Management Options for Women at Risk for Endometrial Ablation or Endomyometrial Resection (EMR) Failure


Late-onset Endometrial Ablation Failure Solutions
Levonorgestrel-containing Intrauterine Device

As you know, any of the minimally invasive techniques for destroying uterine lining-–endometrial ablation or endomyometrial resection—have some risk of delayed failure.  Late-onset Endometrial Ablation Failure –or LOEAF–most often presents itself in one of 2 ways:  worsening menstrual bleeding or pelvic pain (or both).  

Who are the women at greatest risk for “late-onset endometrial ablation failure (LOEAF)”?  

Women who appear to be at greatest risk for failure include the following:

  1. Women under 40 years of age
  2. Women who have proven or suspected adenomyosis
  3. Women who have an enlarged uterine surface area at the outset of their procedure
  4. Women who have already demonstrated a failure following an endometrial ablation

What can be done to reduce the risk of late-onset failure?

In the past 20 years there have been 5 published studies that have looked at the combination of endometrial ablation or resection with the insertion of an intrauterine devices (IUDs) that emits the hormone, levonorgestrel.  The best-known of these devices is the Mirena IUD although other commercially available IUDs can be used as well.

All of these studies [2-6] show a dramatic difference in outcomes when one compares women who have undergone either endometrial ablation or endomyometrial resection to women who have undergone the same procedure and then had an IUD placed shortly afterwards.  The most meaningful of these studies was reported by Dr. Papadakis at the Mayo Clinic [6]. In the Mayo Clinic report they compared the outcome of 23 women with heavy menstrual bleeding who underwent both endometrial ablation followed by the insertion of a Mirena IUD to a group of 65 women who underwent endometrial ablation alone. The results were dramatic.  In the 65 women who were treated with endometrial ablation alone and followed for 4 years, a total of 24% required hysterectomy by the end of 4 years. In the group of 23 women treated with both the Mirena IUD and endometrial ablation there were no hysterectomies by the end of 4 years.

These results are dramatic and are in agreement with the 4 other studies on this very subject.

Why does the combination of Endomyometrial Resection (EMR) or Endometrial Ablation with an IUD work to reduce late-onset failures?

There appear to be at least 2 ways in which the insertion of a hormone-containing IUD appears to reduce the possibility of a late onset failure.

  1. The IUD allows scarring to occur around it.  This allows an open channel between the uterine cavity and the cervix and prevents the accumulation of blood within the uterus that can cause pain.
  2. The IUD also contains the hormone, levonorgestrel.  This hormone is a progestin, which inhibits the growth of endometrial cells.  Following an endometrial ablation or an endomyometrial resection there is a kind of competition that goes on between cells that eventually forms scar tissue and cells that form endometrium (uterine lining tissue).  During this competition our goal is to get the scar tissue to “win”. In other words, the best outcomes following endometrial ablation (or EMR) occur when there is little or no endometrium present after healing occurs.  If a significant amount of endometrium is present it may cause blood to accumulate and can lead to a painful hematometra (accumulation of blood within the uterine cavity).

What has been our experience so far?

In February of 2017 we began offering the placement of a commonly used hormone-containing Intrauterine Device (IUD).  As of March of 2018—a period of 25 months we have inserted 51 IUDs in women following endomyometrial resection (EMR) or ultrasound-guided reoperative hysteroscopic surgery (UGRHS), which is a procedure performed for women who have already experienced a failure either from an endometrial ablation or from an endomyometrial resection.  

As of this writing we have removed 3 of the devices.  One device was removed in a woman who felt that she was experiencing mood-changes that resulted from the IUD.  The other 2 devices were removed in women who experienced pelvic pain that they attributed to the device. All 3 devices were removed without difficulty.  In the 2 women who experienced pelvic pain it is noteworthy that their pain persisted even after the IUD was removed.  In the remaining 48 women who have undergone both a hysteroscopic procedure and the insertion of an IUD all appear to be doing well as of this writing.

At the present time it appears that our information is completely consistent with other published reports and that women treated with both surgery and an IUD appear to do far better than women who are treated with only one of these methods.

What hormones are contained in the IUD?

All of the IUDs we utilize contain the hormone levonorgestrel.  Levonorgestrel is a progestin and not an estrogen.   Estrogen has a stimulatory effect on uterine lining tissue and would not be appropriate following an EMR.  However, progestin has an opposite effect and inhibits the growth of endometrium, making it quite useful in women who have undergone an EMR.

What are the other benefits of the IUD?

The real benefits of the IUD can be summarized as follows:

  1. Contraception.  For women who require contraception the IUD provides at least 5 years of birth control.
  2. Scarcontrol.  The IUD cannot prevent scarring.  However, the device interferes with scarring and causes scar formation to occur around it leaving an opening between the upper uterus (fundus) and the cervix.  This allows any blood to have a means to escape.
  3. Inhibits endometrium (uterine lining) from growing.

What are the risks of the IUD?

There are several risks to having an IUD inserted.

  1. The person performing the insertion can accidentally cause a uterine perforation.  This is a very rare occurrence since our IUD insertions are performed by an experienced surgeon and under ultrasound guidance.
  2. The IUD can, in some women, cause depression or anxiety.  Typically this occurs only in women who have an underlying issue with depression or anxiety.  If it occurs it is likely to occur early in the immediate post-insertion period.
  3. There may be difficulty in removing the IUD in the future.  This may require a minor surgical procedure. Alternatively, based on present and future information, the decision may be to allow the IUD to remain in place once “it has run out of hormone.”   This information will be updated as we gain experience with the IUD.

Can the IUD get “dislodged” on its own?

The quick answer is no!   IUDs can fall out and this has been reported.  They have been known to pass painlessly through the cervix and into the vagina.  However, they do not spontaneously move through the uterine wall.

Lastly…

The insertion of an IUD is not a requirement!  It is only being suggested to you as a way to reduce the possibility of further surgery.

Food and Drug Administration Approval

The use of a hormone containing intrauterine device (IUD) following either an endometrial ablation or an Endomyometrial resection is not an  approved use by the United States Food and Drug Administration.

REFERENCES

  1. http://www.cmdrc.com/wp-content/uploads/2018/10/Endometrial-Ablation-Past-Present-and-Future-part-II-center-for-menstral-disorders-rochester-ny.pdf
  2. Römer TH. A prospective study on combined hysteroscopic-local hormonal therapy of recurrent refractory hypermenorrhea. Gerburtsh Frauenheilk 1997;57:614–6.
  3. Bratschi HU. Hysteroscopic Endometrial Resection. In: Hysteroscopy: State of the Art. Köchli OR (ed). Contrib Gynecol Obstet. Basel, Karger, 2000 vol 20, pp 121–136.
  4. Maia H, Maltez A, Coelho G, et al. Insertion of Mirena after Endometrial Resection in Patients with Adenomyosis. J American Assoc Gynecol Laparosc 2003;10:512–16.
  5. Vaughan D, Byrne P. An evaluation of the simultaneous use of the levonorgestrel-releasing intrauterine device (LNG-IUS, Mirena®) combined with endometrial ablation in the management of amenorrhea. J Obstet Gynaecol 2012;32:372–4.
  6. Papadakis EP, El-Nashar SA, Laughlin-Tommaso SK, et al. Combined endometrial ablation and levonorgestrel intrauterine system in women with dysmenorrhea and heavy menstrual bleeding: novel approach for challenging cases. J Minim Invasive Gynecol 2015;22: