Has anyone had micro fat grafting?
Comments
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Lizzymack1,who is your doctor? There is a separate thread to post doctors who do the fat grafting.They are few and far between right now,so every one we know about helps!I wonder if there should be a separate thread where those who have it done could post their stories?
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I asked my Dr. if he was familiar with Dr. Khouri's method and this is how he replied:
Yes, I met Dr. Khouri at a meeting in Jan. I also am familiar with the
Brava. I agree with his fat grafting results. The Brava is used by my
colleagues a the Shriner's Hospital and the results are not as good as Dr.
Khouri has been able to do himself.Thanks
Wes -
bher wrote:
I am scheduled for surgery in early July with Dr K for removal of implants and alloderm and 1st stage fatgrafting. Looks like I may need four surgeries to make it right.
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Hi bher, come on over to fatgraftpatients com and just start a new thread under patients stories and call it bher's surgery and just start talking. You don't have to read the whole site. There is a thread for tips on what to bring, preop and post op. Also lots of info on Brava wear.
I am curious about what Dr K is doing for you. I am also a uni implant but he did not want to just remove my implant and start building a breast. For some reason he insists on replacing the implant with a smaller implant and fat, then next stage maybe remove the smaller implant. He told me I would not be happy with the way I looked in between stages. I don't care about that; I just want to get rid of my badly contracted over-10-year-old implant. But I am scheduled for Aug 5 stage one the way he wants to do it. I wonder why he is willing to remove your implant completely.. maybe because of the alloderm? You have a small implant in the native side too, is he removing that and fat grafting? Sorry for all the questions. You can pm me if you would rather discuss it offline. Or at fatgraftpatients where there is less traffic.
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Hi Kareenie - I think Dr. K is removing my implant and not replacing it with a smaller implant on the first surgery because of the alloderm and also my incision has been draining and there is possible infection going on. He mentioned putting a smaller implant in with more fat grafting on the second surgery. At this point in time, I just want them (implants) out! The small implant on my native side is coming out too and fat grafting. The radiation and implant just did not mix well in my case. I will check out the fatgrafting website. Thanks
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Wow... this thread has suddenly gone quiet!
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I went to a talk yesterday with a couple of surgeons who were explaining the different procedures used for recon. I asked about the microfatgrafting. One of the docs, who just returned from a few years of practice in L.A, knows about it and the brava system .No one here in Ontario is doing it and she said if it starts here, it will have to start as a clinical trial but there are no plans to start that yet
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It's been so quiet around here lately...
I am going to see Dr. Khouri next week. Any words of wisdom for me? -
For some reason my page wasn't showing that this thread had been updated so I missed weeks of postings! I've got to catch up!
bher- Glad to hear you have a surgery date with Dr. K! That's exciting!
BJB1- I understand your anger in knowing there was something out there that was a better option for recon and not having it. You said your error was in not doing more research but I think the error lies in the fact that surgeons are not required by law to tell us all our options- whether they can provide them or not. This is something that needs to be changed for all our sakes! I'm just glad I did go years being miserable before I found Dr. K. He has made such a difference in my life.
I think Lee already answered this but Dr. K let me choose where I wanted the fat taken from. I told him my stomach since that's the hardest area for me to lose. He said there wasn't enough there (which I found hard to believe) so I told him to pick additional spots where ever he thought best.
Some of you were wondering about the replacing vs removing the implants. What Dr. K told me is he used to just remove the implant with the first procedure but he found it was too devastating psychologically for his patients. He said it felt like a giant step backwards for most of them because they would have so much loose skin for months. He found it was better for them emotionally if he replaced with a smaller implant once or twice until the whole breast was fat. That's why with my first surgery he swapped them out. I have lots of Alloderm so that wasn't a factor in why he chose to do it this way as far as I know.
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I just got back from my PS and the next step in my very long breast reconstruction (diep then te/implants under diep to improve balance) is fat grafting. He says he will take fat from my thighs to fill out my foob and it will be an out patient procedure.
Is this going to hurt? What was recovery like for those of you that have had it?
Oh, just to clarify, this is not BRAVA or Dr. K. We are talking lipo here.
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chinablue- I had Dr. K but here is my experience. Most of the discomfort came from the lipo itself but it's pretty short lived. I was very sore the first 2 days but every day after that was better than the one before. I was bruised where the fat had been taken from but, again, these went away pretty quickly. The worst bruising (I had the fat taken from my stomach, hips and thighs) seemed to be my inner thighs. The lipo areas were tender under the skin for about 2-3 weeks, though, and I still have a tiny scar at each spot which should go away with time. After the lipo you'll usually have some drainage for about the first 24-48 hours as well.
