Essure Permanent Birth Control

Market Assessment

February 2007

PROJECT OBJECTIVES

Evaluate the market potential for Conceptus’ Essure, an alternative to tubal ligation.

Specifically:

• Test physician perceptions of product
• Assess facilitators and barriers:
• Less invasive procedure:  infection risk, no general anesthesia, quicker return to daily activities
• Favorable reimbursement
• Training on procedure and use of hysteroscope – Accreditation and Certification programs
• Patient perspective: need for follow up HSG, delay in efficacy
• Competition on the horizon

companies and Products mentioned in this report

Key Findings

Current approach: OB/GYNs discuss all short- and long-term options with their patients

• Options: Essure, Laparoscopic Tubal Ligation (LTL), vasectomy (for partner – effective and safer), IUD (non permanent, also treats irregular bleeding)
• There are several factors that impact treatment decisions:
• Patient characteristics: preference, surgical risk factors, health history (e.g., weight), marital status, number of children (if 1-2 may recommend non permanent solution), insurance coverage
• Physician experience: Essure USERS placed in a higher median percent of patients (50%) than IUD (30%), LTL (22%), vasectomy (15%)
• Ideas to Increase Essure Use: increase physician confidence in placing via hysteroscope, have adequate reimbursement for the procedure, increase patient awareness, eliminate the need for HSG follow-up requirement

High awareness of Essure among MDs: OB/GYN magazines, training courses, residency, colleagues, the company’s sales force and family planning meetings have provided information on Essure.

Perception of Essure: High volume USERS are very satisfied with the product and comment on ease of use, quicker procedure time, and safety.

• Notable attributes: permanent, inserted hysteroscopically, takes 3 months to work and requires follow-up HSG, issues with post-procedural MRI
• Panelists discussed difficulty placing coils if endometrium was not well prepared or if the patient has any intrauterine abnormalities--current users estimate difficulty in ~5% of cases

Essure versus LTL: compares favorably, easier and safer

Nonusers were moderately interested in using the product and wanted to see several cases performed and understand the technical aspects of getting fibers into fallopian tubes.

Hysteroscopes:  Most panelists do NOT own their own hysteroscope but use hospital-owned equipment for Essure and other procedures, e.g., diagnostics, operative: polyps, fibroids, endometrial ablation

• If revenue from Essure procedures (adequate volume) offsets financial outlay for hysteroscope, it maybe worth the investment.

Required training: Those trained in using the product, described it as quick, painless, involving 1-6 mos and ~5 procedures; most non-users were interested in a training program.

Reimbursement:  Most reimbursement experiences commented on were positive, facilitating use of Essure

• Reimbursement for in-office procedures was twice that of hospital-based procedures and may influence practice patterns.  More important than reimbursement is procedure familiarity and patient safety.

Expected trends: <10% patients were aware of Essure, usage will increase with increased patient awareness.

• 6-12 mos: 10-50% increase--patient awareness, physician training and desire to stay competitive, and new residents start practicing
• 1-2 years: potential to reach 30-50% of all sterilizations

inclusion criteria and Respondent demographics

9 obstetrician/gynecologists from high volume practices

• Mix of Essure users/ nonusers
• Treating high volume of patients with tubal ligation and/or Essure

Representative Institutions:

• Jackson County Memorial Hospital
• Montefiore Hospital
• Boston Medical Center
• Ocean Womens Healthcare Group
• St. Alexius Hospital
• Geauga Regional Hospital
• Lutheran General Hospital
• Piedmond Medical Center

Primary Question Index

TRANSCRIPT

Q1: Current practices

Please explain your current practices for patients who are looking for permanent birth control. What
options do you provide, and how does this differ by patient type? 
 

Panelist 1: I discuss all options with patients including both long and short term birth control

options. I have a chart that lists all forms of birth control that I use as a visual cue. No difference

in patient type. Patients make the final decision as to what type of birth control they want. 

Panelist 9: I first make sure it is understood that it is permanent, and nonreversible. I offer

essure and LTL, but lean more toward advising essure. This is especially true in patients who

have risk factors for surgery

Panelist 3: I like the Essure. If the pt's ins won't cover it, I recommend traditional tubal or

vasectomy. I always recommend vasc first to a married woman. 

Follow-up Panelist 3: Vasectomy recommendations

Why do you first recommend vasectomy? Is it due to health/recovery/cost differences compared to tubal, or compared to Essure? 

Panelist 7: vasectomy is a reasonable alternative to essure, and is still safer and as effective.

Panelist 3: Vasectomy is cheaper, safer, and easier to check. There is no reason that men should not share some of the burden of reproductive health and control. 

Panelist 9: I don't first recommend vasectomy. It is just one of the options I present to the patient 

Panelist 4: vasectomy is a reliable and safe procedure. I believe it is safer than tubal ligation as well as Essure. All alternatives are given to the pt with the pros and cons of each.

Panelist 7: I first offer Essure, as well as vasectomy and laparoscopic btl. If a patient has a

history of multiple surgeries, I especially recommend Essure. 

Panelist 2: Patients who are looking for permanent birth control are offered an IUD and tubal ligation. If patients are younger or have only 1 or 2 children, then I may offer the IUD as an option to permanent sterilization. The types of tubal ligation procedures that I have performed include hulka clips, fallope rings, essure and most commonly cautery. I tend to use clips more commonly on the younger women or those with a small number of children just in case they ever desire fertility in the future. 

Panelist 4: I explain nonreversible, permanent birth control and offer my pt's BTL or vasectomy, putting more weight on vasectomy. For those younger pts. I offer and lean towards IUD. I don't perform Essure as yet. 

Panelist 6: Currently I use laparoscopic tubal ligation with a Fallope ring. This is the option I

offer to all patient types. 

Panelist 8: It depends on the patients. We can provide any method of temporary or permanent

birth control, so we tailor the selection 

Panelist 5: Patients are offered post partum tubal ligation, either at the time of c-section or immediately after a vaginal delivery. If the desire does not correlate with a current pregnancy then the patient is offered a laparoscopic bipolar tubal cautery or the husband is referred to a Urologist for a vasectomy. Vasectomy would be encouraged in a woman who was deemed to be at increased surgical risk of complications due to medical problems or significant previous abdominal surgery.

Follow-up ALL: Breakdown by type

Please provide a percentage breakdown of how you manage patients seeking permanent birth control. (Answers should range from 0 to 100% for each category, and should sum to 100%.) * IUD * Tubal ligation * Hulka clips * Fallope rings * Cautery * Essure * Other * Vasectomy (partners referred for this alternative) * Other 

Panelist 5: IUD-- 10% Tubal Ligation-- 40% Tubal Cautery-- 30% Vasectomy--- 20% 
Panelist 1: IUD - 30 Other - 50 Essure - 10 Vasectomy - 10
Panelist 3: IUD is not permanent---however I place 60% Mirena is women who initially think
 

they want sterilization. Tubal --postpartum 10% Fallope rings 10% Cautery %10 Essure %10
 

Panelist 6: IUD 50%, Tubal ligation 5%, Hulka clips 0%, Fallope rings 10%, Cautery 0%,
 

Essure 0%, Vasectomy 35%, Other 0%. 
 

Panelist 4: IUD 20% Tubal ligation 60% Vasectomy 20%
 

Panelist 2: IUD-10% Vasectomy-10% Tubal ligation-20% Cautery-50% Hulka clips-10% 
 

Panelist 9: iud--25% tubal ligation cautery--5% essure-- 65% vasectomy-- 5% 
 

Panelist 7: Essure 50% Vasectomy 25% laparoscopic electrocautery 25%
 

Panelist 8: 40% IUD Essure 50% Vasectomy rarely accepted, (10% try) Hulka clips or
 

Falope-Rings, 19% 

Follow-up ALL: Essure use

Several panelists use Essure around 10% of the time? What would need to happen to cause you to use it in the majority of your patients? 

Panelist 6: That I would be completely confident that I could place it by hysteroscope,

that the reimbursement would not be a negative issue. Sad to say, but if insurers paid

markedly more for the procedure than others I would have a much greater interest. 

Panelist 1: I think more ads to make patients more aware of the product will help. Most

patients are still wary of this new procedure 

Panelist 7: I recommend it to all patients who want permanent sterilization who don't

have nickel allergies. 

