Tubal Sterilization Treatment & Management
- Author: Robert K Zurawin, MD; Chief Editor: Michel E Rivlin, MD more...
Surgical approaches for female sterilization include laparoscopy, hysteroscopy, microlaparoscopy, laparotomy (concurrent with cesarean delivery), minilaparotomy, and vaginal approaches. Although minilaparotomy is the most common approach worldwide, laparoscopy is used most commonly for interval procedures in the United States. Hysteroscopic procedures are rapidly gaining popularity. For postpartum procedures, although some studies describe successful use of laparoscopy, the subumbilical minilaparotomy is used most commonly in the United States and worldwide. Vaginal colpotomy approaches are rarely used because they are associated with a higher incidence of infection and can no longer be recommended.
Local anesthesia is used for more than 75% of sterilizations worldwide. Although some US providers use local anesthesia for laparoscopic sterilization, general anesthesia (for interval procedures) and regional anesthesia (for postpartum procedures) are most common.
For the hysteroscopic approach, local anesthesia is the standard approach, and it may be supplemented by oral or IV sedation as needed.
One meta-analysis identified 9 randomized, controlled trials that compared 5 commonly used methods. Aspects such as training, costs, and maintenance may be important factors in deciding which method to choose.
Note the images below.
Puerperal tubal sterilization
In comparison with interval sterilization, infraumbilical minilaparotomy following delivery in the early puerperium is convenient, simple, and cost effective. However, if maternal or infant complications exist, sterilization should be delayed.
Bilateral tube ligation (BTL) may be performed after closure of the uterine incision during cesarean delivery or following completion of a vaginal delivery within 72 hours. Postpartum BTL is technically simple because the uterine fundus is at the level of the umbilicus, making the fallopian tubes readily accessible through a small periumbilical abdominal incision.
If the procedure is delayed for several days or if the patient has a significantly involuted uterus (as might occur after delivery of a preterm infant), then delaying to an interval procedure is usually prudent, although puerperal laparoscopic BTL has been reported.
Minilaparotomy is defined as a laparotomy with an incision size smaller than 5 cm. The operation can be performed through a suprapubic incision in the interval after pregnancy and through a subumbilical incision within the first 48 hours after delivery.
A 2- to 5-cm periumbilical semilunar incision is made with the skin tented with Allis clamps. Dissection is carried down to the fascia, which is grasped with hemostats or Allis clamps and opened transversely, exposing the peritoneum, which can then be entered sharply. With uterine manipulation and retraction, the tubes can be visualized and grasped with a Babcock clamp. Often, the oviducts can be palpated at their utero-tubal junction and the uterus may then be rotated to position the isthmus of the tube under the incision anteriorly with the aid of Army-Navy retractors. The fallopian tube is "walked" with Babcock clamps until the fimbriated end is identified. A major cause of failure of sterilization is the inadvertent ligation of the round ligament mistakenly identified as the fallopian tube.
After the BTL, the minilaparotomy incision is closed in layers. Closure of the peritoneum is optional. The fascia is closed with running 2-0 or 0 delayed absorbable suture. Subcutaneous closure is optional, and the skin is closed with 3-0 or 4-0 absorbable suture in a subcuticular manner or with acrylic glue.
Advantages include small incisions, full access to the oviducts, rapid recovery, and the ability to inspect the pelvis and upper abdomen.
Disadvantages include the need for general anesthesia, the risks of vessel/viscera injury with needle insufflation/trocar entry, and difficulty associated with laparoscopy in patients who are obese or in the presence of abdominal and/or pelvic adhesions. Entry accounts for 30-50% of all laparoscopic sterilization complications.
The failure rate of the laparoscopic approach according to the US Collaborative Review of Sterilization (CREST) ranges from 7.5 per 1000 procedures for unipolar coagulation to a high of 36.5 per 1000 for the spring clip. The Filshie clip was not included in the CREST study, but its failure rate is reported to be between 1 and 2%.
According to one study, the success rate of laparoscopic sterilization on the first attempt is 99%. The same study estimates the success rate of hysteroscopy to be 88% on the first try. These rates account for 6% of women whose first attempt with hysteroscopy is unsuccessful and are ultimately sterilized via laparoscopy.
The patient should always have an examination under anesthesia, and the bladder should be catheterized. A uterine manipulator and the use of the Trendelenburg position enhance exposure.
Microlaparoscopy involves use of 1.2- to 2-mm microendoscopes with 5- to 7-mm suprapubic ports for bipolar coagulation or mechanical occlusive devices. This surgery is possible because of improved technology in light transmission and fiberoptic bundles.
