Skyes’ Preventive Double Mastectomy

Updated 3/2017-- all links removed (except to my own posts) removed as many no longer active. 

When Wanda Skyes, 47, had a bilateral breast reduction in February, the pathology returned with DCIS present in the left breast specimen.  Recently the comedian appeared on  "The Ellen DeGeneres Show" and during the interview revealed her breast cancer diagnosis and her decision to have a double mastectomy.

Sykes continued, "It wasn't until after the reduction that in the lab work, the pathology, that they found that I had DCIS [ductal carcinoma in situ] in my left breast. I was very, very lucky because DCIS is basically stage-zero cancer. So I was very lucky."

But, she added, "Cancer is still cancer. I had the choice of, 'You can go back every three months and get it checked. Have a mammogram, MRI every three months just to see what it's doing.' But, I'm not good at keeping on top of stuff. I'm sure I'm overdue for an oil change and a teeth cleaning already."

Because she has a history of breast cancer on her mother's side of the family, Sykes explained she opted to have a bilateral mastectomy.

"I had both breasts removed, because now I have zero chance of having breast cancer," she said. "It sounds scary up front, but what do you want? Do you want to wait and not be as fortunate when it comes back and it's too late?"

The American Cancer Society has a nice article which reviews the risk factors for breast cancer.  The risks factors for Sykes (which can be garnered from the news article) include a family history of breast cancer (don’t know which relative on mother’s side), a personal history of breast cancer, African-American, and age.

I don’t think I would have advised her to have a bilateral prophylactic mastectomy on this information, but perhaps with more info I would have.  Though an effort is made to remove all breast tissue with a prophylactic mastectomy, it is wrong for us doctors/surgeons to ever suggest that we actually DO get it all.  More truthful to say we have removed most (90% plus).

While we are on the topic of breast cancer, please, take a look at Elaine Schattner, M.D., Medical Lessons, post from Monday:  NEJM Publishes New Review on Breast Cancer Screening.

Related posts:

Risk Factors for Breast Cancer (October 2, 2007)

Prophylactic Mastectomy (January 28, 2009)

Women Don’t Regret Prophylactic Mastectomy (May 5, 2011)

Is Prophylactic Mastectomy Worth It? (August 2, 2011)

Media Sources

Wanda Sykes' double mastectomy is aggressive treatment for DCIS; Karen Kaplan; Los Angeles Times/For the Booster Shots blog, September 23, 2011

Wanda Sykes has double mastectomy;  Ann Oldenburg; USA Today, Sep 23, 2011

Wanda Sykes: I had a double mastectomy; Jessica Derschowitz; CBS News, Sep 23, 2011

For more information on DCIS

Breast Cancer; PubMed Health, last updated December 2010

DCIS - Ductal Carcinoma In Situ; BreastCancer.org, last updated August 12, 2011

Ductal carcinoma in situ (DCIS); Mayo Clinic, last update June 23, 2011

Genetic Breast Cancers Show Up Earlier in Next Generation

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

Somewhere along the line I learned to encourage women with a family history of breast cancer to begin getting mammograms at an age 10 years prior to when their mother was diagnosed and to encourage their daughters to begin getting mammograms at an age 10 years prior to when they themselves were ever diagnosed. 

I learned this prior to the discovery of BRCA genes.  It was a trend that had been noted among women with strong family histories.  The new study (see full reference below) in the journal Cancer verifies that genetic breast cancers show up earlier in the next generation – on average by 8 years.

The study from MD Anderson looked 2 generations of families with the BRCA gene to assess the age at diagnosis.  Using the pool of 132 BRCA-positive women with breast cancer who participated in the high-risk protocol at The University of Texas MD Anderson Cancer Center (Gen 2), 106 women could be paired with a family member in the previous generation (Gen 1) who was diagnosed with a BRCA-related cancer (either breast cancer or ovarian cancer).

The median age of cancer diagnosis was 42 years (range, 28-55 years) in Gen 1 and 48 years (range, 30-72 years) in Gen 2 (P < .001). In the parametric model, the estimated change in the expected age at onset for the entire cohort was 7.9 years (P < .0001). Statistically significant earlier ages at diagnosis also were observed within subgroups of BRCA1 and BRCA2 mutations, maternal inheritance, paternal inheritance, breast cancer only, and breast cancer-identified and ovarian cancer-identified families.

