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

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 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

FOR IMMEDIATE RELEASE CONTACT: Julia Smith RN
August 11, 2009 (919) 656-8204

TUBAL REVERSAL SURGEONS REVERSE ESSURE PROCEDURE
Implantation technique allows for successful reversal of sterilization procedure

(CHAPEL HILL, NC) – Chapel Hill Tubal Reversal Center in Chapel Hill, North Carolina, announces the successful completion of sterilization reversal of the Essure procedure, previously considered a permanent form of female birth control.

More than 115,000 women worldwide have undergone sterilization with the Essure device since 2002. The Essure procedure involves placing a small, flexible plug into each fallopian tube at the junction of the uterus and the tube. Once in place, over a 3-month period, scar tissue grows into the micro inserts blocking the tubes to prevent the sperm from fertilizing the egg. The permanent nature of the procedure is related to this scarring and the previous belief that tubal ligation reversal surgery would be impossible.

The procedure Dr. Gary Berger and Dr. Charles Monteith use to reverse the Essure method involves cutting the device out of the uterine muscle and then implanting the remaining fallopian tube segment into the uterine cavity through a new opening in the uterus. This procedure is called tubouterine implantation. The reason the Essure device is removed is that part of the metal spring projects into the uterine cavity. If a pregnancy were to occur with the device in place, this could be harmful to the pregnancy.

Since the Essure has only been available since 2002 – and most women who have had this sterilization procedure do not desire or seek reversal – there is currently not enough data on the outcomes of Essure reversal to provide pregnancy statistics. However, the tubal reversal surgeons at Chapel Hill Tubal Reversal Center have performed the tubouterine implantation procedure hundreds of times for other situations and the success rate in those cases has been 25% -50% depending on the amount of healthy tube remaining and the age of the patient.

Chapel Hill Tubal Reversal Center is the only facility in the United States that is limited specifically to the practice of tubal reversal surgery. Additional information regarding tubal reversal surgery 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.

More about Reverse Essure Procedure

Interview with Dr. Charles Monteith
Tubal Reversal Surgeon at Chapel Hill Tubal Reversal Center

Charles Monteith, M.D. speaks about his education, training, and certifications. Dr. Monteith says he currently performs tubal reversals eight to twelve a week and the reasons women mention for wanting to have their tubes reversed. He says these include a new partner, or people have just changed their minds and decide they want to have more children. He adds a lot of women have experienced changes in their bodily functions after tubal ligation, and that patients refer to this as Post Tubal Ligation Syndrome.

Transcript of Video Interview With Dr. Monteith

Interviewer: Can you tell us about your medical school and residency training?

Dr. Monteith: I went to medical school in San Francisco, University of California in San Francisco and finished my MD degree there and then subsequently returned to the University of North Carolina, Chapel Hill to do my obstetrics and gynecology residency.

Interviewer: How long have you been performing reproductive surgery?

Dr. Monteith:I have been performing Gyn. surgery since 1997 but as of a year and a half ago dedicated myself exclusively to working with Dr. Berger and doing tubal reversal surgery.

Interviewer: And before you started working with Dr. Berger did women frequently ask for tubal reversal procedures was that something that something that came in your practice prior?

Dr. Monteith: As a generalist I did not see a lot of women that requested tubal surgery. However, our practice was a majority of young pregnant women. So I didn’t get a fair assessment of how many women were out there that wanted to have tubal ligations reversed. However I did have a partner that did perform exclusive GYN services she fairly often had requests or inquiries about tubal reversal surgery.

Interviewer: What made you pursue a certification in tubal reversal?

Dr. Monteith: I think I had had practiced high risk obstetrics and gynecology for a good seven years after I finished my residency and just one day I realized I needed to change what I was doing or I wasn’t going to last very long doing it. The way medicine has become is very high volume very stressful and little time with patients. I felt like I really wasn’t helping people to the best of my ability. Patients would come they would go. They would their insurance and have to go find another provider. People would come with job movement in the middle of pregnancy or leave in the middle of pregnancy and I just found that I didn’t get a lot of personal fulfillment out of it. I especially like my role as a tubal reversal provider because I like I’m being with a physician is supposed to be. I’m using my skills to help people to the best of my ability. And I especially feel because it’s not a widely offered service that I’m doing even better for a lot of women.

Interviewer: How many reversals do you perform each week?

Dr. Monteith: On average about eight to twelve a week currently.

Interviewer: What are some of the reasons women mention for wanting to have their tubes reversed?

Dr. Monteith: It seems like the most common reason is basically none of us can predict the future and most commonly it seems women find themselves in new relationships. Usually it is bad marriages, separations and divorce. And they find themselves with a new partner and just very strongly they would like to have children together. A close second to that would be to people that have just changed their minds and decide they want to have more children. And then a lot of women have experienced changes in their bodily functions after tubal ligation.

Interviewer: Are you referring to Post Tubal Ligation Syndrome?

Dr. Monteith- Ah yes, what most patients refer to as Post Tubal Ligation Syndrome.

Interviewer: And how frequently do you hear that as a condition that women feel they have developed?

Dr. Monteith- We hear it very commonly. There are probably a lot of women who come through here that never voice it or share it. But, at least in my experience here, I see a patient at least once a day if not every other day that has experienced worsened menstrual symptoms or bodily functions after a tubal ligation procedure.

Interviewer: And how much follow-up or are you able to follow-up after the surgery to see if that has improved?

Dr. Monteith: I am in the process of doing that now. Last year, we did a small case study on five women that had tubal ligations and experienced Post Tubal Ligation Syndrome. This summer it will be a full year and thus far in talking with them it seems at least about 70% of them have gotten better. Very frequently I am amazed that women post on the message board how much improvement they feel after they have reversal surgery.

Interviewer: How much contact do you have with patients after their reversal surgery?

Dr. Monteith: Most patients come from long distances so there is not a lot of direct contact but the most amazing thing is our tubal reversal patients seem to keep close contact by email and through electronic means. So, we hear from a large number of our patients.

Interviewer: What’s the best part of tubal reversal surgery and what you’re doing currently?

Dr. Monteith: The best part is really just using my skills to help a woman, a couple or a family to achieve what they would otherwise not be able to achieve and that is to add more children to their family or their relationship. Or to improve their perceptions about their body.

Interviewer: What do you like about Chapel Hill Tubal Reversal Center?

Dr. Monteith: The thing I like the most about this center and I come from my experience of working a large university and also from working at a large good quality hospital in Raleigh is that this center works with amazing efficiency. We take great care of patients. The staff seems to be real happy and motivated. And we are all dedicated to doing just one thing and that’s tubal surgery. And it feels good to work in a place with such high efficiency for the betterment of patients.

Interviewer: How does Chapel Hill compare to the in patient care of a hospital?

Dr. Monteith: There about the same as some of the best hospitals I have worked at and probably even better. Mainly because we are all focused on one thing and the staff really knows their jobs. And we are all dedicated to making that one goal happen, and that’s safe outpatient tubal repair surgery.

More Information about Dr. Monteith