Tubal Reversal Surgeons Reverse Adiana Sterilization

Doctors at Chapel Hill Tubal Reversal Center become the first to reverse tubal sterilization by the Adiana technique

October 9th, 2009 (Chapel Hill, NC) – Julia Smith, RN, Nurse Administrator at Chapel Hill Tubal Reversal Center in Chapel Hill, North Carolina, today announced the first successful tubal reversal procedure to repair the fallopian tubes in women who have undergone the Adiana method of tubal sterilization. This is the first pregnancy after Adiana reversal for the newly approved sterilization system.

Adiana sterilization was approved for use in the US by the FDA in July 2009. The procedure can be performed in a physician’s office and involves using radio frequency energy to remove cells in the lining of a small area of the fallopian tubes nearest the uterus. The device itself is then implanted in this prepared area. The Adiana system is similar to the Essure sterilization method in being a non-surgical female sterilization method which promotes scarring to create a tubal blockage.

Dr. Gary S. Berger and Dr. Charles Monteith performed the reversal during a one hour and ten minute tubal surgery procedure. The healthy fallopian tubes were separated from the blockage and tubal implantation was performed through a newly created opening in the back of the uterus. Since the Adiana and Essure sterilization methods involve a small segment of the narrowest part of the fallopian tube, long tubal segments remain after the reversal procedure which is a major factor in tubal reversal success rates. The pregnancy success rates can be found in the latest tubal reversal study available at http://press.tubal-reversal.net/2009/pregnancy-rates-by-age-and-tubal-ligation-method.html

Dr. Berger and Dr. Monteith performed the tubal reversal procedure on a 35-year old woman who underwent sterilization by the Adiana technique as part of an experimental trial to test the new sterilization procedure six years ago. Although she underwent tubal sterilization intending for the procedure to be permanent, the patient’s decision to reverse the procedure was promoted by the unexpected and sudden loss of a child.

Chapel Hill Tubal Reversal Center is the only facility in the United States that specializes  in the practice of tubal reversal surgery and repair of blocked fallopian tubes. Patients travel from across the US and from abroad for surgery at the specialty facility with its highly trained and experienced surgeons and staff. Additional information regarding tubal reversal surgery, Adiana reversal and Essure reversal is available at Chapel Hill Tubal Reversal Center, including profiles for Dr. Berger and Dr. Monteith, can be found on the website at www.tubal-reversal.net.

Tubal Reversal Pregnancy Study 2009

Pregnancy Rates By Fallopian Tube Lengths

The fallopian tube lengths remaining after a tubal ligation procedure are important determinants of the chances of getting pregnant after tubal reversal surgery. (Normal fallopian tube length before a tubal ligation is approximately 10 cm or 4 inches.)

Tubal segment lengths are measured routinely during surgery at Chapel Hill Tubal Reversal Center. The average length of the two fallopian tubes after repair was correlated with the likelihood of pregnancy after tubal reversal (Table 6). Women with longer tubal lengths had higher pregnancy rates than women with shorter lengths following tubal reversal. Women with tubal lengths of 7.5 cm or longer had a pregnancy rate of 77%. The pregnancy rate declined as tubal length decreased, but even women with the shortest tubes (less than 2.5 cm) became pregnant (38%).  Although previously unreported in the medical literature, it became apparent during this study that a repaired fallopian tube of any length can result in pregnancy. Based on reports by women with only 1 fallopian tube, we now know that tubal lengths as short as 1 cm can result in a normal pregnancy.

Tubal Ligation Method And Tubal Length

When tubal ligation method and average tubal lengths are taken into account simultaneously, it becomes clear that the amount of fallopian tube remaining after a sterilization procedure is the more important factor predicting the chances of getting pregnant after tubal reversal surgery (Table 7). This makes sense, since the less damage that occurs to the fallopian tube during a sterilization procedure, the more remains to be able to function normally once the tube has been surgically repaired.

