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Remote Controlled Breast Implants

Remote Controlled Breast Implants

CREATED Oct 23, 2013

CAMPBELL, Calif. (Ivanhoe Newswire) - Thirty-three percent of women choose to get breast reconstruction surgery after having a mastectomy. This low rate may come as a surprise to some, but when you consider today's long process of using needle-based, saline expanders, you might see why some women opt out of this process. Now, a new remote controlled device is helping ease some of that pain and fear.

Marie Jobson and her husband are bringing southern BBQ to California, but her restaurant had to be put on the backburner when she was diagnosed with breast cancer.

"The double mastectomy was the right choice for me," Marie told Ivanhoe.

But following a mastectomy, she had to make a very personal choice on breast reconstruction.  Traditional saline expanders can take up to six months, with at least one, 15 minute doctor visit a week, and with each visit comes a painful needle.

"It requires poking a needle through skin, through muscle, and into the implant," Kamakshi R. Zeidler, MD, Plastic Surgeon, Diplomate, American Board of Plastic Surgery, Aesthetic & Reconstructive Surgery, Campbell, California, told Ivanhoe.

 Now, there is a new remote controlled device called the AeroForm that uses air instead of saline.  It cuts the expansion time from months to a couple of weeks. It also allows women to inflate the implant at their own rate, up to three times a day, with no needles!

"Within this implant is a cartridge of compressed CO2 and this little red area is an antenna. It's activated by the remote," Dr. Zeidler said.

All a woman has to do is push a button, then the remote activates a valve and the CO2 is released. Marie says she gets three doses a day, each at 10 cc.

"This is one less visit to the doctor," Marie said.

It's giving women like Marie control and time back.

Dr. Zeidler said that patients cannot dose too much.  The remote is programmed to allow only three doses a day and up to 30 cc, which is less than what they put in traditional saline expanders in an average visit. 

RESEARCH SUMMARY

BACKGROUND: Breast implants seem to be known as a cosmetic procedure, but with the increasing rate of women who develop breast cancer, it is more than a confidence boost. Women opt to have a breast augmentation after a mastectomy to reconstruct the damage that breast cancer left behind. A mastectomy is a surgical procedure that removes all of the breast and nipple. A woman may choose to have a mastectomy to remove the entire breast, a partial mastectomy that removes some of the breast, or a lumpectomy to remove the tumor and surrounding breast tissue. (Source: http://www.webmd.com/breast-cancer/mastectomy)

SIGNS: If you are experiencing any of the signs below, it is suggested that you schedule a visit with your physician.

TREATMENT: When it comes to deciding what to do when you are diagnosed with breast cancer, most patients are encouraged to go through radiation and chemotherapy. If surgery becomes necessary, then a patient is to decide between a lumpectomy or a mastectomy. If a mastectomy is the final decision as far as surgery, then a woman may consider going back under the knife after remission. This surgery entails breast reconstruction or breast augmentation. There are two different makes of implants; silicone and saline. Each option will depend on the patient's physical situation and preference.  (Source:http://www.webmd.com/breast-cancer/cosmetic-procedures-breast-reconstruction)

NEW TECHNOLOGY: The latest make of breast implants are remote controlled. This new technology named, AeroForm entails a CO2 cartridge and an antenna. All the patient has to do is push a button on the remote and relax as the CO2 is released into the expander. This practice cuts down doctor visits and is less painful than traditional reconstructive procedures. Patients cannot overdose on their CO2 releases because the remote is programmed to allow up to thirty cc's a day. Patients opt for this new procedure because it does not require months to inflate and patients don't have to endure the pain of a needle during traditional procedures. (Source: http://www.airxpanders.com/

INTERVIEW

Kamakshi R. Zeidler, MD, Plastic Surgeon, Diplomate, American Board of Plastic Surgery, Aesthetic & Reconstructive Surgery in Campbell, California, talks about a new way to help breast cancer survivors who are going through breast reconstruction surgery.

How many people do you see on a daily basis with breast cancer?

Dr. Zeidler:  The majority of the new patients I see in my practice have breast cancer. I see three to four new patients each week.

Does it start with tissue expanders?

Dr. Zeidler: There are many options for breast reconstruction, and the most common choice is implant-based reconstruction, using the same types of implants used for cosmetic purposes. Reconstruction is more complicated because the breast is removed. An extra step is done to place temporary implants called tissue expanders.

What are tissue expanders?

Dr. Zeidler: Tissue expanders are temporary breast implants that are placed at the time of mastectomy. They go in deflated and are designed to hold the breast space. After a woman heals from the mastectomy, the expanders can be filled to stretch out the skin to create space for a more permanent implant. This usually takes a few weeks. The tissue expanders are filled with saline that is injected though a needle, which is placed through the skin into a special port in the tissue expander. These injections are done once a week in the doctor's office. Once the skin has been stretched, a second operation is done to remove the tissue expander and replace it with the final implant.

Can expanders really speed up the process?

Dr. Zeidler: Tissue expanders themselves don't speed up the process, but placing them at the time of the mastectomy helps get the process started right away.