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Pinkbutterfly - Good luck next week! I'm sure you will see why those of us who have been lucky enough to have Dr. Khouri do our reconstructions/revisions, are so fond of him. An expert surgeon, a true artist, but most of all a compassionate human being. Hugs and best wishes!
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Chinablue - Like Kate, Dr. Khouri did my revision. To me the lipo pain was like the soreness after a super intense workout. First two days hurt, but then then each day gets better. Bruising took 2-3 weeks to clear up, but sometimes tenderness and numbness can linger for quite a while. Really nothing to be anxious about. Take the pain meds the first couple of days and then you will be fine. Good luck!
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Thanks Lee!!!
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pinkbutterfly- Definitely write down all your questions for Dr. K. It's easy to forget once you're in there. This will probably be your only appointment prior to seeing him on surgery day so take advantage. I would also ask him for an email address you can use to write to him in case you think of any other questions later. He runs late a lot of time so bring something to do. I had to wait 2 hours for my consult (but he was worth it!). He will do an exam and take pictures. If you decide to move ahead with surgery Cindy will give you a list of pre-op testing you need to have done about a week before the surgery. I would also try to get everything pre-authorized by your insurance company, find out what is in network and what it's all going to cost so there's no surprises. Good luck with your appointment!
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Thanks so much ladies for sharing your experience. My PS suggested taking fat from my inner thigh. I am wondering if any of you had permanent numbness at donor sights.
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chinablue - I've had fat taken from inner and outer thighs, inner knees and lower back (muffin top). No permanent numbness anywhere. Areas that took the longest to heal were inner knees (actually just one leg, lol) and lower back.
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Oh what a relief! Thanks so much.
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chinablue- My surgery was mid May and I just have a little bit of numbness left on the inside of the thighs. All my lipo areas were really numb right after so it seems to be improving every week.
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I found a doctor 2.5 hours from me that does fat grafting.I have an appointment with him on Monday.I am still worried about the cost of the Brava and skin complications,but I have read on this thread that it is in the process of being cleared by the FDA. So I decided to contact the FDA and see where it is in the clearance process.Figured if it was going to be in the next few months,I would wait and have insurance cover it and be more assured with its safety.The FDA told me there has been no application for the Brava to be used as a medical device for fat grafting or any other purpose except breast enhancement.I have to say,this concerns me, when it clearly states on the Brava website that it is not to be used by mastectomy patients,those having a breast scar larger than an inch or have a history of breast surgery.I honestly thought this was going to be FDA approved in the near future.I thought that was part of the purpose of the clinical trial.Why would they NOT apply for approval if it is safe?I also wonder if this is keeping more doctors from jumping on board.Does this bother anyone else or just me? I was so happy thinking I was going to be able to have the recon method that was right for me...I guess I could still go ahead,I do feel the fat grafting is safe,but this makes me feel the Brava is all a scam...especially since there are doctors who do not use it...
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Pandazankar - Brava was initially used for breast enhancement and goes way back. Women just used the domes to expand their breasts and that was it. No further treatment at all. Since the expansion worked, the idea of injecting fat into this fertile tissue was developed and that was the initial clinical trial. Since then the trial has been expanded and since the results from the enhancements were so encouraging, thankfully, breast reconstruction is now a part of it as well. That Brava works to expand the tissue is proven - just look at the expansion photos of some of the ladies on the fatgraftpatients forum. To have fat injected into the expanded tissue and have it survive is also dependent upon the fat grafting technique. Lots of doctors don't use the Brava - lots of ladies report the fat grafting doesn't take. I've never had "traditional" fat grafting, but I can certainly attest to the fact that I've lost very, very little of the fat that Dr. Khouri injected AND I can personally tell you that the Brava dome pulled my indentation out and provided the space necessary for the grafts.
I can only imagine the lengthy process and the jumping through hoops necessary to get FDA approval.
Yes, fat grafting is considered safe but I'd rather have it done in a manner that assures me the highest chance of the fat surviving. Using Brava (even if just on one area) along with the tedious, yet essential, droplet by droplet method of grafting certainly did that for me.
I know it's tough to wade through all the differing and sometimes contradictory information out there, but for me and for many other women, this has been a miracle.
