- Email: [email protected]
The “U” technique: A new method for Norplant®∗ implants removal
The “U” technique: a new method for Norplant@ implants removal’ Un tung Praptohardjo
* and Susilo Wibowo f
*Departments of Obstetrics and Gynecology and tAndrology Section, Department of Biology, Faculty of Medicine, Diponegoro University; IPPA Central-Java, Jl. Jembawan No. 8, Semarang, Indonesia
The standard technique for Norplant implants removal was compared with a new technique called the “U” technique, which employs the use of a modified no-scalpel vas deferens holding forceps to grasp and remove the capsules. Seventy-six women requesting Norplant implants removal were randomly assigned to Group 1 (standard removal technique) or Group 2 (“U” removal technique). Variables measured included: (a) time required for complete removal, (b) number of capsules not broken or damaged during removal, and (c) number of incisions required for removal of all six capsules. In clients with visible or palpable capsules, the standard removal technique required significantly more time to remove all six capsules, on average, than the “U” technique (19 versus 7 minutes, p < 0.001); also more capsules were damaged during removal (5.6 undamaged versus 6.0, p < 0.01). In addition, with the standard technique, five clients required two incisions for removal of all six capsules while none of the clients required more than one incision with the “U” technique. Our conclusion is that the “U” technique is a quicker and easier method of removing Norplant capsules than the standard technique. Keywords:
Norplant@ implants; removal; forceps; capsules.
‘This new technique has been named the “U” technique after its developer, Dr.
Untung. Submitted for publication September 8, 1993; accepted for publication November 3, 1993. Address correspondence to: Dr. Untung Praptohardjo, Department of Obstetrics and Gynecology, Faculty of Medicine, Diponegoro University, IPPA Central-Java, Jl. Jembawan No. 8, Semarang, Indonesia Norplant@ is a registered trademark of The Population Council, Inc.
526
Contraception
1993:48,
December
0 1993 Butterworth-Heinemann
New method for Norplant implants removal:
Praptohardjo and Wibowo
Introduction At the present time two countries, Indonesia, and the United States, have the largest Norplant@ contraceptive implant system programs. In Indonesia over 1.5 million women have received Norplant implants during the past ten years, while more than 600,000 women in the United States already have had Norplant implants inserted since its approval by the United States Food and Drug Administration in December 1990.’ Because of the need to have the implants removed after five years, and replaced (if desired), large-scale use of this contraceptive method poses special problems for family planning service delivery programs as well as for the clinicians responsible for removing the implants (capsules). In Indonesia, where clinicians have had more experience with the large-scale use of the Norplant system than in any other country in the world, the national family planning program is now entering a new, steady-state phase where the number of acceptors per year (about 300,000) equals, or exceeds, the number of women requesting removal. The need to provide large numbers of women ready access to removal services has had considerable impact on the health care system, and has led to a systematic assessment of how best to maximize the quality, and availability, of removal services while minimizing the time and effort required. The current removal method using Crile and/or mosquito forceps, hereafter referred to as the standard technique, was developed in the early 1980s. Details of this technique are fully described in the WHO guidelines published in 1990.2 Since that time, however, several investigators have reported modifications to the standard technique, most recently Darney et al. who described the “pop-out” method in 1992.3,4 The fact that improvements in the method of removal continue to be sought, while changes in the insertion technique have been few, strongly suggests that the standard removal technique is not entirely satisfactory. This observation is borne out by the experience in Indonesia and confirmed in other countries as well. Removal requires more patience and skill than insertion. Moreover, with atypically placed capsules (i.e., those inserted too deep and/or in an irregular pattern), removal using any technique takes longer (up to 45 minutes or more) and reportedly is associated with more blood loss than insertion.2,” For the last several years, at the Indonesian Planned Parenthood Association (IPPA) Central-Java at Semarang, frequently we have experienced difficulty using all of the reported Norplant implants removal techniques. In response to the need for an easier way to remove Norplant implants, we developed a new removal technique called the “U” technique. This technique involves use of a modified no-scalpel vas deferens holding forceps, hereafter referred to as the Norplant implants holding forceps, for grasping and removing the Norplant capsules.6
Contraception
1993:48, December
527
New method
for Norplant
implants
removal:
Praptohardjo
and Wibowo
This communication reports the details of a comparative study of the standard and the “U” technique which was conducted from June 1991 to May 1992 at the branch of the IPPA Chapter of Central-Java Clinic in Temanggung district, Temanggung regency, Central- Java, Indonesia. This is one of 35 branches of the IPPA Chapter of Central-Java Province. At the Central-Java Clinic, the following methods of contraception are provided: IUDs, oral contraceptives, condoms, injectables, vasectomies, tubectomies, and Norplant implants. At the IPPA branch in this regency, 502 Norplant implants insertions were performed in 1991 and 380 in 1992. At the time of this study, all Norplant implants removals were performed by the authors.
