Is Essure Reversal Possible?
Essure Side Effects and Essure Complications
According to information provided by Conceptus, the most frequent adverse events and side effects reported upon insertion of Essure micro-inserts were cramping (29.6%), pain (12.9%), nausea/vomiting (10.9%), dizziness/hotheadedness (8.8%), and bleeding/spotting (6.8%). During the first year of reliance on the Essure micro-inserts for contraception (approximately 15 months after micro-insert placement), the following episodes were reported as at least possibly related to the Essure Micro-inserts: back pain (9.0%), abdominal pain (3.8%), dyspareunia [painful intercourse] (3.6%). [Source - http://www.essure.com/Portals/0/Skins/Conceptus_Skin/PDFs/CC-0366-01%2013Nov08F.pdf]
Internet Reports of Essure Problems
There are numerous web sites and blog sites where women have reported long-term complications they have had with the Essure inserts – most commonly excessive bleeding and pain. One blog site entitled "Essure Problems Continue Among Women" has over 400 women's comments about side effects and complications. In some cases, their doctors have recommended and performed hysterectomies, presumably because they thought the devices were not able to be removed.
Essure Reversal and Pregnancy
Despite the manufacturer’s statement that Essure is not reversible, the tubal reversal doctors at Chapel Hill Tubal Reversal Center have removed Essure devices and reversed Essure sterilizations with the technique of tubouterine implantation as outpatient surgery. Successful pregnancies have followed Essure reversals among women who regretted the sterilization operation and had the coils removed. Numerous medical studies have shown that approximately 10% of women who undergo surgical sterilization subsequently regret the procedure and want to become pregnant again. In some cases, women underwent Essure removal, but not tubouterine implantation, since they did not want to become pregnant but only wanted the Essure removed. The most frequent reasons for seeking removal of the Essure Micro-inserts were persistent pain, excessive and prolonged bleeding, and possible allergic reactions to nickel which is contained in the coils.
Post Marketing Surveillance of Essure Problems
The FDA maintains a reporting system for complications related to medical devices called MAUDE (Manufacturer and User Facility Device Experience). This is a voluntary reporting system for doctors. If a doctor reports a complication of a medical device to the manufacturer, it is required for the manufacturer to submit the adverse event report to the FDA. A search on Google for “FDA adverse events Essure” produced only a single adverse event report for Essure in MAUDE as shown here:
CONCEPTUS, INC. ESSURE KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
Model Number ESS 205
Event Date 12/07/2007
Date FDA Received 01/08/2008
Event Type Other Patient Outcome Hospitalization; Required Intervention
Add'l info will be added if physician sends a pathology report info and any info from add'l post operative visits.
This physician reported on 12/6/07, that he was going to remove the essure micro-inserts the next day due to persistent pain, this pt experienced after having them placed in 2007. The physician evaluated the pain with pelvic examinations which were normal, and a ct scan which showed the micro-inserts to be properly located within the respective fallopian tubes. A white blood cell count was normal. The day after surgery, he reported both micro-inserts were removed laparascopically without difficulty; they appeared normal in the right location without any inflammation. There was no pathology he could find to explain the pelvic pain. He performed a d&c, hysterectoscopy and laparoscopy. He reported to conceptus on 1/7/08 via fax, that during her post operative visit 2 weeks later, her symptoms were much improved and pain seemed to be resolved, but he would continue to monitor her. This physician feels the pain was essure related as he could not find any other pathology to explain her symptoms.
With the hundreds of adverse events and complications women have reported on various internet sites, the single adverse event reported to the MAUDE database represents the tip of the iceberg. The actual long-term complication rate associated with Essure sterilization is unknown.
Women who want to become pregnant after Essure sterilization should be informed that Essure reversal is possible. And women who experience persistent pain or bleeding following insertion of Essure coils should be informed that Essure removal is possible. It is very unfortunate for a young woman to have a hysterectomy to treat problems associated with Essure when a simpler, safer, and more conservative approach is feasible. For more information about Essure removal and Essure reversal, call (919) 968-4656 for a free consultation with a tubal reversal nurse at Chapel Hill Tubal Reversal Center.