Cytori Celution Improves Soft Tissue Transplantation

A lumpectomy is less drastic than having a mastectomy, but it leaves you with a scar and a dimple where a smooth, full curve used to be. The breast can also end up much smaller causing significant breast asymmetry in some women. This asymmetry is often exacerbated by the contraction (shrinkage) caused by the radiation therapy that usually follows lumpectomy. An investigational breast reconstruction technique is being studied that uses your own fat and stem cells to repair the shape of your breast. This technique is called Cell-Enhanced Reconstruction, and was presented at the 2007 San Antonio Breast Cancer Symposium.

A Technique for Partial Breast Reconstruction

Women who have had breast-conserving surgery (lumpectomy, partial mastectomy) currently do not have any options for breast reconstruction. Mastectomy patients can choose from implants and tissue flap procedures for recreating a lost breast, but lumpectomy patients have been left behind - until now.

Japanese Investigational Study

Dr. Keizo Sugimachi, of Kyushu Central Hospital in Fukuoka, Japan, has used this new fat graft procedure on 21 patients, 79% of which said they were pleased with the results. His colleague, Dr. Kitamura, who led the Japanese study, said, “The investigational procedure offers hope to partial-mastectomy patients who have limited options,” said Dr. Kitamura. “Unfortunately the concept of ‘breast conserving therapy’ can often times be misleading, as even minimally invasive resections can result in defects that leave patients dissatisfied with the cosmetic outcome.”

Stem Cell Enhanced Breast Reconstruction

Cell-enhanced reconstruction uses your own fat tissue (adipose) that is a rich source of stem and regenerative cells. These stem cells are not the controversial embryonic stem cells. Soft tissue transplants have been done for many years, but this new procedure uses a special process to ensure that the transplanted cells will live and adapt to the transplantation site. The process was developed by Cytori, and uses a machine called CelutionTM System EU.

Stem and Fat Cell Liposuction and Injection

Cytori Celution System is used to remove fat and stem cells. These cells are processed to create a mixture of concentrated stem cells combined with fat cells. This concentrated mixture is injected into your lumpectomy area in 3 places, to fill out the missing tissue. Your breast won’t immediately look like it has been repaired; it will need about a month for the transplanted cells to settle into position and fill out the lumpectomy cavity.

The Reconstruction Technique:

1: Standard liposuction removes fat, regenerative, and stem cells from abdomen.(
2: Cells go into the Cytori Celution processing system
3: Celution system separates regenerative and stem cells from fat cells. The regenerative and stem cells are then washed and concentrated.(
4: The concentrated stem cell mixture is combined with the fat cells.(
5: The final mixture is injected into the lumpectomy area, where it fills in and replaces tissue volume.

One Surgical Procedure

Fat cells (adipose tissue) can be extracted from your abdomen, thighs, hips, or lower back. Only one surgical procedure is required for this breast reconstruction technique. In the Japanese study, patients were followed for up to 18 months after the procedure, with no loss of tissue volume and no recurrence of breast cancer.

Planned Clinical Studies

Women who participate in a clinical trial of cell-enhanced reconstruction must be recovered from their breast conservation surgery and any follow-up treatments, and must be recurrence-free for at least two years. There will be two clinical trials in Europe during 2008, which will involve about 90 patients. If approved, clinical studies will begin in the United States after 2008.

Sources:

1) Kitamura K, et al “Stem cell augmented reconstruction: a new hope for reconstruction after breast conservation therapy” Breast Cancer Res Treat 2007; 106 (Supp1): Abstract 4071.
2) Medpage Today. Medical News from SABCS: San Antonio Breast Cancer Symposium Meeting. Fat-Derived Stem Cells Used for Breast Reconstruction. Published: December 17, 2007.
3) Cytori Therapeutics. Cytori Therapeutics Receives FDA 510(k) Clearance for the Cytori Fat Transfer System. Published: December 12, 2007.

