I've just spent a considerable amount of time, researching the accessdata, successful essure proceedures and failures.
One thing that I have noted, is that both people and physicians have sent in reports and the Companies replies on most of those seem to be, a non-understanding on the physicans side, of the whole proceedure, but there has also been a couple whereby it seems the trigger button is faulty.
I've listed two that I located.
Also from what I can note, "not Company reps", but some people have successfully had the procedure... I've listed who shouldn't be viewing this proceedure below.
There seems to me to be a failure of knowledge of the physicians as well as failure to disclose the risks, expected problems. Perhaps also therefore, a failure in training from the Company.
I'm going to cut and paste some information I located:-
Companies information of who not to have the proceedure:-
The Essure
One thing that I have noted, is that both people and physicians have sent in reports and the Companies replies on most of those seem to be, a non-understanding on the physicans side, of the whole proceedure, but there has also been a couple whereby it seems the trigger button is faulty.
I've listed two that I located.
Also from what I can note, "not Company reps", but some people have successfully had the procedure... I've listed who shouldn't be viewing this proceedure below.
There seems to me to be a failure of knowledge of the physicians as well as failure to disclose the risks, expected problems. Perhaps also therefore, a failure in training from the Company.
I'm going to cut and paste some information I located:-
Risk mgmt noted that physician had not been trained on the essure procedure by a conceptus rep. A second physician who had experience with the essure wasproctoring the physician. During the procedure, physician used at least three devices during placement. It was reported that the uterus or fallopian tubes was perforated two or more times during the procedure. During the required f/u hsg (not an x-ray as reported to medwatch), it was observed that more than one micro-insert was located outside of the pt's fallopian tubes. At least one of the incorrectly placed devices was removed. From the facts relayed to conceptus by the rptr, there is no info indicating that the devices were out of spec or failed to perform as intended.
| . |
| Event Description |
| Medwatch report stated that "after deployment of essure devices by pelvic x-ray, it appeared that only part of device was in left tube. " after receipt of this report from fda, conceptus representatives followed up with the rptr of this event. Conceptus was not contacted by the physician or hosp about this procedure. Risk mgmt noted that physician had not been trained on the essure procedure by a conceptus rep. A second physician who had experience with the essure wasproctoring the physician. During the procedure, physician used at least three devices during placement. It was reported that the uterus or fallopian tubes was perforated two or more times during the procedure. During the required f/u hsg (not an x-ray as reported to medwatch), it was observed that more than one micro-insert was located outside of the pt's fallopian tubes. At least one of the incorrectly placed devices was removed. From the facts relayed to conceptus by the rptr, there is no info indicating that the devices were out of spec or failed to perform as intended. |
| Manufacturer Narrative |
| Per the physician's instructions for use (ifu), federal law restricts the sale of essure by order of a physician. Essure should only be used by physicians who are knowledgeable hysteroscopists, have read and understood the info in the ifu and in the physician training manual, and have successfully completed the essure training program. Completion of the essure training program includes preceptoring in essure placement until competency is established. Per the ifu, perforations of the uterus or fallopian tubes were observed in the clinical trials at a rate of 3. 4% and 1. 1%. The rate of reported perforations in commercial use is significantly lower and is typically not diagnosed until the time of hsg. Most of these pts remain asymptomatic. If tubal or uterine perforation occurs or is suspected, the ifu directs the user to immediately discontinue essure device placement procedure, and work-up the pt for a perforation. Retrieval of perforating micro-inserts, if necessary, requires laparoscopy or other surgical methods. |
| Event Description |
| Medwatch report stated that "after deployment of essure devices by pelvic x-ray, it appeared that only part of device was in left tube. " after receipt of this report from fda, conceptus representatives followed up with the rptr of this event. Conceptus was not contacted by the physician or hosp about this procedure. Risk mgmt noted that physician had not been trained on the essure procedure by a conceptus rep. A second physician who had experience with the essure wasproctoring the physician. During the procedure, physician used at least three devices during placement. It was reported that the uterus or fallopian tubes was perforated two or more times during the procedure. During the required f/u hsg (not an x-ray as reported to medwatch), it was observed that more than one micro-insert was located outside of the pt's fallopian tubes. At least one of the incorrectly placed devices was removed. From the facts relayed to conceptus by the rptr, there is no info indicating that the devices were out of spec or failed to perform as intended. |
| Manufacturer Narrative |
| Per the physician's instructions for use (ifu), federal law restricts the sale of essure by order of a physician. Essure should only be used by physicians who are knowledgeable hysteroscopists, have read and understood the info in the ifu and in the physician training manual, and have successfully completed the essure training program. Completion of the essure training program includes preceptoring in essure placement until competency is established. Per the ifu, perforations of the uterus or fallopian tubes were observed in the clinical trials at a rate of 3. 4% and 1. 1%. The rate of reported perforations in commercial use is significantly lower and is typically not diagnosed until the time of hsg. Most of these pts remain asymptomatic. If tubal or uterine perforation occurs or is suspected, the ifu directs the user to immediately discontinue essure device placement procedure, and work-up the pt for a perforation. Retrieval of perforating micro-inserts, if necessary, requires laparoscopy or other surgical methods. |
Essure should only be used by physicians who are knowledgeable hysteroscopists, have read and understood the info in the ifu and in the physician training manual, and have successfully completed the essure training program. Completion of the essure training program includes preceptoring in essure placement until competency is established.
