- Email: [email protected]
Prospective analysis of office-based hysteroscopic sterilization
Journal of Minimally Invasive Gynecology (2006) 13, 98 –101
Prospective analysis of office-based hysteroscopic sterilization Mark D. Levie, MD, and Scott G. Chudnoff, MD From the Department of Obstetrics & Gynecology and Women’s Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (both authors). KEYWORDS: Hysteroscopy; Sterilization; Essure; Office
Abstract STUDY OBJECTIVES: To evaluate the efficacy of performing the Essure hysteroscopic sterilization in an office-based setting. DESIGN: Prospective, longitudinal analysis (Canadian Task Force classification II-3). SETTING: University out-patient office. PATIENTS: All patients undergoing permanent sterilization in our outpatient office who opted for hysteroscopic sterilization were included. INTERVENTIONS: Hysteroscopic placement of the Essure device in an office-based setting with only non-steroidal antiinflammatory drugs and paracervical block. MEASUREMENTS AND MAIN RESULTS: Multiple data points were collected on each patient including demographic data, specific procedural information, and 12-week hysterosalpingogram data. Most of our patients were Hispanic and had an average body mass index of 30.3. Average time to perform the procedure was 12.4 minutes, with the steepest improvement in the first 13 cases. Bilateral placement of the device was successful in 98 (96%) of 102 patients. Of these patients 92 have 12-week hysterosalpingography results (6 patients were lost to follow-up), with 90 (98%) showing bilateral tubal occlusion. There were no intraprocedural or postprocedural complications. CONCLUSION: In our institution and in our experience, office-hysteroscopic placement of the Essure device is a feasible and effective approach for permanent sterilization. © 2006 AAGL. All rights reserved.
In the United States 700 000 women undergo tubal sterilization each year, with more than 188 million women using this method of contraception as of the last national survey in 1995.1 Tubal ligation, either via laparoscopy or laparotomy, has long been the technique of choice for tubal occlusion. This procedure is most commonly performed in
Corresponding author: Mark D. Levie, MD, Department of Obstetrics & Gynecology and Women’s Health, Montefiore Medical Center, Albert Einstein College of Medicine, 3332 Rochambeau Avenue, Bronx, NY 10467. E-mail: [email protected] Submitted July 12, 2005. Accepted for publication November 20, 2005.
1553-4650/$ -see front matter © 2006 AAGL. All rights reserved. doi:10.1016/j.jmig.2005.11.010
the operating room with the patient under general anesthesia and requires entry into the peritoneal cavity. Recent data from the Collaborative Research group for tubal sterilization has elucidated some important data about tubal ligations. The cumulative failure rate was higher than previously reported, and the risk of failure persists for years after the procedure. The 10-year failure probability is 18.5 pregnancies per 1000 procedures (95% CI, 15.1–21.8).2 Furthermore, the risk of complications from laparoscopic interval tubal sterilization is 1.6%, with an unintended laparotomy rate of 0.9%.3 Although these rates are small, considering the number of procedures done each year, they are not insignificant. The risk associated with these proce-
Levie and Chudnoff
Office hysteroscopic sterilization
dures is 2-fold: the general anesthesia, as well as the entry into the peritoneal cavity. In November 2002, the U.S. Food and Drug Administration approved a new approach to tubal occlusion. This technique uses a hysteroscopic approach to catheterize the fallopian tube and place a nickel-titanium-Dacron, stainless steel coil across the uterotubal junction. Data from the phase II and phase III clinical trials showed high success rates, and no pregnancies have been reported to date.4,5 The major advantages of a hysteroscopic approach are that it can be done with the patient under local anesthesia and the peritoneal cavity is not entered. This combined with miniaturization of hysteroscopes with operative channels and the small diameter of the delivery system makes this procedure amenable for an office-based approach.
99 a senior faculty member with expertise in hysteroscopy. Approximately half of the procedures were done directly by residents, fellows, or attending physicians learning the procedure. Procedural time, defined as the time the hysteroscope was placed in the cervix until its withdrawal, was calculated. Bilateral placement success rates, intraprocedural findings, co-procedures, and complications were documented. Reasons for inability to successfully complete the procedure were also assessed. Subsequently, hysterosalpingogram (HSG) data were collected to identify the presence of the Essure coils, their location, and tubal occlusion. The HSGs were performed at least 12 weeks after the procedure as per the recommendations from the manufacturer. Average rates were calculated for the placement success, presence of bilateral occlusion, and demographics.
