Prophylactic Mastectomy in BRCA Carriers: Can the Nipple Be Preserved? (an article review)

Updated 3/2017 -- photos and all links removed as many no longer active.

The entire article is available via open access (full reference below).  Women with the BRCA gene (both 1 and 2) often elect to have prophylactic mastectomy to reduce their risks of developing breast carcinoma.  This is even more so for the contralateral breast when a primary is found.  Skin-sparing mastectomies (SSM) and nipple-sparing mastectomies (NSM) greatly improve the cosmetic results for women undergoing reconstruction.  Traditionally, the NAC has been removed due to concerns of possible tumor recurrence or development of a new primary in the remaining breast tissue of the NAC. 

The article notes "numerous retrospective studies have shown a wide range(0-58%) of nipple involvement by tumor in mastectomy specimens." 

This retrospective study involves a small cohort of 33 patients (25 BRCA1, 8 BRCA2) who underwent mastectomy between March 1987 and June 2009 treated at Mayo Clinic.  The entire nipple-areolar complex (NAC) was excised and evaluated histologically.  There was a total of 62 NACs available for evaluation. [TDLS = terminal duct lobular units]

Sixty-two NACs from 33 women (25 BRCA1, 8 BRCA2) were studied. TDLUs were present in 15 (24%) NAC specimens. No evidence of atypical hyperplasia, carcinoma in situ, or invasive carcinoma was found in any of the 33 prophylactic mastectomy specimens. Among the 29 breasts with cancer and available tissue, 2 (7%) had malignant findings and 1 (3%) had atypia in the NAC. One woman who underwent bilateral mastectomy for bilateral invasive carcinoma had one nipple with tumor within lymphatics, and her contralateral nipple had atypical lobular hyperplasia. A second woman had ductal carcinoma in situ involving a single major lactiferous duct..

They conclude the probability of premalignant or malignant lesions in the NAC of BRCA carriers is low overall.  It must be remembered that it is higher (10%) in the subgroup of women undergoing therapeutic mastectomy.  It may be safe for select women with BRCA mutations to have a nipple sparing procedure, but she and her physicians (oncologist and surgeon) should have a frank discussion about her individual case.

REFERENCE

Prophylactic and Therapeutic Mastectomy in BRCA Mutation Carriers: Can the Nipple Be Preserved?; Carol Reynolds, Jennifer A. Davidson, Noralane M. Lindor, Katrina N. Glazebrook, James W. Jakub, Amy C. Degnim, Nicole P. Sandhu, Molly F. Walsh, Lynn C. Hartmann and Judy C. Boughey; Annals of Surgical Oncology Volume 18, Number 11, 3102-3109, DOI: 10.1245/s10434-011-1908-8

Timing of Radiotherapy in Implant-Based Breast Reconstruction

 Updated 3/2017-- all links (except to my own posts) removed as many no longer active.

As Jackie Fox, Dispatch From Second Base, writes the choices after getting diagnosed with breast cancer can be overwhelming.  These choices (dependent on type and stage of breast cancer, desire for reconstruction, treatment needed, etc) can make the timing tricky when it comes to radiotherapy and reconstruction choices. 

The current issue of Plastic and Reconstructive Surgery Journal (first reference below) seeks to shed some light on the question of timing in implant-based breast reconstruction.

The authors looked at three populations  who received implant-based reconstruction from October of 2003 to October of 2007, a total of 257 patients (mean age, 49 years) were prospectively involved in this study.  All patients underwent a two-stage immediate breast reconstruction with subpectoral temporary expanders (ST 133; Allergan, Inc., Irvine, Calif.) and permanent implants (ST 410-510; Allergan).  Median followed up was 50 months.

• The first population (group 1, n = 109 patients) was made up of women affected by early-stage breast cancer with extensive nodal involvement that required postmastectomy radiotherapy and adjuvant chemotherapy.  This group received radiation on permanent implants (radiotherapy plus permanent implants).
• The second population (group 2, n = 50 patients) was made up of patients with locally advanced breast cancer who preoperatively were candidates for radiotherapy and who received chemotherapy before surgery.  This group  received radiation during the expansion phase of STE (radiotherapy plus tissue expanders).
• A third population (n = 98 patients) who did not receive radiotherapy was included as a control group.

The estimate of the totally failed reconstruction rate was the principal endpoint of this study. Capsular contracture rates and patients' and surgeons' subjective evaluations were the secondary endpoints.

Highlights of the study:

The totally failed reconstruction rate was significantly higher in group 2, with 40% (20/50) of unsuccessful reconstructions, compared with 6.4% (7/109) in group 1 and 2.3% (2/98)  in the control group (p < 0.0001).

Half (10/20) the failed reconstructions in group 2 involved those stopped at the first stage with removal of temporary expander for extrusion (5 cases) or infection (5 cases).

The other half of the failed reconstructions in group 2 occurred during the second stage and were converted to flap surgery --  2 due to extrusion, 3 due to infection, and 5 due to poor results (e.g., asymmetry, Baker grade IV capsular contracture).

The 7 failures in group 1 were due to severe capsular contracture (5), wound dehiscence (1), and an infection that required implant removal (1).

The incidence of Baker grade IV capsular contracture rate was significantly higher for group 1 (10.1%) and group 2 (13.3%) compared with the control group which did not receive any radiation (0%),  p = 0.0001).

The shape assessment performed by the surgeons demonstrated a higher incidence of good results in group 1, although the highest value was still reported in the control group (group 1, 58.7 %; group 2, 30.8 %; control group, 74.2 %; p = 0.0009).

