UPDATE: surgery dilemma (long)

[hardysmom]

We had cranialfacial issues when my twins were tiny. I know your littly guy has been sick and I can't imagiine going through all of this a month after having a baby, you must be one tough mom...

Surgery is so expensive and there is always a risk of complicatins... I would work my bottom off to get option #1, but if it isn't going to be covered, I think the traditional surgery as darn good results.

Just because the first team WANTS to do the new procedure doesn't mean they can't do the older method, My guess is they probably have to do it frequently for various reasons. Can ypou schedule the surgery with team #1 and let their office work on your insurance? If it is less invasive, they may be able to make a cost-benefit appeal to your insurance.

stephanie

[Marisa6826]

What are the success rates *so far* with the new method? Things progress so quickly in the surgical world, that two years is actually a pretty long time.

Can this controversial group provide you with the names of previous patients and their families? Maybe pick their brains to see why they chose to go with a new technique, if they would have done anything differently, etc.

Honestly, I think that unless you've been in a situation where your child has been there/done that, you can't really be in a position to make the call. As such, the families that have already gone through it are the ones to talk to, kwim?

If you find that your insurance *won't* cover the new technique, then obviously, your hands are kind of tied.

With regard to a younger surgeon, don't discount his abilities just b/c of his age and experience. Remember that he's gone through 7+ years of training, and his team has the reputation behind them.

If I were in your position, I'd lean toward the newer method, but that's just me.

What does your gut say? How soon would they want to do it?

What are the recovery times for each method? Would the fact that PC has had RSV problems impact how/when they'd do the surgery?

Hang tough, Girlie. You've made it this far!!

hugs

-m

[megs4413]

>
>Honestly, I think that unless you've been in a situation where
>your child has been there/done that, you can't really be in a
>position to make the call. As such, the families that have
>already gone through it are the ones to talk to, kwim?
>

actually i'm finding the cleft boards i'm on completely unhelpful. people are quite slanted to tell you what they did and why it's best. they seem to kind of defend what they have done. very few people have had this new procedure and they are quite unfamiliar with it in other parts of the country. so i think their view is a bit off....

the procedure thusfar is quite successful...BUT because the face changes and the child grows so much in such a short time, it remains to be seen if the procedure is good in the long term (meaning it does not require frequent revisions). there are no long term cases to go off of...so...basically it's "so far so good", but is that good enough for my boy?

[shilo]

i think you will just "know", as you say. this is one case where your gut is all you've got when it comes down to splitting hairs like this. i've learned with my both my DH's and DS's medical conditions (both entirely unrelated to a cleft) that you will always, always find yourself with two options in the end. do or don't. do you believe in one? do you 'feel' one more than the other? who do you just instinctively find yourself trusting? you can drive yourself crazy with the what if's. for every "i couldn't forgive myself if i went with the risky new procedure and something went wrong down the line" there is the opposite... could you live with yourself if the new procedure is the gold standard in another 3 years and your DS didn't have it? if the ans. is yes, then you should go with the old standard, if the ans. is no, then you also may have your answer.

i have BTDT with DH's case. he did almost die about three months before our wedding when he had a rare complication arise from his chronic medical condition. that night, i did have a go with the gut momment and fired the specialist who was on call for the service. it ended up being the best decision i could have made. the service chief wound up taking on DH's case and is still his MD 7 years later. that night he recommended a non-fda approved (off lable use) of a brand new class of drugs. in another 'go with the gut' i just 'knew' that this doc was going to give him back to me, and that whatever he thought was the right thing to do, was. that drug is now approved and one of the gold standards for DH's disease. it was the beginning of a remission for him that has lasted 7 years.

i know nothing about cleft repairs, so forgive my ignorant questions... but if you went with the new cutting edge procedure and it didn't work as well as anticipated, what is the outcome down the line? would it just mean the same number of additional surgeries he'd have with the old standard anyway to get him back on track? there are so many crazy things they can accomplish with plastics these days, are the odds good that if he didn't have a 100% outcome with the 'new' procedure, that they'd be able to go back in and do a more traditional fix at some later date?