Materials and Methods Seventy-six Norplant implants removal clients, all of whom had been using Norplant implants for five years, were selected to participate in this study. To eliminate bias and error due to difficulties in locating unpalpable implants, only clients who had visible or palpable implants were selected. Among implant users considered for this study, 13.63% (12/88) were classified as having implants that were difficult to palpate; these clients were considered ineligible for the study. Clients were randomly assigned, using a random numbers table, to Group 1 (standard removal) or Group 2 (“U” removal). Client preparation, includingpositioning of the arm and injection of the local anesthetic, was the same for both groups. Because the amount of time required for injecting the local anesthetic varied from client to client, removal time was measured from the time the incision was made until all six capsules were removed. In addition, the number of undamaged/unbroken capsules as well as the number of incisions required were counted and compared. Each removal was performed by one of the authors. To minimize risk of postoperative infection and possible risk of serious disease transmission to clients and clinic staff, recommended infection prevention practices were followed. In rural areas, where sterilization was not possible, highlevel disinfection by boiling or soaking instruments and other items in a high-level chemical disinfectant was done.’ The Standard
Technique
For the standard l l l
528
technique,
the following
equipment
was used:
Mosquito forceps Crile forceps Scalpel
Contraception
1993:48,
December
New method for Norplant implants removal:
Praptohardjo and Wibowo
After the capsules were located by palpation and their positions marked using a ballpoint pen, the client’s arm was cleansed with antiseptic solution and draped with a sterile or high-level disinfected cloth. Next, a syringe was filled with about 3 ml of local anesthetic (1% without epinephrine), and the needle inserted under the ends of the capsules nearest the elbow. The needle was then gently advanced about one-third the length of the first capsule (1 cm) and a track of anesthetic (about 0.5 ml) was laid to raise the end of the capsule as the needle was withdrawn. Without removing the needle from under the skin, its tip was slid over and inserted under the next capsule. This process was repeated until the ends of all six capsules were raised (see Figure 1). To prevent local anesthetic toxicity, the total dose did not exceed 10 ml of a 10 g/l (1% without epinephrine) local anesthetic. After the local anesthetic was administered, a 4-mm transverse incision was made close to and below (toward the elbow) the distal ends of the capsules (see Figure 2). After this, the capsules were pushed gently toward the incision with the gloved fingers of one hand until the capsule tip became visible (or could be grasped with the mosquito forceps). After grasping it and bringing it into the incision, surrounding fibrous tissue was removed until the capsule tip was visible. Finally, the capsule was removed using the second
FIGURE 1. Injecting the anesthetic
Contraception
1993:48, December
under the capsules.
529
New method
for Norplant implants removal:
Praptohardio
I
and Wibowo
4mm lncislon
FIGURE 2. Location of incision in the standard technique.
(Crile) forceps. In many cases, the technique for removing hard-to-retrieve capsules (suggested by the manufacturer) was required.2,” Furthermore, in some cases, a second incision was necessary to remove hard-to-retrieve capsules. The “U” Technique For the “U” technique, l
l l
Norplant at the tip diameter Mosquito Scalpel
the following
equipment
was used:
implants holding forceps in. which the diameter of the ring of the forceps is reduced from 3.5 mm to about 2.2 mm, the of the Norplant capsules (see Figure 3). or Crile forceps
As with the standard technique, the capsules were located by palpation and their positions marked with a ballpoint pen. The location and volume of anesthetic used were the same as in the standard technique. After the local anesthetic was administered, a 4 mm incision was made. In this case, however, the position of the skin incision differed from the standard technique as follows: l
l
530
the 0.5 the ure
incision was made between capsules 3 and 4, starting approximately cm above (proximal to) the distal ends of the capsules, and incision was made longitudinally rather than transversely (see Fig4).