The estimate of patients' opinions demonstrated a higher prevalence of good results in group 1 in comparison with group 2, although as with the surgeons assessment it was highest in the control group (good opinion: group 1, 52.2%; group 2, 46.2%; and control group, 68.1%; p = 0.04)

The study authors conclusions:

This study demonstrated that a higher total failure rate affects breast reconstructions that undergo irradiation during tissue expansion. For this reason, we suggest that if tissue expansion can be performed during postoperative chemotherapy, chest wall irradiation should be delivered on permanent implants. The second surgical step can be scheduled 3 weeks after the end of chemotherapy, and the irradiation should not begin more than 3 weeks later. Patients whose need for radiotherapy is not known preoperatively can, in this way, improve their surgical outcome.

REFERENCES

Outcome of Different Timings of Radiotherapy in Implant-Based Breast Reconstructions; Nava, Maurizio B.; Pennati, Angela E.; Lozza, Laura; Spano, Andrea; Zambetti, Milvia; Catanuto, Giuseppe; Plastic & Reconstructive Surgery. 128(2):353-359, August 2011; doi: 10.1097/PRS.0b013e31821e6c10

BreastCancer.org:  When Is Radiation Appropriate?, last updated August 6, 2008

FDA Updates Safety Data for Silicone Breast Implants

Updated 3/2017:  all links except to my own posts were removed as many no longer active and it was easier than checking each one.

 

Yesterday, the FDA published this press release:  FDA provides updated safety data on silicone gel-filled breast implants

In November 2006, the FDA approved silicone gel-filled breast implants for breast augmentation in women over age 22 and for breast reconstruction in all women. 

This latest report includes preliminary safety data from post-approval studies conducted by each of the two breast implant manufacturers (Allergan and Mentor), a summary and analysis of adverse events received over the years by the FDA, and a comprehensive review and analysis of recent scientific publications that discuss the safety and effectiveness of silicone gel-filled breast implants.

Based on the report, women should know:

• Breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications. One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as 1 in 2 will require removal 10 years after implantation.
• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries) and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection. Check out the FDA booklet for patients:  Breast Implants Complications Booklet.
• Preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis.  However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far.

At this time, the FDA is recommending that health care professionals and women who have silicone gel-filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals.  The FDA recommends women with silicone gel-filled breast implants undergo MRI screening for silent implant ruptures at 3 years post-implantation, and every 2 years thereafter.
• Be aware and pay attention to changes. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring and infection.  Women should notify their health care professionals if they develop any unusual symptoms.
• Stay in touch. If a woman has enrolled in a manufacturer-sponsored post-approval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

Related Posts: 
It’s Happened Again (June 5, 2007)
Breast Implants -- Some History (March 3, 2008)
Silicone vs Saline Breast Implants (March 4, 2008)
Silicone Implants and Health Issues  (March 5, 2008)
Saline or Silicone? (November 18, 2010)
More on Link Between Breast Implants and ALCL (April 25, 2011)

………………………………

Okay, now I want to rant just a bit about some of the headlines I found on this story.  All of these headlines were under the Google news/health section this morning.  I am not fond of misleading or sensationalized headlines, especially when it comes to health news.  This topic is serious to all women who have implants and they don’t deserve to be misled or inappropriately scared.

I did not read each of the following articles.  I am only commenting on my “gut” reaction to their titles.

Examples of headlines I find appalling:

Celebs who should worry about FDA's breast implant alarm (PHOTOS) (International Business Times)

Hollywood celebrities will not keep breast implants for life (Daily Gossip)
FDA: Silicone breast implants have expiration date (The Imperfect Parent) 
Bummer! FDA Says Women Can't Keep Breast Implants for Life (HyperVocal (blog))

Women who are celebrities are no different when it comes to implants than other women.  No implant has a specific expiration date.  Implants are man-made and wear out over time.  A small percentage fail in the first few years, about 20% fail by 10 years, the other 80% last more than 10 years.

The FDA did not say “women can’t keep breast implants for life.”  The FDA did make it clear that no implant currently on the market has a life expectancy equal to the normal life expectancy for a woman.

These headlines I applaud:

FDA: Silicone Implants 'Mostly Safe' and None Last Forever (33 KDAF-TV)
Silicone implants not a lifetime device (UPI.com)
Both are simple with no fear tactics included.

These headlines I find acceptable:
FDA stands by decision to put silicone breast implants back on market (Los Angeles Times)
FDA Says Silicone Breast Implants Are Safe For Women (SmartAboutHealth)
FDA Leaves Silicone Implants on Market Despite Risks (Wall Street Journal)
Breast Implants Basically Safe but Not Lifetime Devices, Say Experts (ABC News)
Breast implants reasonably safe (Washington Post)
Breast implants 'relatively safe' (BBC News)
FDA urges caution for silicone breast implant recipients (Boston Globe)
FDA Sees No New Safety Signals for Silicone Breast Implants (MedPage Today)
Most women with silicone breast implants need more surgery (msnbc.com)
Breast implants safe but not problem-free, FDA says (CBS News)
Silicone Breast Implants Deemed Safe in FDA Side Effects Review (Bloomberg)
Long-Term Complications Likely With Silicone Breast Implants (Medscape)

Women Don’t Regret Prophylactic Mastectomy

Updated 3/2017--  all links (except to my own posts) removed as many no longer active. 

I was alerted to the presentation at the American Society of Breast Surgeons meeting (first reference below) by Judy Boughey, MD by @MedicalNews’ tweet:

ASBS: Prophylactic Mastectomy Good Even Years Later (CME/CE) http://bit.ly/kMCsdr

Boughey and colleagues note that previous researchers using cross-sectional surveys have found that the majority of women are satisfied with their decision to have contralateral prophylactic mastectomy (CPM) one to several years after the procedure.