Panelist 5: I don't use Essure at all 

Panelist 3: Medicaid does not cover it in OK 

Panelist 9: I already use it in the majority of patients. it is my preferred method and I use LTL only if for some reason the patient would prefer it 

Panelist 4: Since I don't perform Essure I can only say that, if the procedure is easy to

perform I would make my #1 procedure. 

Panelist 2: At this time, I do not perform the procedure, however, if Essure was easy to perform and the length of time required to perform the procedure was equivalent to that of laparoscopy then I would definitely be willing to learn and perform the procedure. In addition, the need for an HSG 3 mos later makes Essure less attractive. Eliminating this additional step would help as well. Finally, reimbursement would also be a consideration.

Follow-up ALL IUD Users

The IUD is used frequently; what it is it about this approach that is appealing? 

Panelist 6: It is easy and quick to place in the office setting. I am comfortable and know

all of the side effects and have personally seen most side effects and can manage them

comfortably. 

Panelist 1: It is easily reversible and it also treats other problems like menorrhagia. 

Panelist 7: The mirena IUD not only protects against pregnancy, but is an excellent

method of controlling irregular bleeding in perimenopausal woman and others. 

Panelist 5: Nonsurgical easy insertion. Long duration of action with reasonable cost for

patient and the cost to have a few in the office is also reasonable. No special equipment

needed for insertion. The IUD is also a reversible form of contraception which many

women like just in case they change their minds at a later date. 

Panelist 3: The Mirena controls bleeding and pain. Tubals do not do this  Panelist 9: It is highly effective, reversible, and easy for the patient, which makes it particularly attractive. The main drawback I find is the uneven insurance coverage for the device 

Panelist 4: It's a reversible but long term method 

Panelist 2: The IUD acts as a form of permanent birth control but is very easily reversed. I have found that some patients truly do not understand the permanency of sterilization and in this small population of patients, the IUD works very well to meet their needs. I also like the fact that the IUD can be placed in the office usually in less than 5 mins time. Furthermore, the patients are able to return to their routine activities immediately most often with little to no cramping. 

Panelist 9: I offer laparoscopic tubal ligation, essure, and vasectomy. I try to encourage essure in most patients, especially those at surgical risk 

Q2: Awareness and perception of Essure

Prior to this discussion, were you aware of Conceptus’ product, Essure, a non-surgical option for permanent birth control? If so, what do you know about Essure, and how did you learn about this option? If not, how interested are you in an alternative to tubal ligation for permanent birth control, and why? 

Panelist 1: I learnt about Essure through my ob/gyn magazines. I took the essure training

course and now perform Essure procedure. 

Panelist 3: I am aware of the essure and I do them 

Panelist 7: I have been doing the Essure procedure for about a year now.

Follow-up Panelists 3, 7

What is the source of your awareness? 

Panelist 3: Conferences, Journals, on-line education 

Panelist 7: Read about Essure in a journal and was invited by conceptus to a training session

Panelist 2: Yes, as a resident, we performed essure more commonly in patients with prior abdominal surgery or in those who wanted to avoid an abdominal incision. However, during the course of learning the procedure, we found it difficulty to place the coils through the tubal ostia due to uterine synechiae. There were some instances in which we had to proceed with tubal ligation. I'm also of the fact that patients had to be followed up with a HSG in order to confirm that the tubes were no longer patent. 

Follow-up ALL: Residency

Panelist 2 mentions learning to perform Essure during residency. Is the true for anyone else and also do you think that learning Essure is now becoming part of many OB/GYN residency programs? 

Panelist 6: Increasingly so. I have this perception that at most major academic medical centers they are exposed to what may be perceived as cutting edge technology. 

Panelist 9: it is in our residency

Panelist 1: I think learning the Essure procedure should be part of a residency program. However, I can't comment as to its availability in most programs. 

Panelist 7: We teach all our residents to do the Essure procedure. 

Panelist 5: I work in a community hospital without a residency program so I wouldn't know if residents are receiving any exposure to Essure or not. 

Panelist 3: Mirena was not available during my residency.

Panelist 4: Essure was not available during my residency and I have no way of knowing what 's being taught today. 

Panelist 2: During residency, we trialed Essure for a short time and unfortunately, the

procedure was not adopted by most of the attending physicians in the program for the

reasons previously stated. This was approximately 5 yrs ago and I am not sure whether

the program has started to use Essure again.

Panelist 9: yes, I was aware and have been using it for about 1 1/2 years. Learned about it from other doctors in my department doing it 

Panelist 4: I was aware of Essure as a result of a colleague that performed one procedure as well as an article I had read. Recently I was detailed by our local rep. I am moderately interested in another form of permanent birth control. 

Panelist 6: I am aware of Essure through a presentation from a company representative and literature. I know that it is a permanent birth control device that is inserted hysteroscopicall, that it takes three months to work and that you can never have an MRI afterward. 

Panelist 9: My understanding is that you can have an MRI safely, but the local area around

the insert may not show clearly

Panelist 8: I knew about Essure for years now because of family planning meetings. 

Panelist 5: Heard of Essure and have friends who have taken the course and who occasionally use this procedure. I prefer to stay with the procedures that I am currently comfortable with. 

Follow-up ALL: Difficulty placing coils and HSG follow-up

Panelist 2 stated: ”…we found it difficulty to place the coils through the tubal ostia due to uterine synechiae. There were some instances in which we had to proceed with tubal ligation. I'm also of the fact that patients had to be followed up with a HSG in order to confirm that the tubes were no longer patent. For those of you who use Essure, do you agree with Panelist 2’s assessment that is it sometimes difficult to place the coils? If so, how often, and how much of a barrier is this? For all panelists, how much of a barrier is the need to follow-up with and HSG, and why? 

Panelist 5: It is always more difficult to have a mutli-stage process for an elective procedure. Patients are likely to have the Essure procedure done and then not show or cancel the HSG. This causes more follow up from your staff to get the patient to reschedule not to mention that you must tell the patient that the HSG is not the most comfortable test to have performed. At least with tubal ligation when you finish the surgery you only need a post op office visit and if the patient fails to show there will not be much to worry about. 

Panelist 1: Yes, it is sometimes difficult to place the coils. This happens to me about 10

20% of the time. However, it has not deterred me from offering the essure procedure. It can

be a barrier to follow up with an HSG because patients are not always reliable. 

Panelist 3: I treat many military women. They are often deployed or transferred prior to the

follow period. I have not had any difficulty placing the coils 

Panelist 6: I can imagine that visualizing the ostia and placing the device could be

potentially difficult in some cases, but I have no personal experience. The need for an HSG

is a minor barrier for use of this device, largely because of the expense and trouble of

scheduling, and less so due to the radiation exposure. 

Panelist 4: HSG is a moderate barrier to performing the procedure solely because of the

inconvenience and potential discomfort of the procedure for the patient. It also begs the

question, "Maybe the procedure didn't work?"

Panelist 2: It seemed to be a problem about 30 to 40% of the time back then which is why

most of the physicians abandoned the procedure. However, I'm sure that the technique has

improved although I don't have any recent experience. The HSG was at times problematic

due to patient non-compliance and discomfort during the procedure. 

Panelist 9: At times it is, especially if the endometrium is not well prepared or if there are

intrauterine abnormalities. This is infrequent and is not a barrier to me using the method. I

have not resistance from patients regarding the HSG. The radiologist needs to know the

HSG is for post Essure confirmation, not for infertility. Then he/she will apply less force and

the procedure will be far more comfortable for the patient  Panelist 7: I have been able to place the essure in every patient, but some were quite

difficult. The HSG has been a huge dissatisfier, especially if they needed more than one.

Most patients have not objected to having to do the hsg when I explain that it is good to

document if their tubes are blocked. 

Panelist 8: Sometimes it is difficult to see the ostia. There may be a filmy covering. When

you try to wipe it off, it bleeds. Also sometime the tubes are very lateral and it is difficult to

start the feed into the tube. HSG is a MAJOR block. We have been doing a lot of the HSGs

at 1 month, which is much more acceptable. 

Follow-up ALL: Difficulty placing coils

Panelists #1 says that coils are hard to place 10-20% of the time (another panelist said 30-40%). That does not seem to jive with the clinical trial result of around 95% ability to do both tubes. Has this been others’ experiences? Do you think it has to do with something that is different about placing the coils in the “real world” versus the clinical world? If so, what? Panelist 1: in the 10-20% of times you have difficulty placing coils, have you ever not been able to place them eventually? 