Adapted from article by Pam Stephan

ASPS Report Examines Reconstruction Innovations for Breast Cancer Patients Including Partial and Full Mastectomies

For Immediate Release: April 2008
ARLINGTON HEIGHTS, Ill.  Lumpectomy or breast conservation surgery is the most common type of breast cancer surgery currently performed. A benefit of the surgery is that only part of the breast is removed, but a drawback can be the resulting physical appearance of the breast, which may be disfigured, dented or uneven. A report in Aprils Plastic and Reconstructive Surgery® , the official medical journal of the American Society of Plastic Surgeons (ASPS), examines advances plastic surgeons have made in breast reconstruction to repair the damage left when cancer is removed.

Although breast conversation therapies are a huge advance in the treatment of breast cancer, women are still concerned about how their breast will look after surgery, said Sumner Slavin, MD, ASPS Member and report co-author. Breast conservation surgery or lumpectomy can mean many things; a biopsy, partial mastectomy, wedge resection, or having a quarter of the breast taken. Women are often left with portions of their breasts removed and there are currently no implants that can address this unique cosmetic issue.

After lumpectomy or breast conservation surgery, plastic surgeons are now approaching the challenge of misshapen breasts by immediately remodeling the breast with remaining breast tissue or tissue taken from another area of the body. The result is a more natural looking breast that is more symmetrical with the unaffected breast.

Three additional advances the report examines are nipple-sparing mastectomy, deep inferior epigastric perforator (DIEP) flaps and acellular dermis graft slings. These are options for women who require a full mastectomy and young women who opt for preventative mastectomy due to a strong family history of breast cancer.

In nipple-sparing surgery, cancerous tissue and the duct system of the breast are removed, but a pocket of skin, the nipple and areola are saved. Plastic surgeons insert either an implant or the patients own tissue into the pocket to recreate the breast. The result looks very similar to the patients original breast because the original nipple and areola are used. Nipple-sparing surgery is still somewhat controversial, but if the origin of the tumor is away from the nipple and areola, it is considered safe, according to the report.

DIEP flap surgery involves using skin and fat from the lower abdomen to recreate the breast. The muscle is left intact, eliminating potential muscle weakness in the donor area, according to the report.

For patients undergoing a mastectomy, the DIEP flap procedure may allow them to better resume normal activities since they have not loss muscle function in their abdomen.

Finally, the use of acellular dermis (connective tissue layer of the skin) derived from cadaver tissue (such as “Alloderm”) allows plastic surgeons to create a new breast pocket, in patients undergoing a mastectomy, without using a tissue expander. A breast implant may then be inserted, creating an aesthetically pleasing breast. This one-stage method of breast reconstruction is often referred to as “Alloderm one-step breast reconstruction”.

Many women dont know the full scope of their reconstructive options or are intimidated to ask, said Dr. Slavin. For breast cancer patients, even though they are living through the anguish of cancer, there are reconstructive procedures that will improve their quality of life and reduce the negative long-term impact of the disease and its treatment.

In the United States today, there are nearly 2.5 million breast cancer survivors  the largest group of cancer survivors in the country, according to Susan G. Komen for the Cure. More than 56,000 breast reconstructions were performed in 2007, according to the ASPS.

Learn more about your breast reconstruction options here.

Can DIEP flap breast reconstruction prevent detection of breast cancer recurrence? This is a very important issue that is often not discussed.

A handful of studies have shown that breast reconstruction (with any reconstructive technique) does not impact local recurrence or long term survival in patients with early breast cancer (stage I and II). The rate of local recurrence and length of survival is the same in patients with stage I and II disease whether they undergo immediate breast reconstruction (ie reconstruction at the same time as mastectomy) or not. For this reason most institutions (including ours) will offer breast cancer patients with early disease immediate breast reconstruction whenever possible.