Contraception
1993:48, December
New method for Norplant implants removal:
Praptohardjo and Wibowo
Inside diameter 2.2 mm
FIGURE 3. The Norplant implants holding forceps.
FIGURE 4. Location of incision in the “U” technique.
After inserting the Norplant implants holding forceps through the incision, the forceps was advanced until it touched the nearest capsule. As shown in Figure 5, the capsule was stabilized by placing the index finger just lateral and parallel to the capsule’s long axis. Next, the capsule was grasped, with the Norplant implants holding forceps, at right angles to its long axis and within 5 mm of the distal tip. After grasping and gently pulling the capsule toward the incision, the handle of the forceps was
Contraception
1993:48, December
531
New method
for Norplant
implants
removal:
Praptohardjo
and Wibowo
rotated toward the client’s shoulder, bringing the tip of the capsule into view in the incision (see Figure 6). The soft tissue surrounding the exposed portion of the capsule was then cleaned and opened with sterile gauze. (As an alternate method, a scalpel was used to scrape away the fibrous tissue.) Then, using the second forceps, the exposed part of the freed capsule was grasped and the capsule removed.
FIGURE 5. Stabilizing the capsule.
FIGURE 6. Grasping the capsule in the “U” technique.
532
Contraception
1993:48,
December
New method for Norplant implants removal:
Praptohardjo and Wibowo
Results Sample data collected from this study showed that removal times followed a normal distribution; however, the number of undamaged/unbroken Silastic capsules as well as the number of incisions did not. Therefore, the pooled T test was employed for comparing the time for removal and the Mann-Whitney test for the other two variables. As shown in Table 1, with the standard technique, removal of all six capsules ranged from 6 to 35 minutes, with a mean of 19.87 minutes. By contrast, with the “U” technique, removal time was significantly reduced, ranging from 3 to 14 minutes with a mean of 6.79 minutes. Also, more capsules were damaged during removal with the standard technique (5.6 undamaged versus 6.0, p < 0.01). In addition, five clients required two incisions for removal of all six capsules with the standard technique, while none of the clients required more than one incision with the “U” technique.
Discussion During the course of this study, many of the difficulties encountered using the standard removal technique were avoided when the “U” technique was employed. For example, it was not necessary to use blunt dissection of the tissue surrounding the capsule before grasping it, and most importantly, once the capsule was grasped, it seldom slipped out of the Norplant implants holding forceps-a frequent problem with the standard technique. Compared to the “U” technique, the standard technique clearly required more time and produced more damaged or broken capsules. In addition, with the standard technique, five clients required TABLE 1. Comparison of the standard and the “U” Norplant implants removal techniques showing mean removal time, number of undamaged/unbroken capsules and number of incisions
Variables
Standard Technique
‘I-f” Technique
Statistical Analysis
Time’
Mean + SD Range
19.87 +- 6.30 6-35 minutes
6.79 t 2.70 3-l 4 minutes
Pooled T test P = 0.000000
Capsules2
Mean 2 SD Range
5.63 f 4-6
0.59
6.0 f 6.0
0.0
Mann-Whitney P = 0.0091
test
Incision3
Mean f Range
1.13 f l-2
0.34
1.0 * 0.0 1
Mann-Whitney P = 0.3262
test
SD
‘Time required for complete removal (in minutes). *Number of undamaged/unbroken 3Number of incision(s) per client.
Contraception
1993:48,
December
capsules.