Their study chose to look at the consistency of satisfaction and changes in adverse effects in the same women with longer term follow-up.

To do this, they surveyed a previously established cohort of women with unilateral breast cancer who had contralateral prophylactic mastectomy at the Mayo Clinic between 1960 to 1993. All of the women had a positive family history.  All were surveyed at two time points and the results compared.

The initial survey was done at a mean of 10.3 years after prophylactic mastectomy (second and third references below).  This survey involved 583 women.

Of the 583 women who responded to the initial survey, 523 were alive and resurveyed 10 years later. Data from both surveys are available for analysis on 269 women.

The researchers found the majority of women continued to be satisfied with their decision to have contralateral prophylactic mastectomy (86% initial survey; 90% follow-up survey, p=0.06).

Similar numbers to that of the initial survey reported neutral feelings or dissatisfaction with their CPM decision on follow-up survey (8% and 6%, respectively, initial survey; 4% and 6% follow-up survey).

There was no significant change in the proportion indicating they would choose CPM again, but as with satisfaction, the proportion was slightly higher on the follow-up survey (95% initial survey; 97% follow-up survey, p=0.27).

The most frequently cited adverse effects were similar at both time points and included body appearance (29% vs 31%, initial vs follow-up survey, p=0.61), sense of femininity (21% vs 24%, p=0.25) and sexual relationships (24% vs 23%, p=0.68).

From the MedPage News article:  "This information is useful in the education of patients and physicians," said Boughey. "Patients should consider their choice carefully and be made aware of adverse events. However, those that decide for contralateral prophylactic mastectomy are likely to remain satisfied with the decision in the long term."

A related post of interest is one from Dr. Dialogue:  Is Watchful Waiting too Difficult? (originally posted there on March  13, 2010 and on Better Health on May 1st, 2011:  Why Double Mastectomies Are Popular: Watchful Waiting Is Too Difficult?)

REFERENCE

1.  Contralateral prophylactic mastectomy: Consistency of satisfaction and psychosocial consequences over time;  Boughey JC, et al; ASBS 2011; Abstract 1693 (pdf file)

2.  Satisfaction After Contralateral Prophylactic Mastectomy: The Significance of Mastectomy Type, Reconstructive Complications, and Body Appearance; Frost MH, Slezak JM, Tran NV, Williams CI, Johnson JL, Woods JE, Petty PM, Donohue JH, Grant CS, Sloan JA, Sellers TA, Hartmann LC;  JCO Nov 1, 2005:7849-7856; DOI 10.1200/JCO.2005.09.233.

3.  Contralateral Prophylactic Mastectomy: Efficacy, Satisfaction, and Regret (Editorial); Marc D. Schwartz; J Clin Oncol 2005, 23: 7777-7779; DOI: 10.1200/JCO.2005.08.903

Advances in Nipple-Sparing Mastectomy – an article review

Updated 3/2017-- photos and all links (except to my own posts) removed as many no longer active. 

There is a very nice review article of the advances in nipple-sparing mastectomy surgery in the March 2011 issue of the Aesthetic Surgery Journal (full reference below).

Dr. Patrick Maxwell and colleagues includes some history of nipple-sparing mastectomy (NSM):

NSM was attempted in the 1980s but never gained popularity owing to the controversies surrounding oncological safety. Now, better technologies for preoperative staging and assessment of lesion distance from the NAC, along with an increased understanding of the anatomy of the breast ducts with relation to the nipple, are encouraging a return to the concept. One of the key publications that renewed and increased enthusiasm for this technique was the multicenter publication of 192 patients undergoing NSM with only four recurrences, all of which occurred distant from the NAC. Recurrences were seen in the upper outer quadrant, where nearly all recurrences are found with simple mastectomies, at the junction of the tail of the breast and axillary tissue.

In recent years, there has been a sudden increase in reports of NSM for prophylaxis and cancer treatment. Of the approximately 1868 NSM procedures performed for breast cancer treatment and published in recent literature, only three local recurrences within the NAC have been reported, representing 0.16% of local events attributed to patients with NAC preservation. Note, however, that most of these studies have short follow-up periods, thus rendering definitive conclusions premature.

While NSM is not an option in all cases, it is an option that when available is worth using.  No surgeon can create a nipple as lovely as the one that would be removed by the mastectomy, so if it can be used it greatly adds to the finished results.

Exclusion criteria included tumors larger than 3 cm, clinical invasion of the NAC, tumors within 2 cm from the nipple, evidence of multicentric disease, a positive intraoperative retroareolar frozen section, and nodal disease, excluding isolated immunohistochemistry positivity.

The article does a quick review of some of the techniques for NSM (photo credit, 1st reference article):


The article is worth your time to read.



REFERENCES

1.  Advances in Nipple-Sparing Mastectomy: Oncological Safety and Incision Selection;  Maxwell G.P., Storm-Dickerson T, P Whitworth P, Rubano C, and Gabriel A; Aesthetic Surgery Journal March 2011 31: 310-319, doi:10.1177/1090820X11398111

2.  Nipple-Sparing Mastectomy for Breast Cancer and Risk Reduction:  Oncologic or Technical Problem?; Sacchini V, Pinotti JA, Barros AC, et al; J Am Coll Surg 2006;203:704-714

Are Patients Making Good Decisions About Breast Reconstruction?

Updated 3/2017-- all links removed as many are no longer active and it was easier than checking each one.