Purpose Results We wanted to assess the feasibility of performing the Essure hysteroscopic sterilization technique in an office setting using only nonsteroidal anti-inflammatory medication and local anesthesia.
Methods The Institutional review board at Montefiore Medical Center approved this study before commencing. This was a prospective, longitudinal study carried out at the academic practice of Montefiore Medical Center. Patients desiring tubal sterilization were educated with regard to their options of interval laparoscopic tubal sterilization or the Essure procedure. Extensive preprocedural counseling was done with regard to the risk benefits and alternatives to permanent sterilization. Consents were obtained as per New York City law 30 days before the procedure and reconfirmed on the day of the procedure. All patients choosing the Essure procedure were included in this study and underwent routine preprocedural screening, which included a Papanicolaou smear, a urine pregnancy test, as well as cultures for gonorrhea and chlamydia. No patients were excluded from participating in this study on the basis of historical factors, and no patients refused participation. Demographic data were collected and compiled. Prior history of parity (including route of delivery), surgery, sexually transmitted diseases, or gynecologic conditions was documented. All patients were offered ketorolac (Toradol) 60 mg approximately 30 minutes before the procedure, as well as a paracervical block with approximately 10 mL of 2% lidocaine at the time of the procedure. The procedures were all performed in an office setting using a 5.5-mm, oval, Olympus hysteroscope and normal saline solution with a pressure bag as a distention medium. All of the procedures were done under the supervision of the primary investigator,
To date 102 patients have undergone this procedure in our office, of which 94 have had an HSG to confirm tubal occlusion. The average age was 35 years old (range 22– 44, SD ⫾ 5.9), and parity was 3 (range 0 – 8, SD ⫾ 1.28). The average body mass index was 30.3 (range 18.6 –51, SD ⫾ 6.9). Most patients choosing this procedure were of Hispanic origin—which mirrors our patient population. Additional demographic data are listed in Table 1. All but three patients received intramuscular Toradol before the procedure, and all but 1 patient received the paracervical block. The average time to perform the procedure was 12.4 minutes (SD ⫾ 6.35). The greatest improvement in time occurred after the first 13 cases (average time ⫽ 17.2 minutes), where the average time decreased to 11.2 minutes (SD ⫾ 6.46) (Figure 1). Of the 102 patients, 98 (96%) had successful placement of the devices bilaterally (Figure 2). One patient originally was unable to be placed, but subsequently had the procedure repeated with bilateral success. In the four patients in whom we did not have successful placement, three were due to anatomical considerations. One of these had a bicornuate uterus; one had extremely lateral tubes and was severely obese, preventing appropriate alignment; and one had a concomitant polypectomy of a polyp obscuring the tubal os, after which the os was not clearly visualized. In the fourth patient, one of the tubal ostia was unable to be visualized. Six patients had concomitant procedures at the time of the Essure placement, mainly polypectomies. There were no intraprocedural or postprocedural complications. Of the 98 patients who had successful placement, 90 had confirmed tubal occlusion at the 12-week HSG. Six patients were lost to follow-up. Excluding the patients lost to followup, there was a 98% tubal occlusion rate. Three patients originally had one-sided tubal patency. One of these patients subsequently had the procedure repeated with confirmation of tubal occlusion on HSG, leaving 2 patients with one-
100 Table 1
Journal of Minimally Invasive Gynecology, Vol 13, No 2, March/April 2006
Discussion
Demographic data
Characteristic Race Hispanic Black White Asian Other STD history Chlamydia Gonorrhea PID/Salpingitis/TOA Prior abdominal/pelvic surgery Cesarean sections (ⱖ 1) Prior contraception Condoms Oral contraceptives Depo-Provera Patch Abstinence Rhythm IUD None Household income ⬍$25,000 $25,000–$50,000 $50,001–$75,000 ⬎$75,000 Declined to state Education Grade school Some high school High school Community college Bachelors degree Vocational school Graduate school Declined to state Prior ectopic pregnancy
No. (N⫽102) 63 27 5 1 6 10 4 3 45 38 42 15 12 10 8 3 3 9 39 38 11 13 1 2 14 49 17 11 1 4 4 3
STD, Sexually transmitted disease; PID, pelvic inflammatory disease; TOA, tubo-ovarian abscess; IUD, intrauterine device.