533
New method
for Norplant implants removal:
Praptohardjo
and Wibowo
two incisions for removal of all six capsules. By contrast, technique, only one incision was required in all cases.
with the “U”
Factors Contributing to Difficult Removals Capsule Ends More than One Centimeter from Incision Site. In many of the removal procedures, some capsule ends were more than 1 cm from the incision site. When using the standard technique, often it was difficult to push these capsules close enough to the incision to grasp them easily with the mosquito forceps and pull them into the incision. By contrast, when using the “U” technique, distant capsules were more likely to be less than 1 cm from the incision site, because the “U” technique incision is made above (proximal to) the distal tips. Even those capsules whose ends were more than 1 cm from the incision were easier to remove with the “U” technique, because they were held more securely when grasped at right angles to the long axis of the capsules instead of by the tips. Slipping of the Silastic Tube. The cylindrical Silastic tube is slippery and can easily slide out from the open tips of the mosquito forceps. To keep the capsule from slipping during the standard removal technique, the capsule must be grasped tightly. When grasped too tightly, however, the Silastic tube can be broken or damaged during the removal attempt. Moreover, after several unsuccessful attempts, especially if the tips of the remaining capsules were more than 1 cm from the incision, sometimes it was necessary to make a second incision closer to the tips of these capsules to facilitate their removal. When the Norplant implants holding forceps was used with the “U” technique, this problem was avoided. The circular tip (ring) of the modified forceps acted as an excellent grasping device, held the cylindrical Norplant capsule securely in place once it was grasped, and enabled the capsule tip to be pulled out through the incision without slipping (see Figure 7). Thick Tissue at Capsule Tips. The fibrous tissue at the tips of the capsules sometimes was thicker than the tissue surrounding the long axis of the capsules. Consequently, when using the standard technique, which required the capsules to be grasped by their tips, more time for cleaning and removing the soft tissue was required to expose the capsules than with the “U” technique. Conclusions This study clearly demonstrates that the “U” technique, using a specially modified forceps [adapted from the no-scalpel vas deferens holding forceps) is a quick and easy technique for Norplant implants removal. Using this technique, an experienced clinician can perform Norplant implants re-
534
Contraception
1993:48, December
New method for Norplant implants removal:
Praptohardjo and Wibowo
FIGURE7. Position of the capsule in the Norplant implants holding forceps.
moval as quickly as insertion, without damaging or breaking the Silastic tubes and without making a second incision. For these reasons, the “U” technique is more convenient and preferable to both the clinician and the client.
Acknowledgments From June 2-6, 1993, a four-day workshop sponsored by the Indonesian Society of Obstetrics and Gynecology (POGI) was conducted in Jakarta, Indonesia, to evaluate the “U” technique. The authors wish to thank representatives from the Association for Voluntary Surgical Contraception (AVSC), the Indonesian Planned Parenthood Association (IPPA), Family Health International (FHI), Johns Hopkins Program for International Education in Reproductive Health (JHPIEGO), the Population Council and Leiras Oy, as well as officials from the Indonesian National Family Planning Coordinating Board (BKKBN), and the Ministry of Health for their expert comments and suggestions regarding the data and text of the study reported in this communication. In addition, the authors wish to thank Dr. Endang Ambarwati, Mrs. Didit Budiningsih and Mr. Abadi for their help in data collecting. Thanks also go to Dr. Fatimah Moeis, M.Sc., for her help in preparing this manuscript, and to Chris Davis of JHPIEGO for her assistance in editing and formatting the article.
References 1. United States Food and Drug Administration (USFDA). Norplant System (Levonorgestrel Implants): Prescribing Information. Washington, DC: USFDA, 1990.
Contraception
1993:48, December
535
New method for Norplant implants removal: 2. 3.
4. 5. 6.
7.
536
Praptohardjo and Wibowo
World Health Organization [WHO). Norplant@ contraceptive subdermal implants: managerial and technical guidelines. Geneva: WHO, 1990. Darney PD, Klaise CM, Walker DM. The ‘pop-out’ method of Norplant@ removal. Advances in Contraception. Abstracts, Eighth Annual Meeting. Barcelona, Spain, 2831 October 1992; 8(3):188. Darney PD et al. Sustained-release contraceptives. Curr Prob Obstet Gynec Fertil, May/June 1990:87-125. McIntosh N, Riseborough P, Davis C, eds. Norplant@ guidelines for family planning service programs. Baltimore: JHPIEGO, 1993. Li S-Q. Vasal sterilization techniques: teaching material for the national standard workshop. Chongqing, China: Scientific and Technical Literature Press, 1988:1976. Tietjen L, Cronin W, McIntosh N. Infection prevention for family planning service programs. Durant, Oklahoma: Essential Medical Information Systems, Inc., 1992:152-67.