Patients diagnosed with advanced disease are more likely to be candidates for delayed breast reconstruction once they have undergone mastectomy, completed their cancer treatment and remained disease free for several months.

Breast reconstruction (with a DIEP flap or any other method) does not encourage or enhance breast cancer recurrence or shorten long term survival in any way.

By Megan Rauscher

Women with breast cancer faced with treatment decisions are often not told by their surgeons about the possibility of breast reconstruction after a mastectomy, a study confirms. When these conversations do occur, many more women choose mastectomy, researchers found.

In a survey of 1,178 women who had breast cancer surgery, only 33 percent reported that their surgeon had discussed breast reconstruction with them during the surgical decision-making process.

“We found it surprising that very few patients were informed about their options for breast reconstruction, and that information regarding reconstruction was more likely to be given to younger women who were more educated,” Dr. Amy K. Alderman of the University of Michigan Medical Center, Ann Arbor, told Reuters Health.

The survey, posted online Friday by the medical journal Cancer, also indicates that women who had these discussions with their surgeon were four times more likely to have a mastectomy compared to women who did not discuss reconstruction.

“Women need to be fully informed about all of their surgical options for breast cancer: lumpectomy, mastectomy and mastectomy with reconstruction,” Alderman said. “All are great options with the same long-term survival.”

Breast reconstruction, continued Alderman, “is a personal decision for each woman that is influenced by her body image, sexuality, fear of recurrence, etc. Women should be educated consumers of their healthcare.”

She concluded: “We, as physicians, need to make sure that all women, regardless of the patients’ education and socioeconomic status, are fully informed of their surgical choices for breast cancer care.”

To learn more about your breast reconstruction options click here.

SOURCE: Cancer, February 1, 2008

“Will insurance pay for my DIEP flap breast reconstruction?”

This is a question we are asked repeatedly. The easy answer is “they should”. However, some women have experienced difficulties with their insurance companies in terms of getting their DIEP flap procedure covered.

The good news is that there are a handful of plastic surgeons across the country that do routinely offer these advanced procedures and to my knowledge, many of them accept insurance. Unfortunately most women will have to travel to gain access to them.

Our group, Plastic, Reconstructive & Microsurgical Associates (PRMA) is located in San Antonio, Texas. We perform over 300 microsurgical breast reconstructions per year, the vast majority of which are covered by insurance. We have staff specifically for dealing with insurance issues, particularly prior authorization so our patients typically dont need to worry about the insurance side of things themselves. We accept the following insurance plans:

Aetna Healthcare PPO
Aetna Healthcare HMO
Aetna TRS Care
BCBS (Blue Cross Blue Shield) Par Plan
BCBS Blue Choice (not Blue Choice Solutions)
BCBS HMO Blue
Beech Street
Benefit Planners
Baptist PHO (certain limitations apply)
Cigna PPO
Cigna HMO
Community First Health Plan
First Health Plans
Great West Healthcare
Humana HMO (not Humana Gold Classic)
Humana PPO (not Humana Preferred)
Humana POS
Medicaid (certain limitations apply)
Medicare Part B
Methodist Physician Alliance (certain limitations apply)
PacifiCare HMO
PacifiCare PPO
Private Healthcare Systems
San Antonio Employers Health Alliance
Secure Horizons (certain limitations apply)
Texas True Choice

If your insurance plan does not appear on the above list, or for more information, please call Toll Free (800) 692-5565 or (210) 692-1181. Discounted local accommodation can be arranged for traveling patients.

To learn more about DIEP flap surgery please click here.

by Ann M. Geiger and others

Is this for me? If you have been diagnosed with breast cancer in one breast and are considering having the other breast removed to reduce your risk of developing a new breast cancer or having the cancer coming back, you might want to read this article.