Panelist 6: I don't have experience placing coils but I can imagine that not being able to visualize the ostia in some rare patients could make the process very difficult. 

Panelist 7: I have been successful placing 100% of my devices, with 5% being "difficult". I believe that it has to be done in the proliferative phase or else it can be very difficult dealing with the endometrium. 

Panelist 1: Some hysteroscopies are more difficult than others. The difficulty with

placing the coils has to do with visualization of the ostia. The ostia could be hidden by

small fibroids, excess tissue etc thus making the essure procedure difficult. I definitely

think that the real world is very different from the clinical world. No, I was not able to

place the coils eventually. 

Panelist 5: Clinical trials may have used gynecologists who were extremely experienced with operative hysteroscopy and therefore they had less trouble with the coil insertion. Years ago we had Norplant and we were told by the reps that they were simple to insert and easy to remove after 5 years. We all know what happened to this contraceptive. 

Panelist 3: I have not had any problems placing them in the tubes. However, did get

them in too far a couple of times because the notch was hard to see 

Panelist 9: My experience is that it is difficult about 5% of the time. The key is endometrial preparation-- either to do the procedure during the early proliferative phase or use either OCP's or progestational agents to keep the lining thin 

Panelist 4: I can't respond since I don't perform the procedure. 

Panelist 2: I believe that the problem in placing the coils was a direct result of an inability to visualize the ostia. I don't remember the specific instructions regarding timing of the procedure but I can imagine that performing the procedure while the endometrium was thick may have contributed to the problem. In my limited experience, the real world is definitely different from the clinical world because 5% seems low especially when we take into consideration the prevalence of leiomyomata. Fibroids alone can obstruct the view and they are common. 

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Q3: Essure versus tubal ligation

What is your impression of Essure? How does this method compare to tubal ligation, in your opinion? What are the advantages and disadvantages of Essure? 

Panelist 1: Essure is an excellent tubal ligation option. It compares favorably to other tubal

ligation options. Disadvantage is the 3 months it takes to ensure its efficacy. Also, it is

sometimes difficult to see the ostia. Advantage is the lack of need for surgical scars. 

Panelist 9: I feel essure has many advantages over tubal ligation, both for the patient and the

practitioner. I can do it without leaving my office and disrupting my day by dealing with the

inefficient operating room. The patient avoids the risks of general anesthesia, and laparoscopy.

the patient can resume her normal life the next day. The one disadvantage is the need for 3

months contraception and HSG, but I feel this is minor 

Follow-up Panelist 9

You mention you do not own a hysteroscope but do perform in-office procedures. Please clarify.

Panelist 7: you can do ablations without scopes 

Panelist 3: Balloon, Ablation, leep etc. Are done in office. We will hopefully add Essure next year.

Panelist 9: The rep from conceptus brings the scope when we have cases 

Panelist 4: We are not performing any therapeutic procedures in office at this time. 

Panelist 3: It can be done in the office. It is great for obese women! It is very easy to learn. The only down side to the Essure is the followup HSG. 

Follow-up PANELIST 3: Obese women

Panelist 3, why is this procedure particularly good for obese women?

Panelist 3: Obese women are harder to scope. They have more anesthetic risk. OK has many morbidly obese women. We can't even get the scopes to reach on some because my Hospital doesn't have the extra long scopes. 

Panelist 7: It is harder to do a scope on an obese woman. 

Panelist 8: They don't need anesthesia. The Essure isn't much more difficult, if at all. They're sometimes very motivated if they have had trouble with other hormonal methods.

Panelist 6: Agree with 3,7--hard to get the needle and trochar through a lot of fat. 

Panelist 7: I think that the Essure procedure is far easier and safer than the traditional

laparoscopic btl. However, patients have been concerned about its newness and definitely do

not like having to do an HSG 3 months later. Our practice now has 3 patients who have not

shown tubal occlusion at 6 months. We are unsure if this was true or just errors by our

radiologists who are performing the hsgs. 

Panelist 2: Essure is a safe option for tubal ligation. The most obvious benefits are the avoidance of abdominal incisions, laparoscopy and general anesthesia. However, the need for HSG 3 months following the procedure seems to be its downfall. Also, the inability to visualize the ostia while performing the procedure can make it difficult. Finally, it seems to take a little longer than laparoscopy. 

Panelist 4: My impression of Essure is that it requires a bit more of technical ability and that the effect is delayed. It also requires a post-op HSG which is not always the most comfortable procedure. On the other hand, it can be done in an outpatient setting without general anesth. and avoids entering the abdomen and all of those inherent risks. 

Follow-up Panelists 1 and 4: HSG as a barrier

Panelists 1 and 4: How many times has a woman turned down the Essure procedure because of the required HSG follow-up?

Panelist 7: I haven't had any patients turn down essure due to the hsg requirement. 

Panelist 1: I would say about 3 times. 

Panelist 3: 50% because I serve a airforce training base and they don't want to worry about at their next station 

Panelist 4: It was my opinion that it might be a barrier for a woman to choose this procedure. Since I don't yet perform them I've never had anyone turn it down. 

Panelist 6: In theory my impression of Essure is favorable, and it compares favorably to tubal ligation. I think the advantages of Essure are that recovery time is shortened, that the patient does not have a surgical scar, and that the procedure can be done through the hysteroscope. The disadvantages as I mentioned before are that the patient cannot have an MRI, that it takes three months to start working, and that patients need a hysterosalpingogram to confirm that the fallopian tube is occluded. 

Panelist 8: For most women Essure is preferable. It's an outpatient procedure, doesn't have the risk of anesthesia, and has very little discomfort after the procedure. This disadvantage is that it's sometimes technically difficult or impossible, and that it's not effective immediately. 

Panelist 5: Effectiveness is the same for both procedures. Obviously with Essure you don't need a general anesthetic, an operating room or an invasive procedure. The disadvantage is the need to be comfortable with operating through the hysteroscope and being comfortable with the placement of the Essure device. 

Follow-up ALL: Dependence on radiologists

Panelist 7 states, ”Our practice now has 3 patients who have not shown tubal occlusion at 6 months. We are unsure if this was true or just errors by our radiologists who are performing the hsgs.” Have other users had similar experiences? For all panelists, how much of a barrier is the reliance on radiologists to accurately perform HSGs? 

Panelist 5: When I perform an HSG the radiologist is obviously in the room but I don't

depend on his or her interpretation of the test without my input. We discuss the findings and

come to a mutual agreement on the patency of the tubes. 

Panelist 1: I perform my own HSG's with my radiologist, thus I can tell where exactly the

essure coil is. I have only had one patient whose coil was located in her pelvis, not in the

fallopian tube. Since I do my own HSG's, there is no barrier. 

Panelist 3: No Such experience yet. I can do my own HSG's 

Panelist 6: I have not had the experience mentioned above. As far as reliance on radiologists I would think it would be a minor barrier. To get the best possible HSG we would likely refer to our nearby academic medical centers to get the most qualified and experienced radiologists to get it right the first time. 

Panelist 4: We rely on radiologists exclusively for interpreting, and for that matter,

performing our HSGs. I don't find this to be a barrier. 

Panelist 2: I am not currently doing the Essure procedure, so I can not comment on failure

rate, however, when I perform HSGs for fertility, I have not had a problem with the

radiologists accurately interpreting the results. 

Panelist 9: I haven't experienced this. I think you need to use radiologists who are familiar

with the difference between a post essure HSG and an infertility HSG. I work in a university

setting with a large essure experience so we are quite comfortable with our radiologists. 

Panelist 7: I plan on doing the hsg myself in the future to avoid having to have the

radiologists read the films. 

Panelist 8: I think most radiologists put much too much pressure. We had a session about a year ago, and after that the patient complaints (and it seems, the number of "patent" tubes) decreased. We need to do it again. We've have had help from Conceptus. 

Follow-up ALL: Time for procedure

Panelist 2 states, ”…Finally, it seems to take a little longer than laparoscopy.” Do other panelists agree the Essure procedure takes longer to perform than laparoscopy? If so, how much of a barrier is this additional time? Is this negated by the ability to perform the procedures in office? Please explain. 

