I received an email message today from a patient that prompted me to write about informed consent for tubal ligation. (See my previous blog about informed consent for tubal reversal.) Here is the message that was sent to me.

Hello, Dr. Berger,

You performed tubal reversal surgery on me on 10/29/07, and I just found out that I’m pregnant. Thank you so much! This is such a blessing. I filled out the report and have heard back from Sarah Meacham. I’ll make sure to follow her instructions.

I’m writing because I have a friend named Samantha who wants to get reversal surgery, but she would like to make sure she’s a candidate based on the information in her operative report. I told her that I would send it to you so you can look it over, so it’s attached. She and her husband have two cute little girls, but she agreed to the tubal ligation on the operating table after she gave birth to her youngest at the prodding of her doctor. She said that she made a terrible mistake and wants more children. And like me, no one she’s asked in south Florida will even consider the procedure that you do. When I told her about you, she was ecstatic. And now that I’m pregnant, she knows that it works!

Thank you again for the miracles you work for so many women. God bless you and your staff!

Sincerely,
Amy P.

I was glad to hear that Amy was pregnant and had recommended to Samantha that she come here for her tubal reversal procedure, but this part of the message caught my attention:

“…she agreed to the tubal ligation on the operating table after she gave birth to her youngest at the prodding of her doctor. She said that she made a terrible mistake…”

What Is Informed Consent?

Before performing a tubal ligation - an elective operation - a doctor should always obtain the patient’s informed consent. Informed consent is the process through which the patient becomes educated about the procedure - including its benefits, risks and alternatives - and makes the decision to have the procedure performed. Informed consent implies that the patient fully understands the issues, has asked any questions she has, had her questions answered, and makes her decision under no duress. Adequate time should be allowed for a patient to think about all of the issues before consenting to the operation.

Should Consent For Tubal Ligation be Made During Childbirth?

Many tubal reversal patients have told me that the first time they discussed a tubal ligation with their doctor while they were on their way to the operating room for a C-section. Some regretted their decision while they were on the operating table or when they awoke in the recovery room. Other patients have said they had a tubal ligation in response to pressure from their spouse, parents, or their doctor. Labor and delivery is not the best time to think about an issue with such profound and lasting results as surgical sterilization. This should be discussed and thought about at leisure, not during the stress of childbirth.

Dr. Berger’s Comment

Besides the doctor’s responsibilities in obtaining informed consent, the patient also has a responsibility when giving it. A tubal ligation is not an emergency operation. Having a tubal ligation is a decision that should be carefully considered and not made in haste. There is adequate time during the pregnancy for a doctor and patient to discuss the issue of sterilization. Bringing this up for the first time on the way to the delivery room is a mistake, in my opinion. A more deliberate approach to the process of informed consent by both doctor and patient would help avoid mistaken decisions, such as in Samantha’s case.

I recently received an email from a patient who had an ectopic pregnancy subsequent to her tubal reversal. Unfortunately, the pregnancy continued to the point of tubal rupture with the loss of the fallopian tube.

Patient’s History

I was hoping you could help me understand why my ectopic pregnancy was not detected early enough to prevent the loss of my right tube. I need to know this for the future as after my surgery I have only my left tube remaining.

I went to my doctor at approximately 3 weeks pregnant and made sure that they understood the importance of checking for ectopic pregnancy. I gave them a copy of your instructions and told them my goal is to prevent losing my tube if it is ectopic, so I told them to please check and make sure it is not ectopic. They did blood work 3 times and did a vaginal ultrasound at approximately 4 weeks and said everything was normal and the sac was in the uterus, not the tube. They did not check anything again until I spotted Tuesday of this week. I went in Wednesday and they did a vaginal ultrasound and said it was ectopic with a heartbeat and I needed surgery and my tube would have to be removed.

My tube was removed because it was starting to rupture. I never expected that to happen because I took the precautions necessary.

Can you please tell me what normal pregnancy hormone levels are for each week of pregnancy versus ectopic hormone levels?

When is an ectopic visible on ultrasound? Could this have been prevented? Was there anything else that could have been done?