An outcomes article in the January 2011 issue of the Journal of Plastic and Reconstructive Surgery asks the question:  Are Patients Making High-Quality Decisions about Breast Reconstruction after Mastectomy?

The objective of the study was to “measure women's knowledge about reconstruction and to evaluate the degree to which treatments reflected patients' goals and preferences.”

Their conclusion (bold emphasis is mine):

Women treated with mastectomy in this study were not well-informed about breast reconstruction. Treatments were associated with patients' goals and concerns, however, and patients were highly involved in their decisions. Knowledge deficits suggest that breast cancer patients would benefit from interventions to support their decision making.

Granted the study was small, but it left me wondering if we the medical community fails to educate these women.  

The study involved a cross-sectional survey of early-stage breast cancer survivors from four university medical centers.  The survey included measures of knowledge about specific reconstruction facts, personal goals and concerns, and involvement in decision making.   Only 84 patients participated (59% response rate).

Participants answered only 37.9% of knowledge questions correctly.

 

Here are the general information questions asked in the survey with the correct answers: 

1.  In general, which women are more satisfied with their breast
reconstruction --those who have reconstruction at the time of the mastectomy or who have delayed reconstruction?

They are both equally satisfied (only 33.3% of the women surveyed knew this)

2.  After which type of breast reconstruction are women more satisfied with the look and feel of the reconstructed breast—implants or flaps?

Flaps (only 15% knew this)

3.  Mark whether or not it is true for breast reconstruction with an implant -- uses fat and tissue from other parts of the body to make a breast.

Answer is false. (only 13.1% knew)

4.  Mark whether or not it is true for breast reconstruction with a flap -- usually requires more than one surgery.

Answer is true. (only 28.6% knew)

5.  Which breast reconstruction surgery is easier on the body, that is, heals faster? 

Implants are easier (only 57.1% knew this)

6.  Of every 100 women who have breast reconstruction, about how many will have a major complication, such as needing hospitalization or an unplanned procedure, within 2 years?

The answer is 25–50.  (only 3.6% knew the correct answer)

7.  How does breast reconstruction affect future screening for breast cancer?  

It has little or no effect on finding cancer  (only 35.7% knew this)

 

 

Which is right for you depends on many things. 

Are you a candidate for flap surgery and if so which is best for you – TRAM, Latissimus Dorsi, etc. 

What kind of recovery time are you willing to put up with?  Recovery from flap surgery is longer than for implant surgery

Does the thought of having a foreign body (implant) in your body bother you?  If so, then put up with the longer flap recovery time and forgo the implants.

Ask to talk with other patients who have been through the surgery, preferably with your surgeon.  They can tell you better than we can about recovery (ie the little things that can make life miserable or better).

 

 

REFERENCES

1.  Are Patients Making High-Quality Decisions about Breast Reconstruction after Mastectomy? [Outcomes Article]; Lee, Clara N.; Belkora, Jeff; Chang, Yuchiao; Moy, Beverly; Partridge, Ann; Sepucha, Karen; Plastic & Reconstructive Surgery. 127(1):18-26, January 2011.doi: 10.1097/PRS.0b013e3181f958de

2.  Determinants of Patient Satisfaction in Postmastectomy Breast Reconstruction; Alderman, Amy K.; Wilkins, Edwin G.; Lowery, Julie C.; Kim, Myra; Davis, Jennifer A.; Plastic & Reconstructive Surgery. 106(4):769-776, September 2000.

3.  Sacramento Area Breast Cancer Epidemiology Study: Use of Postmastectomy Breast Reconstruction along the Rural-to-Urban Continuum; Tseng, Warren H.; Stevenson, Thomas R.; Canter, Robert J.; Chen, Steven L.; Khatri, Vijay P.; Bold, Richard J.; Martinez, Steve R.; Plastic & Reconstructive Surgery. 126(6):1815-1824, December 2010.; doi: 10.1097/PRS.0b013e3181f444bc

4.  Patient Satisfaction in Postmastectomy Breast Reconstruction: A Comparative Evaluation of DIEP, TRAM, Latissimus Flap, and Implant Techniques; Yueh, Janet H.; Slavin, Sumner A.; Adesiyun, Tolulope; Nyame, Theodore T.; Gautam, Shiva; Morris, Donald J.; Tobias, Adam M.; Lee, Bernard T.; Plastic & Reconstructive Surgery. 125(6):1585-1595, June 2010.; doi: 10.1097/PRS.0b013e3181cb6351

Risks of Fat Grafting in Breast Cancer Patients

Updated 3/2017-- all links (except to my own posts) removed as many are no longer active and it was easier than checking each one.

Fat grafting as a means of either (cosmetically) enlarging breasts or (reconstructively) correcting defects / asymmetries after breast cancer surgery/radiation therapy has been gaining ground as an acceptable method in the past few years.  True, much debate is still occurring but research is being encouraged to answer questions regarding safety (short and long-term) and efficacy.

The two articles (full references below) from researchers at the University of Pittsburgh School of Medicine suggests that it is NOT safe to use adipose-derived stem cells (ADSC) that may be part of fat grafting in any patient with active tumor cells. 

From the first article’s abstract (bold emphasis is mine):

Adipose-derived stem cells (ASCs) have been proposed to stabilize autologous fat grafts for regenerative therapy, but their safety is unknown in the setting of reconstructive surgery after mastectomy. ….

Here, we ask whether ASC promote the in vitro growth and in vivo tumorigenesis of metastatic breast cancer clinical isolates. Metastatic pleural effusion (MPE) cells were used for coculture experiments. ASC enhanced the proliferation of MPE cells in vitro (5.1-fold). ……… The secretome profile of ASC resembled that reported for MSC, but included adipose-associated adipsin and the hormone leptin, shown to promote breast cancer growth. Our data indicate that ASC enhance the growth of active, but not resting tumor cells. Thus, reconstructive therapy utilizing ASC-augmented whole fat should be postponed until there is no evidence of active disease.