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My concern is that it was posted here that the Brava is awaiting FDA approval,that led me to believe that it had at least been applied for.I feel like I was lied to.( I am NOT saying Alexandra-aa lied,but was supplied with wrong information)I cannot believe that a doctor who professes to care so much about women, would not go the extra mile to get the Brava approved and covered by insurance,especially if it will change the whole concept of breast reconstruction.Surely he is aware of the many many women(and I am one of them)who after cancer are still in trouble financially and/or scared when they read "do not use if you have had a mastectomy".
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My understanding was that brava was evaluated for 510(K) compliance at FDA and the FDA has decided not to regulate it at this time. Not sure if that statement applies to using the brava for breast augmentation through. FDA doesn't regulate all devices in the same way and I think it doesn't regulate some devices at all.
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I found this link on clinicaltrials.gov titled "Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting".
http://clinicaltrials.gov/ct2/show/NCT00466765
It says it is currently recruiting participants.
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Hi pandazankar
Honestly, I was just posting back what I read in this thread last year: in this post (click here).
And the study I referred to is the one Kate linked to. The only approval it currently has is for costmetic expansion, independent of fat grafting. Sorry for any confusion.
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Just read this in an article about using Brava/fat grafting for reconstruction-
Dr. Khouri has the world's best documented experience on the subject. Dr. Khouri's work was just awarded the best scientific achievement at the Annual Meeting of the European Association of Plastic Surgeons (EURAPS) and he will be delivering his presentation and receiving the award at the 2011 Annual Meeting of the American Association of Plastic Surgeon. -
I find it hard to believe that a device of this type would not require approval for use in women with a history of breast cancer. Having said that, it would certainly require a lengthy trial and approval process that would likely cost millions of dollars, thousands of patients, and a long follow-up period. I asked a few questions along this line of Alexandra a while back and I never did see a response posted.
I have done extensive research in the form of asking experts ( my breast surgeon, my medical oncologist, my radiation oncologist, an oncologist at MD Anderson, my plastic surgeon, the Susan love foundation, and I'm sure a few others that I can't recall) as well as reading all the scientific literature available on the Internet in English. Most stated that it was their belief that fat grafting is safe. However, this is not based on the types of randomized controlled clinical trials that would be required to prove this definitively. This is separate from the issue of whether Brava itself is safe for women with a history of breast cancer. One of the experts I asked said that not enough was known about Brava and who it would be safe for. My RO, not knowing anything about the specifics of this procedure, found it very far fetched that it might cause cancer cells to grow. So, it is basically used off-label, which is legitimate as long as patients are informed of the risks (not all of which may be known). In Europe, patients who undergo fat grafting are required to be monitored through a clinical trial so that outcomes can be measured, however, there is no standard treatment, nor is there a control group.
I think it is safe to say that these questions will not be resolved for years to come.
Not to sound like an infomercial, but these are my own opinions and the results of my own research, and it is certainly not my intention to mis-represent any facts, so if anyone has more info or knowledge on these issues, please post.
In the end, it's going to be an informed decision to be made on an individual basis whether someone feels comfortable with this or not. Doesn't resolve the insurance coverage question, though.
I've been struggling with this issue myself ever since I learned about this procedure. There, got it off my chest. I'll be quiet now. -
My email to FDA I am a woman who was diagnosed with breast cancer and
have spent the last two years researching reconstruction.A Dr.Khouri in
Miami Florida is performing fat grafting for total breast
reconstruction.This appeals to me for a number of reasons, fewer
scars,shorter recovery,etc.He requires the use of an external device called
the Brava bra.I have been told that this device is approved for breast
augmentation for cosmetic purposes,but it is not approved for breast
reconstruction.It is my understanding,that for a medical device to be
covered by insurance,it must be FDA approved for that purpose.I would like
to know if this device is in the approval stage and if so,how long before it
will be approved and covered by insurance. Thank you.
Jaclyn D.Hall Their response:Your interest in contacting the US Food and Drug Administration
(FDA) through your recent email is appreciated.
My research into our medical device database reveals that the
Brava breast enhancement system is listed with the FDA as required at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=216710&lpcd=LCJ. However,
this is considered a "preamendment" device meaning that the company was
marketing it in the United States prior to the Medical Device Amendments of
1976. If there have been no significant changes, then it may continue
marketing until final classification, or until a premarket notification
application is required. The actual device classification is available
at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5190.