Tubal Reversal Pregnancy Study 2009
Table Of Contents:

• Overview
• Study Method
• Patient Population – US States
• Patient Population – Age and Tubal Ligation Procedures
• Pregnancy Rates by Age and Method
• Tubal Reversal Pregnancy Rates by Tubal Lengths (this page)
• Pregnancy Outcomes
• Tubal Reversal vs. IVF
• About Pregnancy Statistics

Pregnancy Outcomes After Tubal Reversal

Tubal Reversal Pregnancy Report 2009

Study Method

Prospective Study

This is a prospective observational study of 5,046 women who had tubal reversal surgery from July 2000 through June 2008 at Chapel Hill Tubal Reversal Center – an outpatient facility exclusively for tubal ligation reversal. This ongoing study was begun in 2000 with the development of a computerized database to record information for subsequent analysis. Patients who had tubal reversals prior to the initiation of the database are not included in this study report. The study cut off date of June 2008 was chosen to allow for at least one year of follow-up for all patients in the present analysis and report.

Information about pregnancies is collected through the Center’s ongoing patient follow-up protocol. Patients are asked to notify the Tubal Reversal Center staff when a pregnancy occurs by completing an online Pregnancy Report Form. All women reporting pregnancies are contacted by staff nurses to determine the outcome of each pregnancy. The information is entered into the center’s electronic patient database for subsequent statistical analyses.

Tubal Reversal Techniques

The tubal reversal procedures were performed using outpatient mini-laparotomy surgical and anesthetic techniques that minimize tissue injury, blood loss, anesthesia time, postoperative pain, and recovery time. Dr. Berger explains these advanced techniques in a video recording of the surgery entitled Outpatient Tubal Reversal. This video has been shown on “The Operation” television series broadcast on Discovery,The Learning Channel (TLC), and the CBS Early Show.

The tubal reversal operations for these 5,046 women included the following techniques depending on the requirements of each patient:

• tubal anastomosis
• salpingostomy
• tubouterine implantation

Tubal Reversal Pregnancy Rate

From July 2000 to June 2008, 5046 women underwent tubal ligation reversal at Chapel Hill Tubal Reversal Center. The operative techniques of microsurgical tubal anastomosis, tubouterine implantation, and salpingostomy were used as appropriate to each patient’s situation, and often these techniques were combined in a single case. Including all women’s ages, methods of tubal ligation, and operative techniques used for tubal reversal, the overall pregnancy rate was 66% based on 3317 pregnancies reported during this 8 year interval.

Subsequent pages in this report break down this overall pregnancy rate for all patients into more specific pregnancy rates based on age, type of tubal ligation, and the remaining tubal lengths available for repairing. These statistics will help women wanting to get pregnant after a tubal ligation. With this information, they can make informed decisions based on their chances of getting pregnant after tubal reversal that are specific to their age and method of tubal ligation.

Tubal Reversal Pregnancy Report 2009
Table Of Contents:

• Overview
• Study Method (this page)
• Patient Population – US States
• Patient Population – Age and Tubal Ligation Procedures
• Pregnancy Rates by Age and Method
• Pregnancy Rates by Tubal Length
• Pregnancy Outcomes
• Tubal Reversal vs. IVF
• About Pregnancy Statistics

DVD of “The Operation” Shows Dr. Berger’s Tubal Reversal Procedure Step-by-Step

Tubal Reversal Pregnancy Report 2009

Patient Population

The study population consisted of 5,046 women who underwent tubal reversal surgery from July 2000 through June 2008 at Chapel Hill Tubal Reversal Center – the only medical facility exclusively for tubal ligation reversal – located in Chapel Hill, North Carolina.

Where Patients Came From

The women came from throughout the United States and from 23 foreign countries. The following map shows the geographic distribution of the resident locations of the US patients.

Figure 1. Where Patients Came From For Tubal Reversal Surgery

Tubal Reversal Pregnancy Report 2009
Table Of Contents:

• Overview
• Study Method
• Patient Population – States (this page)
• Patient Population – Age and Tubal Ligation Procedures
• Pregnancy Rates by Age and Method
• Pregnancy Rates by Tubal Length
• Pregnancy Outcomes
• Tubal Reversal vs. IVF
• About Pregnancy Statistics

Pregnancy Rates At Chapel Hill Tubal Reversal Center

Tubal Reversal Study Report 2009

Pregnancy And Birth Rates: Tubal Reversal vs. IVF

Women who want to get pregnant after a tubal ligation have two treatment options: tubal ligation reversal or in vitro fertilization (IVF). To compare the success of these two treatments, the tubal reversal pregnancy statistics from Chapel Hill Tubal Reversal Center can be compared with the latest available national IVF statistics (National Summary and Fertility Clinic Reports).