The theoretical advantages of less pain, less cost, and faster patient recovery have not been assessed through randomized, controlled trials, although several studies have been reported in an office setting. Despite almost 20 years of availability, office microlaparoscopy has not become widely accepted.
Advantages include offering the most cost-effective, minimally invasive approach without the need for abdominal incisions or general anesthesia, thereby avoiding complications associated with trocar injury or thermal burns. Hysteroscopy is regularly performed in an office setting using local anesthesia, thus affording patients a rapid return to normal activity (usually within 24 hours). Compared with laparoscopic techniques, hysteroscopic sterilization studies cite cost savings of >50% in the OR.[7, 8, 9] Prior abdominal surgery and obesity are not contraindications for hysteroscopy, nor are cardiovascular or anatomic contraindications to general anesthesia. Long-term 5-year Essure data from the Phase II and Pivotal Trial continue to demonstrate safety, high patient satisfaction with zero reported pregnancies.
Essure has been shown to be 99.80% effective in preventing pregnancy after 4 years of follow-up. Essure labeling reports a bilateral placement rate of 94.6%. and published papers report placement rates ranging from 96-99%.[12, 13, 14, 15, 16, 17] Since its approval in the commercial setting, the evaluable performance of Essure is still consistent with the age-adjusted effectiveness of 99.85%. The hysteroscopic failure rate is the lowest of any surgical approach with 0.5/1000 at 1 year.
Hysteroscopy requires an FDA-mandated hysterosalpingogram to confirm correct placement and to document tubal occlusion. Patients often find this procedure a reassuring confirmation that the tubes are indeed occluded.
Informed consent and preoperative counseling
Inform the patient that a sterilization procedure is intended to be permanent and irreversible and that, as with any form of contraception, a small chance of failure exists. In some languages, sterilization is synonymous with castration. Therefore, the patient must have a very clear grasp of the surgical procedure; diagrams and take-home pamphlets are helpful.
The relative likelihood of an ectopic pregnancy is increased when sterilization failure occurs in all procedures involving occlusion or excision of the isthmic or ampullary segments of the tube, but ectopic pregnancy has not been demonstrated in the hysteroscopic approach. Inform the patient that complications exist, although the incidence of major complications is low. For minilaparotomy and laparoscopic techniques, complications may include injuries to the gastrointestinal and genitourinary tracts, infection, hemorrhage, and complications of anesthesia. For the hysteroscopic approach, the same complications associated with diagnostic hysteroscopy apply — uterine perforation, bleeding, excessive absorption of distention media, and infection.
Alternatives to permanent female sterilization include vasectomy and reversible methods of contraception (eg, injectable and implantable progestins, the levonorgestrel intrauterine system and other commercially available intrauterine devices). Although reversible methods of contraception (eg, injectable and implantable progestins, the levonorgestrel intrauterine system and other commercially available intrauterine devices) are sometimes prescribed in lieu of a permanent solution, these methods are associated with hormonal side effects such as irregular uterine bleeding and are not intended as long-term solutions. For example, Mirena labeling counsels that their product should only be used for up to 5 years for pregnancy prevention.
Screen for risk indicators for regret, including young age, low parity, single parent status, or marital instability. Stress the need to use condoms for protection against sexually transmitted diseases and HIV infection if the patient is at risk of exposure. Document the informed consent process in the patient's medical record. The patient should also receive a copy of the completed consent form to review and retain.
Physicians must be aware of and follow any applicable federal and state requirements regarding informed consent for sterilization procedures, including time intervals between consent and sterilization. If federal funds are used for the procedure, the required US Department of Health and Human Services consent form must be signed 30-180 days prior to surgery. Furthermore, this consent cannot be obtained if the patient is younger than 21 years, in labor, under the influence of drugs or alcohol, mentally incompetent, or having an abortion.
Review the preoperative history and perform a physical examination to determine if any contraindications exist for elective surgery.
Intraoperative details are described for puerperal techniques, laparoscopic approaches, and mechanical techniques.
This technique is the simplest and most commonly performed puerperal tubal sterilization.
The mid portion of the oviduct is grasped with a Babcock clamp, creating a loop, which is tied with 2-0 or 0 plain catgut suture, and each limb of the tubal knuckle is cut separately. Specimens are submitted to pathology. The endosalpinx at the cut ends may be cauterized (optional). The ligation sutures are held while the tube is cut to prevent retraction of the tubal stumps into the peritoneal cavity before they can be adequately examined for hemostasis.
