Carbon Dioxide-Based Tissue Expanders for Breast Reconstruction

Wallis

I'm 8 weeks out from a PBM with TE and am scheduled for exchange surgery in March. I'm enrolled in a trial of a new kind of expander that is filled w/ gas rather than saline. Whippetmom thought some of you might be interested in hearing about this and I'm starting this thread at her suggestion.

 

The device is supposed to make the expansion process easier, faster, and less uncomfortable, and to give the patient greater control over the rate of her own expansion. Inside each expander is a little cartridge of compressed gas. At each expansion the cartridge releases 10 cc of gas. The patient triggers the expansion herself, using a hand-held remote-control device. She can do it up to three times a day. The remote-control device has some kind of microchip that makes it impossible to over-expand. (You can click only once at a time, and only up to three times in a 24 hour period.)

 

3 expansions equals 30 cc per day per breast, or 210 cc per week. You can reach 800 cc in a month. The process, as I understand it, is much faster than with saline expanders.

 

Because each increment is so small (10 cc), expansion is less uncomfortable.

 

On the other hand, if 30 cc per day is too much, the patient can go slower: can expand once or twice a day, or for that matter, once or twice a week. She can control the pace of her own expansion. 

 

No needles, and theoretically fewer visits to the PS.

 

I've read that some women find their saline expanders "heavy." Needless to say, the gas-filled ones feel light. They are hollow. When I tap on mine, they sound a bit like a drum.

 

One big DISADVANTAGE to be aware of: you're not allowed to fly while the TEs are in your chest. I suppose they're worried you might explode at high altitude (not joking.) So this isn't the expander for women who need to travel as part of their work.

 

Theoretically, the expanders have a "natural" shape, rather like those gummi bear implants I keep reading about: the point of highest projection is about 2/3 of the way down. In fact, I have to say that mine don't look particularly natural or beautiful. But then again, they're not fully expanded. Maybe they would project in a more natural way if they were filled to capacity. 

 

Like saline expanders, they are hard and uncomfortable but perfectly bearable. If you want to know more about these expanders, go to www.AirXpanders.com

 

whippetmom

I am doing some further research on this novel approach to tissue expansion.  One of the primary benefits seems to be referable to the complicated and controversial issue of pain. There are numerous threads here on bc.org relative to pain and severe discomfort with current tissue expander devices.  Here is a photo of the TE, and also depicted is the patient-controlled device which enables the patient to control the degree of expansion on a daily basis.

Sassa

I wonder if there is also any thought given to changes in altitude.  As a flatlander (50 feet above sea level), I imagine I would have a problem if I decided to go out to Denver (one mile above sea level) and then explore the Rockies. 

Wallis

Sassa, here's what the manual says:

"C02 expansion at high altitutde may cause discomfort, overstretching of the skin and tension on your incision.

It is unlikely, but possible, that this could lead to wound separation or rupture of the expander.

For this clinical investigational study, it is recommended that you do not travel by air or ascend more that 3,300 ft during the time the TE is in place."

I guess that rules out the Rockies, at least for those of us who live at sea level. (There's got to be a joke there about expanders and rockies.)

Sassa

LOL, Wallis.  I guess the fact that I use to be a Team leader for review of investigational medical devices at FDA still shows up. I would have looked at the application and asked the engineer doing the review about the altitude. 

I'm glad someone was on the ball on this issue.

whippetmom

Wallis:  What is your pain level with your tissue expanders?  Can you describe how they feel on your chest wall?

Wallis

Whippetmom:

At this stage, 8 1/2 weeks out from PBM, my pain level is close to zero. I feel a mild tightness every time I expand, but that's all. How do the expanders feel on the chest wall? It's hard to describe the sensation. They feel like foreign bodies, hard and light, but they don't hurt at all. Of course, I've never experienced traditional saline expanders, so I can't really say how they compare.They're most uncomfortable when I sleep: when I roll over on my side or front, they wake me up.

whippetmom

About 30% of those of us with traditional tissue expanders complain of moderate to fairly severe pain after MX. Probably 10 to 20% of these women are in considerable pain and discomfort throughout the entire expansion process - approximately two months to six months - to the exchange. 

whippetmom

Had to edit my numbers above a bit....I think that many of us experience discomfort to some degree, during the tissue expansion phase, but pain is something different indeed. 

Layla2525

Wow, anything could be an improvement over the way the TE feels once the docs cut you off from your pain meds. My PS absolutely refuses to write any prescrips which is weird,if she is an md then why cant she write prescripts,she is obviously a surgeon. ??? board certified. My BS had to write out all my meds and wont do anymore cause I am no longer her patient, The PS makes me wait 2 wks to get an appt with my primary dr where I could end up catching a cold there and then see if that dr will write it. Why is it all so complicated?

whippetmom

bump

webmd

I am interested to hear how the final stages of your expansion went Wallis ?  A physician colleague of mine has put in 15 of these devices with no problems at all.  His patients expanded faster than they would have with saline and of course you already no about the benefits of not having to be poked with a needle every week to ten days.  As I understand it, the altitude restriction is just in effect during the clinical trial.  The company has now completed the testing to verify that these TE's can be used during air travel and elevations up to 10,000 feet. I guess that would preclude the very top of China Bowl in Vail or base camp in the Himalaya's, but most everywhere else would be good.  

webmd

I am interested to hear how the final stages of your expansion went Wallis ?  A physician colleague of mine has put in 15 of these devices with no problems at all.  His patients expanded faster than they would have with saline and of course you already no about the benefits of not having to be poked with a needle every week to ten days.  As I understand it, the altitude restriction is just in effect during the clinical trial.  The company has now completed the testing to verify that these TE's can be used during air travel and elevations up to 10,000 feet. 