when we were trying to decide what to do in DS's case, someone said to me, no matter what else happens, he will always know that at the time you made the decision, you made it with your heart and your head - because even if he doubts the outcome, he won't ever have to wonder if you love him. and it's true megan. no matter what, jj will never question your unconditional love for him, that's just the kind of mother you are - it oozes from every word you type about your children. anyway, hindsight will ALWAYS be 20/20. all you can do is make the best decision you can with the knowledge you have at the time. it may not be the 'right' decision twenty years from now, but all that matters is that it's the 'right' decision today.

hth, lori
Sam 5/19/05 How lucky I am that you chose me.

[Marisa6826]

What does your GUT tell you?

Can you not talk to patients specifically of this controversial team (and not off a board)?

What is the worse case scenario if you do the new method? Would PC would have to go back and have corrective surgery later if the new technique turns out to be unsuccessful or incomplete?

I think that you need to make a list of questions for both teams and then sort out the pros/cons - kind of like you already have, but after you've met with the doctors and gotten an answer from your insurance company.

Where does your DH stand on all of this?

-m

[Tondi G]

First things first I think you need to A~ see if you can talk to other parents of children or patients who have had the New proceedure done! B~ You need to see if your insurance will cover the newer non FDA approved surgery

Personally I would probably go with the newer proceedure (if my insurance would cover it). What would it mean if things didn't continue to go as "planned" He would need another surgery? a bone graft?

I have a friend who ended up having a VERY premature baby while on a business trip in Mexico. Her son had a heart defect or a hole in his heart and was given some kind of medication to correct it that is not FDA approved, thus not available in the US. If he was born here he would have faced open heart surgery! Although it was difficult she swares there is a reason she was in Mexico when her kiddo decided to come early!!!!

Someone has got to have the guts to "try" new things. Advancements in the medical field would never be made without people will to take a chance that could change the lives of many!!!!

I know a mom who has a daughter my older DS's age and she had a little boy a couple of years ago who was born with a cleft palate. If I can dig up her email addy I'll ask her if she wouldn't mind talking with you! lemme see if I can get in touch with her!

HUGS and Good Luck with your decision.

[o_mom]

If #1 didn't work, would it mean more surgeries than #2 overall or just that you would be back to doing what you would have with #2?

[KBecks]

I think I'd need to know more about the risk of the "risky" method. What are the possible negative consequences? Is it just doing the bone graft later that was to be avoided, or would there be considerable surgical "re-work"? Or worse, soemthing "unfixable?" What are the odds of those things?

I'd be very interested to know what risks they say there are, because they have a responsibility to lay out the potential pitfalls (same with the traditional surgery).


Anyway, it's impossible to know for sure, and very possibly, either situation could work out well for you. I'd see if you can talk to parents of patients who have gone with the unconventional method.

Also, perhaps the specifics of your son's condition make him a better candidate for one method or the other, so I'd ask each team to be very specific about his individual circumstances.

As I've shared, I'm sometimes a horribly conflicted decision-maker over the littlest things, so I wish you lots of success with your decision-making process and satisfaction with your final choice.

ETA: I'm reading a book on decision-making right now, the paradox of choice. While I'm in the middle of the book, I would make a suggestion based on the reading so far. And that is, stay focused to the goal, which is the best correction of the cleft issues for his entire lifetime. So, analysis of the techniques, approaches and the doctors' skills are the most important factors. Short-term factors, such as, how nice the hospital is, or the doctor's bedside manners, do not impact your long term goal, and shouldn't have much weight in the decision.