The original description consisted of forming a loop of the ampullary segment of the fallopian tube and ligating the base of the loop with a double strand of 1-0 chromic catgut, followed by resection of the top of the ligated loop. The rationale for this technique is based on prompt absorption of the suture ligature with subsequent separation of the cut ends of the tube, which then become sealed by spontaneous reperitonealization and fibrosis. A resultant natural gap of 2-3 cm should occur between the severed proximal and distal segments of the tube.
Many modifications of the Pomeroy technique have been described; the most common involves doubly ligating each loop.
Failure rates are reported to be 1 case in 300-500 patients.
The Parkland technique is a midsegmental resection similar to the Pomeroy technique, except each leg of the loop is tied separately. The Parkland technique was designed to avoid the intimate approximation of the tubal cut ends, as occurs with the Pomeroy technique, thereby theoretically reducing the risk of subsequent recanalization.
An avascular area in the mesosalpinx directly under the tube is perforated with a hemostat, and the jaws are opened to spread the mesosalpinx, thereby freeing approximately 2.5 cm of tube. The tube is then ligated proximally and distally with a 0 or 00 plain or chromic suture, and a 1- to 2-cm tubal segment is excised and submitted for pathologic confirmation.
Failure rates are reported to be 1 case in 400 patients.
The mid portion of the oviduct is raised with 2 Babcock clamps. The tubal serosa is hydrodissected from the muscularis by subserosal injection of a dilute (1:100,000) saline solution of epinephrine or isotonic sodium chloride solution. A linear incision is made parallel to the axis of the tube in the ballooning serosa on the antimesosalpingeal aspect with a scalpel, #15 blade. The serosal peritoneum is grasped on either side of the tubal incision with hemostats, and a third hemostat is used to bluntly dissect and reflect the serosa and the surrounding areolar tissue from the tubal muscularis. With the tubal muscularis exposed,
a relatively long (5 cm) segment of tubal muscularis is ligated proximally and distally with a 0 or 0-0 plain catgut suture and resected. The serosal edges are then reapproximated, burying the proximal exposed tubal end within the leaves of the broad ligament, leaving the distal end exposed.
During the puerperium, Uchida modified the sterilization procedure by including fimbriectomy.
Clearly, the excision of such a large segment of tube, combined with a fimbriectomy, accounts for the low rate of failure for this technique. For all practical purposes, it is a salpingectomy.
The Irving technique is designed to be used in conjunction with cesarean delivery.
A mesosalpingeal window is created beneath the tube approximately 4 cm from the uterotubal junction. The tube is doubly ligated with 0 or 00 absorbable suture and severed, with the sutures on the proximal end left long. The proximal tubal stump may require mobilization by dissecting it free from the mesosalpinx. A small nick is made into the serosa on the posterior (or anterior) uterine wall near the uterotubal junction. A hemostat is used to deepen the incision, creating a pocket in the myometrium approximately 1-2 cm deep. The 2 free ends of the proximal stump ligature are then individually threaded onto a curved needle and brought deep into the myometrium tunnel and out through the uterine serosa. Traction on the sutures draws the proximal tubal stump deep into the myometrial tunnel, and the sutures are tied. The serosal opening of the tunnel is then closed around the tube with fine absorbable suture.
An additional option is to bury the distal end of the tube between the leaves of the broad ligament as originally described by Irving.
Failure rates are less than 1 case in 1000 patients.
The use of electrosurgery is preferable when the fallopian tube is edematous, thickened, or cannot be mobilized easily for mechanical device placement. This technique should always be readily available during laparoscopic BTL, both as a backup method of sterilization and for control of unexpected bleeding. However, the technique causes greater tubal damage, making
tubal reversal more difficult if the patient regrets her decision.
Bipolar current is theoretically inherently safer than unipolar current because tissue destruction is essentially confined to the area between and immediately adjacent to the bipolar paddles.
The oviduct is identified and grasped at the mid isthmus region, at least 2.5-3 cm lateral to the uterotubal junction, with the bipolar forceps. The tube is elevated to ensure the forceps are not in contact with any other structure (eg, bowel, sidewall), and current is applied. Older electrosurgical generators do not have active feedback, and excessive tissue destruction is the rule, not the exception. High voltage results in excessive heat and tissue charring, sometimes causing sticking of the electrodes. Extensive damage to the tissue may facilitate future fistula formation and encourage failure. Modern bipolar generators have circuitry that measures tissue impedance, so that when desiccation of the tissue is complete, an audible alert is given. The procedure is repeated 2-3 times for each tube to create a 3-cm contiguous area of desiccation.