Background and importance of the study: If you have been diagnosed with breast cancer, your risk of developing a new cancer is higher than that of a woman who has never had the disease. The size of this risk varies from person to person, because each person has different risk factors. For the average woman who has had breast cancer, the risk of developing a new and different breast cancer in the other breast (not a recurrence of the first one) is about 1% per year. This means a risk of about 10% over 10 years. Put differently, out of 100 women who have a personal history of the disease, about 10 will get a new breast cancer on the other side within 10 years.

The risk of a new breast cancer is higher for women who have additional risk factors. If you’ve been diagnosed with breast cancer and also have a strong family history of the disease, your risk is likely to be higher than 1% a year. If you have a proven genetic abnormality, your risk is even higher. If you have both a strong family history of breast cancer AND a known breast cancer gene abnormality, on top of a personal history of breast cancer, the risk is higher still. The range of higher risk is about 2% to 5% per year, depending on all of these factors, plus other things that might affect how an abnormal gene behaves. Over 10 years, this translates to a risk that ranges from 20% to 50%.

If you have a personal history of breast cancer plus other risk factors for a new breast cancer, it’s important for you to help reduce your risk. You may want to seriously consider extra preventive measures, including lifestyle changes, medications, and surgery.

Preventive surgery to remove the other breast is a serious option with real benefits and side effects. While removing the breast can substantially reduce your risk of breast cancer, it involves permanent changes that can change your quality of life. The higher your risk of breast cancer, the more likely you are to benefit from preventive surgery. Removal of the breast can decrease the risk of a new breast cancer by about 90%. That’s a big reduction. If your risk is estimated to be 80%, it could be lowered to about 8% by preventive breast removal. If your risk is 10%, it could be lowered to 1%.

The surgical option of breast removal is called “prophylactic,” which means “preventive.” If you take this step, you are doing something that will significantly reduce your risk for cancer in the future (although there is no guarantee). This option is permanent and irreversible.

Earlier studies have shown that for women with a personal history of breast cancer and other strong risk factors, preventive removal of the other breast (called contralateral mastectomy) reduces their risk of developing a new cancer and is associated with improved survival. Up to this point, however, no one had looked at how happy or satisfied women were with their choice.

In this study, the researchers asked women how content they were with their choice to have or not have preventive mastectomy.

Study design: In this study, the researchers asked 772 women who had preventive mastectomy and 105 who didn’t have preventive mastectomy how content they were with their choice.

All the women had been diagnosed with breast cancer in one breast between 1979 and 1999 at one of six Cancer Research Network health care system centers in the United States. The women were aged 18 to 80.

To determine how content women were with their preventive mastectomy choice, the researchers mailed them a survey that asked questions about:

1) quality of life,
2) satisfaction with the surgery,
3) body image,
4) sexual satisfaction,
5) depression,
6) breast cancer thoughts, and
7) health perception.

About 73% of the surveys were returned, from 519 women who had preventive mastectomy and 61 women who didn’t. Of those 61 women, 30 had single mastectomy and 31 had lumpectomy.

The research was funded by the National Cancer Institute.

Results: Of the 519 women who had preventive mastectomy, 86.5% were satisfied with the procedure and had no second thoughts about it, and 76% were very content with their quality of life.

Similarly, of the 61 women who did not have preventive surgery, 75% were very content with their quality of life.

There was no association between women reporting having a lower quality of life and having had preventive mastectomy or breast reconstruction, or with the women’s age, race, education, or body mass index. But a lower quality of life WAS linked to:

1) poor perception of one’s own general health,
2) possible depression,
3) unhappiness or self-consciousness about appearance,
4) unhappiness with sex life, and
5) feeling the need to avoid thoughts of breast cancer.

The results also showed that almost 75% of the women who didn’t have preventive mastectomy were concerned about breast cancer, compared to 50% of the women who had the preventive surgery.

Conclusions: The researchers concluded that most women who have preventive mastectomy are satisfied with their choice and report having a good quality of life. The women who had preventive mastectomy were less likely than the other women to be concerned about breast cancer.