From the second article’s abstract (bold emphasis is mine):

There is often a pressing need for reconstruction after cancer surgery. Regenerative therapy holds the promise of more natural and esthetic functional tissue. In the case of breast reconstruction postmastectomy, volume retention problems associated with autologous fat transfer could be ameliorated by augmentation with cells capable mediating rapid vascularization of the graft. …..

. Available evidence from case reports, cell lines, and clinical isolates favors the interpretation that regenerating tissue promotes the growth of active, high-grade tumor. In contrast, dormant cancer cells do not appear to be activated by the complex signals accompanying wound healing and tissue regeneration, suggesting that engineered tissue reconstruction should be deferred until cancer remission has been firmly established.

The early research suggest that fat grafting as a reconstructive tool in breast cancer survivors is safe (non-tumor causing) as long as care is taken to be sure any remaining tumor cells are dormant and non-active.

It must be remembered that fat grafting is a surgical procedure and as such is not risk free.  All surgical procedures carry the risks of infection, bleeding, etc.  The fifth reference below reminds us that fat grafting is not always a simple, benign procedure.

Autologous fat grafting to the breast for breast reconstruction and cosmetic breast augmentation has gained much attention recently. However, its efficacy and the severities of its associated complications are of concern. The authors experienced one case of multiple breast abscesses after augmentation mammoplasty by autologous fat grafting. ………. 

Immediate complications such as edema, hematoma, and infection require serious consideration after autologous fat grafting in the breast. In particular, infection probably is the most serious complication because the volume of the fat injected is large and can induce systemic infections such as sepsis and distort the contours of the breast. To avoid such infections, systemic and multicenter studies are required to determine how fat grafting should be performed to minimize the risks of fat necrosis and infection.

REFERENCES

Regenerative Therapy and Cancer: In Vitro and In Vivo Studies of the Interaction Between Adipose-Derived Stem Cells and Breast Cancer Cells from Clinical Isolates; Ludovic Zimmerlin, Albert D. Donnenberg, J. Peter Rubin, Per Basse, Rodney J. Landreneau, Vera S. Donnenberg; Tissue Engineering Part A. September 2010, ahead of print.

Regenerative Therapy After Cancer: What Are the Risks?; Vera S. Donnenberg, Ludovic Zimmerlin, Joseph Peter Rubin, Albert D. Donnenberg; Tissue Engineering Part B: Reviews. November 2010, ahead of print.

Fat Grafting to the Breast Revisited: Safety and Efficacy; Coleman, Sydney R.; Saboeiro, Alesia P.; Plastic & Reconstructive Surgery. 119(3):775-785, March 2007; doi: 10.1097/01.prs.0000252001.59162.c9
Autologous Fat Grafting to the Reconstructed Breast: The Management of Acquired Contour Deformities; Kanchwala, Suhail K.; Glatt, Brian S.; Conant, Emily F.; Bucky, Louis P.; Plastic & Reconstructive Surgery. 124(2):409-418, August 2009; doi: 10.1097/PRS.0b013e3181aeeadd
Sepsis With Multiple Abscesses After Massive Autologous Fat Grafting for Augmentation Mammoplasty: A Case Report; Keu Sung Lee, Seung Jo Seo, Myong Chul Park, Dong Ha Park, Chee Sun Kim, Young Moon Yoo and ll Jae Lee; Aesthetic Plastic Surgery, November 2010; DOI: 10.1007/s00266-010-9605-8

Saline or Silicone?

Updated 3/2017-- all links (except to my own posts) removed as many are no longer active and it was easier than checking each one.

There really is no simple answer to saline or silicone whether the choice is for a reconstructive or cosmetic patient.  For me it comes down to discussing the pros and cons of each with the patient and trying to help them decide which is best for them.

A recent article in the journal Cancer suggests that reconstructive patients are more satisfied with silicone implants over saline.  Upon looking at the information closer, it is an ever so slight increase in satisfaction as to be laughable.

Colleen M. McCarthy, MD, MS, of Memorial Sloan-Kettering Cancer Center in New York City, and colleagues conducted a multicenter, cross-sectional survey of 482 postmastectomy, implant-based reconstruction patients.  A total of 672 women were asked to complete the BREAST-Q (Reconstruction Module), but only 482 completed them (176 women had silicone implants and 306 chose saline).

BREAST-Q Reconstruction Module scores satisfaction in 15-items including  breast shape, feel to the touch, appearance, feelings of "normalcy," and integration into self.  The score averaged 58.0 for silicone implants versus 52.5 with saline implants on a 100-point scale in a univariate analysis.

Why are the scores so low (58.0 and 52.5)?   This study wasn’t planned to discern those answers though it did note that the addition of radiation to the mix lowered the satisfaction scores.

The article by Scott Spear, MD is a wonderful review of the pros and cons of each.  It is well worth reading.  He summarizes at the end of his article:

As implant choices have evolved, certain concepts have proven useful. When the main determinant for patient satisfaction is the shape and feel of the implant (and in cases where the implant might be especially visible), a silicone gel implant is the better choice. In cases where the primary concerns are safety (real or perceived), minimal access incisions, and ease of monitoring, saline may prove to be a better choice.

