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Tips and advice for Essure removal


 

Essure tubal microinserts were not designed to be removed. However, a small minority of women are requesting removal because of regret, complications, or the development of pelvic pain and other symptoms that may or may not be caused by the device.

Minimally invasive gynecologic surgeons have developed a variety of removal procedures and techniques for these women. There is general agreement that hysteroscopic removal is feasible only in the first 3 months following insertion of the device. After that, laparoscopic removal has become the norm. Small published reports and case series have documented the use of laparoscopic bilateral salpingectomy (BS) with and without hysterectomy, laparoscopic BS with cornuectomy, and laparoscopic salpingostomy, often followed by salpingectomy. There is not yet enough data to demonstrate that one method is superior to another, and we each have our own preferred approaches for preoperative imaging and removal.

Dr. Sarah Cohen of Brigham and Women's Hospital

Dr. Sarah Cohen

Several principles clearly guide each of us, however. One is that the outer portion of the Essure microinsert is brittle and at risk of breaking if subjected to too much tension or to electrocautery. The other is the importance both of patient counseling regarding expectations from removal and of a thorough gynecologic history and assessment for alternate etiologies of symptoms that may be overlooked.

Here is some of our advice on working with patients to assess the need for, and possible outcomes of, removal, as well as how to approach the surgery.

Counseling, assessment, and consent

Dr. Cohen: We have to be frank with our patients that symptoms may or may not improve following Essure removal. In a recently published case series of 52 women who underwent Essure removal at our institution, three-quarters of the patients reported near or total improvement in the quality of life. However, a relatively high number – roughly 30% – reported some ongoing symptoms (J Minim Invasive Gynecol. 2017 Jun 6. doi: 10:1016/j.jmig.2017.05.015).

The most common indication for Essure removal in this series was pelvic pain (96%), followed by abnormal uterine bleeding (35%) and patient-reported allergic reaction (21%). The indications were not mutually exclusive.

An Essure device is disected out of the fallopian tube. Courtesy Dr. Sarah Cohen

An Essure device is disected out of the fallopian tube.

When evaluating possible reasons for symptoms following Essure placement, I ask numerous questions: Could the patient have an infection related to the placement? That’s fairly rare, but it’s certainly possible. Are there signs of malposition or migration of the device? Could it have perforated through the uterus, for instance, or become entangled with bowel adhesions? If the symptoms are more systemic – such as headache, fatigue, nausea, and weight gain – could the patient be reacting to the polyethylene terephthalate (PET) fibers in the device?

Importantly, could endometriosis or another underlying condition have developed since placement or worsened over time? Or, could her pelvic pain be worsened because of the cessation of hormonal contraception that coincided with Essure placement, rather than the device itself? For some women, Essure removal alone will not cure their symptoms.

In our cohort of 52 women, interestingly, 44% of those with pelvic pain had one or more concomitant or alternate causes of pain, including endometriosis, adenomyosis, and adhesions.

Dr. Levie: We can’t assume that Essure coils are at fault when patients present with pain and other symptoms, nor can we minimize complaints and concerns. We have to explore them.

It’s important that we inform women that pain may not be related to Essure microinserts. However, if, after thorough evaluation, the patient believes that the coils are the etiology of her pain and I cannot find another reason – or if she has regrets or is concerned about potential problems in the future – I am happy to remove them.

Dr. Mark Levie of Montefiore Medical Center

Dr. Mark Levie

The majority of women will have resolution of pain after removal, but a certain percentage – up to 25%-30% – might not. I counsel patients accordingly, and I mention that the incidence of pelvic pain and abnormal bleeding rises with age. I also inform patients that, during removal, there is a small chance that a small fragment of the device might be left behind.

Dr. Yunker: In our case series of 29 women who underwent removal for the primary indication of pelvic pain, 88.5% reported significant relief at their postoperative visit (Contraception. 2016 Aug;94[2]:190-2). This, and other unpublished data, show that patients with gynecologic complaints specifically are the most likely to have resolution of symptoms, compared with those with more systemic or nongynecologic complaints.

Dr. Amanda Yunker of Vanderbilt University

Dr. Amanda Yunker

The timing of the onset of pain after Essure placement can vary widely, and it is possible that even correctly placed Essure coils can be a source of pain. In our group of 29 women, intraoperative findings included the presence of incorrectly placed devices and endometriosis in some. The majority, however, had no abnormal findings.

Some patients have systemic symptoms that they feel are related and new since the device was placed. My counseling in these cases is that, while I do not have any physiologic evidence that the Essure coil is causing their symptoms, I’m hopeful that symptoms will improve with removal. If they do not, these patients must follow up with their primary care doctor for further work-up.

Device structure and use of imaging

Essure is a 4-cm long device (0.8 mm in diameter) with two parts: an inner coil made of stainless steel and PET fibers, the latter of which induces the fibrosis responsible for tubal occlusion, and an outer coil made of nitinol, a nickel titanium alloy.

Dr. Cohen: While the exact mechanism is unclear, it’s possible that the PET fibers may be drivers of the systemic inflammatory-type symptoms that some women report. Nickel allergies are also possible albeit uncommon. They appear to manifest as rash, urticaria, and other symptoms characteristic of contact allergic reactions.

