4/7/06njm

**Q. What does the Essure sterilization procedure entail?**

A. A coil is placed in the fallopian tube / is 99.8 % effective. It
needs a post-op HSG. See details

The Essure permanent birth control procedure is a minimally invasive
hysteroscopic technique for permanent tubal occlusion. A tiny coil
mechanism is inserted into the fallopian tube hysteroscopically under
local anesthesia. The device appears to induce fibrosis, which occludes
the tubes over a three month period. In clinical studies including
several hundred women, effectiveness at 2 years was 99.8 percent; data
beyond 2 years is not available. Patients must use alternative
contraception until a hysterosalpingogram (HSG) performed three months
postoperatively confirms tubal occlusion.

**More issues:**

One provider questioned:

-if the procedure as expensive

-requires 2 post operative hysteroscopies?

-does it have a current role in severe obesity?

-limited to certain at risk populations?

-what if the patient will lose her coverage before the 3 month post-op
period is up?

**Quick answer(s)**

The pricing of Essure is variable, but is only an outpatient procedure
and requires no general anesthesia. It does require an outpatient HSG at
3 months post op.

The patient needs a post-op hysterosalpingogram which is a radiographic
procedure, not a hysteroscopy, which is an outpatient surgical
procedure. Hence the patient receives one hysteroscopy to place the
coils and one HSG to check to confirm effectiveness 3 months later, not
2 operative hysteroscopies.

Yes, theoretically if the first post-op HSG is not conclusive, then a
patient could need a second HSG. At 99.8 % effectiveness, the number of
repeat HSGs is not large.

Many laparoscopic instruments are not designed for the severely obese,
so many providers would prefer to try this procedure hysteroscopically,
depending on their skill level with each modality.

The Essure is not indicated in a patient who will not return for her 3
month f/u HSG, or is unwilling to take a back up birth control method in
the post op interval.

**Here is a quote from one center that uses the Essure**

".... We\'ve pretty fully integrated Essure and, since Medicaid pays for
it here (and the reimbursement is better than for a tubal), we are
offering to everyone.  We also haven\'t had a problem with private
insurance covering it.  Obesity is a particularly great reason to do an
Essure.

Although Essure can be a little more challenging in the morbidly obese,
patients don\'t encounter the same risks\--either anesthetic or
surgical\--as with a laparoscopic tubal. 

We have a fairly generous Medicaid Family Planning waiver, so we
haven\'t had the problem of women losing their insurance.  I would
suggest you/he get in touch with the Essure representative.  It was our
representative who helped us frame the argument about why it would be a
good idea to offer.  We are planning to move the procedure to the clinic
(as soon as we have one\...) and then it will be even more cost
efficient than it is now. "

**Another center says...**

The Essure method of sterilization might be recommended over a
laparoscopic procedure for women with any of the following conditions: 
obesity, inability to use general anesthesia, multiple sclerosis,
coagulopathy, or personal preference to avoid major surgery.

**Contraindications for Use:**

According to the FDA-approved labeling, the Essure System is
contraindicated in any woman who:

-   Unsure about desire to end fertility, this procedure is
    irreversible.

-   Patients in whom only one micro-insert can be placed (including PTO
    and unicornuate uterus).

-   Patients who have previously undergone a tubal ligation.

Or any patient with any of the following conditions:

-   Pregnancy or suspected pregnancy.

-   Delivery or termination of a pregnancy (\< 6 weeks before
    placement).

-   Active or recent upper or lower pelvic infection or abnormal pap
    smear that has not been evaluated.

-   Known allergy to contrast media, or known hypersensitivity to nickel
    confirmed by skin test.

Although not a contraindication, placement of Essure micro-inserts into
women who are undergoing immunosuppressive therapy (e.g., systemic
corticosteroids or chemotherapy) is discouraged, because the
immunosuppressive therapy is expected to negatively affect the tissue
response to Essure that leads to tubal occlusion

**Summary**

The Essure system provides a reasonable method of minimally invasive
permanent sterilization.

This method does require a patient willing to receive an HSG in 3 months
and to take a 'back up' birth control method during the 3 month post
operative interval.

At this early date in the Essure usage, the main concern is that it is a
new procedure without long term data.