During 2006 in the United States, 99,199 IVF cycles using fresh non-donor eggs or embryos were begun. Of these, 34,719 (35%) resulted in pregnancy and 28,404 (29%) resulted in live birth deliveries. Pregnancy rates after tubal reversal and after IVF were compared based on the age categories reported in the National Summary and Fertility Clinic Reports (Figure 3). The pregnancy rate after tubal reversal was higher than after IVF within every age group.

Figure 3. Pregnancy Rates After Tubal Reversal vs IVF

Tubal Reversal

IVF

Age

Similarly, birth rates were higher after tubal reversal at Chapel Hill Tubal Reversal Center than after IVF for women of all ages and the differences increased with increasing maternal age (Figure 4).

Figure 4. Birth Rates After Tubal Reversal vs IVF

Tubal Reversal

IVF

Age

Comparing Tubal Reversal and IVF

Tubal reversal surgery differs from IVF in significant ways. The chances of getting pregnant after tubal reversal continue each month following the surgery. The pregnancy rate after tubal reversal, therefore, continues to increase over time and more than one pregnancy and birth can result from a sterilization reversal procedure. With treatment by IVF, the outcome is immediate. If pregnancy does not occur, then a couple must decide whether or not to go through the treatment process again. Since the chances of getting pregnant after tubal reversal are cumulative over time, this procedure results in higher pregnancy and birth rates than after an IVF cycle.

Tubal Reversal Pregnancy Study Report 2009
Table Of Contents:

• Overview
• Study Method
• Patient Population – US States
• Patient Population – Age and Tubal Ligation Procedures
• Pregnancy Rates by Age and Method
• Pregnancy Rates by Tubal Length
• Pregnancy Outcomes
• Comparison Of Tubal Reversal vs. IVF (this page)
• About Pregnancy Statistics

Comments About Tubal Reversal Pregnancy Statistics

Tubal Reversal Pregnancy Report 2009

Pregnancy Outcomes After Tubal Reversal At Chapel Hill Tubal Reversal Center

Pregnancy Outcomes By Age

Table 8 shows the relationship between age and pregnancy outcome following tubal ligation reversal at Chapel Hill Tubal Reversal Center. With increasing age, the percentage of pregnancies resulting in births declined due to an increasing percentage of miscarriages. Among women under age 35, over half of pregnancies resulted in birth or ongoing pregnancy while one third miscarried. The birth rate declined and the miscarriage rate increased significantly for women ages 40 and older. The overall ectopic pregnancy rate for all patients (14%) was higher than that found in the general population of women who have not had a tubal ligation, which is approximately 3%. The ectopic pregnancy rate after tubal reversal surgery may be overestimated, since some early pregnancy losses were reported as ectopic pregnancies when serum HCG levels did not rise normally but without confirmation of the diagnosis by ultrasound or laparoscopy. In the case of very early pregnancy loss, the actual site of the pregnancy (uterine or ectopic) is unknown. Whether there is an increased risk of miscarriage associated with tubal reversal is unclear. The miscarriage rate reported in the general population ranges from approximately 20% to 50% depending on a woman’s age and how early pregnancy testing is performed.

Pregnancy Outcomes By Tubal Ligation Method

Table 9 shows the relationship between the tubal ligation method and pregnancy outcomes. Tubal ligation reversal after tubal clips (Hulka clip, Filshie clip) has the best outcome of all tubal ligation methods, with the highest birth rate (69%) and lowest miscarriage rate (25%) and ectopic pregnancy rate (6%). Reversal of tubal rings (Falope ring, Yoon ring) has the second best outcome, followed in order by ligation/resection and coagulation. These findings are almost certainly related to the minimal damage to the fallopian tube caused by tubal clips and rings.

Pregnancy Outcomes By Fallopian Tube Length

Longer tubes are associated with better pregnancy outcomes than shorter tubes (Table 10). Among women with average fallopian tube lengths measuring 7.5 cm or longer, 61% gave birth or had an ongoing pregnancy. Birth rates declined while miscarriage and ectopic pregnancy rates increased with shorter tubal lengths.