It is reasonable to encourage these women with significant family history of breast cancer to begin surveillance at an earlier age than the general population. 

REFERENCE

Earlier age of onset of BRCA mutation-related cancers in subsequent generations; Litton JK, et al;  Cancer 2011; DOI: 10.1002/cncr.26284.

Breast Cancer Patients With BRCA Gene Diagnosed Almost Eight Years Earlier Than Generation Before; Science Daily, September 12, 2011

Mom's Cancer Shows Up Earlier in Daughters; Michael Smith, Dori F. Zaleznik, MD; MedPage Today, September 12, 2011

Bariatric Surgery Should Come Before Breast Reduction

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

Many women with large breast and weight issues seek breast reduction.  I was taught to encourage them to lose weight first.  Now there is a very small study that backs this up  (full reference below).

The American Society of Plastic Surgeons issued a press release entitled “Breast Reduction and Bariatric Surgery—Which Should Be Done First?” and provided the answer “ Final Results May Be Better When Weight Loss Comes First.”  I agree, but find it odd that such a small study was published.  There should have been more patients included.

Jeffrey A. Gusenoff, MD, and colleagues reviewed two groups of patients who sought consultation for body contouring surgery August of 2008 and February of 2010 after massive weight loss (defined as a weight loss of greater than 50 pounds).

Group I (n=15) included any patients who underwent reduction mammoplasty for symptomatic macromastia before massive weight loss.  Group II (the control group, n=14) included any patients who did not undergo breast surgery before massive weight loss.

The patients were given a prospective phone survey to assess self-ratings of breast appearance before and after breast reduction and after massive weight loss, ability to exercise, which would have preferred to have first—massive weight loss or breast reduction surgery—and what they would recommend to a friend.

Of the 15 patients (7.9%) in group I, 14 completed the survey (93%). 

For group I, all patients felt the appearance of their breasts improved after reduction (p < 0.001) but felt appearance worsened or stayed the same after weight loss (p = 0.003).

Seventy-one percent of patients were able to exercise more and 64 percent were able to lose weight on their own because of their reduction. ……..

Ten patients (71 percent) would recommend that a friend lose weight before breast reduction surgery. …

For group II, 79 percent of patients felt the appearance of their breasts worsened or stayed the same after massive weight loss (p = 0.03). ……

All 14 patients (100 percent) would recommend losing weight before undergoing breast surgery.

Even though I tend to agree that patients should loss weight prior to breast surgery.  It is much easier to achieve the cosmetic goals of the patient if she is at or near her goal weight.  Otherwise, the surgeon and patient are left to guess at how her skin will retract with weight loss and how much deflation or loss of volume will occur.

I wish the study had ask how many of the Group I patients desired an augmentation as part of their revision. 

Eleven patients (79 percent) felt a secondary lift following massive weight loss should be covered by insurance, and seven patients (50 percent) plan on having revision breast surgery.

They noted it with Group II patients

Eleven patients (79 percent) wished their breasts currently appeared different, with eight (57 percent) desiring lifted breasts, seven (50 percent) desiring general reshaping, two (14 percent) desiring reduced breasts, and two (14 percent) desiring larger breasts.

I have augmented four patients over my 21 years of practice who had previous breast reductions prior to losing weight (one was mine).  This should be included in the discussion as well as the high probability that a revision to reshape or re-lift the breasts will be needed if the reduction is done prior to the (massive) weight loss.