Panelist 5: I don't perform Essure so I can't comment on which procedure is quicker.

Certainly a tubal ligation under general where you are able to enter the abdominal cavity

quickly is a short procedure where as the Essure procedure must proceed more slowly

because you must keep your patient relaxed by talking and trying to be as gentle as

possible. 

Panelist 1: No, the Essure procedure is quicker than ltl. 

Panelist 3: I think Essure will take less time after I have more experience. 

Panelist 6: I cannot comment specifically about the length of the procedure, but I would guess it would be about the same amount of time as lapyroscopy but probably less. And as such it would not be a barrier to my using Essure, in fact it would probably be an encouragement. Performing the procedure in the office would not be negated even if the procedure took a little longer. One would then have to factor in travel time to the hospital saved which would be immense. 

Panelist 4: I'm unable to respond since I've never performed the procedure. 

Panelist 2: When we attempted the procedure 4 to 5 years ago, approximately 20 - 30 % of cases were extremely difficult because we were unable to place the coils. This increased the procedure time significantly. An uncomplicated laparoscopy can be performed in 15 to 20 mins.

Panelist 9: I disagree. it takes usually less than 15 minutes from the time I walk in the room until completion. It does not interfere with my office session. Laparoscopy, at best takes about 2 hrs of my time between travel to and from hospital the procedure and waiting around

Panelist 7: My essures take between 5 and 15 minutes, which is considerably shorter than the laparoscopic approach. 

Panelist 8: The procedure itself take 8-15 minute in most cases (even with a resident). I seems longer since we set up our own equipment etc., and the patient often recovers in the same room. The OR is slower if you look at turnaround time. I can't do a 10 minute laparoscopic tubal with a resident. 

Follow-up ALL: Technical skill

Panelist 4 states, ”My impression of Essure is that it requires a bit more of technical ability and that the effect is delayed.” Do others agree, particularly users, that Essure requires more technical ability than laparoscopy? If so, why, and how much of a barrier do you expect this will be for community-based practitioners in the adoption of Essure? 

Panelist 5: Operative hysteroscopy is definitely more demanding of skill then the majority of laparoscopic tubal ligations. Most gynecologists have been performing diagnostic laparoscopies and tubal ligations since their resident days so they feel much more comfortable with these procedures. It is like the old saying-- tough to teach old dogs new tricks.

Panelist 1: No, the Essure is much easier than laparoscopy. I guess the amount of hysteroscopy training you have plays a factor in the ease of the Essure procedure. 

Panelist 3: I feel that less skills are needed than for a scope. 

Panelist 6: I don't think it would require an enormously larger amount of technical skill than lapyroscopy. While I cannot comment specifically, I don't think this would be a barrier at all. 

Panelist 9: if you're comfortable with hysteroscopy in general, then essure is not technically difficult. I think its just that many physicians are more comfortable with laparoscopy than hysteroscopy

Panelist 2: I do not believe that the procedure itself is difficult especially when the ostia are clearly visible. I feel that the problem arises when uterine synechia, leiomyoma, etc are present. I believe that most residents are well trained in both hysteroscopy and laparoscopy; therefore, both procedures are relatively easy to perform. However, as we all know, they both may be equally challenging as well. I do not see the adoption of essure by community-based practitioners as a problem. 

Panelist 7: I think that essure can be technically more difficult than btl. In the office, when you are dealing with potential patient discomfort, it is more difficult than in the or. 

Panelist 8: No, There are a lot of laparoscopic procedures that are harder.

Follow-up: Definition of new

Several of you mention that Essure as “New” although the product has been on the market for 5 years and the clinical trial data is even a few years longer than that. What constitutes new in the patient and physician mind? How long does a procedure take not be considered “new” anymore?

Panelist 6: From the patient perspective if you have never heard of something before it's "new" to you even if it's been around for a decade. New in the mind of the physician is probably on the order of 1-2 years post product release. The last part of the question relates to degree of widespread use. If more than half of physicians are using it within a year or two it's less new than if it takes many years for a small fraction to use it. 

Panelist 7: Having 5 year data makes the procedure not new anymore. 

Panelist 1: Familiarity with a product is what makes it new or old. There has not been enough publicity about the essure procedure, thus making it new to many patients. However, the procedure is not new to physicians. 

Panelist 5: To me if a procedure has been FDA approved for more than 3 or 4 years then it

isn't new anymore. 

Panelist 3: between five and ten years is new. I don't want to be the last Dr. to start a

procedure, but I don't want to be the first either--unless I was at an academic /research

center.

Panelist 9: I would say after 5 years I would not consider a procedure new, especially if

clinical experience backs up the original data 

Panelist 2: In my opinion, a procedure is considered new to patients if they are not aware of it. I believe that publicity for Essure is lacking because I have not heard much about it since I stopped performing it 5 yrs ago. The patients for the most part are not asking about it either. I do not consider it a new procedure since I was aware of it shortly after it was placed on the market. I just don't understand why the representatives have not stopped by my office to market their product. I would also add that a product is no longer considered new when the data collection is complete. Since an HSG is still necessary following Essure, that suggests that the product has not been on the market long enough to say that it is without a doubt as trustworthy as other methods of permanent sterilization. 

Q4: Experience with Essure

For those of you with experience with Essure, please discuss how satisfied you are with the product, company support you’ve received, and how your patients have responded to this therapy option. For those of you who have not had experience with Essure, how interested would you be in learning more about this product and having this option for your patients? Please explain. 

Panelist 1: Very satisfied with this product. Patients have also responded favorably.

Panelist 9: The product could use some modifications in terms of water splashback, but overall it is a relatively easy technique to learn in someone who is experienced already in hysteroscopy. Company support has been superb, and patients have been very satisfied, especially with the minimal discomfort of the procedure under local anesthesia

Panelist 3: I really like the product. The biggest problem was the rep not showing up when we had four cases scheduled!!!! I got them all done successfully, but it would have been much better if the rep had showed up to trouble shoot. Instead we destroyed two units trying to get the job done. 

Panelist 7: I have done 2 Essure's in the office, and one was easy and one was very difficult. The company has advertised this as a "walk into your doctor's office and get immediately sterilized" procedure. I think that this is misleading and when I have to talk about the risks and benefits of this procedure, many patients have been surprised that it is not as easy as advertised. 

Panelist 2: I have not performed the procedure recently. My experience was in 2002 and 2003. Overall, for the obese patient and for those with pelvic adhesive disease, it seems worthwhile and I was very satisfied. The patients were satisfied as well but overall were not thrilled with the idea of continuing temporary birth control until the HSG in order to ensure that the procedure was successful. They wanted assurance immediately. I believe that the decision to stop essure back then was based on a few cases that were extremely difficult and time consuming. Those patients were eventually sterilized by laparoscopy. 

Panelist 4: Since I have had an in-office demo, I believe I would be more comfortable with the procedure by observing an experienced practitioner perform several cases. 

Panelist 6: I am only mildly interested in learning more about Essure. I have had limited inquiries from patients. Also I am concerned about the technical aspects of getting the fibers into the fallopian tube. What if I could only place the fibers into one tube and couldn't visualize the other ostium.

Panelist 9: usually this would be due to spasm and the procedure could be completed at a

2nd session 

Panelist 8: the company has been very supportive of starting the service, and providing training sessions for the residents, and providing technical information whenever I've asked. They've been great!

Panelist 5: Not interested. Content with the procedures that I am currently performing and I

haven't had any bad outcomes so I am not changing now.

Q5: Safety and efficacy

Please discuss the safety and efficacy of Essure, particularly in comparison to tubal ligation. Is this a superior option, why or why not? 

Panelist 1: Essure is definitely safer than other tubal ligation methods. It also appears to be just as efficacious.

Panelist 9: I believe essure to be much safer than tubal ligation. Perforation risk is low. Efficacy

might be lower with Essure in the sense that if the ostia can't be accessed the procedure can't

be completed. however with appropriate endometrial preparation this problem can usually be

avoided 

Panelist 2: Essure seems to be safer than traditional tubal ligation procedures due to the

avoidance of laparoscopy and its associated risk. It also appears to be just as efficacious. 

Panelist 4: As I mentioned above, because Essure obviates the need for entering the peritoneal cavity, all of the obvious, inherent risks are avoided. Also, if this can be done comfortably, without general anesthesia, those risks would also be avoided. 