Karen

[pb&j]

What are the possible bad outcomes of the experimental surgery? What are the results like so far? Is any other cleft team in the country using this technique? What are their results? What circumstances would require additional surgeries? Is their anything that would exclude DS from being a candidate for the surgery? How many cases like your son's (type, severity) have they done, and what have been the results with those specific cases? Can you speak with other parents whose children have had this surgery? Ask to read and be explained all the informed consent documents.

For the standard procedure, how long has the surgeon been doing them? How long has been head of the team? What types of complications has he encountered?

If you haven't yet spoken personally with each of the surgeons, I'd do so before making any decisions.


-Ry,
mom to Max the one year old
and my girl in heaven

http://www.windsorpeak.com/dc/user_files/37124.gif

[o_mom]

Wanted to add one more thing. The FDA does not 'approve' surgeries, to my knowledge. I couldn't find anything on their website about approving procedures. They approve medical devices for use in surgery, but there is no list of approved surgeries like there are medicines. The insurance considering it 'experimental' is not related to the FDA unless there is a new device involved. That will be a different battle to get approval from the insurance company.

Anyway, I personally had a 'new' surgery for infertility and now have two wonderful kids and another on the way because of it. The doctor who did it has done many of these, but it is not something that is widely known about or done and would probably be considered radical by many in the field. I was very comfortable with the results he had in house and the data he shared (much of it was unpublished at the time), but it was still a risk.

I hope you are able to make a decision that you are comfortable with!

[denna]

First I want to say ((hugs)) Megs. It stinks you have to make such a HUGE decision so soon and after you've already been through so much.

I dont really have a set opinion on this but I have a few ideas or questions to throw at you. First, has this 'controversial' surgery been performed in any other country...is there anything in the British Medical Journals on this? If I could look at all of the research I may be more suited to answer your questions since I have no BTDT experience. Is there any hospitals in IL, maybe Chicago area that have teams you'd consider looking at so you can feel more comfortable with the WHOLE decision. Or any other large city closer to St. Louis?

I personally would not blow off the first choice just because the procedure is new. People are often scared of the unknown. You said that the procedure has been around 2 years, correct? How are these patients doing so far? I know your main concern is 10-12yo down the road but has *anything* happened so far in the surgery to this patient.

I am torn with this too. I would try to consult variuos drs. on the 'controversial' decision. Whats the worse that could happen? That JJ would have to have the bone graft that is already a given with the standard procedure? If that is the only possible issue then I would definitely go with the first procedure you mentioned. You definitely seem more comfortable with this team.

Im sure Ive only brought up questions/ideas that you have already been over yourself but I hope that I have helped a little bit.

Good luck Megs. This is such a tough decision.

[hcsl]

I just wanted to say that you shouldn't discount something just because it's new. With our advances in technology the sciences are moving forward at an incredible speed. If your ds had cancer, for instance, would you want him treated the way it has been done for the past 15 years or would you want to utilize a plan that takes advantage of new research, computer models, etc.?

I can't offer any BTDT advice, but the fact that the lead surgeon on team #1 has a cleft palate would mean something to me. He has BTDT. This is something that he knows first hand and has dealt with his entire life. It really makes sense that he wants to help children have as little to deal with regarding the palate as possible. It doesn't seem like someone in his situation would be using children as 'guinea pigs' unless he truly believed in his approach.

Good luck. I don't envy your position of making a difficult decision.

[tarahsolazy]

I'd be hesitant to go with #1 unless they have patients who have been followed to at least around adolescence. Just because of facial bone growth, etc. But, I don't really know the issues involved with the surgeries, of course.

[megs4413]

the new procedure includes the use of a synthetic protein that uis not fda approved for this use...

the protein is used to grow bone

[o_mom]

OK, then that makes sense!

Not being approved for a particular procedure wouldn't necessarily rule it out for me. Manufacturers, not doctors decide what label claims they will file for. It is expensive to file for each claim, so they usually go for the ones that are going to get them the most return for their money. Most allergy drugs or antibiotics, for example, are not approved the symptoms or infections they are most often used for. It doesn't mean they aren't effective or safe. Getting the insurance to pay for that can be tricky, but not unheard of.