Related posts:
Reduction Mammoplasty (December 19, 2007)
Breast Reduction: Safe in the Morbidly Obese?—Article Review  (August 25, 2008)
Tennis Star Brings Breast Reduction Surgery into Press (June 4, 2009)
Impact of Obesity on Breast Surgery Complications – article review  (June 16, 2011)


REFERENCE

Reduction Mammaplasty, Obesity, and Massive Weight Loss: Temporal Relationships of Satisfaction with Breast Contour; Coriddi, Michelle; Koltz, Peter F.; Gusenoff, Jeffrey A.; Plastic & Reconstructive Surgery. 128(3):643-650, September 2011; doi: 10.1097/PRS.0b013e318221da6b

Recent FDA Advisory Meeting on Implants

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

It’s amazing what you will find sorting through more than 20 years of stuff.  This picture of 3 implants includes:  top -- an old McGhan double lumen (silicone gel implant surrounded by a saline implant); bottom left – Dow Corning textured silicone implant; and bottom right – Dow Corning smooth silicone implant.  Dow Corning has not made breast implants since approximately 1992.

Last week the FDA met to discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants.  As a condition of placing silicone implants back on the market in 2006, both Mentor and Allergan (McGhan) were suppose to enroll patients in 10-year-long follow up studies on side effects related to implants.  The aim was for 80,000 women.

I agree these studies are needed, but it is difficult to get women to return year after year.  This is evident in the data presented at the meeting:

After two years, about 60 percent of Allergan patients were still participating, but just 21 percent of Mentor patients were involved.

I, like Dr Rob Oliver (Plastic Surgery 101 Blog),  found the requirement of routine MRI screening at three years after getting implants and every two years following to look for silent ruptures to be unrealistic and unnecessary.  Insurance often did not cover this expense to the patient.  The FDA has now removed this requirement.

Several advisory panel members said the FDA's requirement that women have frequent MRIs to make sure the implants haven't ruptured is unrealistic and should be removed from the product label. Insurance usually doesn't pay for the scans, so most women don't get them done. But it's the only way to find out whether the implant has ruptured in the absence of symptoms.

The advisory panel did recommend the creation of a nationwide database to follow women who have had silicone-gel breast implants for at least a decade after they had the surgery.  I think it should be for 20 years.

Related posts:
Breast Implants -- Some History (March 3, 2008)

FDA Updates Safety Data for Silicone Breast Implants  (June 23, 2011)

REFERENCES
Breast Implant Safety to Be Focus of FDA Panel; Emily P. Walker, Washington Correspondent, MedPage Today; August 29, 2011

Breast Implant Follow-Up Far Short of FDA Goals; Emily P. Walker, Washington Correspondent, MedPage Today; August 30, 2011

FDA Panel Calls for Silicone Breast Implant Registry; Emily P. Walker, Washington Correspondent, MedPage Today; August 31, 2011

F.D.A. Affirms Safety of Breast Implants; Gardiner Harris, NY Times, August 31, 2011

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

Is Prophylactic Mastectomy Worth It?

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

There is a recent article which asks this question (full reference below).  I think it is a question which must be answered on an individual basis.  

For someone like me, the answer would be no.  I have no family history or personal history of breast cancer.  I have small, more dense than fatty breast, but have always had normal mammograms.  I have never had any lesions which needed biopsy.

For an individual woman with a strong family history of breast cancer (especially genetically proven, BRCA1 and BRCA2) and a person history of breast cancer (ie right mastectomy for lobular carcinoma), then it is easy to say “Yes, a prophylactic left mastectomy would be worth it for you.”

In between these two examples is the gray area, and this article doesn’t necessarily make the gray area any clearer.

There is plenty of evidence that prophylactic mastectomy lowers the risk of breast cancer in the high–risk population in at least 95%.

The authors of the June 2011 Aesthetic Plastic Surgery Journal article performed a retrospective study by reviewing the records of all their patients (n=52) who underwent prophylactic mastectomy within a 25-year period to look at the aesthetic and long-term oncologic outcomes, complications, and patient satisfaction.

Of the 52 patients, 40 had the surgery on one side only (contralateral prophylactic mastectomy) and 12 had bilateral (bilateral prophylactic mastectomy), giving a total of 64 prophylactic mastectomies.

Of the 52 patients/ 64 mastectomies, there was 1 (1.56%) case of unexpected breast cancer in the mastectomy specimens.

Two thirds (42/64) were subcutaneous prophylactic mastectomies and the other third (22/64) were simple total prophylactic mastectomies.