Panelist 3: Not having to enter the abdominal dramatically reduces risk. The only reason to do a traditional tubal is with a c-sec, post-partum, or if the insurance won't pay.

Panelist 6: I think that the safety is probably greater than tubal ligation because it requires less

anesthesia. I think that the efficacy is probably about the same as tubal ligation. Since I don't

have personal experience with using it I cannot say if it is a superior option. It is probably an

equivalent option or slightly better than tubal ligation because of the anesthesia issue. 

Panelist 8: Essure is much safer. We've had 2 people in our hospital who did not have occlusion (>100-200 cases), and needed the device replaced, and one perforation (suspected at the time; she hater had a laparoscopic occlusion of that tube). We've also had a few cases when the device wouldn't go into the tube, and the tube was later shown to be blocked. It's unnerving when that happens because you won't know until later whether the tube was blocked or whether you jus couldn't get it in. 

Panelist 5: It all depends on the experience of the gynecologist. If you have a lot of experience

with operative hysteroscopy then the procedure is simple but if you only perform diagnostic

hysteroscopy then this will be more of a challenge and I don't see the need from deviating from

the laparoscopic tubal or post partum tubal. 

Follow-up ALL: Challenges and need for Essure

One panelist explains physicians not experienced with operative hysteroscopy may find this procedure challenging, and sees no reason to deviate from laparoscopic or post-partum tubal. Do other panelists agree the advantages (e.g., avoidance of general anesthesia, risks associated with laparoscopy) are not worth developing the technical skill required to use Essure, given the adequacy of laparoscopic or post-partum tubal procedures? For users, were any of you not experienced with operative hysteroscopy prior to Essure training, and if so, how difficult was it to learn the procedure?

Panelist 5: If you perform a lot of operative hysteroscopy then I don't believe that the Essure procedure would be difficult to master however if you rarely perform operative hysteroscopy then I don't believe the comfort level will be there and most would continue with tubals. We must always remember our oath-- first do no harm. If I am not completely comfortable with a procedure then I shouldn't be subjecting my patients to this unnecessary risk. 

Panelist 1: The ease of the Essure procedure is related to a physicians experience with

hysteroscopy. In good hands, the Essure is easier and safer than a ltl. 

Panelist 3: It was very easy for me to learn the procedure. However, I was already

comfortable with operative hysteroscopy. 

Panelist 6: Avoidance of anesthesia and a surgical procedure is a great advantage of Essure. I think it might be worth developing the technical skill provided there is a need from the community. 

Panelist 4: Truly, the advantages are certainly worth the effort needed to develop the skills. Because we perform laparoscopy under general anesthesia all the time, I think we tend to be somewhat complacent since the majority of cases go without a hitch. Indeed, the potential complications certainly make it worth the effort to learn the necessary skills for Essure.

Panelist 9: I think patients will demand less invasive sterilization procedure and that panelist might find less patients coming to him for sterilization. The advantages are too much to feel that the others are good enough. I had minimal experience with operative hysteroscopy and found the essure to be fairly easy to do after mentoring with about 5 procedures 

Panelist 2: I believe that Essure has a place especially when used in the right patient. Being able to perform this procedure seems worthwhile when the risks of laparoscopy and anesthesia are taken into consideration. Also, essure allows the patient a much quicker and less painful recovery which is what some prefer. Therefore, I feel that we must be willing to leave our comfort zones and stay abreast of the newest procedures in order to provide the best procedure for each individual patient. I also believe that as this becomes more publicized, patients will began to request it and therefore, knowing how to perform essure allows us to remain competitive with our neighbor physicians. 

Panelist 7: In obese patients or those with multiple operations with adhesive disease, Essure is significantly safer than btl. One has to feel very comfortable to perform operative hsc and this can take time to acquire. 

Panelist 8: I had experience with op hysteroscopy but wasn't facile. I had much more

experience with laparoscopy. 

Follow-up ALL: Additional information

What additional information, if any, would make your more comfortable with adoption Essure in your practice? 

Panelist 5: It is not the Essure procedure per se but the amount of operative hysteroscopy that is needed on a regular basis to achieve and maintain ones competency. 

Panelist 1: I am already comfortable with the Essure procedure. 

Panelist 3: none 

Panelist 6: I would be more comfortable with Essure if I witnessed my colleagues using it at our local hospital. To date none are using it. 

Panelist 4: Probably seeing several procedures actually performed. 

Panelist 9: none 

Panelist 2: I would like to observe several procedures to see if some of the same problems that we encountered several yrs ago remain an issue. If it appears to be comparable to laparoscopic BTO in regards to ease and time then I would be comfortable adopting the procedure. 

Panelist 7: Possibly having more experience with hysteroscopic trainers or working with

other doctors who are trained. 

Panelist 8: I feel quite comfortable. If I do 500 more, then I'll be really good (like any other procedure) 

Panelist 7: Because you are not entering the abdomen blindly, I believe that essure is safer. I also think that essure is as effect as btl. 

Q6: Hysteroscope

Do you own a hysteroscope? If not why? If so, do you use the hysteroscope for many other procedures

(aside from Essure)?

Panelist 1: No, I perform my procedures in the hospitals O.R. Yes, I use the hysteroscope for

other procedures 

Panelist 9: no, it hasn't made it through capital budget yet 

Panelist 2: I do not own a hysteroscope. The procedures were performed in OR at the hospital.
Yes, I do use the hysteroscope for other procedures. 
Panelist 4: I do not own a hysteroscope because, to date, all of our procedures have been done
 

at our affiliate hospital.
 

Panelist 3: yes

Follow-up Panelists 3, 4

Do you use hysteroscopes for operative procedures other than Essure? 

Panelist 3: yes

Panelist 4: Yes, both diagnostic and operative 

Panelist 7: I plan on using a hysteroscope for endometrial ablation procedures. 

Panelist 6: Our practice does not own a hysteroscope but we use one at the local hospital. With the availability so close we have not felt the urgency to get a scope of our own. We do use the hysteroscope for diagnostic hysteroscopies and operative histeroscopies for polyps and fibroids.

Panelist 8: I work in a hospital, so I don't own it myself. Yes, it is used for some other things.  Panelist 5: Only perform diagnostic hysteroscopy and do these in the outpatient surgical center. I use their equipment. 

Follow-up ALL: Reimbursement and purchase of equipment

Do you think Essure’s premium reimbursement justifies the purchase of a hysteroscope? What would lead your office to purchase a hysteroscope? 

Panelist 5: If I had the volume of cases in the office where the financial outlay was offset by

the revenue and the experience with the procedure was a positive one with the cases that I

performed in the OR then I would consider the purchase of a hysteroscope. 

Panelist 1: No. Nothing would lead me to purchase a hysteroscope for my office. 

Panelist 3: yes, we are already putting it in the budget for next year

Panelist 6: I don't think a more reimbursement would do it for us. We have ready access to

a scope at a facility adjacent to our office. What would probably facilitate our purchase of a

scope for the office would be the number of Essure cases we do. 

Panelist 4: Yes the premium reimbursement justifies the purchase of a hysteroscope. 

Panelist 9: As long as the reimbursements remain in the range they are now, I think it would be cost effective if the volume is high enough. We're working on getting our administrators to agree to purchase the equipment 

Panelist 2: The ability to generate revenue for the office after purchasing the equipment

would be the determining factor. 

Panelist 7: With the recent notice of decreased reimbursement for essure, this will

negatively effect people buying their own equipment. We need more patients to want the

essure to justify buying the equipment. 

Panelist 8: I work in a hospital, so I can't contribute. We did, however, convince them to buy the hysteroscopes. 

Panelist 7: We are in the process of purchasing a hysteroscope. The main issues are the cost

and the risks of doing procedures in the office rather than the OR. 

Panelist 7: We are in the process of buying one. Cost and fear of doing procedures in the office rather than the comfort of the or 

Q7: Patient perspective

Now, step into the shoes of your patients for a minute, and imagine how they would respond to the option of Essure. a) Are your patients asking about Essure? What percentage of patients would you estimate are familiar with the Essure procedure? b) If you have offered Essure to patients, please discuss their reactions. Why do they like the idea? What are their concerns? If you have not offered Essure to patients, what do you imagine would be their reaction? Would you expect patients to be more or less excited about Essure compared to other permanent sterilization options, and why? 