Role of Serum HCG in Early Pregnancy Monitoring

HCG levels alone do not differentiate between uterine and ectopic pregnancy. The HCG levels provide the earliest evidence of whether implantation has occurred successfully (but not where it has occurred) and indicate when ultrasound examination should be able to find a gestation sac if the pregnancy is in the uterine cavity. This occurs when serum HCG reaches 1500-2000 mIU/dL. If serum HCG levels are rising too slowly, or if ultrasound does not find a gestation sac in the uterus when HCG is at the level of 1500-2000, then the pregnancy is not a normal one. It could be outside of the uterus (ectopic) or it could be an abnormal pregnancy in the uterus (blighted ovum).

Role of Transvaginal Ultrasound

A careful transvaginal ultrasound exam can detect a normally developing pregnancy in the uterus very early. It is apparent in this case that the initial ultrasound findings were not interpreted correctly. How could this occur?

An intrauterine gestation sac is a dark oval shaped area of fluid surrounded by a bright white ring or halo (the trophoblastic tissue). Probably in this case there was a small amount of fluid in the uterine cavity that was mistakenly thought to be a gestation sac. This has been described as a “pseudo-sac”. A pseudo-sac does not have the distinct white halo or ring of a true gestation sac.

In a normally developing uterine pregnancy, a follow-up ultrasound exam will show the presence of a yolk sac (the small circle within the gestation sac) within a week of the appearance of the gestation sac. If the initial ultrasound exam had been followed-up with another ultrasound scan, it would have shown that this was not a normal uterine pregnancy.

Comment

There is an increased risk of ectopic pregnancy following tubal reversal surgery. Our follow-up pregnancy statistics show that the risk of ectopic pregnancy remains constant with each pregnancy. In other words, it is the same for a first, second, third, or subsequent pregnancy after tubal reversal surgery. It is important, therefore, to monitor any pregnancy after tubal reversal early and closely.

Recommendations for early pregnancy monitoring are given on our website page entitled I’m Pregnant. Although the recomended tests were performed, the most critical one - the ultrasound exam to document the location of the gestation sac - was interpreted erroneously.

An experienced ultrasonographer should be able to differentiate between a true gestation sac and a pseudo-sac by the presence or absence of the bright halo surrounding the fluid filled sac. If there is any doubt, a repeat ultrasound exam looking for the appearance of a yolk sac should be performed.

Although ectopic pregnancy is not preventable, the complication of tubal rupture always should be. In the absence of clear ultrasound evidence of an intrauterine pregnancy, early treatment with Methotrexate is recommended. It is important to monitor serum HCG levels until the HCG level returns to less than 10 mIU/dL. This will prevent a possible ectopic pregnancy from advancing to the complication of tubal rupture.

Patient’s History

Ana G. was one of the 4 patients I operated on today at Chapel Hill Tubal Reversal Center. She is a 28 year old woman from Angola, the mother of 3 children - ages 9, 8, and 6. She married when she was 15 and was in an abusive marriage. To keep from becoming pregnant again, she had a tubal ligation. When she had this done, all she could think about was not becoming pregnant again.

Ana eventually ran away and divorced her husband. Several years later she met a man who she fell in love with and who has treated her very well. He has no children. Now remarried, Ana feels that her second husband will want children in the future, so she decided to have a tubal ligation reversal. Although she doesn’t intend to become pregnant soon, she says that if it happens that would be fine.

Ana’s Tubal Reversal Procedure

Ana’s tubal reversal was performed by the technique of tubotubal anastomosis. Her fallopian tubes were in excellent health, with no fibrosis and with normal fimbriae and tubal endothelium. The anastomoses were isthmic-ampullary on the right and isthmic-isthmic anastomosis on the left. The tubal lengths after repair were 6.5 cm on the right and 8 cm on the left side.

Dr. Berger’s Comments

Every patient who comes to Chapel Hill Tubal Reversal Center has a unique story to tell that led up to the decision for a tubal reversal procedure. Divorce and remarriage is a common theme, and a history of abuse in the prior marriage is often one of the reasons given for the divorce.

Ana’s story is unusual in that she married at age 15 and had her tubal ligation by age 21. This may be due to the cultural differences in some African countries from the US. Although most of our patients come from the United States, couples come from many other countries to have me perform their tubal reversal surgery.

Although Ana’s operative report stated that Filshie clips had been applied to her tubes, no clips were found during surgery. It is not clear whether the operative report was incorrect, or whether the clips migrated to other locations in the abdominal cavity. This can occur if the pressure from the closed clips causes necrosis or death of the tissue within the clip. I have seen this occasionally in other patients.

