Permanent contraceptive device removal: A precision alternative to hysterectomy

Robotic surgery with CO2 laser articulating fibers permits removal of Essure without invasive surgery.

A permanent contraceptive device called Essure (Bayer), designed as a less invasive alternative to tubal ligation, has been sold more than 750,000 times to date.1 For a small percentage of patients who experience complications, the device is removed. Hysterectomy has been the common approach for removal, but for two years, I have been removing Essure devices using a laparoscopic CO2 laser robotic approach. Gynecologists and surgeons need to be aware that there is a safe, conservative application for 100% complete removal of Essure without the trauma and morbidity of a hysterectomy.

Complex Removal
Essure is an FDA-cleared device for permanent contraception. In an in-office insertion procedure, it is embedded in the fallopian tube where it joins the uterus. Scar tissue then forms all around the coil.

In some cases, complications can originate with the coil’s composition, which is 55% nickel,2 to which about 1 in 5 American women is allergic or hypersensitive.1 As their bodies absorb nickel from the device, they can develop symptoms similar to chronic fatigue syndrome.3 These complications are often confused with natural age-related changes.

When doctors identify Essure as the cause, they explain to patients that the device must be removed to reverse the symptoms. Complete hysterectomy is usually chosen because removing just the fallopian tubes would leave about one third of the device in the uterus, and pulling on the coil would fracture it, leaving fragments behind. Hysterectomy is major surgery. It may lead to menopause and hormonal supplement dependency, which is why is has been important to pursue a less traumatic approach.

Removal with Robotic CO2 Laser Fiber
In 2015, surgeons who were preparing to perform a hysterectomy to remove Essure approached me seeking a less invasive method. They thought that my experience performing CO2 laser robotic myomectomy to remove fibroids could be applied to Essure removal as the same level of delicacy and precision is required in both cases

Using the da Vinci Robotic System (Intuitive Surgical) and AcuPulse DUO CO2 laser (Lumenis), I have performed many myomectomies. The system allows me to access the pelvic surgical plane with seven points of articulation and remove both large and small fibroids at all locations around the uterus. Highly magnified 3D high-definition visualization is particularly helpful for ensuring that small objects or residual tissue are removed completely.

I agreed with my colleagues that this platform was a good fit for Essure removal, and, after some research and planning, I performed the procedure for the first time. The robotic platform let me see the coil very easily and know with certainty that it was completely removed. Using the CO2 laser, I was able to precisely separate the adhesions formation, cut just distal to the zone of scar tissue around the coil at the fallopian junction, and safely remove the coil, leaving no fragment behind and, equally important, creating no thermal spread to surrounding anatomy. I sewed up the targeted zone on the fallopian tubes with a robotic suturing technique.

This outpatient procedure took about 1.5 hours. The patient recovered quickly, and her Essure-related symptoms ceased in about 1 to 2 weeks. I presented the case to an FDA advisory panel the same year; since then, I have used the CO2 Fiber Laser to remove Essure for 60-70 patients per year, improving their quality of life and sparing them the need to go through unnecessary hysterectomy.

Added Advantages of the CO2 Laser
The success of this approach relies on several advantages of the CO2 laser. The highly accurate platform has a low thermal impact on non-target tissue and limited depth of penetration – perfect for layer-by-layer removal of undesired pathology with great precision and no disturbance to adjacent tissue. The flexible format of the AcuPulse DUO CO2 laser fiber is also key. The FiberLase CO2 laser fiber is used along with the FiberLase Drop-In Guide, which is the robotic platform enabler. A red aiming beam aligned with the laser beam helps me target tissue more precisely. We can create angles during surgery that the human wrist cannot achieve, so we always have the precise perpendicular orientation to the tissue that we need for myomectomy, Essure removal and other procedures related to women’s health.

With the CO2 laser, blood loss for this procedure is very low (less than 20 ml with injection of vasopressin to constrict blood vessels). The tissue control is better than traditional electrocautery and leaves no necrotic tissue. The durability of FiberLase has allowed me to smoothly complete surgery with just one fiber.

Encouraging Outcomes
As a surgeon, I find this procedure extremely gratifying. Many of my patients open their eyes in recovery and find that symptoms like foggy thinking, headache and blurred vision are gone. In performing surgery for 25 years, I have never seen such a dramatic resolution of symptoms so rapidly after surgery. Patients go home the same day and return to normal activities in about a week. Every one of my patients has seen resolution of their Essure-related symptoms.

Because these patients typically have no other pathology, they are resuming healthy, active lives. It is very meaningful to me to help them do this with precise removal of the Essure device so they can avoid highly invasive hysterectomy.

1. Block J. The Battle Over Essure. The Washington Post, 26 July 2017.

2. Zurawin RK, Zurawin JL. Adverse events due to suspected nickel hypersensitivity in patients with essure micro-inserts. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):475-82.

3. Sills, SE (editor). Essureal Journey: Concepts, Concerns and Considerations for Hysteroscopic Sterilization. Nova Science Publishers, July 2017.

N. Edward Dourron, MD, is a fertility specialist at Southern Fertility and Surgery Services in Atlanta, Georgia, and Life IVF Center in Irvine, California. Dr. Dourron is a consultant for Lumenis.

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