Tubal Reversal Pregnancy Study 2009
Table Of Contents:

• Overview
• Study Method
• Patient Population – US States
• Patient Population – Age and Tubal Ligation Procedures
• Pregnancy Rates by Age and Method
• Pregnancy Rates by Tubal Length
• Pregnancy Outcomes (this page)
• Tubal Reversal vs. IVF
• About Pregnancy Statistics

Pregnancy and Birth Rates After Tubal Reversal vs. IVF

Tubal Reversal Pregnancy Study Report 2009

About Tubal Reversal Pregnancy Statistics

Gary S. Berger, MD
Medical Director

What To Believe

Claims about the chances of getting pregnant after tubal reversal are often made without supporting documentation such as the number and characteristics of the patient population, study method, and length of follow-up after surgery. These are essential for understanding the basis of pregnancy rates. Statistics must be based on specified numbers of patients for any characteristic, such as age or tubal sterilization method. Most internet sites about tubal reversal do not provide any data at all. Although a doctor can say that his patients have a high success rate, supporting documentation is needed to know whether the claim is valid. The accuracy of any claim of success rates should be questioned in the absence of detailed information.

Evidence Based Medicine

The only way a doctor can truly know what the pregnancy and outcome statistics are for his or her patients is to maintain ongoing patient contact about the outcomes of treatment and record the information systematically in an analytical database. At Chapel Hill Tubal Reversal Center, nurses enter information into an electronic patient database at the patient’s registration, the surgical procedure, and all post-operative communications between patients and staff. Patients are contacted routinely by our nurses during the first year after their tubal reversal procedures.

Chapel Hill Tubal Reversal Center Database

The comprehensive follow-up database at Chapel Hill Tubal Reversal Center is unique. We know of no other doctor or medical facility with a follow-up system and database that can provide such accurate statistics about the chances of getting pregnant after tubal reversal and the outcomes of the pregnancies that occur.

Limitations And Possible Under Reporting

Although we encourage patients to inform us when they have a positive pregnancy test, not all pregnancies are ascertained. Some patients become lost to follow-up after surgery. This occurs when someone moves or changes email address and telephone numbers but does not provide their new contact information to us. In these cases, we may not find out about the long term outcomes of their tubal reversal procedures unless they complete the Pregnancy Report Form each time they conceive. We know that not all patients adhere to this protocol. From the women who do remain in contact with us over the long term, however, it is clear that new pregnancies continue to occur as time passes after surgery. The pregnancy rates reported in this study, therefore, are minimal estimates of the cumulative pregnancy rates for patients at Chapel Hill Tubal Reversal Center.

Tubal Reversal Pregnancy Report 2009
Table Of Contents:

• Overview
• Study Method
• Patient Population – US States
• Patient Population – Age and Tubal Ligation Procedures
• Pregnancy Rates by Age and Method
• Pregnancy Rates by Tubal Length
• Pregnancy Outcomes
• Tubal Reversal vs. IVF
• About Pregnancy Statistics (this page)

Weekly Pregnancy Announcements From Chapel Hill Tubal Reversal Center Patients

Tubal Reversal Pregnancy Report 2009

Patient Population and Characteristics

The study population consisted of 5,046 women who underwent tubal reversal surgery from July 2000 through June 2008 at Chapel Hill Tubal Reversal Center.

Women’s Ages

The women in the study ranged in age from 20 to 51 (Figure 1). The mean average was 34 years of age.  Approximately three-fourths of the women were in their 30s.

Figure 1. Age Distribution of Study Population

Years of Age

Tubal Ligation Methods

The type of tubal ligation that was performed is an important factor affecting the outcome of  tubal reversal surgery. The most common method involved tying and cutting out a segment of the tube (ligation/resection). The second most common method was tubal coagulation (burning the tubes) followed in frequency by mechanical occlusion with tubal clips or rings. Other procedures, including fimbriectomy (removing the end of the fallopian tube) were the least common. In cases where the patient’s operative report of the tubal ligation was not available, the method was classified as unknown.