The brittle nature of the outer coil makes a grasp-and-pull approach disadvantageous, unless you’re removing coils early on hysteroscopically. In general, one must avoid fracturing the outer coil, or parts of the device will be left behind. Pulling too hard may also cause the outer coil to unravel and expand to be quite long, which further increases the risk of fracture.

Hysterosalpingogram (HSG) and ultrasound are typically first-line options for looking at coil position. A diagnostic hysteroscopy may also help identify coils, and intraoperative fluoroscopy may be useful for either the hysteroscopic or laparoscopic approach, if there’s any question about portions of the device not being recovered.

Dr. Levie: Ultrasound is often sufficient for operative planning, but, if it does not detect devices in the cornual region, then further imaging may be warranted.

It’s important to be aware that some devices that appear to have correct placement on ultrasound or HSG may actually be partially tracking subserosally. In these cases, the distal portion of the device may have tracked through the mucosal layer and along the muscularis but below the serosa in the fallopian tube, causing pain. Imaging won’t be helpful in making this diagnosis. It will be identified laparoscopically.

Dr. Yunker: When patients have completed the 3-month HSG (to confirm occlusion of the Fallopian tubes post placement), I will review the images myself rather than relying on the report. Without an HSG – and, in many cases, even when I have it in hand – I will order a plain film x-ray of the abdomen and pelvis to look for coils. In almost all cases, I also order an ultrasound, which is helpful in assessing for ovarian and uterine conditions.

I’ve found plain film imaging to be valuable for identifying additional or misplaced Essure inserts. I have found up to four in one tube. In interpreting x-rays, one must appreciate that the outer coil is not radio-opaque (other than the tiny marker at the end) and will not show up. Occasionally we’ll add hysteroscopy to see how much of a coil is trailing into the uterus, but the ultrasound and x-ray are usually enough.

Some patients ask about postremoval imaging. I do not routinely do this, but I’m not opposed to it.

Surgical techniques

Dr. Cohen: I advise dissecting around each coil without cutting the outer portion and removing the coil intact, resecting all the way down to the interstitial portion of the tube, then proceeding with bilateral salpingectomy to ensure contraception.

If the patient’s symptoms are systemic and possibly reflective of PET fiber reactions, a wedge resection of the cornua may provide more peace of mind that PET fibers will not be left in situ. This procedure can be approached similarly to myomectomy, with the use of hemostatic agents such as misoprostol or vasopressin and suture closure in multiple layers.

If there are multiple coils present in the cavity, one option, to avoid having to pull them all out from the abdominal side, is to transect and remove the intracavity portion of the device hysteroscopically then dissect and remove the tubal/interstitial potion laparoscopically. As a general rule, I send all the removed tissue to pathology.

Dr. Levie: In general, I do a linear salpingostomy after using a uterine manipulator and a grasper to first identify the site of the distal portion of the device. One can usually feel where the tubes bend onto the device.

A bit proximal to where I visually and mentally mark the distal end of the device, I make a 2-3 cm incision over the device. With a fine-tip grasper, I can usually release the distal portion of the inner coil. Using two graspers over the inner and outer coils together and a hand-over-hand motion, I pull without excess traction in the access of the tubes, and the proximal portion will usually follow and deliver fairly simply. If the proximal portion breaks, I advise looking for it hysteroscopically and delivering it through the uterus.

Some surgeons have recommended hysteroscopy at the beginning of the procedure with cutting (using scissors) at the proximal end of the outer coil to avoid its getting caught in the cornua.

Most patients continue to want permanent sterilization, so we proceed with salpingectomy. Sometimes, given underlying pathologies, we’ll decide on laparoscopic or vaginal hysterectomy as well or bilateral salpingectomy without doing the salpingostomy. When hysterectomy is part of the surgery, we don’t need to worry at all about broken devices.

When the device is removed separately from the fallopian tube, one should inspect it afterward to ensure that all four markers of the device – the markers that are recommended by the manufacturer for radiologic confirmation of proper placement – have been delivered.

Dr. Yunker: When everything looks normal on the ultrasound – and when the coils on either HSG and/or plain film x-ray appear to be in the appropriate position in the tubes – then removal of the coils and tubes only is an option.

The closer the coil is to the fimbriae, the easier it is to come straight across the tube as you would in a regular salpingectomy without concern of breaking or cutting the coil. However, the closer the coil is the uterine side, the deeper you’ll need to dissect into the cornual region of the uterus. A cornual wedge resection may be necessary in order to remove the coil intact.

Our procedure has evolved over the years and we have moved away from salpingectomy as a means to dissect out the coils. With the theoretical risk of retained coil fragments and PET fibers, we prefer to remove the coils and tubes en bloc.

Dr. Cohen is director of research and the fellowship program director of minimally invasive gynecologic surgery at Brigham and Women’s Hospital, Boston. She reported that she has no financial disclosures. Dr. Levie is professor and associate chairman of the department of obstetrics and gynecology and women’s health and director of the minimally invasive surgery fellowship at Montefiore Medical Center, New York. Dr. Levie reported that he is an investigator in two studies involving Essure and sat on the Essure medical advisory board for Bayer but did not receive personal renumeration. Dr. Yunker is an assistant professor of obstetrics and gynecology at Vanderbilt University, Nashville. She reported that she is a consultant for Olympus.

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Endometriomas: Classification and surgical management

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