Women who reported having a lower quality of life were more likely to have poor body image, be unhappy with their sex life, possibly be depressed, feel the need to avoid thoughts of breast cancer, and have a poor general health perception.

Take-home message: If you have been diagnosed with breast cancer in one breast and are considering a preventive mastectomy, this study offers strong support that no matter which decision you make, you are likely to be content with that decision later.

More than 75% of women in each group were very content with their quality of life. The adage “whatever decision you make will be right for you” seems to carry truth for women grappling with this decision.

Of course, you need to balance the potential benefits of preventive surgery against the side effects. Every woman is unique. How you balance the benefits and side effects in your own situation is very personal.

In general, factors that might make you more likely to choose preventive mastectomy are:

1) a strong family history of breast cancer,
2) a serious diagnosis of breast cancer in the other breast,
3) being very fearful of another cancer,
4) lacking confidence in the power of early detection, and
5) feeling determined to never go through cancer therapy again.

This wasn’t a randomized study, in which women are assigned to different groups. Every woman made her own decisions, and the women who chose preventive surgery are probably different in many ways from the women who chose not to have this procedure. As a result, comparing the two groups has limited value.

You probably know that we all need to believe in the big decisions we makeparticularly important decisions about our health. But even when we get used to a big decision, it’s normal to have mixed feelings. Although mastectomy can give women more peace of mind, it’s also normal for women to have concerns about their body image and to miss their breast.

Also remember that no procedure, even surgery, totally eliminates the risk of cancer. Even when a breast has been removed, cancer can still develop in the area where the breast used to be. Close follow-up is necessary for all women, even after preventive surgery.

You have time to decide. The decision to have preventive surgery is not an emergency. Of course, the decision to have preventive surgery at any age requires much thought, and must be made in consultation with your health care team.

For more information on breast reconstruction options click here.

SOURCE: Journal of Clinical Oncology; breastcancer.org

Women with breast cancer who are involved in the process of selecting their surgeon are more likely to be treated by more experienced surgeons and in hospitals/centers with established breast cancer programs, according to a study published in the Journal of Clinical Oncology.

Surgeon and hospital characteristics can influence the outcomes of breast cancer treatments, the authors explain, but little is known about the factors that influence how referrals are made.

Dr. Steven J. Katz from the University of Michigan, Ann Arbor, and colleagues used survey data from women recently diagnosed with breast cancer and their attending surgeons to determine how surgeons are selected, and if there is any association between the referral process and characteristics of the surgeon and hospital.

Most women were referred to their breast surgeon by another doctor or by their health plan. They chose their surgeon for a number of reasons — the surgeon’s reputation, the institution’s reputation, the recommendation of family or friends, or convenience of the location.

The investigators found that 54.3 percent of women were referred and did not select their surgeon; 21.9 percent were referred, but were also involved in selecting their surgeon; 20.3 percent selected their surgeon and were not referred by a provider or plan; and the rest of the patients had a prior relationship with their surgeon.

Women who selected their surgeon by reputation were twice as likely to have a surgeon who performed many procedures (high-volume surgeon) and to be treated at a cancer center designated by the National Cancer Institute or a program approved by the American College of Surgeons, the team reports.

Patients referred by another doctor or health plan were less likely to be treated by a high-volume surgeon or in hospitals with approved cancer programs, the researchers note.

Previous studies have shown that surgical patients often have better outcomes if they are treated by highly experienced surgeons and at hospitals that perform many similar procedures each year.

More research is needed to investigate the implications of the different referral patterns in this study, Katz and colleagues point out. “In the meantime, women with breast cancer should be aware that provider-based referral might not connect them with the most experienced breast surgeons or the most comprehensive practice setting in their community.”

“Patients might consider a second opinion,” the researchers suggest, “especially if they are advised to undergo a particular procedure without a full discussion of treatment options or a clear medical rationale for the recommendation.”

SOURCE: Journal of Clinical Oncology