However, the FDA has no regulatory authority
over insurance coverage which is at the discretion of the individual
insurance carriers. You may wish to pursue this matter with your own
insurance carrier before making a decision on your medical course of
action.
Hopefully, this response will be of assistance and you are wished
the best in the management of your health care!
Cynthia Benson
Office of Communication, Education
and Radiation Programs
Center for Devices and Radiological Health
U.S. Food and Drug Administration
1-800-638-2041 I then asked for clarification....Thank you so much for your prompt response.I want to be sure I am understanding this. The Brava has FDA approval to be used as breast enhancement but there is no application in process to have it approved for use in breast reconstruction in cancer patients and the response :Upon further consultation with
our experts, Jackie, I learned that the Brava device does not have FDA
premarket notification clearance for the indication of
fat grafting. So perhaps this information will further assist your
decision-making.
Cynthia Benson I wanted to be very sure I understood,so I sent one more email "So the Brava is FDA cleared for breast enhancement,but something additional should have been filed for it to be cleared for fat grafting..correct?" and the reply : Yes, that is correct that there needs to be a
separate clearance for the indication of fat grafting, Jackie." I know this is hard to read,but I was cutting and pasting.....From what I have read on the FDA website,getting the Brava approved for fat grafting would not be that difficult,since it is all ready approved for another similar use....maybe someone else could read it,I may have missed something.Alexandra-aa,I mentioned you because you were the last to post about it waiting for approval and I did not want you to think my anger was being directed at you.I am wondering where jseda got her information that it was waiting for FDA clearance? She stated it with such authority,I thought she knew what she was talking about.I am glad I found the truth. I honestly do not think the Brava would cause problems,BUT as pinkbutterfly mentioned,it is being used off label.I know from experience with my pets,if you use anything off label,you have no recourse if something does go wrong.My local plastic surgeon went to a seminar and his complaint was only positive outcomes were shown,he cannot believe that there is a 100% success rate.He felt some less than perfect examples included would have helped them know what that looked like too.I think Dr.Khouri is a very talented physician and microfat grafting is what breast reconstruction should be,but with the Brava not covered by insurance, he is making it impossible for women with limited income to have the procedure done..not to mention that most doctors doing it do not accept insurance,so there are possible out of network costs.This angers me, ALL women should be able to have the breast reconstruction of their choice. -
Pandazankar,
Getting a medical device approved for a new indication in healthy patients is one thing, but my gut tells me that getting it approved in patients with a known history of cancer would be more difficult. Like you, I too would like to see this. Until more studies are done, we are basically left to fend for ourselves. I'm grateful for the options we do have, but sometimes it feels like we're still in the dark ages with cancer and reconstruction. I feel your pain. -
Ok, just found out for any medical device or drug to start the process of being covered by insurance,it must first be approved by FDA.Which makes sense to me.
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pandazankar- Not sure how it all works but wouldn't they first have to do clinical trials before applying for approval from the FDA? On both the Brava site, and the government clinical trials site, they say there are clinical trials underway testing Brava to be used in conjunction with fat grafting. Here's what the Brava site says-
11. Are there any new clinical trials offering options for breast reconstruction following a mastectomy or lumptectomy?Yes, The Brava System is presently being used in a major clinical study by leading Plastic Surgeons in the U.S. and Europe, to assist in the transfer of Autologous Fat from other parts of the body (e.g. stomach and thighs) to the breasts.This revolutionary study is on-going with encouraging preliminary results. The scientific theory is that the Brava System helps enhance the endurance and the survival of the new cells that are grafted into the breasts from other parts of the body. The Brava System also allows for a greater size increase in the breasts by allowing a greater amount of cells to survive the fat transplant due to better blood circulation to the area and the expansion of tissue in the breast area that will accommodate the transfer of the new Autogolgous Fat cells.The preliminary results have been presented at a major medical conference and the study is presently being submitted for publication in a major medical journal. To learn more about this clinical trial study,http://www.clinicaltrials.gov/ct/show/NCT00466765?order=1.Learn more about Fat Grafting to the Breasts:
http://www.youtube.com/watch?v=syx1guRVfmM
http://www.youtube.com/watch?v=H2_cK-ddpnw
http://www.plasticsurgerypa.com/index.cfm?event=ProductView&CategoryID=33&SubcategoryID=29&ProductID=337
http://www.plasticsurgerypa.com/index.cfm?event=ProductView&CategoryID=33&SubcategoryID=29&ProductID=503
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