Contraception 1993:48, December
* and Susilo Wibowo f
*Departments of Obstetrics and Gynecology and tAndrology Section, Department of Biology, Faculty of Medicine, Diponegoro University; IPPA Central-Java, Jl. Jembawan No. 8, Semarang, Indonesia
The standard technique for Norplant implants removal was compared with a new technique called the “U” technique, which employs the use of a modified no-scalpel vas deferens holding forceps to grasp and remove the capsules. Seventy-six women requesting Norplant implants removal were randomly assigned to Group 1 (standard removal technique) or Group 2 (“U” removal technique). Variables measured included: (a) time required for complete removal, (b) number of capsules not broken or damaged during removal, and (c) number of incisions required for removal of all six capsules. In clients with visible or palpable capsules, the standard removal technique required significantly more time to remove all six capsules, on average, than the “U” technique (19 versus 7 minutes, p < 0.001); also more capsules were damaged during removal (5.6 undamaged versus 6.0, p < 0.01). In addition, with the standard technique, five clients required two incisions for removal of all six capsules while none of the clients required more than one incision with the “U” technique. Our conclusion is that the “U” technique is a quicker and easier method of removing Norplant capsules than the standard technique. Keywords:
Norplant@ implants; removal; forceps; capsules.
‘This new technique has been named the “U” technique after its developer, Dr.
Untung. Submitted for publication September 8, 1993; accepted for publication November 3, 1993. Address correspondence to: Dr. Untung Praptohardjo, Department of Obstetrics and Gynecology, Faculty of Medicine, Diponegoro University, IPPA Central-Java, Jl. Jembawan No. 8, Semarang, Indonesia Norplant@ is a registered trademark of The Population Council, Inc.
526
Contraception
1993:48,
December
0 1993 Butterworth-Heinemann
New method for Norplant implants removal:
Praptohardjo and Wibowo
Introduction At the present time two countries, Indonesia, and the United States, have the largest Norplant@ contraceptive implant system programs. In Indonesia over 1.5 million women have received Norplant implants during the past ten years, while more than 600,000 women in the United States already have had Norplant implants inserted since its approval by the United States Food and Drug Administration in December 1990.’ Because of the need to have the implants removed after five years, and replaced (if desired), large-scale use of this contraceptive method poses special problems for family planning service delivery programs as well as for the clinicians responsible for removing the implants (capsules). In Indonesia, where clinicians have had more experience with the large-scale use of the Norplant system than in any other country in the world, the national family planning program is now entering a new, steady-state phase where the number of acceptors per year (about 300,000) equals, or exceeds, the number of women requesting removal. The need to provide large numbers of women ready access to removal services has had considerable impact on the health care system, and has led to a systematic assessment of how best to maximize the quality, and availability, of removal services while minimizing the time and effort required. The current removal method using Crile and/or mosquito forceps, hereafter referred to as the standard technique, was developed in the early 1980s. Details of this technique are fully described in the WHO guidelines published in 1990.2 Since that time, however, several investigators have reported modifications to the standard technique, most recently Darney et al. who described the “pop-out” method in 1992.3,4 The fact that improvements in the method of removal continue to be sought, while changes in the insertion technique have been few, strongly suggests that the standard removal technique is not entirely satisfactory. This observation is borne out by the experience in Indonesia and confirmed in other countries as well. Removal requires more patience and skill than insertion. Moreover, with atypically placed capsules (i.e., those inserted too deep and/or in an irregular pattern), removal using any technique takes longer (up to 45 minutes or more) and reportedly is associated with more blood loss than insertion.2,” For the last several years, at the Indonesian Planned Parenthood Association (IPPA) Central-Java at Semarang, frequently we have experienced difficulty using all of the reported Norplant implants removal techniques. In response to the need for an easier way to remove Norplant implants, we developed a new removal technique called the “U” technique. This technique involves use of a modified no-scalpel vas deferens holding forceps, hereafter referred to as the Norplant implants holding forceps, for grasping and removing the Norplant capsules.6
Contraception
1993:48, December
527
New method
for Norplant
implants
removal:
Praptohardjo
and Wibowo
This communication reports the details of a comparative study of the standard and the “U” technique which was conducted from June 1991 to May 1992 at the branch of the IPPA Chapter of Central-Java Clinic in Temanggung district, Temanggung regency, Central- Java, Indonesia. This is one of 35 branches of the IPPA Chapter of Central-Java Province. At the Central-Java Clinic, the following methods of contraception are provided: IUDs, oral contraceptives, condoms, injectables, vasectomies, tubectomies, and Norplant implants. At the IPPA branch in this regency, 502 Norplant implants insertions were performed in 1991 and 380 in 1992. At the time of this study, all Norplant implants removals were performed by the authors.