Formation of tuboperitoneal fistula, with a subsequent risk of pregnancy (including ectopic pregnancy) or possible pelvic inflammatory disease (PID), is minimized by maintaining the most proximal burn no closer than 2 cm to the uterine cornu. Leaving a 2- to 3-cm pedicle allows enough space for absorption of intrauterine fluid under pressure, such as during menstruation, and minimizes the risk of fistula formation.
However, the downside of this technique becomes apparent if the patient later undergoes endometrial ablation for menorrhagia. Endometrial ablation causes varying degrees of intrauterine synechiae (Asherman syndrome). Since islands of endometrium frequently survive the ablation procedure, small amounts of menstrual fluid are still produced. In most cases, the blood exits the cervix, but occasionally the surviving endometrium is located in the cornual region of the uterus and is surrounded by postablation synechiae. When this happens, the menstrual fluid is forced through the tubal ostium and creates a small hematosalpinx in the surviving segment of fallopian tube. This is accompanied by severe cyclic pain and frequently requires additional surgery, often hysterectomy, to correct.
In surgery, using monopolar energy, the current passes through the entire patient to complete the circuit between the electrode and the electrosurgical generator. Faulty instrumentation or improper techniques increase the possibility of stray current causing thermal injury to adjacent structures. Details on electrosurgery and its complications may be found in a separate chapter.
The initial popularity of unipolar current occurred during the early years of laparoscopic sterilization when it was often the only instrumentation available. Its use has diminished following many documented bowel injuries. Although all surgeons should have a proper understanding of the principles of electrosurgery that would enable them to avoid complications, unipolar current has largely been replaced with bipolar electrodesiccation.
A return electrode is placed on the patient. The unipolar current applied to the oviduct flows from the electrode through the patient's body and completes the circuit to the generator through the return electrode. The use of a metal trocar sleeve avoids capacitative coupling between the forceps and the sleeve, and any electrical current flowing to the trocar is dispersed through the patient's abdominal wall. An electrocoagulating grasping forceps is placed completely around the isthmic portion of the tube, approximately 4 cm from the uterine cornu. The oviduct is mobilized away from any viscera and the sidewall. A low-voltage generator, with a maximum peak of 600 V and maximum power of 100 W, is used to apply current for approximately 5 seconds, until blanching and swelling of the tube is visible. The highest success rates are achieved when at least 3 cm of tube is destroyed.
Thermal injury to the bowel may occur either from direct current flow via the tube being coagulated or from undetected contact between the forceps or trocar sleeve and bowel. Patients with thermal injuries tend to present with an acute abdomen several days after the procedure.
Falope (Yoon) ring technique
A nonreactive silicone rubber band measuring 3.6 mm in outer diameter and incorporating 5% barium sulfate for radiographic identification is used. The applicator consists of inner grasping prongs and an outer double-barreled sheath. The Falope ring is stretched around the base of the applicator sheath. Some devices allow for double-loading of the rings so that the applicator
needs to be inserted into the abdominal cavity only once.
The isthmic portion of the fallopian tube is identified. The forceps of the applicator are extended and a segment at least 3 cm from the uterine cornu is grasped, taking care to avoid the proximity of any vessels in the mesosalpinx. Approximately 2.5 cm of tube is gently pulled into the barrel using a slow "milking" technique. This may be difficult with edematous tubes, or in the presence of chronic pelvic adhesions. The larger-diameter outer barrel then pushes the Falope ring over the knuckle of tube, and the ring then returns to its former state, with an inner diameter of 1 mm.
The loop of tube should clearly contain 2 complete lumens of tube. Slowly advancing the entire applicator toward the tube while gradually retracting the tongs and tube into the applicator and avoiding excessive traction on the tube are important.
Failure to do this can result in mesosalpingeal hemorrhage and tubal laceration, which occur in approximately 1-5% of cases. This can be treated with bipolar coagulation, or a Falope ring may be placed on each transected end.
Falope ring application has traditionally been considered more painful postoperatively secondary to ischemia; however, this was not established in a randomized controlled trial. The failure rate is reported to be 3.3 cases per 1000 patients.
Hulka-Clemens clip technique
The clip is designed to be applied at a right angle to the isthmic portion of the tube 2.5-3 cm from the uterotubal junction. When properly applied, only 4 mm of tube and virtually none of the blood supply is destroyed.