Wallis

I had my exchange surgery yesterday. I'm all bandaged up and so haven't seen the results yet: am keeping my fingers crossed. As for the expansion process, I have to say it was all very easy. By all accounts, this new type of expander takes much less time to reach the desired size (bm to exchange surgery in about 2 1/2 months, in my case) and is much more hassle-free than the saline type. And using the remote-control device (dare I say it) is even kind of fun: it makes flashing lights and beeping noises like something out of Star Trek. I expect this type of expander will soon become the norm.

whippetmom

Wallis: Congratulations!  Please let me know about your results once you can take a peek! I hope you remain on this thread - keeping it active, so you can help educate others who might be starting their journey and would like to locate a plastic surgeon who has access to this new type of tissue expander. 

Deborah

whippetmom

Patient-Controlled Tissue Expansion:

Here is a link to the clinical trials information.  At the bottom of the page you will find the list of the plastic surgeon-investigators participating in the study.

http://clinicaltrials.gov/ct2/show/NCT01425268

Wallis

Wallis

Here's a segment about the new tissue expanders that was on CBS News a few weeks ago. I can't figure out how to copy-and-paste a link on this site. But if you google the following title, it'll take you straight to the relevant youtube page.

After mastectomy CBS Report: Needle free tissue expander for breast reconstruction by AeroForm

whippetmom

Wallis:  Thank you for this.  Here is the link....

http://www.youtube.com/watch?v=Fv6YOMK182E

whippetmom

If you are in the beginning stages and have not gone through reconstruction yet, please consider this method of tissue expansion.  I think it might be advantageous for those who feel compelled to complete their reconstruction from TEs to implants within a calendar year for insurance purposes. You can PM me - I have the names of doctors who are in clinical trials with AeroForm.

Deborah

whippetmom

Bumping for Karenr

CityFi

I, too, am in this clinical trial. I had the UMX on 4/25 so I've been "wearing" the AirXpander for two weeks to the day. I haven't been given the device yet to inflate myself since I had nipple-sparing surgery and my survivor is still a bit bruised. The PS wants to wait until the bruising is down before allowing me to expand.  As for discomfort, apparently these TEs are slightly bigger than the usual ones, but depending on my position, I can forget I have anything inside me. But as Wallis said, sleeping on my side can be tricky. Not impossible but I can only lean so far without feeling it press against my breastbone - not fun.

Two out of three women who agree to be in the study randomly get the new TEs. My PS says that he actually feels bad for the women who don't get it because by the time they agree to enroll in the study, it's because they want the new expanders and are very disappointed when they don't get them. He's had one woman expand in two weeks. The good news is they expect these to be the standard of care in 5-10 years so more and more women who opt for implants will have access to them. 

CityFi

On a funny note, my PS first name is Jeffrey and since he's the only doctor in NY in the study, my patient navigator calls them the Air Jeffreys. 

whippetmom

City:



Thank you for your post. Please keep us updated on your journey!

CityFi

Will do. I have yet to have any expansions. My PS woud like me to heal more before handing over the remote. :-)

CityFi

No expansions yesterday either. The PS didn't even bring the remote into the room like he did last week since my nipple is taking her sweet time healing. I'm not mad at her LOL! 

CityFi

So yesterday I had just one fill of only 10 ccs in my plastic surgeon's office. While it has not fully healed, the scab on my nipple was small enough to give it a try. It felt like I was taking a breath. :-) 

Today I saw my breast surgeon, and he explained to me that because the AirXpanders are slightly larger, they have experienced occasional issues with small-breasted women with their surgical incisions opening. The standard TEs are smaller, and before they're filled, not as tight whereas the AirXpanders already give some shape and are tight from the start because of the way they're designed. So that's why they're being very careful about not expanding until all surgical wounds are fully healed.  

I should get my remote in about a week or two, and then expansion should go very quickly - a couple of weeks.  

whippetmom

CityFi: Please continue to post here about your journey with the AirXpanders.  It will be helpful as other women join the clinical trials for this device.  Thank you!

CityFi

Over the past few weeks, I've had a few fills now that the remaining scab I had was very small.  At first, just one shot of 10 ccs at the last two visits. But last week I got lucky and the PS thought I could handle more.   He broke out the override key and allowed me to expand myself 30 more ccs. We joked about what would happen if boyfriends and husbands ever got their mitts on that key!  Anyway, he brought up another great advantage of this new technology. I began chemo last Monday, and he said that I had the standard TEs, I would have had to wait until after chemo to start expanding again. Since the current TES require injections, they would suspended so as not to put patients at risk of infections. My PS in on vacation so I won't see him this week, but he thinks when I see him next, he'll be able to let me take home the remote. Finally!  I'm like a kid waiting for Christmas to get my new gadget. 

whippetmom

CityFi: that is pretty exciting and hilarious about what men could do if they got their hands on that remote. Keep the updates coming!

whippetmom

AEROFORM TISSUE EXPANDERS

ASK YOUR PS ABOUT THESE NEW TISSUE EXPANDERS.....RECENT FDA APPROVAL!

UPDATE: I was just contacted by the representative of AeroForm...the company producing the tissue expanders which the patient can easily fill at home. LINK IS ABOVE