Materials and Methods Seventy-six Norplant implants removal clients, all of whom had been using Norplant implants for five years, were selected to participate in this study. To eliminate bias and error due to difficulties in locating unpalpable implants, only clients who had visible or palpable implants were selected. Among implant users considered for this study, 13.63% (12/88) were classified as having implants that were difficult to palpate; these clients were considered ineligible for the study. Clients were randomly assigned, using a random numbers table, to Group 1 (standard removal) or Group 2 (“U” removal). Client preparation, includingpositioning of the arm and injection of the local anesthetic, was the same for both groups. Because the amount of time required for injecting the local anesthetic varied from client to client, removal time was measured from the time the incision was made until all six capsules were removed. In addition, the number of undamaged/unbroken capsules as well as the number of incisions required were counted and compared. Each removal was performed by one of the authors. To minimize risk of postoperative infection and possible risk of serious disease transmission to clients and clinic staff, recommended infection prevention practices were followed. In rural areas, where sterilization was not possible, highlevel disinfection by boiling or soaking instruments and other items in a high-level chemical disinfectant was done.’ The Standard
Technique
For the standard l l l
528
technique,
the following
equipment
was used:
Mosquito forceps Crile forceps Scalpel
Contraception
1993:48,
December
New method for Norplant implants removal:
Praptohardjo and Wibowo
After the capsules were located by palpation and their positions marked using a ballpoint pen, the client’s arm was cleansed with antiseptic solution and draped with a sterile or high-level disinfected cloth. Next, a syringe was filled with about 3 ml of local anesthetic (1% without epinephrine), and the needle inserted under the ends of the capsules nearest the elbow. The needle was then gently advanced about one-third the length of the first capsule (1 cm) and a track of anesthetic (about 0.5 ml) was laid to raise the end of the capsule as the needle was withdrawn. Without removing the needle from under the skin, its tip was slid over and inserted under the next capsule. This process was repeated until the ends of all six capsules were raised (see Figure 1). To prevent local anesthetic toxicity, the total dose did not exceed 10 ml of a 10 g/l (1% without epinephrine) local anesthetic. After the local anesthetic was administered, a 4-mm transverse incision was made close to and below (toward the elbow) the distal ends of the capsules (see Figure 2). After this, the capsules were pushed gently toward the incision with the gloved fingers of one hand until the capsule tip became visible (or could be grasped with the mosquito forceps). After grasping it and bringing it into the incision, surrounding fibrous tissue was removed until the capsule tip was visible. Finally, the capsule was removed using the second
FIGURE 1. Injecting the anesthetic
Contraception
1993:48, December
under the capsules.
529
New method
for Norplant implants removal:
Praptohardio
I
and Wibowo
4mm lncislon
FIGURE 2. Location of incision in the standard technique.
(Crile) forceps. In many cases, the technique for removing hard-to-retrieve capsules (suggested by the manufacturer) was required.2,” Furthermore, in some cases, a second incision was necessary to remove hard-to-retrieve capsules. The “U” Technique For the “U” technique, l
l l
Norplant at the tip diameter Mosquito Scalpel
the following
equipment
was used:
implants holding forceps in. which the diameter of the ring of the forceps is reduced from 3.5 mm to about 2.2 mm, the of the Norplant capsules (see Figure 3). or Crile forceps
As with the standard technique, the capsules were located by palpation and their positions marked with a ballpoint pen. The location and volume of anesthetic used were the same as in the standard technique. After the local anesthetic was administered, a 4 mm incision was made. In this case, however, the position of the skin incision differed from the standard technique as follows: l
l
530
the 0.5 the ure
incision was made between capsules 3 and 4, starting approximately cm above (proximal to) the distal ends of the capsules, and incision was made longitudinally rather than transversely (see Fig4).