The clip consists of 2 toothed jaws of Lexan plastic joined by a stainless steel hinge pin. The lower jaw has a distal hook. A gold-plated spring maintains the clip in an open position. When completely advanced, the spring closes and locks the jaw.
The Hulka applicator is 7 mm in diameter with a 3-ring configuration at the upper end consisting of a central ring (designed to accommodate the thumb for stabilization) and a pair of lower rings (to accommodate the index and middle fingers and control the clip application mechanism). The distal end of the applicator has a fixed lower jaw to accommodate the clip. A mobile upper jaw, when retracted, permits placement of the open clip and, when advanced, closes the clip. When completely advanced, a central piston locks the spring.
Once the oviducts have been identified laparoscopically and deemed suitable for clip sterilization, the Hulka clip applicator is introduced with the clip in the closed position, and the clip is opened after the applicator is intra-abdominal in position. The hook of the lower jaw is placed against the posterior mesosalpinx, the tube is tented slightly upwards, and the clip is applied. The clip may be opened and repositioned repeatedly until the correct position is achieved, at which time the center piston is advanced to permanently lock the clip and unseat it from the applicator. If the clip has not been applied satisfactorily, a second clip is placed immediately alongside the first.
The applicator is withdrawn from the abdomen and reloaded, and the contralateral tube is treated in the same fashion. Failure of the Hulka clip should not exceed 2-3 cases per 1000 patients.
A review by Harrison et al of randomized, double-blind, placebo-controlled studies indicated that postoperative pain following laparoscopic ring or clip tubal ligation can be significantly reduced through the administration of local anesthetic during the procedure. The investigators reported that this strategy substantially decreased pain for up to 8 hours postsurgery.
Filshie clip technique
This technique is widely used in Canada, the United Kingdom, and Australia and was approved for use in the United States in 1997. This technique involves a 12.7-mm long clip of titanium with a silicone rubber lining. The clip is applied laparoscopically with an applicator, much like the Hulka spring clip, at right angles to the isthmus approximately 2-2.5 cm from the uterotubal
Initially, the clip occludes the tubal lumen by pressure. As tubal necrosis occurs, the rubber expands to maintain blockage of the lumen. The tube eventually divides, and the stumps heal closed. The Filshie clip usually remains attached and is eventually covered by peritoneum. Theoretically, because the silicone rubber of the Filshie clip is able to expand and provide continuous pressure even when the tube becomes ischemic, any residual tubal patency, such as may occur with the spring clip, is prevented.
Rare reports of migration of the Filshie clip into the bladder, vagina, peritoneal cavity, and appendix have been published, as have reports of expulsion of Filshie clips from the vagina, urethra, and rectum (occurring at a similar rate as expulsion of the Hulka clip). Migrations and expulsions are usually symptomatic and of little clinical significance. In all cases, the clips were found closed, the tubes were fully occluded, and no long-term adverse sequelae occurred.
Cumulative data at 24 months of follow-up (based on findings of Family Health International, which has conducted 11 studies of the Filshie clip at 43 sites in 10 countries) report a failure rate of 7 cases per 1000 patients.
The Essure microinserts device consists of polyethylene terephthalate (PET) (Dacron) fibers wrapped around a stainless steel core, surrounded by 24 coils of nickel-titanium alloy (Nitinol), a substance widely used for coronary artery stents and cardiovascular devices. The microinserts are dynamic, spring-like devices that are inserted into each fallopian tube. Once deployed, the effectiveness of the Essure microinserts is believed to be due to a combination of the space filling design of the device and a local occlusive, benign tissue response to the PET fibers. This process takes approximately 3 months to form complete occlusion, which is then documented by a low pressure hysterosalpingogram. Hysteroscopy may be performed in the office setting under local anesthesia, which is preferred, although regional or general anesthesia may be selected according to patient or surgeon preference. Successful bilateral placement rates vary from 94.6-99%.[11, 17, 16]
The procedure is basically identical to the Novy cannulation of the fallopian tube for tubal obstruction. A 5-mm operative hysteroscope with a 5-French operating channel is inserted under direct vision through the cervical os, and the uterine cavity is entered. Normal saline is used for the distension medium, which minimizes the risk of fluid overload and virtually eliminates the risk of electrolyte imbalance inherent in the use of isotonic solutions (glycine and sorbitol).