Is the type of the expanders most people are using saline based?

Dr. Zeidler: Yes. The tissue expanders currently approved for use are saline expanders. There have been modifications over the past couple of decades to make them better, more efficient, and they come in different shapes and sizes. They all basically have the same principle that a needle has to be placed through the skin into the built in port in the tissue expander in order to fill it with saline.

What are the downsides of saline expanders?

Dr. Zeidler: The saline itself is really not the issue, it's more the fact that we have to get it into the implant and that requires poking a needle through skin.  So, the downside is that the needle and the stretching of the tissue can cause discomfort and it requires multiple visits to the doctor's office which can be inconvenient. Many women feel this is an additional insult and burden after getting the diagnosis of breast cancer.

How many visits would the saline take for most women?

Dr. Zeidler: For most women it would take a minimum of four to six, sometimes eight expansions, There's a lot of variation based on the size of the breast and how quickly a woman heals after the mastectomy.

That's eight times coming in. How long does each time take?

Dr. Zeidler: It takes about 15 minutes. 

How often, is it like twice a week, three times a week?

Dr. Zeidler: Usually, it is once a week. For patients who have a difficult time with it, sometimes it takes a little bit longer. So, we do it every two weeks.

So, now there's a new way of doing it?

Dr. Zeidler: Yes. 

What's that called?

Dr. Zeidler: The new investigational device is called the AirXpander, and it is really a revolutionary idea. The idea behind the new technology is in trying to make this whole process more comfortable, convenient and faster.

How do they work?

Dr. Zeidler: The AirXpander has a cartridge of compressed air within it. The air is CO2, which is a very safe gas used for many things in modern medicine. This cartridge of compressed air is housed within the implant. There's a small antenna that can communicate with a remote control. The remote activates the AirXpander and causes a small valve to open and this releases a small amount of air. So, instead of being poked with a needle to inject saline, the remote control can be used to release air that expands the expander from within. 

So, there are no needles?

Dr. Zeidler: No needles! The other benefit is that multiple doses can be done in a day. Smalldoses. So, there's not one big bolus that could be putting a lot of stretch all at one on the muscle and the tissues. Instead, the small doses can be done three times a day, each dose being so small that a woman can hardly feel any stretch on the skin. We would never do that with needles because we wouldn't want to poke someone three times a day. The tiny doses are more comfortable. What we are seeing preliminarily in this clinical trial is that women are getting to that completion stage (where the expander is switched out to a more permanent implant) much faster.

So, I was talking to Marie and she said she expands hers three times a day, that's the most she can do. If she's not feeling like it she doesn't do it. Do you think this puts the person back in control of what they're doing?

Dr. Zeidler: Yes, I think being diagnosed with breast cancer makes many women feel out of control. As a physician, I want to make this process as easy and comfortable to my patients as possible. Many of the patients in this trial have enjoyed being able to literally have the controls in their own hands. The remotes are programmed to allow a safe range of three small doses a day and each patient can go at their own pace, and dose when they feel up to it, and can go as slow or a fast as they want. They really enjoy having an element of control at a time in their lives when many things are out of their control.

Do the expanders come out when the silicone implants go in?

Dr. Zeidler: These new investigational AirXpanders function just like the saline expanders and are temporary implants to create space for a more permanent implant. Once that space has been created, another surgery is done to remove the expander .When the expander is removed, any type of implant can be placed. A saline implant, a silicone implant, and within silicone there's various styles. This past year, the newer highly cohesive silicone gel implants with a natural tear drop shape became available. Therefore, women have many choices when it comes to the more permanent implant.

Are there any downsides to the AirXpanders that you see?

Dr. Zeidler: This is an investigational device that is still in clinical trials, so only certain women have access to them where the study is being done. Like many new technologies, we learn how to make things better as we learn what works and what doesn't as it's used more and more. I believe my patients who have participated in this trial are courageous and are helping us to develop better techniques for reconstructing new generations of women who will suffer from breast cancer.

Are you part of the clinical trials?

Dr. Zeidler:  Yes.

What have you seen from the women, what have they told you about it?

Dr. Zeidler:  I think most women are very excited about this technology. I think that it's been wonderful to see patients have the control and undergo less discomfort. When a patient comes in for filling a saline expander, I see my patients closing their eyes, holding their breaths, and waiting for the poke of the needle. To eliminate that is great and to see that patients have a much easier experience is thrilling.

Has there been any women who do it too much? Is there such a thing as too much air? 

Dr. Zeidler: Many people have this initial concern. There are a lot of things in medicine where we give patients a little bit of control, but in a very safe and measured fashion. This AirXpander is designed the same way. They are programmed to only allow 3 doses in a 24 hour time period and they shut off if a patient tries to do more too soon.

So instead of seeing them once a week now, you can see them once every two weeks?

Dr. Zeidler:  That would be our hope for the future, after the trial is completed.

FOR MORE INFORMATION, PLEASE CONTACT:

Kamakshi R. Zeidler, MD
Diplomate, American Board of Plastic Surgery
Campbell, California
408-559-7177
zeidlermd.com 
DrZ@zeidlermd.com