obstet Gynecol 127: 109, 1977.
- Hulka JF et al: Spring clip sterilization: one year follow up of 1,079 cases, Am J Obstet Gynecol 125: 1039, 1976.
- Siegler AM et al: Reversibility of female sterilization, Fertil Steril 43: 499, April 1985.
- Erb RA, Reed TP: Hysteroscopic oviductal blocking with formed in place silicone rubber plugs: method and apparatus, J Reprod Med 23: 65, 1979.
- Houck RM et al: Hysteroscopic tubal occlusion with formed in place silicone plugs: a clinical review, Obstet Gynecol 62: 587, 1983.
- Peterson HB, Xia, Z, Hghes JM et al: The risk of prenancy anftertubal sterilization: findings from te U.S. collaborative review of sterilization. AM J Obstet Gynecol 1996;174:1161-70.
- American College of Obstetricians and Gynecologists: Sterilization for women and men, AP011, April 1991.
- Proceedings of the Russian Interdepartmental Scientific Committee and the Russian Conference of Science and Practice, Moscow, November 21-23, 1995.
- Frolova OG, Volgina VF, Pugacheva TN: Medical and social aspect of the problem of the reproductive health of women. In Proceedings...1995 above.
- Sleptsova SI: The role of famly planning in solving demographic problems. In Proceeding...1995 above.
- Regulation 303 of USSR People,s Health Committee, August 7, 1939.
- Regulation 484 of the USSR Ministry of Health, Dec. 14, 1990, for "The permission for performance of the operation Surgical Sterlization of women".
- Regulation 303 of The Ministry of Health of the Russian Federation, December 28, 1993, "The application of medical sterilization of citizens".
- Proceedings of The Russian Association for Family Planning, 1991.