Related posts
Patient Satisfaction Following Breast Reconstruction Using Implants (June 7, 2010)
Silicone vs Saline Breast Implants (March 4, 2008)



REFERENCES
Patient Satisfaction with Postmastectomy Breast Reconstruction: A Comparison of Saline and Silicone Implants; McCarthy CM, et al; Cancer 2010; DOI: 10.1002/cncr.25552.

Breast Implants: Saline or Silicone?; Spear, Scott L., Jespersen, M. Renee; Aesthetic Surgery Journal July/August 2010 30: 557-570, doi:10.1177/1090820X10380401

Fiorina’s Infection Highlights Reconstruction Complications

Updated 3/2017-- all links (except to my own posts) removed as many are no longer active and it was easier than checking each one.

The news report of California Republican U.S. Senate Candidate Carly Fiorina’s recent hospitalization due to an infection related to her breast reconstruction is an opportunity to talk about the risks of complication associated with breast reconstruction surgery.

Fiorina was diagnosed with breast cancer diagnosis in February 2009.  She was treated with chemotherapy, radiation and a double mastectomy.  I found several articles that note she had her reconstructive surgery at Stanford University Medical Center, the San Jose (Calif.) in July 2010, but none mention the reconstruction technique used.

My guess would be implant based reconstruction considering how quickly she returned to campaigning.  Recovery time for a TRAM flap (free or pedicle) or any other flap based reconstruction would have been much longer.

The chemotherapy and radiation put her at increased risk of surgical complications.  It’s all a balancing act.  Weighing the need/desire for reconstruction against the risks.  Treatment of the breast cancer is always the first priority.

As noted by in the eMedicine article (1st reference below)

The occurrence of complications using expander-implants can exceed 40% in published studies. However, despite a significant rate, the complications themselves are usually minor and do not prevent completion of a satisfactory reconstruction. In experienced hands, good to excellent aesthetic outcomes can be obtained in more than 80% of patients.

The 40% includes every little complication that can occur:  capsular contracture, infection, wound healing issues, seroma/hematoma, assymetry, poor implant position, etc.

Breaking it down better is the table found from the Mentor Large Simple Trial data that lists the complications that occur within 3 years.

Additional Operation (Reoperation)	40%
Loss of Nipple Sensation	35%
Capsular Contracture III/IV or grade unknown	30%
Asymmetry	28%
Implant Removal	27%
Wrinkling	20%
Breast Pain	17%
Infection	9%
Leakage/Deflation	9%
Irritation/Inflammation	8%
Delayed Wound Healing	6%
Seroma	6%
Scarring	5%
Extrusion	2%
Necrosis	2%
Hematoma	1%
Position Change	1%

What these numbers don’t do is individualize the risk.  You can’t tell from these numbers who had only radiation, who had only chemotherapy, who had both, which ones smoked, who had diabetes, etc.  All of these things increase the risk to the individual.

Related Post:

Infected or Exposed Breast Prosthesis (Sept 1, 2010)

Patient Satisfaction Following Breast Reconstruction Using Implants (June 7, 2010)

REFERENCES

Breast Reconstruction, Expander-Implant; eMedicine article, October 2009; Jorge I de la Torre, MD, FACS, Luis O Vasconez, MD, FACS

Breast Reconstruction Overview; eMedicineHealth

About Breast Reconstruction; Cancer Help UK

Infected or Exposed Breast Prosthesis

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active.

This is a tough situation for both patient and surgeon.  Dr. Scott Spear has published an article in the April issue of the Journal of Plastic and Reconstructive Surgery which reviews his management of this issue  (full reference below).

Rates of infection have ranged from 0.4 to 2.5 percent for augmentation mammaplasty and from 1 to 35.4 percent for prosthetic breast reconstruction. Furthermore, rates of exposure have been reported between 0.29 and 2 percent for breast augmentation and between 0.25 and 8.3 percent for device-based breast reconstruction.

Dr. Spear published an algorithm for the management of breast device infection and/or exposure in 2004.   The current article is a retrospective study of his experience with infected or exposed breast prosthesis between 1993 and 2008.   During this 15 year period, he managed 69 patients with 87 events of breast device infection and/or exposure.

The mean patient age was 49.8 years.  The average BMI was 23.4.   Other key traits:  smoking history 18.4%, history of chemotherapy use 35.6%, history of radiation therapy 23%.

Events of device infection and/or exposure were classified into one of seven groups using the published algorithm: 

group I, mild infection; group II, severe infection; group III, threatened exposure; group IV, threatened exposure with mild infection; group V, threatened exposure with severe infection; group VI, actual exposure with no/mild infection; and group VII, actual exposure with severe infection.

Mild infection was defined as warmth, swelling, cellulitis, or nonpurulent drainage that was responsive to initial antibiotic therapy.

Severe infection was defined as persistent or substantial warmth/erythema/swelling despite antibiotic therapy, purulent drainage, atypical organisms on wound culture (e.g., methicillin-resistant Staphylococcus aureus, Gram-negative rods, mycobacteria, or yeast), or serious signs and symptoms of systemic infection (e.g., high fever, hypotension).

“Device salvage” was defined as the continued presence of a prosthetic device after surgical intervention, though not necessarily retention of the original device.

Dr. Spear reports that the mean postoperative time to breast prosthesis infection/exposure was 5.5 months.  He managed to obtain an overall device salvage rate of 64.4%.

Thirty-four events involved breast prostheses with mild infection, classified as group I, and were associated with a 100 percent salvage rate.

Twenty-six events concerned devices with severe infection, categorized as group II, and resulted in a 30.8 percent salvage rate.

He concludes:

Salvage of the infected and/or exposed breast prosthesis remains a challenging but viable option for a subset of patients. Keys to success include culture-directed antibiotics, capsulectomy, device exchange, and adequate soft-tissue coverage.