It is a huge decision though. I hope you can find some clarity in all of this. (((HUGS)))

[megs4413]

exactly my concern, tarah....first procedure wase in 04 i think....on an 8yo maybe (not sure). this may end up being the gold standard, but right now we're not even sure what the complications might be long term.

[saschalicks]

Megs,
I PMed you I hope you don't mind.

[maestramommy]

If it were me I'd go with the standard team. But Dh and I are leery of anything in medicine that is too new, and certainly something not yet approved by the FDA would make us even leerier.

I understand that you want the top surgeon, but at least the younger surgeon will be working with a team, and learned from the best. That's saying something I'm sure.

[tarabenet]

Megs, as frustrating as I'm sure it is to just read people defending what they chose, there's a major plus in that too: whatever you do, chances are quite good your family will feel solid about it down the road! Hopefully that is something that can allwo you to trust yourself a little bit more as you make this decision, too.

I think the first thing you should do, before you make this choice for sure, is take a little while to get *yourself* OK with the whole thing. Know that whatever you choose will be light years better than the previous only option of "live with the cleft". Your darling child will have the benefit of cosmetic and actual correction, such that no one will ever know it was something your family confronted!

We've seen you here. We know you to be a strong and confident mama who carefully considers her parenting. We know you will do no less with this decision. And whatever the outcome, and whether he must ultimately face one procedure or two, you must know and trust in your very gut that you have done your best for your child.

Like Marisa, I suspect I would lean toward the newer procedure. If a second procedure became necessary later, I would certainly not be happy about that, but I would do my best to remember this: we make the very best decisions we can with the information available to us at the time, and we can't demand more of ourselves than that!

[icunurse]

Personally, I think I'd be somewhat leery that the surgery is so new that they really don't know the long-term outcome vs an almost "sure thing" with the standard surgery though it will require more surgeries. Many, many children have received the standard surgery for a long time and they look remarkable and have come through with flying colors, so the success of that shouldn't be ignored. I would also look into insurance coverage for both now and for possible outcomes for later surgeries (if the newer technique doesn't work out, what are the possible outcome concerns and will insurance pay to repair them?)

As for the younger doctor...I have seen residents with far greater common sense and skills than doctors who have been practicing numerous years. Youth doesn't equate with lack of skill any mroe than a doctor who has been practicing for 30 years means he/she is automatically good. Younger docs may be more familiar with newer literature and newer techniques and be more motivated in the care of their patients. Don't discount for age/experience - they have had a lot before they can practice and it sounds like he has learned from the best.

No matter which option you choose, you are making the right decision for your family. Hang in there and know that we are all cheering for you and your family.

[megs4413]

Thanks to everyone for your replies. it really got me thinking. i also got hooked up with some other cleft moms and got some responses from one of the cleft boards (though i only got 3 responses...no wonder i like it here better!). i'm still very nervous about the decision, but here is where my thinking is right now:

the new procedure:
-the worst case scenario would be that DS would not be able to avoid any of the bone graft surgeries because the BMP didn't work. As far as I can tell, there aren't any other specific risks to the other procedure.

-the real risk is that the long term results of using BMP aren't known, so he could end up needing extra surgeries later if it doesn't produce great results. it could also mean that looks-wise he's never going to be "as good" as some of the kids in the traditional procedure...but again that would be a worst case scenario.

it appears that i can always change to a traditional team if i'm not happy with the new procedure.

another plus i forgot about with the new procedure is that he doesn't have his first surgery til he's 6mos. which i'm more comfortable with.

i have made appointments next week with both teams. the traditional team on tues. and the new team on thurs. i will ask lots of questions and try to get a feel for who we would work well with...right now, though, i'm leaning toward the new team....we will see after next week!