Both tubal ostia are identified. The device is passed through the operating channel and guided into the tubal ostium to the depth of the black indicator on the outer cannula. With the applicator steadied against the hysteroscope, the wheel on the handle is rotated, which causes the outer sheath to retract, exposing the wound-down coils of nickel-titanium. The device is
then deployed by pressing a release button and turning the wheel again. The device is then retracted from the operating channel and the procedure is repeated on the contralateral side. Out of the 24 coils, 3-8 coils must be visible trailing in the uterine cavity to confirm proper placement of the device. Since the Essure microinserts are clearly visible via HSG, this provides physicians and patients reassurance regarding proper placement and tubal occlusion.
Long-term 5-year Essure data from the Phase II and Pivotal Trial continue to demonstrate safety and high patient satisfaction with zero reported pregnancies. Since its approval, in the commercial setting, the evaluable performance of Essure is still consistent with the age adjusted effectiveness of 99.85% (internal Conceptus data, with permission). Perforation of the fallopian tube due to forceful insertion has been reported but did not cause intraoperative or postoperative symptoms and was detected only on hysterosalpingogram. The same risks and complications associated with diagnostic hysteroscopy apply to this procedure.
Another hysteroscopic device was recently approved and is commercially available. Adiana uses radiofrequency energy from a separate electrosurgical generator to desiccate a small segment of the interstitial portion of the fallopian tube, after which a small silicone plug is inserted. This method, using monopolar electrosurgery, requires glycine as the distension medium and introduces the risk of electrolyte imbalance inherent in the use of nonionic solutions as well as the potential risk of thermal injury should the electrode perforate into the abdominal cavity. Since the silicone plug is not radiopaque, its final location cannot be confirmed on HSG to aide in confirmation of occlusion. Twelve-month data for Adiana reported a 1.07% failure rate that included 6 reported pregnancies, 1 of which was ectopic. Two-year data had 3 pregnancies out of 524 pivotal trial patients for a cumulative failure rate of 1.67%. At 4 years there was one pregnancy after 42 months of undetermined origin.
Another device very similar to the Essure microinsert is in trials. The use of quinacrine to cause a chemical occlusion of the fallopian tube is under investigation.
The follow-up visit for open or laparoscopic approaches is 1-2 weeks postoperatively. Instruct the patient to notify her health care provider if she develops fever (38°C or 100.4°F), increasing or persistent abdominal pain, or bleeding or purulent discharge from the incision.
Patients who have undergone hysteroscopic sterilization must be counseled to use an alternate form of contraception for 3 months at which time a low-pressure hysterosalpingogram must be obtained to confirm placement and bilateral tubal occlusion. The importance of the 3-month hysterosalpingogram needs to be communicated to patients at the time of microinsert placement; subsequent office follow-up may be required to ensure patients comply with confirmation test.
Inform all women who have undergone sterilization about the signs and symptoms of pregnancy (eg, amenorrhea, vaginal bleeding/spotting, abdominal pain) and ectopic pregnancy, and advise these women to seek immediate medical attention if such signs occur.
The risk of death from tubal sterilization is 1-2 cases per 100,000 procedures; most of these are complications of general anesthesia. The most common cause of death during laparoscopic BTL appears to be hypoventilation related to anesthesia. Cardiopulmonary arrest and hypoventilation are reported as the leading cause of death in most cases. Sepsis as a cause of death from laparoscopic sterilization is directly related to bowel perforations or electrical bowel burns. The mortality rate is low when compared with the risk of death from hysterectomy (5-25 cases per 100,000 procedures) and from pregnancy (8 cases per 100,000 live births in the United States and 500 cases per 100,000 live births in developing countries).
No deaths have been reported from the hysteroscopic approach.
Unintended laparotomy occurs with 1-2% of laparoscopic procedures; most of these conversions are attributable to technical inability to complete the laparoscopic procedure rather than to complications of the procedure.
Bowel injury can occur during insertion of the insufflation needle or trocar or during electrocoagulation. Small injuries from the needle or trocar with no bleeding or leakage of enteric contents can usually be managed expectantly; otherwise, prompt laparotomy is indicated.
Vascular injury can occur during insufflation needle or trocar insertion. Injury to a large vessel is a life-threatening emergency. Perform an immediate laparotomy with direct pressure over the injury to control bleeding until repair (usually by a vascular surgeon) can be performed.
Method failure (pregnancy or ectopic pregnancy)
Although sterilization is highly effective and considered the definitive form of pregnancy prevention, it has a failure rate during the first year of 0.1-0.8%. At least one third of these are ectopic pregnancies. Recent findings suggest that pregnancy is somewhat more common than previously estimated, that the risk of pregnancy persists for many years after sterilization, and that the risk varies by method and patient age at sterilization.