Contraception
1993:48, December
New method for Norplant implants removal:
Praptohardjo and Wibowo
Inside diameter 2.2 mm
FIGURE 3. The Norplant implants holding forceps.
FIGURE 4. Location of incision in the “U” technique.
After inserting the Norplant implants holding forceps through the incision, the forceps was advanced until it touched the nearest capsule. As shown in Figure 5, the capsule was stabilized by placing the index finger just lateral and parallel to the capsule’s long axis. Next, the capsule was grasped, with the Norplant implants holding forceps, at right angles to its long axis and within 5 mm of the distal tip. After grasping and gently pulling the capsule toward the incision, the handle of the forceps was
Contraception
1993:48, December
531
New method
for Norplant
implants
removal:
Praptohardjo
and Wibowo
rotated toward the client’s shoulder, bringing the tip of the capsule into view in the incision (see Figure 6). The soft tissue surrounding the exposed portion of the capsule was then cleaned and opened with sterile gauze. (As an alternate method, a scalpel was used to scrape away the fibrous tissue.) Then, using the second forceps, the exposed part of the freed capsule was grasped and the capsule removed.
FIGURE 5. Stabilizing the capsule.
FIGURE 6. Grasping the capsule in the “U” technique.
532
Contraception
1993:48,
December
New method for Norplant implants removal:
Praptohardjo and Wibowo
Results Sample data collected from this study showed that removal times followed a normal distribution; however, the number of undamaged/unbroken Silastic capsules as well as the number of incisions did not. Therefore, the pooled T test was employed for comparing the time for removal and the Mann-Whitney test for the other two variables. As shown in Table 1, with the standard technique, removal of all six capsules ranged from 6 to 35 minutes, with a mean of 19.87 minutes. By contrast, with the “U” technique, removal time was significantly reduced, ranging from 3 to 14 minutes with a mean of 6.79 minutes. Also, more capsules were damaged during removal with the standard technique (5.6 undamaged versus 6.0, p < 0.01). In addition, five clients required two incisions for removal of all six capsules with the standard technique, while none of the clients required more than one incision with the “U” technique.
Discussion During the course of this study, many of the difficulties encountered using the standard removal technique were avoided when the “U” technique was employed. For example, it was not necessary to use blunt dissection of the tissue surrounding the capsule before grasping it, and most importantly, once the capsule was grasped, it seldom slipped out of the Norplant implants holding forceps-a frequent problem with the standard technique. Compared to the “U” technique, the standard technique clearly required more time and produced more damaged or broken capsules. In addition, with the standard technique, five clients required TABLE 1. Comparison of the standard and the “U” Norplant implants removal techniques showing mean removal time, number of undamaged/unbroken capsules and number of incisions
Variables
Standard Technique
‘I-f” Technique
Statistical Analysis
Time’
Mean + SD Range
19.87 +- 6.30 6-35 minutes
6.79 t 2.70 3-l 4 minutes
Pooled T test P = 0.000000
Capsules2
Mean 2 SD Range
5.63 f 4-6
0.59
6.0 f 6.0
0.0
Mann-Whitney P = 0.0091
test
Incision3
Mean f Range
1.13 f l-2
0.34
1.0 * 0.0 1
Mann-Whitney P = 0.3262
test
SD
‘Time required for complete removal (in minutes). *Number of undamaged/unbroken 3Number of incision(s) per client.
Contraception
1993:48,
December
capsules.
