FORT LAUDERDALE, Fla. ( Ivanhoe Newswire) - Each year about 100,000 women with breast cancer will undergo a mastectomy. For those who elect reconstructive surgery, it can be a long, painful process. Now a remote control is changing that.
When Michele Stapleton found out she had breast cancer, the busy manicurist wasn't too worried at first.
"and so I said, oh I'll have a lumpectomy no big deal and they said no, the tumor was too large and that I'd have to have a mastectomy," Michele Stapleton, told Ivanhoe.
As a precaution the mother of two had both breasts removed. Her next step, reconstruction, but doctor Ankit Desai said the process can often be long and painful. There's usually not enough skin to insert an implant after a mastectomy, so doctors have to stretch the patient's tissue with an expander and inject saline into it.
"They have to have a needle that's stuck through the skin. Sometimes that can cause some discomfort for patients," Ankit Desai, M.D., from the East Coast Institute for Research, explained.
As part of study, Michele is trying out a new tissue expander using a remote control. It allows patients to expand their breast tissue at their own pace in the comfort of their own home.
"I don't like needles. I don't like pain and if I can control what I do as far as how I expand, it was exciting to me," Michele said.
The remote control is placed against the expander and instead of saline injections carbon dioxide is released.
"And you press the button one time and that's it. It's delivered a dose," Dr. Desai said.
Patients go from weekly visits and injections for several months, to only having to come in twice and can be ready for breast implants in just weeks.
"You have control over it. That's the glory of it," Dr. Desai said.
Giving people like Michele more time for what matters.
The study is actively recruiting all over the country for mastectomy patients planning to undergo breast reconstruction. For more information on the trial go to clinicaltrials.gov or call 408-559-7192 .
RESEARCH SUMMARY
MASTECTOMIES: A mastectomy is the removal of the entire breast and is normally suggested for women with a large tumor in the breast, or when multiple attempts to remove the tumor through a lumpectomy have not been able to completely remove the cancer. Women with a high risk of breast cancer will sometimes have a preventative mastectomy to reduce their risk of developing the cancer and for peace of mind.
TYPES: There are four types of mastectomy that can performed:
"Simple" or "total" mastectomy is when the entire breast, including the nipple, is removed. The lymph nodes are not removed, although sometimes they are located in the breast tissue and are taken out with it. No muscles are removed either.
Modified radical mastectomy is when the lymph nodes are removed as well as the entire breast. Axillary lymph node dissection is performed so that the underarm lymph nodes can be examined to see if the cancer has spread.
Radical mastectomy involves the removal of the entire breast, the underarm lymph nodes, and the chest wall muscles underneath the breast. This is the most extensive mastectomy and is only suggested when the cancer has spread to the muscles underneath the breast. It is now rarely performed.
Subcutaneous mastectomy is performed less often than total mastectomies because the chances of the cancer returning are higher. This is when all of the breast tissue is removed but the nipple is left.
RECONSTRUCTION: Reconstruction of the breast (or breasts) after a mastectomy is common. In "immediate reconstruction" the breasts are reconstructed in the same operation in which the breasts are removed, though some women wait until months after the surgery to do breast reconstruction. Different techniques exist including using tissue from another part of the body, an implant, or both. However, if further radiation is needed, doctors suggest waiting until radiation treatment is complete. (Source: www.breastcancer.org)
BREAST REMOTE CONTROL: Called the AeroForm Patient Controlled Tissue Expander System, the investigational expander gradually inflates in small, pre-set amounts on a daily basis which the patient controls with a remote. The average expansion time is 15 days. The study will continue until a total of 92 AeroForm expanders and 42 saline expanders have been implanted into patients. The FDA has granted AirXpanders (the creators) with an Investigational Device Exemption so that they could carry out the study and it will be judged on how safely and successfully the device expands the tissue in preparation for a breast implant. (Source: www.wsj.com)
INTERVIEW
Dr. Ankit Desai, an investigator for the East Coast Institute For Research, talks about how a remote control is making breast reconstruction less painful.
What is the need for breast reconstruction?
Dr. Desai: Women that are diagnosed with breast cancer have a multitude of options, but one of the options is that they get a mastectomy. Some undergo prophylactic mastectomy and some do it because of the size of the cancer. We strive to provide women with reconstructed breasts than are better than they once had before. I think that reconstruction has evolved over time. Twenty to thirty years ago it was about finding something that looked good to fill a bra and looked good in clothes. Now the demands and the techniques have improved in that It's not just about filling a shirt or a bra but it's actually looking esthetically pleasing to the naked eyes.
What is the chief complaint that comes along with the traditional way of doing things with saline injection?
Dr. Desai: Before we would do an implant base reconstruction, that's one of the most common ways to do breast reconstruction. We put in a tissue expander and they have a port that we can inject saline into. Patients come to the office, usually about once a week, and we inject a needle through the skin into the port of the saline tissue expander and then inject a bolus of saline. That's how we stretch that skin envelope to recreate that pocket for what eventually will be the permanent implant.
The saline expander limitations are the frequent doctor visits. The patients have to come once a week to the office for these injections. They have to have a needle that's stick through the skin which sometimes can cause some discomfort for the patients.They get a bolus injection, meaning they get at least about sixty cc's at a given point in time. The reason for that is, you can't have them come to the office every day for expansion. If you look at anything the most natural way of expansion is little by little, multiple times a day, every day. You see women over nine months undergo gently gradual tissue expansion and that's nature's most natural tissue expansion. As plastic surgeons we're always trying to recreate tissue. When we recreate tissue or expand tissue for bones and jaws for younger kids, they actually undergo daily expansion of the bone. They get a little half turn of a screw twice a day. We haven't been able to simulate something like that with saline breast reconstruction. That's what's wonderful about the Aeroform technology. It will allow us to more gradually expand the patient and I think that the satisfaction and comfort for patients are going to be higher.
You are gradually expanding but in essence, you're able to get the reconstruction going much faster, correct?
Dr. Desai: The advantages of the aeroform expander are less pain because you're gradually expanding multiple times every day. In addition, the overall expansion takes less time. If you look at our growing data and research that's out there traditionally, saline tissue expansion is on the average of about three to four months and Aeroform expansion is really within weeks to a month. The patients are completed with their expansion in a month and that's primarily because they can do it every day, it's more comfortable and they're getting a more gradual expansion. Gradual expansion also means a better aesthetic result in my opinion because we're not putting a lot of pressure on the skin so the skin and the muscle thins out less and you get a better coverage of your permanent implant.
How does this compare to something like Bravo?
Dr. Desai: Bravo is external tissue expansion and it uses suction to actually expand the skin and the soft tissue envelope from the outside. It is temporary, it doesn't create an internal pocket for a permanent implant. If you use the Bravo for external tissue expansion and then stopped using the Bravo then your breast, if you had a mastectomy, go completely flat again. If you did it and you went to go put an implant in there's really not a space to put an implant like there is with a traditional saline tissue expander or the air expander. Typically the Bravo technology is used for external tissue expansion and then to inject fat in to that area.
What's been the response so far in the trial?
Dr. Desai: I think patients are really excited about it. They don't have to have a needle stick; they don't have to come in to the doctor's office as frequently. When I tell them about it they immediately jump on board. Patients not only are excited about it but they find that it's more convenient. They can do it at home.
FOR MORE INFORMATION, PLEASE CONTACT:
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