In the CREST study, 10,685 women were enrolled from 1978-1986; follow-up continued until 1994. The CREST study reviewed procedures performed at 10 large teaching institutions, and the data may not reflect the experience from the private sector. Whether the findings can be extrapolated to the general population is unclear. In addition, the Filshie clip, which has a lower incidence of failure than the other laparoscopic techniques, was not included in this study. The 10-year cumulative probability of pregnancy varied from 7.5 cases per 1000 procedures for postpartum partial salpingectomy and unipolar coagulation to 36.5 cases per 1000 procedures for spring clip application. The CREST study identified a 10-year cumulative failure rate of 18.5 failures per 1000 patients for all methods combined. Pregnancies occurring in the 10th year after sterilization were identified for all methods of laparoscopic occlusion evaluated.
Rodriquez et al also found decreased efficacy with the titanium clip than partial salpingectomy and does not recommend using the titanium clip during the postpartum period.
The risk of pregnancy varied by patient age at sterilization and by method, with the highest risk among young women sterilized with bipolar coagulation (54.3 cases per 1000 procedures). Overall, women sterilized at age 34-44 years were half as likely to become pregnant after sterilization compared to women sterilized at age 28-33 years and were approximately one third as likely to become pregnant as women sterilized at age 18-27 years. When pregnancy occurs after BTL, the risk of ectopic pregnancy is high. The CREST study reported a 32% rate of ectopic pregnancy following tubal ligation. Several studies suggest that the risk is highest after bipolar coagulation, with more than 50% of pregnancies being ectopic.
BTL failures can be grouped into the following categories:
Luteal phase pregnancy is defined as a pregnancy in which conception occurs before the BTL, but pregnancy is diagnosed after an interval tubal sterilization. Strategies to reduce the incidence (reported to occur at a rate of 1-15 cases per 1000 interval sterilizations) include effective contraception, scheduling of BTL during the proliferative phase, and preoperative urine enzyme-linked immunoassay pregnancy testing.
Misidentification of the oviduct because of poor visualization from inadequate exposure, adhesions, adnexal pathology, or poor lighting may result in mistakenly ligating the round ligament, ovarian ligament, infundibular ligament, or dilated broad ligament blood vessels instead of the oviduct. Therefore, initially identifying the fimbriated tubal ends and then tracing the tube medially to the isthmic region is imperative. In postpartum minilaparotomy BTL, Babcock clamps should be placed sequentially along the oviduct until the fimbria is visualized.
Incomplete occlusion of the oviduct occurs because of poorly placed mechanical clips or the use of mechanical devices on edematous or dilated tubes. With correct clip application, the mesosalpinx on the surface of the tube is pulled upward to resemble the flat triangular shape of an envelope flap (the Kleppinger envelope sign). When silastic rings are used, the tubal serosa, but not the tubal lumen, may be pulled into the ring, with absence of the vertical crease formed when the entire loop of tube is included in the ring.
Incomplete tubal occlusion with electrocoagulation is generally associated with too brief an application of current or with the use of modulated/coagulation current instead of unmodulated/cutting current.
Improper technique occurs with the use of the wrong sutures or failure to preserve a 2-cm proximal tubal segment. If a short proximal stump is left, the fluid pressure from uterine contractions could either prevent complete closure of the tubal lumen during healing or cause a fistula to form to relieve pressure after healing is complete.
After laparoscopy, patients may experience some degree of chest and shoulder pain due to trapped gas. Mechanical blocking devices are believed to cause ischemic pain, but this has not been established in a randomized, controlled trial. Mild analgesics are usually sufficient to control postprocedure pain.
Hysteroscopic sterilization has been reported to be similar to the pain experienced during menses and is generally limited to the procedure and immediate postprocedure time period.[21, 22]
Wound infections and hematoma have been associated with minilaparotomy. Pelvic infections and hemorrhage are associated with vaginal approaches. Although prophylactic antibiotics are recommended for women at risk for subacute bacterial endocarditis who are scheduled to undergo a procedure that may lead to bacteremia, the American Heart Association does
not recommend antibiotic prophylaxis for BTL. Hemorrhage is a rare complication (30-90 cases per 100,000 procedures) that usually occurs following major vessel injury during laparoscopic entry and occasionally occurs following mesosalpingeal vessel injury during the occlusion procedure.