sided tubal patency. Of these two patients, one had an HSG showing the presence of two devices and one-sided tubal patency, but the patient declined retesting to see if the tube had become occluded as recommended by the manufacturer. One patient had misinformed the staff regarding her last menstrual period and had the procedure performed on day 14 of her cycle when she was sexually active without contraception. She subsequently resumed sexual activity on the day of the procedure without using any other form of contraception and had a positive pregnancy test at the time of her next expected menses. She subsequently had a spontaneous abortion at 8 weeks gestation. At her 12-week HSG, she was noted to have a free Essure coil in the uterine cavity and tubal patency on that side. She then opted for a laparoscopic tubal ligation, at which time the Essure coil was removed hysteroscopically.
Of the 96 patients who underwent the procedure and on whom we have follow-up data, 90 had bilateral successful placement and HSG-confirmed tubal occlusion. This means that 94% of all patients who underwent the procedure can rely on this method for contraception. This is consistent with the data from the phase II and phase III trials and other published data.4 – 6 One weakness to this study was the six patients who were lost to follow-up. One of these patients moved to Florida, and we are expecting her to have the HSG performed there and to send us the results. Two patients have changed their contact information and are unable to be reached. Three patients declined having the HSG performed. Unfortunately, this may create bias in the study and could potentially alter our results. Nevertheless, the four patients with whom we are still in contact have not had a pregnancy since the procedure. Another point of concern is the patient who ended up with a pregnancy. Although there are no reported pregnancies in patients who have confirmed tubal occlusion, this is an example of the importance in waiting to confirm occlusion before allowing patients to rely on this method and the need for adequate contraception in the interval period. We do not know if the pregnancy was the cause of the expulsion or if it occurred independently, but there were five coils visualized in the uterine cavity at the time of the procedure. Additionally, in patients for whom compliance with postprocedure contraception is likely to be low, serious consideration should be given to other methods of sterilization. A critical benefit observed was the short time required to perform the procedure. Given the amount of time required to perform these procedures via a laparoscopic approach, by performing these procedures in an office setting, we are allowing for a significant improvement in office productivity. Also, the short learning curve to achieve proficiency makes the procedure easy to incorporate into a busy practice. This procedure can be recommended for general obstetrician/gynecologists after an appropriate training course and supervision for the first several procedures. This is evidenced by our experience in training residents.
Figure 1
Time to perform procedure.
Levie and Chudnoff
Office hysteroscopic sterilization
101 Total Patients Enrolled N = 102
Successful Bilateral Placement Initially n = 97
Successful Bilateral Placement on 2nd Attempt n=1
Unsuccessful Bilateral Placement n=4
Total with Bilateral Successful Placement n = 98 Patients With 12 Week HSG n = 92 Confirmed Bilateral Tubal Occlusion on HSG n = 89 Total With Confirmed Bilateral Occlusion n = 90
Lost to Follow-up n=6 Unilateral Tubal Occlusion on HSG n=3
Repeat Procedure With Confirmed Bilateral Tubal Occlusion n=1
Figure 2
Our results support the idea that office-based hysteroscopic sterilization is a feasible and effective method for permanent sterilization. It is easily performed in an outpatient setting without the need for general anesthesia or sedation.
Opted For Laparoscopic BTL n=1
Patient flow
3.
4.
References 5. 1. MacKay AP, Kieke BA, Koonin LM, et al. Tubal sterilization in the United States, 1994 –1996. Fam Plann Perspect. 2001;33:161–165. 2. Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk of ectopic pregnancy after tubal sterilization: findings from the US
Lost to Follow-up n=1
6.
Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174:1161–1170. Jamieson DJ, Hillis SD, Duerr A, et al: Complications of interval laparoscopic tubal sterilization: findings from the United States collaborative review of sterilization. Obstet Gynecol. 2000;96:997– 1002. Kerin JF, Cooper JM, Price T, Herendael BJ, Cayuela-Font E, Cher D, Carignan CS. Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study. Hum Reprod. 2003;18:1223– 1230. Cooper JM, Cargnan CS, Cher D, et al. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102:59 – 67. Ubeda A, Labastida R, Dexeus S. Essure: a new device for hysteroscopic tubal sterilization in an outpatient setting. Fertil Steril. 2004;82: 196 –199.