Tubal Reversal Pregnancy Report 2009
Table Of Contents:

• Overview
• Study Method
• Patient Population – US States
• Patient Population – Age and Tubal Ligation Procedures
• Pregnancy Rates by Age and Method
• Pregnancy Rates by Tubal Length
• Pregnancy Outcomes
• Tubal Reversal vs. IVF
• About Pregnancy Statistics

Pregnancy Rates At Chapel Hill Tubal Reversal Center

Tubal Reversal Pregnancy Report 2009

Pregnancy Rates At Chapel Hill Tubal Reversal Center

From July 2000 to June 2008, 5046 women underwent tubal ligation reversal at Chapel Hill Tubal Reversal Center. The operative techniques of microsurgical tubal anastomosis, tubouterine implantation, and salpingostomy were used as appropriate to each patient’s situation, and often these techniques were combined in a single case. Including all women’s ages, methods of tubal ligation, and operative techniques used for tubal reversal, the overall pregnancy rate was 66% based on 3317 pregnancies reported during this 8 year interval.The following tables show pregnancy rates specific for age, method of tubal ligation, and remaining tubal lengths available for repair and the interaction between these factors.

Pregnancy Rates By Age

As expected, younger women had higher pregnancy rates than older women. The pregnancy rate after surgery ranged from 80% for women under 30 to 31% for women 40 years of age and older (Table 3).

Pregnancy Rates By Tubal Ligation Method

Reversal of tubal clip procedures had the highest pregnancy rate (75%), followed by tubal rings (72%), coagulation (66%) and ligation/resection (63%). Patients with other or unknown methods of tubal ligation had the lowest pregnancy rate (54%).

Pregnancy Rates By Age And Method

Pregnancy rates taking into account both age and tubal ligation method are shown in Table 5. The highest pregnancy rate (90%) was reported by women under 30 years of age who had reversal of a previous clip method of sterilization. Of the two variables, age is more predictive than tubal ligation method regarding the likelihood of becoming pregnant after reversal surgery.

Tubal Reversal Pregnancy Study 2009
Table Of Contents:

• Overview
• Study Method
• Patient Population – US States
• Patient Population – Age and Tubal Ligation Procedures
• Pregnancy Rates by Age and Method (this page)
• Pregnancy Rates by Tubal Length
• Pregnancy Outcomes
• Tubal Reversal vs. IVF
• About Pregnancy Statistics

Pregnancy Rates By Tubal Lengths

Tubal Reversal Pregnancy Study Report 2009

Gary S. Berger, M.D.
Reproductive Surgeon

Overview

Tubal reversal is the most successful treatment for women wanting to get pregnant after having a tubal ligation. This report presents detailed pregnancy statistics from over 5000 patients at Chapel Hill Tubal Reversal Center. It is the largest study ever reported about tubal ligation reversal, pregnancies, and pregnancy outcomes.

Introduction

The desire to have a baby after a tubal ligation is common for women in second marriages, following the loss of a child, wanting to restore their bodies to be whole again, and for a variety of other reasons.

Most people are not aware that tubal ligation – usually considered a permanent method of birth control – can be reversed through low cost, one hour outpatient surgery. Even many doctors think mistakenly that treatment by in vitro fertilization (IVF) is needed for women who want another baby after having a tubal sterilization. The results from this study show that tubal reversal at Chapel Hill Tubal Reversal Center is successful for most women wanting to get pregnant after having their tubes tied.

Tubal Reversal – The Alternative to Treatment by IVF

Information is widely available about in vitro fertilization (IVF) results in the United States from the Centers for Disease Control (CDC). Tubal reversal pregnancy and birth statistics, however, are difficult to find and generally have been based on small numbers of patients under special study conditions. This report analyzes pregnancy rates and pregnancy outcomes for a very large population of women (5,046) who had tubal reversal procedures at Chapel Hill Tubal Reversal Center. This is the most detailed study of tubal reversal surgery available on the internet or in medical publications.

Tubal Reversal Pregnancy Study 2009

Table of Contents:

• Overview (this page)
• Study Method
• Patient Population – US States
• Patient Population – Age and Tubal Ligation Procedures
• Pregnancy Rates by Age and Method
• Pregnancy Rates by Tubal Length
• Pregnancy Outcomes
• Tubal Reversal vs. IVF
• About Pregnancy Statistics

Weekly Pregnancy Report Forum