Physician called the consultation line during a case to report she had detachment difficulties with the essure device. She used 3 essure devices in each fallopian tube, because she was unsure whether the micro-insert detached from the delivery wire. She reports she did not see any trailing coils after attempted placement of the first device in each side, so she attempted placement using a second device in each tube.
A conceptus representative spoke with dr. Distal placement and hsg protocol, were discussed at length. The appearance of the delivery wire after a device has been deployed was described in detail. Dr. Stated that a conceptus representative came out to preceptor two of her cases (after this occurrence) and reviewed the procedure steps, showed her the delivery system post deployment, and reviewed inadvertent forward feed which may lead to distal placement. The importance of stabilizing the essure handle to the scope was emphasized. Distal placement parameter per hsg protocol were reiterated. Dr states she feels that she is comfortable with the procedure steps, and will not make this mistake again.
Companies information of who not to have the proceedure:-
| Physician called the consultation line during a case to report she had detachment difficulties with the essure device. She used 3 essure devices in each fallopian tube, because she was unsure whether the micro-insert detached from the delivery wire. She reports she did not see any trailing coils after attempted placement of the first device in each side, so she attempted placement using a second device in each tube. She didn't see trailing coils again, so she attempted placement of two additional devices ( for a total of 6 attempts, 3 in each tube). However, all six micro-inserts did detach, and the patient has three micro-inserts inside each fallopian tube. The patient was asymptomatic post-procedure. Dr called conceptus to report the patient is now complaining of pelvic pain and has concerns over having so many devices in her body. Patient complains of acute, intermittent abdominal pain 2-3 times per week. Dr offered the patient surgical removal of the devices, and bilateral tubal ligation which the patient agreed to. Surgery is intended to be scheduled, but has not occurred yet. |
The Essure
ä System should not be used for any patient who is
· uncertain about her desire to end fertility;
·
for whom only one micro-insert can be placed (including patients with apparent
contralateral proximal tubal occlusion and patients with a suspected unicornuate uterus);
contralateral proximal tubal occlusion and patients with a suspected unicornuate uterus);
·
has previously undergone a tubal ligation; or
any patient with any of the following conditions:
any patient with any of the following conditions:
·
pregnancy or suspected pregnancy;
·
·
delivery or termination of a pregnancy less than 6 weeks before Essure™ micro- insert
placement;
placement;
·
active or recent upper or lower pelvic infection;
·
·
known allergy to contrast media ; and
·
·
known hypersensitivity to nickel confirmed by skin test. (See Warnings section in
labeling regarding suspected hypersensitivity to nickel.)
labeling regarding suspected hypersensitivity to nickel.)
(I wonder how many people were tested for any of the above?)
Table 4 shows adverse events or side effects reported as a result of the hysteroscopic
placement procedure in the Pivotal Study.
Table 4
Pivotal Study - Adverse events and side effects reported on day of placement
procedure (n=544 procedures)
Event Number Percent
procedure (n=544 procedures)
Event Number Percent
Cramping 161 29.6%
Pain 70 12.9%
Nausea/vomiting 59 10.8%
Dizziness/light headed 48 8.8%
Bleeding/spotting 37 6.8%
Vaso-vagal
response/fainting7 1.3%
Hypervolemia 2 0.4%
Band Detachment 2 0.4%
Other* 16 2.9%
Nausea/vomiting 59 10.8%
Dizziness/light headed 48 8.8%
Bleeding/spotting 37 6.8%
Vaso-vagal
response/fainting7 1.3%
Hypervolemia 2 0.4%
Band Detachment 2 0.4%
Other* 16 2.9%
Adverse events on the day of the placement procedure were reported for
following, all of which occurred in <1% of cases: vomiting, vasovagal response,
16 (3%) women in the Pivotal Study. All events were resolved prior to the woman
being discharged, except for one woman who required overnight observation following
an adverse reaction to pain medication. Day of procedure events included the
being discharged, except for one woman who required overnight observation following
an adverse reaction to pain medication. Day of procedure events included the
following, all of which occurred in <1% of cases: vomiting, vasovagal response,
3. Permanency of Tubal Occlusion (and Sterilization)
The long-term nature of the tissue response to the Essure
ä micro- insert is not known.