Panelist 1: Less than 10% are familiar with this procedure 25% like the idea of essure. Concern is that the procedure is new and my patients don't feel comfortable with new procedures. If there were more publicity about this procedure, patients may be more excited about it. 

Panelist 9: a. yes they are, about 50% b. most are interested, particularly that it can be done in the office and there is no post op down time. Concerns are about if it will be painful and if it is effective

Panelist 2: My patients are not asking about essure. I would estimate that <5% are familiar. This lack of knowledge about essure may be due to the lack of advertisement, etc. I have not offered essure recently to my patients but I imagine that they would be excited about the idea of permanent sterilization without an incision as well as the ability to return to their normal activities much faster than with traditional procedures. However, again, I'm not sure that they would like the idea of needing backup contraception and a HSG. 

Panelist 4: a. my perception is that very few (less than 10%) are aware of Essure. b. I have not offered Essure to my patients, but I believe that if it was an option that I offered, they would be very receptive. c. I believe patients would be more excited about Essure than other current methods.

Panelist 3: Patient's like the Essure concept. Some worry about having to get the follow-up

HSG and their tubes still being patent. Very few of my patients are familiar with Essure. No one

has asked for it be name. 

Panelist 6: I have had one patient as about Essure and I think that less than one percent are

familiar with it. I imagine if I offered Essure that some patients might be interested. I think they

would be excited about not needing a laparoscopic procedure with anesthesia. But they might

be discouraged that they couldn't have an MRI--but probably not to any great extent. 

Panelist 8: My understanding is that pts can have an MRI. There might be some image

degradation around the device itself. 

Panelist 6: The Essure prescribing information sheet makes mention of the device being MR safe at the field strengths produced by a 1.5 telsa magnet. Usual medical MR scanners use up to a 3 telsa magnet. My radiology colleague says that some magnets for various research projects can be as high as 10 telsa. They also tell me that up to 7 telsa magnets are on the way for general medical use in the near future. 

Panelist 8: Some patient are, and it's increasing. I have pts referred for Essure. Even among

patients who have never heard about Essure, almost all of them decide to use Essure. The

advantages are obvious to most people. 

Panelist 5: I don't offer a procedure that I don't perform. If they ask me about Essure I'm happy to tell them about it and if they wanted to go that route I will refer them to someone who performs it.

Panelist 7: About 25% of patients have heard of Essure before entering my office. We have

posters and brochures readily available. 

Follow-up ALL: Permanent implant

In regards to patient push-back, no one mentioned the fact the metal coils remain in the tubes for life? Has this come up as a concern? If so, how often? 

Panelist 6: It has not come up as a concern from the patient perspective, nor any more than if they needed a screw in their bone to fix a fracture. In my mind the metal coil and MR scan issue remains as a possible theoretical future concern. 

Panelist 7: Some patients give me "the face" when talking about the metal coils, and then

decide to go with the scope approach. This is probably less than 10% though. 

Panelist 1: No. All my patients expect to have the coils for life. And they understand that this is a irreversible procedure. 

Panelist 5: No concern. With all the consumer information with joint replacements

nowadays I don't think that metal coils in the tubes would bother too many women. 

Panelist 3: This has not been a patient concern 

Panelist 9: about 10% of patients are concerned about this issue 

Panelist 4: Cannot respond. 

Panelist 2: I am unable to respond. 

Follow-up Essure USERS

Of those of you using Essure, is the MRI issue something you discuss with the patient before the

procedure is performed? How many women have chosen to avoid the procedure due to this issue? 

Panelist 7: what is the mri issue? 

Panelist 1: What’s the issue with MRI? 

Panelist 3: My understanding is that the Essure is considered safe with current MRI. Until

being on this panel, I did not realize that this could be a concern in the near future. 

Panelist 9: I don't bring it up and patients rarely do 

Q8: Required training

Conceptus offers training for physicians interested in offering Essure. Please read the information below and answer the questions that follow. Training The Essure training program is a comprehensive course designed to provide information and skills necessary to select appropriate patients, perform competent procedures and manage technical issues related to the placement of Essure micro-inserts for permanent birth control. Requirements Essure training is available now for practicing OB/GYNs with operative hysteroscopic skills. Process 1. Register on site and choose your training option for the Didactic Program.

2. Complete the Didactic Program. 3. Identify and schedule 2-3 patients for the Essure procedure. 4. Contact your Conceptus representative once patients are scheduled. 5. Complete hands-on training on the Essure device with a Conceptus designated preceptor until competency is established. 6. Complete initial procedures under observation of a Conceptus designated preceptor until competency is established. On completion of your clinical training and certification, the Conceptus Healthcare Affairs Department can provide reimbursement support and office education to your staff. Essure Accredited Practice To assist physicians in offering their patients the very best care and service, Conceptus has created an Essure Accredited Practice program. This program is available to physicians who meet specific criteria. The EAP program may be right for you, if you are: * Offering the Essure procedure in your office * Using minimal anesthesia * Willing to invest your own resources (time/money) in your Essure practice To help physicians become an Essure Accredited Practice, Conceptus has a dedicated team of professionals (Essure Development Team) to assist you in creating the best customer service experience for your patients. The areas of concentration are: * Patient process flow * Education of staff * Development of a referral network

* Outreach to women in your community through marketing and public relations The Essure Development Team can assist you in delivering the levels of customer service that your patients deserve. Along with improving your Essure patient experiences, you also will receive these Essure.com website and Essure Information Center benefits as an EAP practice: * Priority position listing, along with other EAPs in your area, in the "find a physician" service * Additional information you provide for your profile * Your picture included with your listing * The ability for new patients to request an appointment For those of you who are members of the EAP program, what was the reason you sought this training and what was your experience? For those of you who have not participated in this training, why have you not sought out this training? Please discuss how interested you would be in completing such a program, and why. 

Panelist 1: I sought the training to be up to date on the latest ob/gyn care available. My

experience was quick, fun, and painless 

Panelist 9: I have completed the training, but have not participated in the EAP. The training I had was different in that I had an experienced preceptor in my practice who helped me get experience. The essure team though has been excellent in providing any help needed. I would like to participate in the EAP Panelist 7: I am an EAP approved doc. I felt that this is an important surgical option for my

patients. 

Panelist 2: I have not sought training because the procedure has not been talked about much

amongst the physicians in my group. However, I would be interested in completing the training

because I do feel that it would be a great option for my patients who are considered good

candidates. 

Panelist 4: I have not sought out this training because my one colleague, who attempted this

procedure several years ago, described the procedure as extremely difficult to perform. We

recently found out that it was the type of hysteroscope that we were using that made it difficult.

We are now in the process of learning the procedure. 

Panelist 3: I completed the training. I did three procedures, but the rep didn’t show up!!! Luckily, all three were successful--but I broke three devices trouble shooting. 

Panelist 6: I have not done the Essure training because I haven't had any patients ask me for this as a serious choice for their birth control. I am only mildly interested because of the current lack of interest from my patients or perhaps it would be better to say there are no requests. I had one patient ask me about Essure. I told them if they were truly interested I would complete the training program and place the device. As yet they have not chosen any method yet. 

Panelist 8: I was highly motivated to be able to do Essure 

Panelist 5: Have no interest as I don't perform operative hysteroscopy and I am happy with the

procedures I currently perform. I don't feel that all gynecologists need to perform all types of

procedures if they are not comfortable with aspects of a procedure or have not had formal

training in these procedures. 

Follow-up ALL: Training and EAP

How long did it take (in months and procedures) to finish your training and the EAP (preceptorship) with Essure? If it took longer than one year what was the main reason (availability of training MD, time constraints, patient demand, etc.?) 

Panelist 5: Haven't done the training. 

Panelist 1: Training took one hour. EAP took 5 procedures over 3 months.

Panelist 3: I completed the online program about 1 year ago. I have completed three

placements. Since the rep did not show up....What can I say about the training? 

Panelist 6: I have not done the training.

Panelist 4: I have not done the training

Panelist 9: about 6 months and 5 procedures

Panelist 2: I have not done the training.

Panelist 7: Took me just a few months. Had Dr. Charles Miller at my hospital to precept me

and the reps were readily available. I think I needed to do 5 under supervision. 

