Dr. Dan C. Martin's
Clinical Practice is at:
UT Medical Group, Inc.
7945 Wolf River Blvd
Suite 320
Germantown,
TN 38138
Phone (901) 347-8331
Fax (901) 347-8188
The "Random Photos" section is a holding file of material that may be used in other section on this site or at DanMartinMD.com. Although plan is to keep the material here as an archive, it may be moved or at a different site the next time you visit. Bookmarks may not link to the same page.
Essure Device in Endometrial Cavity and Tubes in a Woman with Abnormal Bleeding
Figure
1. The Essure devices are seen in the tubal openings of both tubes in a
woman with abnormal bleeding.
Figure
2. An Essure device is seen in the tubal opening of the right tube.
Figure
3. An Essure device is seen in the tubal opening of the left
tube.
Figure
4. This is a close up picture of the Essure device on the right.
At a subsequent surgery, laparoscopy was used to monitor hysteroscopic removal of the Essure devices. The inner coil was pulled free first. The outer coil was removed using slow tension and observing the coil with both hysteroscopy and laparoscopy. There was no excess bleeding. Dye was injected and there was no spill consistent with a fibrotic cornual occlusion. She was discharged in good condition.
On 2005, Conceptus warned that removal may be attempted, during the actual placement procedure, if 18 or more coils of the Essure micro-insert are trailing into the uterine cavity. "Attempted removal of a micro-insert having less than 18 coils trailing into the uterine cavity may result in fallopian tube perforation or other patient injury." This was previously at http://www.essure.com/hcp/hcp_faq.aspx#faq6 10 for Jul 10, 2005 and can now be found at http://www.fda.gov/ohrms/dockets/ac/02/briefing/3881b1_03.pdf.
Conceptus' November 13, 2008 update concluded:
 | A very small percentage of women in the Essure clinical trials reported recurrent or persistent pelvic pain, and only 1 woman requested device removal due to pain. If a device removal is required for any reason, it will likely require surgery, including an abdominal incision and general anesthesia, and possible hysterectomy |
|
The Essure procedure should be considered irreversible. There are case reports, but no significant data on the safety or effectiveness of surgery to reverse the Essure procedure. Any attempt at surgical tubal reversal will likely require utero-tubal reimplantation. Pregnancy following reimplantation carries with it the risk of uterine rupture and serious complications for the mother and baby including death. |
|
http://www.essure.com/Portals/0/Skins/Conceptus_Skin/PDFs/CC-0366-01%2013Nov08F.pdf |
BM Lannon (Fertility and Sterility 2007) reported 2 patients who requested removal and repeat sterilization. There was no attempt to check tubal function. His cases were at 6 and 5 weeks from the original procedure. It is uncertain how long after placement the devices can be removed. He discussed risks including:
| leaving a residual fragment of the device within the tube, |
|
inducing tubal trauma that may not be seen on hysteroscopy, and |
|
bleeding |
A financial concern about removing the devices is that removal is not recommended by the company. Removal may be considered as experimental by insurance companies. If this is done without preapproval by an insurance company, then complications may not be covered. This could result in $15,000 to $30,000 or more of uncovered fees. Uncovered services could include admission to the hospital, blood transfusion, hysterectomy, and treatment of other complications or associated problems.