Predicted Outcome After Ana’s Tubal Reversal

Based on her age and tubal lengths, Ana’s probability of becoming pregnant is 90% as documented in the post tubal reversal pregnancy statistics among patients at Chapel Hill Tubal Reversal Center.

Tubal Sterilization For Young Women With No Children

One of today’s patients at Chapel Hill Surgical Center was a woman in her thirties who recently become married and had a tubal ligation at age 24 years when she had no children. Her tubal ligation had been performed by a tubal coagulation procedure in which the fallopian tubes were burned at the junction of her uterus. The tubal lumen or opening within the uterine wall was scarred completely on both the right and left sides from the burning procedure. Therefore, the only way to perform a tubal reversal was through the technique of tubouterine implantation.

I mention this case because it was unnecessarily destructive, especially when performed for a young woman with no children. Many studies show that these are women who are most likely to change their minds later on and want to be able to have children. In this case, almost any other tubal ligation procedure would have been preferable. In my view, the best choice of a tubal ligation for a young woman with no children is the clip method (either Hulka clip or Filshie clip).

I have encountered other cases like this in the past. I wonder if the doctor who performed her tubal ligation considered the possibility that the patient might change her mind, and therefore it would be preferable to perform a tubal ligation better suited to reversing at a later time, should the need arise.

Comments Welcome

I am interested in what other people think about this.

Tubal Anastomosis at the Uterine Cornua

Tubouterine anastomosis is a tubal reversal procedure that is intermediate between tubotubal anastomosis and tubouterine implantation. It is also called cornual anastomosis because the tube is joined to the cornual area of the uterus with this operation. The cornu is the area where the fallopian tube normally emerges from the the uterus.

When Is Tubouterine Anastomosis Performed?

Tubouterine anastomosis is performed when there is a healthy tubal segment near the ovary, but no segment remains attached to the uterus, following a tubal ligation procedure. It is also performed when a tubal segment attached to the uterus is scarred and has no open lumen.

An incision is made into the uterus at the cornu to find the opening of the fallopian tube tube as it passes through the uterine muscle. If an opening is found, the tubal segment that remains is rejoined to the uterus at this site.

Case Histories

The topic of tubouterine anastomosis is a timely one. During the past week, 2 patients undergoing tubal reversal surgery at Chapel Hill Tubal Reversal Center required this operative procedure. In one case, each fallopian tube had been coagulated or burned next to the uterine cornu, leaving no segment attached to the uterus. The other patient had developed the condition known as salpingitis isthmica nodosa in the portion of the fallopian tube between the uterus and the a Falope ring. In both cases, tubal reversal was able to performed with the technique of tubouterine anastomosis.

Dr. Berger’s Comment

Frequently, patients have been informed by doctors who are not specialists in tubal ligation reversal that their fallopian tubes cannot be repaired after a tubal ligation. This is especially true when the proximal segments of the fallopian tubes are missing or diseased. But there are a variety of surgical techniques that can be used during tubal reversal surgery by a doctor who is an experienced tubal reversal surgeon. This is one of the advantages patients have when they come to Chapel Hill Tubal Reversal Center for their tubal reversal procedures.

What is Essure?

Essure is a permanent birth control device that has recently become available as an alternative to traditional tubal ligation methods. The spring-like device is inserted through the uterine cavity into the tubal openings using a hysteroscope. This can be done as an in-office procedure. The device expands to fill the tubal opening and then becomes scarred into place, forming a barrier so that sperm cannot reach the egg. Because of the scar formation, it cannot be pulled out of the tube. It is advertised by the manufacturer as a permanent method of birth control. In this respect, it is similar to other tubal ligation methods that are considered by most doctors to be permanent.

Here is a link to an online video animation of the placement of the Essure device into the fallopian tubes.

Is Tubal Reversal Possible For The Essure Device?

I perform 4 tubal reversal procedures each day at Chapel Hill Tubal Reversal Center. The women who come here have all varieties of tubal ligation methods. Today, one of the patients had the Essure sterilization method. When she chose this form of tubal sterilization, she was unaware that she would become remarried and want to be able to try to have a child with her new husband.

Although I could not find any previous references regarding attempts to reverse the Essure procedure, I agreed to attempt to perform a reversal for her. The way I did this was to cut the device out of the uterine muscle and then implant the remaining fallopian tube into the uterine cavity through a new opening in the uterus. This procedure is called tubouterine implantation.

The reason I removed the device was 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. To my knowledge, this is the first time that the Essure sterilization procedure has been reversed.