Panelist 8: A month or two. 

Q9: Reimbursement

Please read the following information on reimbursement and answer the questions that follow. Reimbursement Conceptus, Inc. has resources available to assist you and your office staff with reimbursement issues related to the Essure procedure. Although the hysteroscopic sterilization CPT code has been in place for over a year (effective 1/1/05), there are still many developments in the private and public payer sectors. Please check this page for the latest news. If you are a registered user on www.essureMD.com, you and your staff have 24/7 access to an entire section filled with instructions, templates and tools to assist you with reimbursement. Latest Reimbursement News On February 15, 2006, Cigna added the Essure procedure as a covered benefit for women who have completed childbearing and desire permanent sterilization. Cigna joins United Healthcare, Humana, Aetna and the majority of private payers, including Blue Cross and Blue Shield plans in covering the Essure procedure. In addition, 35 states and the District of Columbia now also cover Essure. The most recent of these Medicaid states include New York, Idaho, Wisconsin, and Texas. It is important to note, that coverage for voluntary sterilization is subject to the terms, conditions and limitations of the individuals benefits as described in their certificate of coverage. What is your opinion of the reimbursement environment for Essure? Please discuss both in-hospital and in-office reimbursement. Do you consider reimbursement a facilitator or barrier to its use, and why? 

Panelist 1: I have had no problems with reimbursement for the essure procedure. 

Panelist 9: reimbursement in general has been excellent in our office based practice, and has been a facilitator to using the technique 

Panelist 7: I am concerned about the recent Medicare changes and reimbursement. 

Follow-up Panelist 7: Medicare

You express concern about recent Medicare changes and reimbursement. Please explain how Medicare coverage would affect the coverage of Essure. 

Panelist 3: Some patient's on disability have Medicare. I have done tubals in a couple of these cases.

Panelist 7: I was referring to the letter that was sent by Conceptus noting decreased

reimbursement and that this would make us not want to go through the aggravation of

doing the procedure in our office when we can easily do it in the or. 

Panelist 2: I am not able to comment on reimbursement since it has been several years since I performed the procedure. 

Panelist 4: I cannot comment on the reimbursement since I have not performed this procedure.

Follow-up Panelists 2, 4

Although you do not have any or recent experience with Essure, based on the information

provided, do you see reimbursement as a facilitator, barrier, or non-issue?

Panelist 4: reimbursement, if it is significant, would certainly be a facilitator

Panelist 2: I see it as a facilitator if in fact the procedure is covered. However, it sounds

like many are having trouble with reimbursement. 

Panelist 3: non-issue 

Panelist 3: We have not yet gotten paid for the three procedures I have done. 

Panelist 6: Like most relatively new pharmaceuticals and devices Essure seems to have incomplete coverage according to the above description. It's fine when it is covered but when we have to write letters to get an insurer to cover the procedure it is a hassle of the highest magnitude, especially when they deny coverage after all that. I'm not sure how in-hospital and in-office reimbursement differs, but I imagine if we did Essure we would do it in the in-hospital setting with their hysteroscope, and I imagine that the coverage might be a little better in hospital. In terms of being a facilitator or a barrier I refer again to the above insurance coverage issues. If the procedure is fully covered, fine, it can be a facilitator. But if it is only partially covered or not covered and the patient has to bear the whole cost it can be a significant barrier. 

Panelist 8: This has not been a major problem for me although I know it has been a big problem for many people. Medical and other government-supported insurance here were on-board very quickly and private insurance has followed steadily. 

Panelist 5: I do not have an opinion

Follow-up ALL: Office procedures

Panelists, if you received up to two times as much reimbursement for in-office procedures versus

hospital-based procedures, would this affect your treatment practices? Please explain. 

Panelist 5: If I was really comfortable with the procedure first in the hospital setting and thought that I could perform this in the office with the patient being comfortable and without any increased risk then I would consider it. Personally, I don't care if I am paid ten times the amount for a procedure, if I feel that the patient experiences more pain or technically I can't do the procedure as well as in the OR, or if I feel that safety is compromised in any way then this is not worth it. 

Panelist 1: Maybe. The safety of the patients always comes first, and I like the knowledge

that if I screw up, I can easily convert to a laparoscopy or laparotomy.

Panelist 3: I am a hospital employee--so I do whatever is best for the hospital "system".

Panelist 6: Sadly, money dictates many of our decisions. But if the reimbursement were at

twice the current inpatient rates our practice would be very much more likely to do these

procedures in the office and we would likely purchase a scope, provided we did a number of

these cases.

Panelist 4: Not necessarily. Depending on the complexity of the procedure, as well as,

equipment and personnel, the hospital could be a better option. For Essure specifically, I

believe we would consider performing this in-office. 

Panelist 9: I try to do as many procedures as possible in the office since going to the

operating room is such an inefficient use of my time. So the reimbursement is not really a

factor

Panelist 2: At this point, I'm not comfortable performing Essure in the office given my limited experience with the procedure several years ago. It was at times a very challenging and lengthy procedure which on a few occasions had to be converted to laparoscopy. I also am concerned about patient comfort and would therefore rather do Essure as a hospital-based procedure. The higher reimbursement in the office would be irrelevant. 

Panelist 7: You have to make it worth our while to do this in the office. 2X maybe worth it,

but just barely.

Panelist 8: I think it work, but then, hospital incentives are perverse. 

Q10: Setting a) Do you use Essure in your office? If for how long (in months and in # of procedures) did it take for you to feel comfortable in the office? If not, why not? 1) Don’t have a hysteroscope 2) Don’t feel comfortable outside of the operating room 3) The technology is too new 4) Colleagues have disliked doing the procedure 5) Reimbursement not enough to encourage you to move to office 6) Other reason b) What do you see as the barriers to transitioning to the office setting? 

Panelist 1: No. I don't have a hysteroscope in my office. 

Panelist 9: yes-- I started in the office setting and it has been comfortable since the beginning.

Since the patients have been quite comfortable during the procedure my stress level has been

low even during the learning curve when it took a little longer to complete

Panelist 2: No, I am not currently doing the procedure and this is because the attending

physicians in my residency program disliked doing the procedure. However, I am interested in

performing the procedure in the future. 

Panelist 7: I have done 2 Essures in my office. One went very well, and one went poorly with

her uterus contracting despite toradol and warmed saline. I was able to complete both

procedures adequately, though the second patient had fairly significant discomfort. With the

decreased reimbursement, I'm not sure that it is worth the investment in hysteroscopic

equipment to do these in my office. There is no question that it is safer to do these in the OR. 

Follow-up Panelist 7: Changes in reimbursement

You mention decrease reimbursement and the value of an investment in purchasing the necessary equipment, training and staff. Please elaborate on how the reimbursement has changed for you. 

Panelist 3: I think reimbursement will be higher in the office. But, so far we have only

done them in the OR 

Panelist 7: I am responding to a letter from conceptus that we should expect a

decrease. I have not seen this yet in our reimbursement yet since I haven't done any

recently. 

Panelist 3: I am doing them in the OR. Now, that I am feeling comfortable with the device we

are moving toward office use.

Panelist 4: a. I do not use it in the office. Since I have not performed this procedure, I would not use it in the office until I felt comfortable performing it. b. The barriers to transitioning to performing this in the office would be purchasing the necessary equipment, training the staff and ensuring that reimbursement made it worthwhile to perform in the office. 

Panelist 6: We do not use Essure in the office because we do not have a hysteroscope in the office. Again for our practice since we have access to a hysteroscope at our local hospital it is very unlikely that we would bear the expense of getting a scope for our office. And as such it would be a significant barrier and we wouldn't place the Essure device in our office. 

Panelist 8: Yes, in a clinic. I was never uncomfortable doing Essure in an office. 

Panelist 5: a. Do not have scope, not comfortable doing procedure in office, not going to spend the necessary outlay to outfit the office to be able to perform this procedure as expected numbers of patients would not be high enough. b. Expense to set up office and comfort level of physician to perform the in-office procedure 

Q11: Competitive products

Other than current tubal ligation procedures, are you aware of any products/therapies in development that could potentially compete with Essure? If so, what are these products/therapies, and what do you know about them in terms of mechanism of action and when they will become available? 