thanks again for all of your thoughtful replies. i still haven't gotten a straight answer from the insurance and i hope to be able to get someone in the doc's office to help us communicate with them. unfortunately, if the new procedure wont be covered by insurance, there isn't any way we'll be able to afford the surgery on our own so we'll have to go with the traditional repair. i'm hoping that we won't be limited by insurance, though, so that i can make the decision that's right for our son and not be forced into anything because of finances.





let me preface this by sayign i realize this is a really personal choice, but i'm just at my wit's end with it and value your opinions greatly. i'd also like to get a lot of feedback, so here we go:

DS has a pretty severe cleft lip/palate. he will need surgery soon. we are very fortunate to live in a city with 3 EXCELLENT cleft teams. i have ruled one out for various reasons leaving us two choices...and i'm T-O-R-N. both are at children's hospitals. both are well known in the cleft community.

#1 the controversial team
-this doc is using a procedure that is not FDA approved currently. it's radical and unique, but very promising and appealing. it eliminates the need for a bone graft later in life (at about 10-12 yo) which is an enormous plus. but since it's not proven and has only been going on for like two or so years, there's no long-term findings to base my decision off of. it woudl require a lot of faith and guts. the cleft community disapproves of this man's procedure because they feel it shoudl be studied longer before being utilized...

Pros
-less surgery
-promises better results
-head surgeon is a cleft himself so he has personal experience and is very easy to get along with and patient focused

Cons
-i couldn't forgive myself if i went with the risky new procedure and something went wrong down the line.
-no one can guarantee results long term cause the procedure is new
-i'm not familiar with the hospital
-it's possibel that insurance would deny our claim because the FDA has not approved the procedure


#2 the old standard
-this team does a traditional repair. all the team members are highly respected in the cleft community, but the head surgeon is younger and is the recent replacemnt for one of the top cleft surgeons in the world who has moved onto the hospital we ruled out. this means that the team working around the surgeon is one of the best in the country, but the surgeon himself is younger, though trained by the best surgeon in the country....

Pros
-i know they will do a satisfactory job as they have done for years
-fabulous hospital...fabulous
-the specialists on the team are some of the best in the country

Cons
-surgeon is less known and less experienced
-traditional repair will mean lots of surgery and a bone graft


anyone care to weigh in? i just don't know waht to do. i wish i didn't have to make this decision so soon! i have an appt with the old standard surgeon next week....i'm hoping against hope that i'll just "know" when i meet with him....

ETA: i asked the 24 hour cleftline person what she thought we should do...and she recommended the old standard team. the controversial team has a poor reputation in the cleft community becuase they've basically thumbed their noses at the standard procedure and gone ahead with a procedure that the overall community feels is being used prematurely. it seems like the cleft experts at the cleftline would know their stuff so i value that opinion greatly....

[elephantmeg]

Amen!!!!!!! Of the surgical group at the hospital I work at the best one IMHO is the youngest guy. Really.
>
> As for the younger doctor...I have seen residents with far
>greater common sense and skills than doctors who have been
>practicing numerous years. Youth doesn't equate with lack of
>skill any mroe than a doctor who has been practicing for 30
>years means he/she is automatically good. Younger docs may be
>more familiar with newer literature and newer techniques and
>be more motivated in the care of their patients. Don't
>discount for age/experience - they have had a lot before they
>can practice and it sounds like he has learned from the best.

[dawell0]

I just spoke with a surgeon on your scenario (he doesn't himself do cleft but works with some who do). He said that it would depend on the possible risks/alternatives of the 1st procedure. I didn't get into the fact that it involves the protein since I figure that could be somewhat proprietary, not that he probably couldn't find it somewhere in the med lit. He also said that his advice would be to talk with them extensively before making any decision. They have to give you the worst case scenario, so don't feel too worried. I would ask for their ideas, come up with a list of questions about each scenario. See why the traditional guys don't like the new procedure and why the new guys want to do the new procedure vs the traditional method. He said that even the old school surgeries are slightly different at each person's hands, but that a young physician may be fresher and wanting the best results, and may be better. Of course, there are different ways of doing many things and that doesn't mean that either choice is bad. As a person that is involved with clinical research, I have seen things work and things not work, so it is hard to guess. Unfortunately, in either situation, you have risks. I understand that you don't want your child to be a test case, but it also may be the best alternative. If you email me more specifics, I can do a literature search for you.

