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