Prospective analysis of office-based hysteroscopic sterilization Mark D. Levie, MD, and Scott G. Chudnoff, MD From the Department of Obstetrics & Gynecology and Women’s Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (both authors). KEYWORDS: Hysteroscopy; Sterilization; Essure; Office
Abstract STUDY OBJECTIVES: To evaluate the efficacy of performing the Essure hysteroscopic sterilization in an office-based setting. DESIGN: Prospective, longitudinal analysis (Canadian Task Force classification II-3). SETTING: University out-patient office. PATIENTS: All patients undergoing permanent sterilization in our outpatient office who opted for hysteroscopic sterilization were included. INTERVENTIONS: Hysteroscopic placement of the Essure device in an office-based setting with only non-steroidal antiinflammatory drugs and paracervical block. MEASUREMENTS AND MAIN RESULTS: Multiple data points were collected on each patient including demographic data, specific procedural information, and 12-week hysterosalpingogram data. Most of our patients were Hispanic and had an average body mass index of 30.3. Average time to perform the procedure was 12.4 minutes, with the steepest improvement in the first 13 cases. Bilateral placement of the device was successful in 98 (96%) of 102 patients. Of these patients 92 have 12-week hysterosalpingography results (6 patients were lost to follow-up), with 90 (98%) showing bilateral tubal occlusion. There were no intraprocedural or postprocedural complications. CONCLUSION: In our institution and in our experience, office-hysteroscopic placement of the Essure device is a feasible and effective approach for permanent sterilization. © 2006 AAGL. All rights reserved.
In the United States 700 000 women undergo tubal sterilization each year, with more than 188 million women using this method of contraception as of the last national survey in 1995.1 Tubal ligation, either via laparoscopy or laparotomy, has long been the technique of choice for tubal occlusion. This procedure is most commonly performed in
Corresponding author: Mark D. Levie, MD, Department of Obstetrics & Gynecology and Women’s Health, Montefiore Medical Center, Albert Einstein College of Medicine, 3332 Rochambeau Avenue, Bronx, NY 10467. E-mail: [email protected] Submitted July 12, 2005. Accepted for publication November 20, 2005.
1553-4650/$ -see front matter © 2006 AAGL. All rights reserved. doi:10.1016/j.jmig.2005.11.010
the operating room with the patient under general anesthesia and requires entry into the peritoneal cavity. Recent data from the Collaborative Research group for tubal sterilization has elucidated some important data about tubal ligations. The cumulative failure rate was higher than previously reported, and the risk of failure persists for years after the procedure. The 10-year failure probability is 18.5 pregnancies per 1000 procedures (95% CI, 15.1–21.8).2 Furthermore, the risk of complications from laparoscopic interval tubal sterilization is 1.6%, with an unintended laparotomy rate of 0.9%.3 Although these rates are small, considering the number of procedures done each year, they are not insignificant. The risk associated with these proce-
Levie and Chudnoff
Office hysteroscopic sterilization
dures is 2-fold: the general anesthesia, as well as the entry into the peritoneal cavity. In November 2002, the U.S. Food and Drug Administration approved a new approach to tubal occlusion. This technique uses a hysteroscopic approach to catheterize the fallopian tube and place a nickel-titanium-Dacron, stainless steel coil across the uterotubal junction. Data from the phase II and phase III clinical trials showed high success rates, and no pregnancies have been reported to date.4,5 The major advantages of a hysteroscopic approach are that it can be done with the patient under local anesthesia and the peritoneal cavity is not entered. This combined with miniaturization of hysteroscopes with operative channels and the small diameter of the delivery system makes this procedure amenable for an office-based approach.
99 a senior faculty member with expertise in hysteroscopy. Approximately half of the procedures were done directly by residents, fellows, or attending physicians learning the procedure. Procedural time, defined as the time the hysteroscope was placed in the cervix until its withdrawal, was calculated. Bilateral placement success rates, intraprocedural findings, co-procedures, and complications were documented. Reasons for inability to successfully complete the procedure were also assessed. Subsequently, hysterosalpingogram (HSG) data were collected to identify the presence of the Essure coils, their location, and tubal occlusion. The HSGs were performed at least 12 weeks after the procedure as per the recommendations from the manufacturer. Average rates were calculated for the placement success, presence of bilateral occlusion, and demographics.