[madelinesmom]

Megs,
I sent you an e-mail but I wanted to say that I did have bone grafts and bone marrow transplants b/c the graft did not work. The places and issues surrounding the graft are very different but they took the bone from my pelvis and it was very painful, I would be so excited for anyone having to go through a bone graft to have this avaliable. I just think it is really exciting news that there is a synthetic out there that would help bone growth.

Jane
Madeline 1/20/03
Emily 11/29/05
http://b4.lilypie.com/l3-em6/.png
http://b1.lilypie.com/-FG1m6/.png

[DrSally]

If it were me, I'd go with #2. In general issues of medicine and science, I tend to go with what the general accepted concensus is among that particular group. There is a lot of experience distilled in these experts and they wouldn't be dubious for no reason, KWIM? Perhaps #1 would be more viable after some studies and several years down the road, but that's not where you're at right now. I don't know alot about cleft palate issues, but many kids have had the traditional surgery(s) and done great, right?

The only drawback I remember you mentioning about #2 is that the surgeon is younger and less well known. I know that those trained by a top notch mentor often do very well as they have had the benefit of a lot of supervised experience under the best. If it were me, I would not hesitate to work with a protege of a famous mentor, esp. if that person had many years of experience under their belts. And you said the hosp. is great. Anyway, that's what I would do if it were me.

ETA: another benefit of going with someone's protege is that they are often easier to get into and less expensive. It takes time to develop the superstar reputation, and often those docs are older and have their supervisees do a lot of the work anyway, so this new doc may have been doing this proceedure for years. Also, as others have said, anyway you can find to talk to pts. who have done #1 would be helpful. If the only thing not FDA approved about #1 is the drug, then I wouldn't see that as a big deal since a lot of meds are used off label. As others have said, find out the worst case scenario with both, even the theoretical worst case with #1 since they don't have a long term view on that one yet.

[ShanaMama]

Megs, I totally understand why you posted this. I am inspired by the replies you've gotten- look what we have here! A community of ppl that don't actually know each other, yet care about, respect & support each other. Reading through the responses here makes me very proud to belong to this community. It also says something very special about you that we all know how incredibly devoted you are to your children, & even though you've been through so much recently, you insist on understanding, researching & making a thorough decision for PC's care.
To get to the point, I'd agree with the posters who said go with your gut. I can't answer which one I'd choose, because I'd meet with each surgeon personally, get a feel for him/ her, detail my concerns, and then decide which one I felt more confident entrusting my child to. If either one brushed off one of my concerns at any point, or refused to meet with me & talk out all the options, I'd run far away from that team.
Unfortunately, finances do play a large part in our healthcare decisions. If at all possible, try to leave that part out of the picture until you feel more comfortable with one option over the other. I don't know your financial situation, but even if insurance would not cover the surgery, I'd consider doing it if it feels right to you. Beg, borrow or steal. This is a decision with long term ramifications, and as much as practically possible, try to put the financial issue on the back burner. If I had unlimited funds, I'd give out grants for this type of thing! It bothers me so much when people are forced to choose medical care exclusively because of $.

Lastly, I agree that you should try to talk to each surgeon's patients. Even though they can't give you long term data, they can tell you how the experience went. Was he completely upfront with them about the risks/ worst case scenario? How did he react if something unexpected came up during the surgery? How much support/ follow up did his office provide after the procedure? Talk to patients of both doctors. You may surprised at what people tell you, and you might just build yourself a little support team right there.
Best of luck with your decision, and you know we are rooting for you. Let us know what you decide.