**Resources**

**FDA: Good website for indications**

[[http://origin.www.fda.gov/cdrh/mda/docs/p020014.html]{.underline}](http://origin.www.fda.gov/cdrh/mda/docs/p020014.html)

**Medical Protocol from Excellus Blue Cross Blue Shield**

[[https://www.excellusbcbs.com/download/files/med_policies/fem_steri_1105.pdf]{.underline}](https://www.excellusbcbs.com/download/files/med_policies/fem_steri_1105.pdf)

**Good website for Adverse effects: Public Domain**

[[http://www.igsapc.com/non_bir_control/ris_info.htm]{.underline}](http://www.igsapc.com/non_bir_control/ris_info.htm)

**Prescribing information from Conceptus**

[[http://www.essuremd.com/static/hcp/prescribing.pdf]{.underline}](http://www.essuremd.com/static/hcp/prescribing.pdf)

**Articles:**

Valle RF; Carignan CS; Wright TC Tissue response to the STOP microcoil
transcervical permanent contraceptive device: results from a
prehysterectomy study. Fertil Steril 2001 Nov;76(5):974-80.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11704120>

OBJECTIVE: The present study examines the safety, effectiveness, and
local tissue response for a new transcervical fallopian tube permanent
contraceptive device, the STOP device (Conceptus, Inc., San Carlos, CA).
DESIGN: Nonrandomized prospective evaluation of tubal occlusion and
histologic response. SETTING: Inpatient, university and
university-affiliated medical centers in the United States and Mexico.
PATIENT(S): Premenopausal and perimenopausal women with benign
indications for hysterectomy who were able to defer their hysterectomy
for 1 to 13 weeks. INTERVENTION(S): A transcervically placed microcoil
(STOP device) was inserted into the fallopian tubes of women who were
scheduled for hysterectomy, and the device was worn for 1 to 12 weeks.
At hysterectomy, hysterosalpingography was done to determine tubal
occlusion; subsequently, the tubes containing the STOP devices were
processed, sectioned, and evaluated to determine the histologic
response. MAIN OUTCOME MEASURE(S): Ability to place a device and
evaluate tubal occlusion and tissue response. RESULT(S): Devices were
placed in 33 women, representing 57 tubes; the women wore the devices
from 1 day to 30 weeks. Histology on 27 women (47 tubes) showed an acute
inflammatory and fibrotic response in the short term that, over time,
became a chronic inflammatory response with extensive fibrosis.
CONCLUSION(S): The localized tissue response and notable absence of any
normal tubal architecture in the segment of the fallopian tube
containing the STOP device supports the postulated mechanisms of action
of the device. Prehysterectomy study findings suggest the usefulness of
the STOP device for pregnancy prevention, this is being evaluated in
long-term safety and effectiveness studies.

The safety and effectiveness of a new hysteroscopic method for permanent
birth control: results of the first Essure pbc clinical study.

Kerin JF; Carignan CS; Cher D

Aust N Z J Obstet Gynaecol 2001 Nov;41(4):364-70.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11787907>

BACKGROUND: Current methods of female surgical sterilisation require
incisional surgery, general anaesthesia and a prolonged recovery time.
We studied the safety and effectiveness of Essure pbc, a minimally
invasive, transcervically placed micro-insert that occludes the
Fallopian tubes, resulting in permanent female contraception. Device
under study: The Essure pbc implant is a dynamically expanding
micro-insert which is placed in the proximal section of the Fallopian
tube using a modified minimal access technology for cannulating the
tube. STUDY POPULATION: Women aged 21-43 seeking permanent birth
control. METHODOLOGY: Essure pbc micro-inserts were inserted into the
proximal portion of the Fallopian tubes under hysteroscopic
visualisation with intravenous sedation or paracervical block. RESULTS:
Bilateral device placement was achieved in 111 of 130 (85%) women who
underwent device placement attempts. Women found the device placement
procedure to be highly acceptable. Of women wearing the device for up to
two years rate, 97% rated it to be very good to excellent. There have
been no pregnancies reported in 1894 woman-months of effectiveness.
Adverse events preventing women from relying on Essure pbc were \< 5%.
DISCUSSION: This first clinical trial showed the Essure pbc method of
permanent contraception to be safe and highly acceptable to women.
Experience and improvements to the delivery system should increase
overall micro-insert placement rates. CONCLUSION: The Essure pbc method
of permanent contraception is an exciting alternative to vasectomy or
laparoscopic sterilisation that does not require general anaesthesia or
incisions.