Purpose Results We wanted to assess the feasibility of performing the Essure hysteroscopic sterilization technique in an office setting using only nonsteroidal anti-inflammatory medication and local anesthesia.
Methods The Institutional review board at Montefiore Medical Center approved this study before commencing. This was a prospective, longitudinal study carried out at the academic practice of Montefiore Medical Center. Patients desiring tubal sterilization were educated with regard to their options of interval laparoscopic tubal sterilization or the Essure procedure. Extensive preprocedural counseling was done with regard to the risk benefits and alternatives to permanent sterilization. Consents were obtained as per New York City law 30 days before the procedure and reconfirmed on the day of the procedure. All patients choosing the Essure procedure were included in this study and underwent routine preprocedural screening, which included a Papanicolaou smear, a urine pregnancy test, as well as cultures for gonorrhea and chlamydia. No patients were excluded from participating in this study on the basis of historical factors, and no patients refused participation. Demographic data were collected and compiled. Prior history of parity (including route of delivery), surgery, sexually transmitted diseases, or gynecologic conditions was documented. All patients were offered ketorolac (Toradol) 60 mg approximately 30 minutes before the procedure, as well as a paracervical block with approximately 10 mL of 2% lidocaine at the time of the procedure. The procedures were all performed in an office setting using a 5.5-mm, oval, Olympus hysteroscope and normal saline solution with a pressure bag as a distention medium. All of the procedures were done under the supervision of the primary investigator,
To date 102 patients have undergone this procedure in our office, of which 94 have had an HSG to confirm tubal occlusion. The average age was 35 years old (range 22– 44, SD ⫾ 5.9), and parity was 3 (range 0 – 8, SD ⫾ 1.28). The average body mass index was 30.3 (range 18.6 –51, SD ⫾ 6.9). Most patients choosing this procedure were of Hispanic origin—which mirrors our patient population. Additional demographic data are listed in Table 1. All but three patients received intramuscular Toradol before the procedure, and all but 1 patient received the paracervical block. The average time to perform the procedure was 12.4 minutes (SD ⫾ 6.35). The greatest improvement in time occurred after the first 13 cases (average time ⫽ 17.2 minutes), where the average time decreased to 11.2 minutes (SD ⫾ 6.46) (Figure 1). Of the 102 patients, 98 (96%) had successful placement of the devices bilaterally (Figure 2). One patient originally was unable to be placed, but subsequently had the procedure repeated with bilateral success. In the four patients in whom we did not have successful placement, three were due to anatomical considerations. One of these had a bicornuate uterus; one had extremely lateral tubes and was severely obese, preventing appropriate alignment; and one had a concomitant polypectomy of a polyp obscuring the tubal os, after which the os was not clearly visualized. In the fourth patient, one of the tubal ostia was unable to be visualized. Six patients had concomitant procedures at the time of the Essure placement, mainly polypectomies. There were no intraprocedural or postprocedural complications. Of the 98 patients who had successful placement, 90 had confirmed tubal occlusion at the 12-week HSG. Six patients were lost to follow-up. Excluding the patients lost to followup, there was a 98% tubal occlusion rate. Three patients originally had one-sided tubal patency. One of these patients subsequently had the procedure repeated with confirmation of tubal occlusion on HSG, leaving 2 patients with one-
100 Table 1
Journal of Minimally Invasive Gynecology, Vol 13, No 2, March/April 2006
Discussion
Demographic data
Characteristic Race Hispanic Black White Asian Other STD history Chlamydia Gonorrhea PID/Salpingitis/TOA Prior abdominal/pelvic surgery Cesarean sections (ⱖ 1) Prior contraception Condoms Oral contraceptives Depo-Provera Patch Abstinence Rhythm IUD None Household income ⬍$25,000 $25,000–$50,000 $50,001–$75,000 ⬎$75,000 Declined to state Education Grade school Some high school High school Community college Bachelors degree Vocational school Graduate school Declined to state Prior ectopic pregnancy
No. (N⫽102) 63 27 5 1 6 10 4 3 45 38 42 15 12 10 8 3 3 9 39 38 11 13 1 2 14 49 17 11 1 4 4 3
STD, Sexually transmitted disease; PID, pelvic inflammatory disease; TOA, tubo-ovarian abscess; IUD, intrauterine device.