533
New method
for Norplant implants removal:
Praptohardjo
and Wibowo
two incisions for removal of all six capsules. By contrast, technique, only one incision was required in all cases.
with the “U”
Factors Contributing to Difficult Removals Capsule Ends More than One Centimeter from Incision Site. In many of the removal procedures, some capsule ends were more than 1 cm from the incision site. When using the standard technique, often it was difficult to push these capsules close enough to the incision to grasp them easily with the mosquito forceps and pull them into the incision. By contrast, when using the “U” technique, distant capsules were more likely to be less than 1 cm from the incision site, because the “U” technique incision is made above (proximal to) the distal tips. Even those capsules whose ends were more than 1 cm from the incision were easier to remove with the “U” technique, because they were held more securely when grasped at right angles to the long axis of the capsules instead of by the tips. Slipping of the Silastic Tube. The cylindrical Silastic tube is slippery and can easily slide out from the open tips of the mosquito forceps. To keep the capsule from slipping during the standard removal technique, the capsule must be grasped tightly. When grasped too tightly, however, the Silastic tube can be broken or damaged during the removal attempt. Moreover, after several unsuccessful attempts, especially if the tips of the remaining capsules were more than 1 cm from the incision, sometimes it was necessary to make a second incision closer to the tips of these capsules to facilitate their removal. When the Norplant implants holding forceps was used with the “U” technique, this problem was avoided. The circular tip (ring) of the modified forceps acted as an excellent grasping device, held the cylindrical Norplant capsule securely in place once it was grasped, and enabled the capsule tip to be pulled out through the incision without slipping (see Figure 7). Thick Tissue at Capsule Tips. The fibrous tissue at the tips of the capsules sometimes was thicker than the tissue surrounding the long axis of the capsules. Consequently, when using the standard technique, which required the capsules to be grasped by their tips, more time for cleaning and removing the soft tissue was required to expose the capsules than with the “U” technique. Conclusions This study clearly demonstrates that the “U” technique, using a specially modified forceps [adapted from the no-scalpel vas deferens holding forceps) is a quick and easy technique for Norplant implants removal. Using this technique, an experienced clinician can perform Norplant implants re-
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FIGURE7. Position of the capsule in the Norplant implants holding forceps.
moval as quickly as insertion, without damaging or breaking the Silastic tubes and without making a second incision. For these reasons, the “U” technique is more convenient and preferable to both the clinician and the client.
Acknowledgments From June 2-6, 1993, a four-day workshop sponsored by the Indonesian Society of Obstetrics and Gynecology (POGI) was conducted in Jakarta, Indonesia, to evaluate the “U” technique. The authors wish to thank representatives from the Association for Voluntary Surgical Contraception (AVSC), the Indonesian Planned Parenthood Association (IPPA), Family Health International (FHI), Johns Hopkins Program for International Education in Reproductive Health (JHPIEGO), the Population Council and Leiras Oy, as well as officials from the Indonesian National Family Planning Coordinating Board (BKKBN), and the Ministry of Health for their expert comments and suggestions regarding the data and text of the study reported in this communication. In addition, the authors wish to thank Dr. Endang Ambarwati, Mrs. Didit Budiningsih and Mr. Abadi for their help in data collecting. Thanks also go to Dr. Fatimah Moeis, M.Sc., for her help in preparing this manuscript, and to Chris Davis of JHPIEGO for her assistance in editing and formatting the article.
References 1. United States Food and Drug Administration (USFDA). Norplant System (Levonorgestrel Implants): Prescribing Information. Washington, DC: USFDA, 1990.
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World Health Organization [WHO). Norplant@ contraceptive subdermal implants: managerial and technical guidelines. Geneva: WHO, 1990. Darney PD, Klaise CM, Walker DM. The ‘pop-out’ method of Norplant@ removal. Advances in Contraception. Abstracts, Eighth Annual Meeting. Barcelona, Spain, 2831 October 1992; 8(3):188. Darney PD et al. Sustained-release contraceptives. Curr Prob Obstet Gynec Fertil, May/June 1990:87-125. McIntosh N, Riseborough P, Davis C, eds. Norplant@ guidelines for family planning service programs. Baltimore: JHPIEGO, 1993. Li S-Q. Vasal sterilization techniques: teaching material for the national standard workshop. Chongqing, China: Scientific and Technical Literature Press, 1988:1976. Tietjen L, Cronin W, McIntosh N. Infection prevention for family planning service programs. Durant, Oklahoma: Essential Medical Information Systems, Inc., 1992:152-67.
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