Visceral (bowel, bladder, uterus) injuries
Organ injuries can occur from sharp trauma (eg, insufflation needle, trocar, scalpel), blunt trauma (eg, from adhesiolysis), or electrical-thermal trauma. Injuries can also occur during inadvertent application of the occlusion device to the incorrect structure. If recognized at the time of occurrence, injuries to the bowel and bladder (which are more common in the presence of adhesions) are relatively easy to manage and will not result in long-term adverse sequelae. Injuries to the uterus, most often caused by uterine manipulators, do not usually lead to adverse sequelae unless bowel or bladder has been perforated simultaneously.
Sterilization is intended to be permanent, but patient regret is not rare. Poststerilization regret is a complex condition often caused by unpredictable life events. Risk factors for regret that may be useful in presterilization counseling include young age, low parity, and single parent status or being in an unstable relationship. As many as 6% of women who are sterilized report regret or request information about tubal reversal within 5 years of the procedure. Follow-up interviews 14 years postprocedure demonstrate that regrets were expressed by 20.3% of women aged 30 years or younger at the time of BTL and by 5.9% of women older than 30 years at time of procedure.
The proportion of women who actually undergo microsurgical tubal reanastomosis is only 0.2% in the first 5 years after BTL. The most important factor in determining the success of reversal by tubal anastomosis is the length of healthy tube remaining after sterilization. Isthmic-to-isthmic anastomoses are most likely to be successful. Sterilization reversal using a sutureless laparoscopic approach yielded a 59% ongoing pregnancy rate with a 3.9% ectopic rate. Age, previous pregnancy, and sperm quality were major factors affecting the outcome.
Outcome and Prognosis
Noncontraceptive benefits are as follows:
Several studies report a protective effect of sterilization against ovarian cancer, with a relative risk ranging from 0.2-0.8. Protection is hypothesized to result from reduced exposure of the ovaries to potential environmental carcinogens and infectious sources of malignant transformation (eg, oncogenic viruses).
Pelvic inflammatory disease
Although BTL does not protect against the acquisition of sexually transmitted disease, sterilization has been demonstrated to reduce the spread of organisms from the lower genital tract to the peritoneal cavity and thus protect against PID. Studies have reported that PID is less common in women who are sterilized compared with women who are not sterilized; however, protection is not absolute because uncommon reports exist of PID in sterilized women within 4-6 weeks or several years following surgery.
In cases of infection occurring within weeks of surgery, manipulation of the cervix, uterus, or oviducts is postulated to exacerbate a chronic infection or facilitate bacterial ascent from the lower genital tract at the time of surgery (eg, chlamydial or gonococcal cervicitis). PID occurring years after BTL results from bacteria ascending through a uteroperitoneal fistula or spontaneously recanalized tube. In these situations, if the patient requires surgery for diagnosis or treatment, relegating or excising the oviducts to help prevent future episodes of infection and ectopic pregnancy is prudent. Case reports have also demonstrated abscesses in the stump of the proximal fallopian tube.
Future and Controversies
Researchers continue to explore the possibility of using various substances that can be introduced through the cervix to occlude the tubal lumen through sclerosis or mechanical occlusion.
Quinacrine (historically used as an antimalarial drug) used for sterilization is instilled into the oviducts via transcervical application through a modified copper T intrauterine device. Although not approved for sterilization purposes in any country, an estimated 100,000 women have undergone this method of sterilization. The mechanism of action is tubal occlusion caused by inflammation and fibrosis of the intramural portion of the tube. Long-term failure rates, complications, optimal doses, and the need for adjuvants (eg, nonsteroidal anti-inflammatory drugs) are not clear because of nonsystematic investigation of the method and poor follow-up of women who have received it. Toxicologic studies and follow-up data are needed before the initiation of any human trials in the United States.
Post–tubal ligation syndrome
Proposed in 1951, this syndrome is a controversial constellation of symptoms, including pelvic discomfort, ovarian cystic changes, and menorrhagia, which are suggested to occur as a result of disruption of the uteroovarian blood supply, with resultant disturbances of ovulatory function after BTL. Often, these patients have a history of these problems before BTL or have been taking birth control pills, which masked their symptoms.
After extensive study, BTL apparently causes few, if any, menstrual abnormalities within several years after sterilization, regardless of the method of tubal occlusion used. Data from the CREST study indicate that women who are tubally sterilized are no more likely than women who have not undergone the procedure to report intermenstrual bleeding or changes in menstrual cycle length. However, women who are sterilized are more likely to report a reduced number of days of bleeding, less overall bleeding and menstrual pain, and increased cycle irregularity. BTL also seems to help reduce blood flow in women who reported very heavy menstrual bleeding at baseline.
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