Panelist 1: no

Panelist 9: I'm not aware of any

Panelist 2: No, I'm not aware of any products/therapies 

Panelist 7: I did read in a throw away journal about 2 competing products that were both placed via hysterscope, but dates that they would be available were not known.

Panelist 4: I am not aware of any other products. 

Panelist 3: Many women choose Mirena over permanent method. 

Panelist 6: I am unaware of any products in development. 

Panelist 8: I know there are other products, but I do not have any information about specifics. 

Panelist 5: No

Q12: Expected trends – 6-12 months

Given what you know about Essure, what do you expect the trends will be in the next 6-12 months in terms of: a. Physician training and adoption b. Use of Essure in the marketplace Do you expect a 1) steady state, 2) decrease or 3) increase in the number of physicians participating in training and adopting Essure, and why? Please indicate in your answer the percentage change you expect. 

Panelist 1: 1) As patients become more familiar with this product, there will be more of a demand for the essure procedure. Thus more physicians will undergo training. I expect a 33% change 

Panelist 1: 3) As patients become more familiar with this product, there will be more of a demand for the essure procedure. Thus more physicians will undergo training. I expect a 33% change 

Panelist 9: I'd expect an increase because it will be demanded by patients. I think I will see twice the volume 

Panelist 2: I believe that once patients hear and learn more about the procedure, the trend will increase by 40 to 50% because more physicians will want to learn the procedure in order to stay competitive. It's always nice to be up to date with the newest information and procedures available.

Panelist 7: I believe that there will be more patients wanted this procedure after talking to

friends and family about it. 

Panelist 3: It will increase as fast as insurances accept it. 

Follow-up Panelists 3, 7

You both mention you expect an increase in procedures. Please do your best to estimate the magnitude of the increase in the next 6-12 months. Other panelists expect the number of procedures to increase by 10-50%; please offer an estimate. 

Panelist 7: I continue having problems with the follow-up HSG's. If this is not corrected, many of us will stop doing the Essures. If this is corrected, I would anticipate a 20-50% increase.

Panelist 3: I plan to do all my tubals this way--as long as the patients insurance will cover it. I can't predict a number at this time. 

Panelist 4: I would expect that there will be a slow increase in the number of physicians adopting the procedure. A guess would be an increase of 10-20%. I believe that as the number of doctors that become comfortable with the procedure their "competitors" will follow suit. 

Panelist 6: I think that the trends for physician training and adoption will be slow over the next 6-12 months and as such Essure will rely on the few doctors that do perform it for its growth as an option in the market. I expect a slow increase (maybe 5%) for physician adoption in the time window because I don't think many patients will know about the device. Even if more physicians adopt it, the need for a training period will limit its growth in the short term. 

Panelist 8: I think many physicians would like to do Essure. It will be interesting to see if insurance pushes outpatients use. As residents go into practice, there will be more support to transition to office practice. I expect use will increase. 

Panelist 8: 20% 

Panelist 5: steady state. I think the initial wave of enthusiasm has dropped and the doctors who are comfortable performing office based hysteroscopy are already doing this and the rest will probably not be joining the group. 

Follow-up ALL: Enthusiasm

Panelist 5 said that he thinks the initial enthusiasm has passed and the rest of the docs would likely not join. Do the rest of you agree - do you feel like the product will plateau until something else occurs that makes it in other physicians best interest to perform the procedure? If so what would that be: patients demanding the product, others? 

Panelist 6: I think that interest could rise as patients learn more about this option whether it be from their physician or a media campaign. I don't think it will plateau until there is more widespread awareness. I think this demand and increased reimbursement would be two highly motivating factors for Essure's adoption.

Panelist 7: I think that those docs who feel comfortable doing essures probably have adopted the technique, and others may come on board if the trend continues. More marketing would help. 

Panelist 1: I believe that as more patients demand the Essure procedure, more doctors will learn to perform them. Thus, the plateau is up to the manufacturer. 

Panelist 5: The majority of the doctors who are the most experienced with operative hysteroscopy are probably already on board. Yes marketing to physicians and to the consumer will generate more sales but it will also cause more doctors to attempt the procedure who probably don't perform a significant amount of operative hysteroscopy. This will lead to higher failure rates and more complications. 

Panelist 3: Come up with a new version that does not require the 3 month fu and I think enthusiasm will rekindle 

Panelist 9: I don't agree. this will be driven by patient demand and physicians who are resistant will lose these patients to those doctors who offer it

Panelist 2: I believe that better marketing and increased publicity will lead to an increase in patient demand. If physicians lose patients to other physicians who are doing the procedure, then more will have a desire to learn Essure in order to stay competitive. I also think that reimbursement will play a role. Providers tend to adopt procedures that have good reimbursement. 

Q13: Expected trends – 1-2 years

Now, thinking further ahead, what do you expect the trends will be in the next 1-2 years in terms of: a. Physician training and adoption b. Use of Essure in the marketplace Do you expect a 1) steady state, 2) decrease or 3) increase in the number of physicians participating in training and adopting Essure, and why? Please indicate in your answer the percentage change you expect. 

Panelist 1: 1) Probably a steady state. Most physicians should be aware and trained in Essure by this time. Thus, 0%. 

Panelist 9: it will continue to increase, hard to say by what percentage 

Panelist 2: I believe that the trend will continue to increase and will probably reach 55% in the next 2 years. I was a resident in Pennsylvania 4-5 yrs ago which is where I first heard about and performed the procedure. It's surprising to me that not many physicians in this area (SE) are performing essure and that it has not caught on at a faster rate. 

Panelist 7: I expect an increase in training and patient demand, even if reimbursement goes down because of safety issues. I don't know about office-I feel more comfortable in the OR. 

Panelist 3: No change after acceptance by all insurances because it will be the most widely used sterilization method. 

Panelist 4: I have no way to anticipate and project further use beyond what I suggested in the previous question. 

Panelist 6: I think over the immediate term of 1-2 years that the adoption and use and percent of the marketplace Essure has the chance to make significant inroads. The reason I think is the internet and instant news media. As more internet savvy patients read up on their birth control options they will learn about and request the procedure. More doctors will respond and train, and I think there could be a significant increase possibly 25% to 50% of all practitioners. I think that no the optimistic side, Essure could supplant up to half of tubal ligations but more realistically could get in the range of 10-30% of sterilizations. 

Panelist 8: I think the trend will continue. Hard to say how fast. Essures are now 50% of interval sterilizations and increasing at our institution.

Panelist 5: steady state. No reason. 

Q14: Other issues

For those of us interested in assessing the permanent sterility marketplace, other than what has been discussed, what other issues are most relevant, and why?

Panelist 1: Ease of use of products, safety and definitely efficacy of product 

Panelist 9: main issues have been discussed 

Panelist 2: I would be interested in knowing how much longer the 3 month f/u with HSG will be necessary. I would also like to hear more about how to make the procedure easier to perform in those difficult patients. 

Panelist 7: Having the patient go through the HSG is a huge dissatisfier. Most radiologists use too much force and it is uniformly uncomfortable. If this requirement could be eliminated, it would help improve patient demand. 

Panelist 3: It would be great if Essure could improve to the point that a three month HSG was not necessary. Pt move, they lose ins. ,Etc. 

Panelist 4: Reliability, reduced complication rate, minimal down-time and ease of use are the most important issues. 

Panelist 6: The important issues in a permanent sterility procedure or device are 1. ease of use and application, 2. a simple and highly effective procedure, 3. overall results equal to or better than tubal ligation with respect to safety and efficacy. 

Panelist 8: Patients are most concerned about effectiveness. The ability to have a procedure anytime (not timed to menses if not on hormonal contraception) would be good. 

Panelist 5: It always comes down to a few factors. Patient safety, comfort, cost and effectiveness coupled with doctor reimbursement, physician comfort level and the ability to perform enough procedures on an ongoing basis to retain the expertise to perform them. 

MRI

Panelists 6& 8 have brought up a concern regarding the safety of MRI--especially as we see the magnet strengths increasing. I have been telling my patients that they can have a MRI. What cautions should be giving them? MRI will probably become more common in general medical use. I think we should assume that every patient will need some sort of MRI study in their life.

Panelist 6: As long as patients give full informed consent, that with today's MR machines some safety data exists. As far as the future and stronger MRI magnets it's hard to say how to advise patients without any additional data. 

Panelist 2: I'm not sure