Relative contraindications to breast device salvage include atypical pathogens on wound culture, such as Gram-negative rods, methicillin-resistant S. aureus, and C. parapsilosis.

Patients with a prior device infection and/or exposure and a history of either radiotherapy or S, aureus on wound culture should be closely monitored for signs of recurrent breast prosthesis infection/exposure and managed cautiously in the setting of elective breast surgery.

REFERENCES

Management of the Infected or Exposed Breast Prosthesis: A Single Surgeon's 15-Year Experience with 69 Patients; Spear, Scott L.; Seruya, Mitchel; Plast Reconstr Surg 125(4):1074-1084, April 2010; doi: 10.1097/PRS.0b013e3181d17fff

Discussion: Management of the Infected or Exposed Breast Prosthesis: A Single Surgeon's 15-Year Experience with 69 Patients; Hammond, Dennis C.; Plast Reconstr Surg.125(4):1085-1086, April 2010; doi: 10.1097/PRS.0b013e3181d18289

The infected or exposed breast implant: Management and treatment strategies; Spear SL, Howard MA, Boehmler JH, Ducic I, Low M, Abbruzzesse MR.;  Plast Reconstr Surg. 2004;113:1634–1644.

Preference for Scar Location

Updated 3/2017 -- photos and all links (except to my own posts) removed as many no longer active.

There is a nice main article along with a discussion article in the August issue of the Journal of Plastic and Reconstructive Surgery which focuses on the preference of the scar location from the woman’s (patient’s) standpoint when the latissimus dorsi muscle flap is used in breast reconstruction.

There is always a “robbing Peter to pay Paul” when donor tissue is used in any reconstruction. Some times there is not a choice in how the donor scar will be oriented, but when there is the patient should be involved in the choice.

The surgeon needs to explain the factors which make one scar choice his/her preference. Factors such as the patient’s age, body mass index, other scars, and amount of tissue needed will all factor into the surgeon’s choice.

The patient’s preference is most likely to be made on how they view their body and on the types of clothing they like to wear (or envision wearing). Will the scar be hidden or visible with the clothing choices?

The article surveyed 250 women between the ages of 20 and 80 years, including 50 women with a history of breast cancer. The participation rate was 96% for a total sample size of 240 subjects.

The women were grouped into the following age categories: 20 to 29 years (n = 46); 30 to 39 years ( n = 32); 40 to 49 years (n = 44); 50 to 59 years (n = 70); and 60 to 79 years (n = 48).

The survey for the article study was done used photographs of a patient's back showing the variations of the latissimus dorsi donor-site locations. I scanned this photo from the first reference article.

As with the above, this one was scanned from the first reference article.

The results of the survey found:

The majority of women (66%) noted that the location of the latissimus dorsi flap donor site was important.

The lower transverse scar was the preferred scar location in 54% of the women surveyed. The second most preferred site was the middle transverse scar location.

The ability to conceal the scar in a low-back top or swimwear was noted to be important by 32%. A chance to improve the body’s contour was noted to be important by 30%.

Women younger than 50 years of age were concerned primarily with concealing the scar with clothing options, whereas women older than 50 years were concerned with both clothing options and contour of the back.

The independent factors of age, body mass index, ethnicity, body image, and clothing options were not found to show any significant correlation with scar location.

Maurice Y. Nahabedian, M.D. notes in his discussion of the article:

Personal experience with the latissimus dorsi musculocutaneous flap resonates with the conclusions of this study. The middle and lower transverse incisions have been preferred because they are better concealed. Women are able to wear certain clothing items and not reveal the location of the scar. There is usually less distortion of the posterior thorax and a better quality scar when compared with oblique or vertical incisions. …….

A final thought on this article is in reference to the evolution of breast reconstruction. ……. The posterior thorax is an equally important though less frequent donor site than the anterior abdomen. However, donor-site issues such as strength, scar, contour, and seroma need to be optimized to improve outcomes and increase patient satisfaction. This study has addressed scar and contour issues related to the latissimus dorsi flap, provided data to support the conclusions, and provided a mechanism to improve outcomes.

REFERENCES

Breast Reconstruction with the Latissimus Dorsi Flap: Women's Preference for Scar Location; Bailey, S; Saint-Cyr, M; Zhang, K; Mojallal, A; Wong, C; Ouyang, Da; Maia, M; Zhang, S; Rohrich, R J.; Plastic & Reconstr Surgery. 126(2):358-365, August 2010, doi: 10.1097/PRS.0b013e3181de1b41

Discussion: Breast Reconstruction with the Latissimus Dorsi Flap: Women's Preference for Scar Location; Nahabedian, Maurice Y; Plastic & Reconstructive Surgery. 126(2):366, August 2010; doi: 10.1097/PRS.0b013e3181de1963

“Women’s Health and Cancer Rights Act of 1998’’

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active.

Recently the New York signed into law requiring hospitals and doctors to discuss breast reconstruction options with the patient prior to her undergoing cancer surgery. 

It troubled me that this law was needed.  Is it not the duty of the physicians and surgeons to educate the patient on the options available? 

We need to make sure the patient and their family know of the treatment options which may vary depending on the diagnosis and stage.  Radiation.  Chemotherapy.  Surgery – lumpectomy, mastectomy, axillary dissection.  A combination of treatments.

Even if the patient and her physicians don’t chose to do immediate reconstruction, isn’t the discussion and information part of the discussion?  At least inform the patient of the option.

Do we physicians and surgeons need another law to ensure we do right by our patients?

