Sterilization with the Essure Device was FDA approved in 2002. Since that time there have been an increasing number of women who have had this medical device used for tubal blockage. Unfortunately, there has also been an increasing number of women reporting problems after placement of the Essure Device.
The Essure Device is composed of three components:
- An inner plastic fiber
- A flexible stainless steel inner coil
- An outer nickel titanium alloy coil
When placed into the fallopian tube, the Essure Device elicits tissue growth in and around the device to block the fallopian tubes. The Essure Device becomes embedded or scarred into the tissue of the Fallopian tube, thereby causing or creating blockage.
SIDE EFFECTS OF ESSURE DEVICE
From 11/4/2002 through 10/25/13, there have been 943 reports of side effects or adverse events reported to the FDA from women who have had an Essure Device placed for sterilization.
These side effects include
- Pelvic pain (606)
- Hemorrhage (140)
- Headache (130)
- Migration of the device (116)
- Patient-device incompatibility* (113)
- Menstrual irregularities (95)
- Fatigue (88)
- Weight fluctuations (77)
- Device operating differently than expected (73)
- Malposition of the device (46)
- Device breakage (37)
*This may be due to a nickel allergy.
Women who experience adverse symptoms following placement of the Essure Device should initially seek a thorough evaluation from their healthcare provider.
RESOURCES FOR WOMEN WITH ESSURE
In fact, there have been so many women complaining of side effects following the placement of the Essure Device that the consumer advocate, Erin Brockovich, has started a website for women who have had the Essure procedure so they could share their stories and concerns about the Essure Device. The site can be found at EssureProcedure.net
“If you follow your heart, if you listen to your gut and if you extend your hand to help another, not for any agenda, but for the sake of humanity, you are going to find the truth.” ~Erin Brockovich
There is also a Facebook page for women experiencing side effects from the Essure Device. These women have reported nausea, vomiting, heavy metal toxicity, itching, rashes, hair loss, anxiety and depression to name a few.
If I have the Essure Device removed will my symptoms go away?
Some women having Essure Device related problems report improvement. There is no guarantee that symptoms will improve or completely dissipate.
If I have the Essure Device removed will I get pregnant?
Removal of the Essure Device will not restore fertility since your fallopian tubes will not be attached to your uterus.
My physician recommends that I have a hysterectomy to remove the Essure Device and improve my symptoms.
A hysterectomy may be the appropriate surgical approach, especially if there is other pathology such as fibroid tumors, polyps or ovarian cysts.
I have no adverse symptoms from my Essure procedure but I am planning to undergo IVF (in vitro fertilization) in the next few months. Should the Essure Device be removed?
This is controversial; however, if no large portion of the device is in the uterine cavity (as determined by a saline infusion sonogram) then most fertility experts would perform IVF.