sided tubal patency. Of these two patients, one had an HSG showing the presence of two devices and one-sided tubal patency, but the patient declined retesting to see if the tube had become occluded as recommended by the manufacturer. One patient had misinformed the staff regarding her last menstrual period and had the procedure performed on day 14 of her cycle when she was sexually active without contraception. She subsequently resumed sexual activity on the day of the procedure without using any other form of contraception and had a positive pregnancy test at the time of her next expected menses. She subsequently had a spontaneous abortion at 8 weeks gestation. At her 12-week HSG, she was noted to have a free Essure coil in the uterine cavity and tubal patency on that side. She then opted for a laparoscopic tubal ligation, at which time the Essure coil was removed hysteroscopically.
Of the 96 patients who underwent the procedure and on whom we have follow-up data, 90 had bilateral successful placement and HSG-confirmed tubal occlusion. This means that 94% of all patients who underwent the procedure can rely on this method for contraception. This is consistent with the data from the phase II and phase III trials and other published data.4 – 6 One weakness to this study was the six patients who were lost to follow-up. One of these patients moved to Florida, and we are expecting her to have the HSG performed there and to send us the results. Two patients have changed their contact information and are unable to be reached. Three patients declined having the HSG performed. Unfortunately, this may create bias in the study and could potentially alter our results. Nevertheless, the four patients with whom we are still in contact have not had a pregnancy since the procedure. Another point of concern is the patient who ended up with a pregnancy. Although there are no reported pregnancies in patients who have confirmed tubal occlusion, this is an example of the importance in waiting to confirm occlusion before allowing patients to rely on this method and the need for adequate contraception in the interval period. We do not know if the pregnancy was the cause of the expulsion or if it occurred independently, but there were five coils visualized in the uterine cavity at the time of the procedure. Additionally, in patients for whom compliance with postprocedure contraception is likely to be low, serious consideration should be given to other methods of sterilization. A critical benefit observed was the short time required to perform the procedure. Given the amount of time required to perform these procedures via a laparoscopic approach, by performing these procedures in an office setting, we are allowing for a significant improvement in office productivity. Also, the short learning curve to achieve proficiency makes the procedure easy to incorporate into a busy practice. This procedure can be recommended for general obstetrician/gynecologists after an appropriate training course and supervision for the first several procedures. This is evidenced by our experience in training residents.
Figure 1
Time to perform procedure.
Levie and Chudnoff
Office hysteroscopic sterilization
101 Total Patients Enrolled N = 102
Successful Bilateral Placement Initially n = 97
Successful Bilateral Placement on 2nd Attempt n=1
Unsuccessful Bilateral Placement n=4
Total with Bilateral Successful Placement n = 98 Patients With 12 Week HSG n = 92 Confirmed Bilateral Tubal Occlusion on HSG n = 89 Total With Confirmed Bilateral Occlusion n = 90
Lost to Follow-up n=6 Unilateral Tubal Occlusion on HSG n=3
Repeat Procedure With Confirmed Bilateral Tubal Occlusion n=1
Figure 2
Our results support the idea that office-based hysteroscopic sterilization is a feasible and effective method for permanent sterilization. It is easily performed in an outpatient setting without the need for general anesthesia or sedation.
Opted For Laparoscopic BTL n=1
Patient flow
3.
4.
References 5. 1. MacKay AP, Kieke BA, Koonin LM, et al. Tubal sterilization in the United States, 1994 –1996. Fam Plann Perspect. 2001;33:161–165. 2. Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk of ectopic pregnancy after tubal sterilization: findings from the US
Lost to Follow-up n=1
6.
Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174:1161–1170. Jamieson DJ, Hillis SD, Duerr A, et al: Complications of interval laparoscopic tubal sterilization: findings from the United States collaborative review of sterilization. Obstet Gynecol. 2000;96:997– 1002. Kerin JF, Cooper JM, Price T, Herendael BJ, Cayuela-Font E, Cher D, Carignan CS. Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study. Hum Reprod. 2003;18:1223– 1230. Cooper JM, Cargnan CS, Cher D, et al. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102:59 – 67. Ubeda A, Labastida R, Dexeus S. Essure: a new device for hysteroscopic tubal sterilization in an outpatient setting. Fertil Steril. 2004;82: 196 –199.