Not all patient’s have health insurance so reconstruction may become unattainable due to finances.   Susan G. Komen has a nice resource page for financial assistance available for breast cancer patients.  I did not see any that would cover reconstruction.  Many will help will obtaining a prosthetic.

Patient’s that do have health insurance are afforded protection under the “Women’s Health and Cancer Rights Act of 1998.”   However, as I was reviewing and researching the WHCRC for this piece I learned that it’s not a blanket protection:

Generally, group health plans, as well as their insurance companies and HMOs, that provide coverage for medical and surgical benefits with respect to a mastectomy must comply with WHCRA.

However, if your coverage is provided by a "church plan" or "governmental plan", check with your plan administrator. Certain plans that are church plans or governmental plans may not be subject to this law.

Breast Reconstruction—Part I (October 2007)
Breast Reconstruction – Part II (October 2007)
Patient Satisfaction Following Breast Reconstruction Using Implants  (June 7, 2010)

REFERENCES

Before Breast Is Removed, a Discussion on Options; New York Times article, August 18, 2010; Anemona Hartocollis

“Women’s Health and Cancer Rights Act of 1998’’ Summary; American Society of Plastic and Reconstructive Surgeons website

Your Rights After A Mastectomy...Women's Health & Cancer Rights Act of 1998; Department of Labor

Patient Satisfaction Following Breast Reconstruction Using Implants

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active. 

As more women turn to postmastectomy breast reconstruction, surgeons are beginning to look at outcomes.  Not simply safety and complications, but also patient satisfaction. 

A recent March 2010 article in the Journal of Plastic and Reconstructive Surgery (full reference below) looked patient satisfaction among women who had reconstruction using implants. 

The authors note that research in this field has been “hindered by the absence of an outcomes measure for use in evaluation of patient satisfaction and health-related quality of life (HRQoL).”

The BREAST-Q is a new questionnaire that specifically measures postsurgical body image and quality of life in the breast reconstruction patient.  The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Br23) [EORTC QLQC30 (Br23)] is a cancer-specific questionnaire that incorporates a breast-specific module and measures overall functioning following breast cancer treatment. 

This study used these two questionnaires to evaluate patient satisfaction and health-related quality of life following alloplastic (implant) breast reconstruction and more specifically if the type of implant used (saline versus silicone) has an effect on health-related quality of life.

A chart review of University of British Columbia patients was performed, compiling data on the following demographic features: type of breast cancer, unilateral versus bilateral reconstruction, history of radiation or chemotherapy, complications, type of implant, follow-up time, age at second stage, timing of reconstruction, and comorbidities.

A total of 280 patients were identified. Sixteen patients were deceased and 17 patients had noncurrent addresses (neither responders nor nonresponders).  Out of the 247 “active” charts, there were 75 silicone implant recipients and 68 saline implant recipients who responded (an overall response rate of 58 %). Chart review was possible for 100 of the 104 nonresponders.

In this patient population, responses to the BREAST-Q indicated a statistically significant higher overall satisfaction with breast reconstruction, higher psychological well-being, higher sexual well-being, and higher satisfaction with surgeon for silicone implant recipients. This finding was maintained after adjusting for variables that differed between groups. In addition, radiation exposure and unilateral versus bilateral reconstruction were included in the regression analysis, as these variables were felt a priori to influence overall satisfaction with outcome.

…………….

Results using the EORTC QLQC30 showed no statistically significant difference on any subscale, with the exception of higher overall physical function in silicone patients and higher systemic therapy side effects in saline patients. This is a cancer-specific questionnaire that examines function and symptom severity in cancer patients. In general, condition-specific measures allow greater responsiveness to intervention-related change compared with generic outcomes measures.

The BREAST-Q was developed at the Memorial Sloan Kettering Cancer Center and the University of British Columbia.  This instrument measures health-related quality of life following breast surgery. The module used in this study was specific to breast reconstruction. This instrument encompasses six scales: (1) psychosocial well-being, (2) physical well-being, (3) sexual well-being, (4) satisfaction with breasts, (5) satisfaction with outcome, and (6) satisfaction with care.

The EORTC QLQC30 (Br23) was developed by the European Organization for Research and Treatment of Cancer at the Netherlands Cancer Institute.   This instrument evaluates health-related quality of life in cancer patients. The QLQC30 module incorporates nine scales (five functional, three symptom, and one global health-related quality of life).

The authors drew these conclusions:

Responses on a surgery-specific instrument show silicone recipients to have overall higher satisfaction with the reconstructed breast(s). After adjusting for age, follow-up time, radiation therapy, and unilateral versus bilateral surgery, silicone recipients scored an average of 64 points for overall satisfaction with breast while saline patients scored 57 points. Similar results were seen for sexual well-being, psychological well-being, and overall satisfaction with surgeon.

Findings using the EORTC-QLQC30 revealed no statistically significant difference in overall global health status. Thus, it may be concluded that increased satisfaction in silicone implant recipients found using the BREAST-Q is not equivalent to increased overall global health as measured by the EORTC-QLQC30. The findings of this study provide reliable data that will allow surgeons to adequately inform their patients preoperatively regarding the expected outcomes of breast reconstruction using silicone and saline implants.

REFERENCE

Patient Satisfaction and health-Related Quality of Life following Breast Reconstruction:  Patient-Reported Outcomes among Saline and Silicone Implant Recipients; Macadam, Sheina A.; Ho, Adelyn L.; Cook, E. F. Jr; Lennox, Peter A.; Pusic, Andrea L.; Plastic and Reconstructive Surgery. 125(3):761-771, March 2010; doi: 10.1097/PRS.0b013e3181cb5cf8