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Laparoscopic Essure tubal reversal: How we do it

Dear Dr. Einarsson,

I read with interest your report, Laparoscopic Essure tubal reversal: How we do it.¹ From the perspective of one who has lived 45 years of our history of reconstructive tubal surgery for both diseases and iatrogenic procedures from simple open surgery through microsurgery with magnification and adjunctive procedures to improve tubal patency to minimally invasive and robotically assisted procedures, I offer 2 comments:

• Hysterosalpingogram demonstrated patency at 4 to 12 weeks post-procedure is a poor measure of anything. The initial healing of the tube-to-tube or tube-to-uterine cornual anastomosis is followed by a 6- to 9-month interval of scar remodeling and it is during this interval that the propensity of all hollow viscus repairs to contract centripetally occurs. 

• As one reports the results of our efforts to help patients, we must remember the only outcome that truly matters: a healthy baby at mother’s breast. It took us a generation for IVF to consistently report live births by age of mother. Unfortunately, your success to date is 0/3 (ages 27-35), an outcome that has a statistical estimate, with 95% confidence, equal to 1.0 (i.e. chance alone explains the finding) and it would be unchanged if all 3 of your patients had conceived.² You have used Dr. Montheith et al’s experience as a benchmark: “…their website reports a 38% pregnancy rate for 282 procedures performed over 9 years.”^1,p.16 In their 2014 publication,³ they had a 24% pregnancy loss rate. Extrapolating that early loss rate plus the reported five ectopic pregnancies to the 108 pregnancies in their website 2018 updated data, the live birth rate (78/108) is 25.5%. 

I congratulate you for continuing to explore new treatments and ask only that investigators report, and journal editors police publishing, evidence-based methods and clinically meaningful outcomes.

Yours very truly,

Ronald C. Strickler, MD FRCS[C] MBA
Wayne State University School of Medicine

In Reply:

Dear Dr. Strickler,

Thank you for your insightful letter regarding our recent article on Essure reversal. You make a number of good points. We agree that a HSG a few weeks out is not a perfect measure of tubal patency and we have plans to repeat this exam 9 to 12 months after surgery. 

In terms of pregnancy outcomes, we clearly acknowledge that we do not have any pregnancies yet and that our success rate therefore is zero. However, the primary reason these patients presented to us was for pelvic pain and other symptoms that they attributed to their Essure implants being in place. Therefore, IVF alone would not have addressed their main complaint. Given that the tubo-uterine anastomosis added minimal risk and surgical time to the procedure, we elected to offer this to our patients. However, they were thoroughly counseled that the efficacy of this procedure was unknown and that the available literature suggested that the chances of pregnancy were fairly low. We have previously published outcomes in 52 patients after Essure removal and we found that approximately two-thirds of our patients had significant improvement in their symptoms.¹ We therefore continue to offer this procedure to our patients.

Best regards,

Jon I Einarsson, MD, PhD, MPHaNisse V. Clark, MD, MPH

Dr. Strickler’s REFERENCES:

• Einarsson JI, Clark NV. Laparoscopic Essure tubal reversal: How we do it. Contemp OB/GYN. 2018;63(10):14-20.

• Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA. 1983;249:1743-1745.

• Montieth CW, Berger GS, Zerden ML. Pregnancy success after hysteroscopic sterilization reversal. Obstet Gynecol. 2014;124(6):1183-1189.

Dr. Einarsson’s REFERENCES:

• Clark NV, Rademaker D, Mushinski AA, Ajao MO, Cohen SL, Einarsson JI. Essure removal for the treatment of device-attributed symptoms: an expanded case series and follow-up survey. J Minim Invasive Gynecol. 2017 Sep - Oct;24(6):971-976.

What has become of our specialty? 

I was so sad to read Dr. Einarsson’s article on the future of gyn surgery and the impact of technology on it. Having retired some 25 years ago and being out of the loop gives me pause to express myself, but looking back, it also made me wonder about some things - things like the 20-minute vaginal hysterectomy (VH) for carcinoma-in-situ (CIS) I once did using only a half hour of OR and anesthesia time with a 2-day hospital stay. And the VH for prolapse in the older woman with an opportunity to make a more functional repair of bladder and rectum when indicated and the smiles I received postoperatively when I inquired about their sexual activity.

A short time ago, one of my daughters-in-law needed a bladder repair for stress urinary incontinence (SUI) and she saw the gynecologist who did the VH and then turned the case over to the urologist to repair the bladder. I was both astounded and dismayed when I asked the former why she couldn’t do both and she replied, “well he can do it better!” It made me wonder what had become of our wonderful specialty, and now I know. Still, it makes me sad.

Irwin A. Herman, MD, FACOG

In Reply:

I want to thank Dr. Herman for his thoughts on my editorial. While I appreciate his comments, I am more optimistic about the future of gynecologic surgery now than ever. The bottom line is that we are now able to provide more patients with safer minimally invasive approaches to surgery with better outcomes than in the past. This is in part due to better technology, but also due to subspecialist training with high level of surgical expertise. There is always a tendency to over-rely on technology and to jump on the new gadget bandwagon too soon and we must continue to be appropriately critical of new innovations moving forward. However, due to advances in surgery, over 90% of our hysterectomy patients are now able to go home the same day after their surgery with a very low readmission rate and we have better options for the treatment of fibroids and endometriosis and other common conditions. In the end, patient safety and clinical outcomes are the most important factors to consider and I do believe we have made some significant strides for improvement there.

Best regards,

Jon I Einarsson, MD, PhD, MPH

On obstetrics and the Hippocratic Oath

As a solo private practitioner for the past 34 years, Dr. Howie Mandel’s words were truly a validation of my daily approach to the general practice of OBG. The oppressive burden that would be imposed by such non-medical parties as insurance companies, bureaucrats and hospital administrators is ever more threatening to doctors and especially the patients that they tirelessly treat. 

I once was caring for the very nice wife of a not-so-nice plaintiff attorney. He studiously avoided the prenatal visits but managed to attend L&D at term. I entered the LDR, spoke cordially, and then intently turned to the EFM, and said nothing. After a very few minutes of my studying a beautiful tracing, the attorney said, “Doctor, what do you think?” I turned and said, “ I don’t know counselor, what do you think? If I was on your witness stand, you’d be an expert on EFM!”

We need to bring a similar pressure to bear on those who would intrude from the safety of the sidelines. On the next difficult clinical situation at 0300, request the on-site help managing a real (or fictitious) nail-biter, from the hospital CEO, or at the very least, the minion on call. MAKE THEM FEEL WHAT WE FEEL EVERY DAY! 

Thanks once more, Dr. Mandel, for a very insightful editorial. 

Regards,

W B Simpson Jr, MD

In Reply:

Dear Dr. Simpson,

Thanks for your kind reply, and your many years of service.

Best regards,

Jon I Einarsson, MD, PhD, MPH