TIME OF PLACEMENT TO TIME OF REMOVAL

Bayer recommends that the ESSURE be removed if 18 or more turns of the insert (outer coil) are visible in the uterus when first inserting the ESSURE.

If the coil is too far in the uterus rather than in the tubes, immediate removal at time of initial insertion should be considered.

Studies suggest that ESSURE can safely be removed from a vaginal approach (hysteroscopic view) if the coils have been in place less than 7 weeks and before significant scarring has occurred which would compromise integrity of the coils and increase the risk of fragmentation.

IMPLANT GRADE POSITION

The recommended surgical approach for ESSURE removal is dependent on the physical position of the coils in relation to the uterus and fallopian tubes.

If the coils are too far into the tubes, than a vaginal or hysteroscopic approach is not feasible. If the coils are too far into the uterus, then a laparoscopic or abdominal approach is associated with higher risks of coil fragmentation.

Implant position is generally defined by a 4 level grading system:

• Grade 1:ABNORMAL18 or greater turns of the outer coil are visible in the uterus or more than 50% of the inner coil is visible in the uterus.
• Grade 2:SATISFACTORY PLACEMENTThe far end or distal end of the inner coil is inside the fallopian tube with less than 50% of the inner coil trailing into the uterine cavity. The entire coil may also be only in the fallopian tubes with the near or proximal end of the inner coil up but less than 30mm from the cornua of the uterus.
• Grade 3:ABNORMALThis is when the ESSURE is in the tube more than 30mm from the cornua of the uterus or when the ESSURE has perforated the tube.
• Grade 4:ABNORMALThe ESSURE is not in uterus or tube and is found in the peritoneal cavity.

DESIRE TO RETAIN THE TUBES OR UTERUS

Bayer IFU recommends the following methods to remove the ESSURE:

1. Salpingotomy (opening the tube) and removing ESSURE
2. Salpingectomy (removal of the tube) and removal of ESSURE
3. Cornual resection (removal of the area between the uterus and tube) with tubal removal (salpingectomy) and removal of ESSURE
4. Hysterectomy, with salpingotomy or salpingectomy

Each option for removal is based on the ESSURE Grade, Surgeon's Preference, and Patient Request

Salpingotomy Alone

Salpingotomy is the surgical opening of the tube; either parallel or linear to the tube; or circumferential, around the tube.

Although salpingotomy is the least invasive option offered for removal, it is generally associated with the most complications associated with coil fragmentation or coil retention.

The techniques used for salpingotomy is relatively contraindicated since they require the forceful manipulation of the coil which increases the risk of fragmentation. Many OBGYN using this technique describe it as a "gentle traction" on the coil. Simply put, there is no such thing as gentle traction.

Salpingotomy also fails to completely remove scar tissue with microscopic remnants of the coil left behind which can continue to induce a foreign body reaction. Salpingotomy is contraindicated in Grade 1 coil presentation and most commonly attempted in Grade 2 and Grade 3 presentation.

Salpingectomy Alone

Salpingectomy is the surgical removal of the fallopian tubes. The techniques used are often the same as with salpingotomy, except that the tubes are removed rather then simply opened.

Like salpingotomy, the techniques used to manipulate the coils are relatively contraindicated due to the risk of coil fragmentation and retention of scar tissue with microscopic remnants of the coils left inside of the uterus.

Salpingectomy is ideal if the coils are in a Grade 3 presentation, most commonly used in Grade 2 presentation and contraindicated in Grade 1 presentation.

Cornual Resection with Salpingectomy

Cornual resection with salpingectomy is the surgical removal of the cornual region of the uterus and removal of the fallopian tubes. It is an appropriate option for ESSURE removal which decreases the risk of implant fragmentation and removes residual scar tissue but is associated with increased risk of bleeding.

Cornual resection is relatively contraindicated in Grade 1 coil presentation due to the difficulty in coring out the ESSURE without stretching and potential fragmentation of the ESSURE or the need to make a larger resection of the uterus leading to excessive bleeding. Cornual resection is most commonly used for Grade 2 presentation and unnecessary in Grade 3 presentation.

Hysterectomy with Salpingectomy

Hysterectomy with Salpingectomy is the surgical removal of the uterus and fallopian tubes. Although hysterectomy with salpingectomy is the most invasive option for ESSURE removal, it is also the least likely to be associated with implant fragmentation or retained microscopic remnants of the ESSURE and decreases the risk of menstrual related abnormal uterine bleeding.

In all cases, it is mandatory that the number and location of the ESSURE coils be determined BEFORE the manner of surgical removal is attempted. The Bayer Information for Use (IFU) clearly states that position of the ESSURE coils be confirmed, and if necessary, intraoperative fluoroscopy be done to avoid the inadvertent fragmentation or retention of the ESSURE coils.

Due to the fact that a significant number of surgeons are known to have put more than 1 ESSURE coil per fallopian tube and the fact that ESSURE has a risk of migration of 4%, preoperative determination of number of coils and coil position be confirmed prior to surgery.

I generally insist on preoperative scans to include ultrasound and abdominopelvic xray be done at most 30 days before surgery. Further, except in cases of hysterectomy bilateral salpingectomy with ESSURE removal as an entire unseparated pathological specimen, intraoperative xray or fluoroscopy is mandatory to avoid retained fragments or remnants of the ESSURE coils.

Grading presentation cannot be determined without preoperative scans and attempts to remove the ESSURE by a technique that is contradicted or difficult and surprise to the surgeon is medical neglect. Further, if the position of the coils is unknown at time of surgery and a complication arise from this neglect on tbe part of the surgeon, this can arise to a case of medical malpractice.

After surgery, if there is any potential risk of ESSURE damage, postoperative scans are again mandatory.

Finally, it is the responsibility of the surgeon to confirm, in writing, that the Pathologist has examined the specimen and that two ESSURE coils are present. A patient should insist on having a copy of their Operative report and a copy of their Pathology confirming the presence of 2 intact ESSURE coils.