The majority of the clinical data regarding PET in the fallopian tube is based on 12-24
maintain occlusion are not known.
The majority of the clinical data regarding PET in the fallopian tube is based on 12-24
months of implantation, with little data at 36 months. Therefore, beyond 24 months, the
nature of the cellular/fibrotic response and the ability of the response and the device to
nature of the cellular/fibrotic response and the ability of the response and the device to
maintain occlusion are not known.
1
In the Pivotal trial, 657 women initially enrolled in the study. Ninety-nine women subsequently changed their mind
about participating. Twenty-three women were subsequently terminated because they did not meet the inclusion
criteria, and 17 failed the screening tests. Therefore, 518 underwent the Essure placement procedure. There were a
total of 13 women who were lost-to-follow-up in the Pivotal trial.
Adverse Events by Body Systems, First Year of Reliance
1,2
(N=476 patients implanted with at least one device)
(N=476 patients implanted with at least one device)
Adverse Events by Body System Number Percentage
Abdominal:
Abdominal pain/abdominal cramps
Gas/bloating
18
6
3.8
1.3
Musculo-skeletal:
Back pain/low back pain
Arm/leg pain
43
4
9.0
0.8
Nervous/Psychiatric:
Headache
Premenstrual Syndrome
12
4
2.5
0.8
Genitourinary:
Dysmenorrhea/menstrual cramps (severe)
Pelvic/lower abdominal pain (severe)
Persistent increase in menstrual flow
Abdominal:
Abdominal pain/abdominal cramps
Gas/bloating
18
6
3.8
1.3
Musculo-skeletal:
Back pain/low back pain
Arm/leg pain
43
4
9.0
0.8
Nervous/Psychiatric:
Headache
Premenstrual Syndrome
12
4
2.5
0.8
Genitourinary:
Dysmenorrhea/menstrual cramps (severe)
Pelvic/lower abdominal pain (severe)
Persistent increase in menstrual flow
3
Vaginal discharge/vaginal infection
Vaginal discharge/vaginal infection
Abnormal bleeding - timing not specified (severe)
Menorrhagia/prolonged menses (severe)
Dyspareunia
14
12
9795
17
2.9
2.5
1.9
1.5
1.9
1.1
3.6
Menorrhagia/prolonged menses (severe)
Dyspareunia
14
12
9795
17
2.9
2.5
1.9
1.5
1.9
1.1
3.6
Risks
The most significant risk with the Essure™ System noted in the Pivotal Study
was the inability to rely on the Micro- inserts for contraception, due either to inability to achieve bilateral placement initially (14%), or misplacement of themicro- inserts which resulted, in turn, in perforation, proximal placement leadingto expulsion, or other unsatisfactory micro- insert location (initially 4.5%,ultimately 2.6%).
was the inability to rely on the Micro- inserts for contraception, due either to inability to achieve bilateral placement initially (14%), or misplacement of themicro- inserts which resulted, in turn, in perforation, proximal placement leadingto expulsion, or other unsatisfactory micro- insert location (initially 4.5%,ultimately 2.6%).
In addition, data from these two clinical effectiveness studies are based on only 1-year and 2-year follow-up. The risks of long term implantation are unknown. This is of special significance with respect to pregnancy, including ectopic pregnancy.
B. Benefits
The Essure™ System provides permanent birth control without invasive surgery or general anesthesia, and their associated risks.
The majority of women returned to normal activities within one day or less afterthe procedure. The vast majority of women rated their comfort with wearing the Micro- inserts at one-week as “good” to “excellent”. The vast majority of womenrated their overall satisfaction with the Essure™ System as “very satisfied”.
In addition to the above benefits, none of the women in the Essure clinical trials became pregnant while relying on Essure for contraception. Essure does not contain drugs or hormones.
The majority of women returned to normal activities within one day or less afterthe procedure. The vast majority of women rated their comfort with wearing the Micro- inserts at one-week as “good” to “excellent”. The vast majority of womenrated their overall satisfaction with the Essure™ System as “very satisfied”.
In addition to the above benefits, none of the women in the Essure clinical trials became pregnant while relying on Essure for contraception. Essure does not contain drugs or hormones.
From all of that, I am tending to believe that the physicians, are not trained well enough, that the information of all involved is not known enough and that the risks are not explained to the patients.
Perhaps the successful proceedures, are because the background checks were carried out first that it was suitable for the patient, and therefore, the Doctor was trained and knowledgeable, in the device as well...
The company is also stating that there were not pregnancy results, this was in the early days however, from what i can gather, in respect to the study. However, it's evident that they also state that they don't know if you can in-deed still get pregnant, as this thread has pointed out, there have certainly still been pregnancies.
I found this very interesting but wonder what the perentages are at present? If anyone has other resources to "current" proceedures, results, cut and paste here as well.
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