Most of their patients chose to have reconstruction with implants (58/64 = 90.62%) while the other 6 (9.37)  chose to use autologous tissue --  5 (7.81%) received latissimus dorsi flaps with implants and 1 (1.56%) had a TRAM flap.

The complications included 4 (6.25%) breasts that developed capsular contracture, 2 (3.12%) cases of hematoma, and 1 (1.56%) infection.

More than 90% of the patients reported being either highly (39/52) or partially satisfied  (10/52).  Only 3/52 reported being unsatisfied. The authors report an overall aesthetic index of 8.8.

There were no deaths among their patients, nor any new development of breast cancer during the time period.

Related posts
Women Don’t Regret Prophylactic Mastectomy (May 5, 2011)

Prophylactic Mastectomy (January 28, 2009)

Advances in Nipple-Sparing Mastectomy – an article review (April 27, 2011)

Are Patients Making Good Decisions About Breast Reconstruction? (February 28, 2011)

REFERENCE

Prophylactic Mastectomy: Is It Worth It?; Jose Abel de la Peña-Salcedo, Miguel Angel Soto-Miranda, Jose Fernando Lopez-Salguero; Aesthetic Plastic Surgery, Volume 35 (3), June 2011;  DOI: 10.1007/s00266-011-9769-x

American Cancer Society:  What are the risk factors for breast cancer?

More on Implant-Related ALCL of the Breast – an Article Review

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

Last week @prsjournal tweeted

Pre-print Article: Patient Death Attributable to Implant-Related Primary Anaplastic Large Cell Lymphoma of the B... http://bit.ly/o9lQ1f

The title definitely caught my eye.  I have finally read it and re-read it.
Here’s the abstract:

Implant-related primary anaplastic large cell lymphoma (ALCL) of the breast is a rare clinical entity. With increasing attention being paid to this disease, most cases reported to date in the literature have demonstrated indolent clinical courses responsive to explantation, capsulectomy, chemotherapy and/or radiotherapy.

We describe a case of bilateral implant-related primary ALCL of the breast that proved refractory to both standard and aggressive interventions, ultimately resulting in patient death secondary to disease progression. We situate this case in the context of the current state of knowledge regarding implant-related primary ALCL of the breast and suggest that this entity is generally, but not universally, indolent in nature.

The story of implant-related ALCL is far from being completely written.  This article notes (as did the recent FDA report) most investigations performed to date suggest an association between breast implants and primary ALCL of the breast.  The specifics regarding this relationship remain poorly defined.

A review of all reported cases of implant-related primary ALCL of the breast demonstrates no obvious correlation with implant fill type (silicone vs. saline), surface morphology (smooth vs. textured), implant position (subpectoral vs. subglandular), or indication for implant placement (cosmetic vs. reconstructive).

The FDA notes (bold emphasis is mine):

ALCL is a very rare condition; when it occurs, it has been most often identified in patients undergoing implant revision operations for late onset, persistent seroma. Because it is so rare and most often identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, it is unlikely that increased screening of asymptomatic patients would change their clinical outcomes. The FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormality.

……..

The FDA is requesting health care professionals report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

Related posts:

More on Link Between Breast Implants and ALCL (April 25, 2011)

ALCL and Breast Implants – an article review (March 9, 2011)
ALCL and Breast Implants (January 31, 2011)
Breast Implants and Lymphoma Risk (June 29, 2009)


REFERENCE

Patient Death Attributable to Implant-Related Primary Anaplastic Large Cell Lymphoma of the Breast: A Case Report and Review of the Literature; Carty, Matthew J.; Pribaz, Julian J.; Antin, Joseph H.; Volpicelli, Elgida R.; Toomey, Christiana E.; Farkash, Evan A.; Hochberg, Ephraim P.; Plastic & Reconstructive Surgery., POST ACCEPTANCE, 19 July 2011; doi: 10.1097/PRS.0b013e318221db96

Is Personalizing Mammogram Screening the Way to Go?

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

I read the LA Times article by Shari Roan, Study urges more individual mammogram guidelines, with interest.  As Roan notes, guidelines to date have mainly focused on a woman’s age and not her other risks factors.

The American Cancer Society recommends that healthy women undergo screening mammograms every one to two years beginning at age 40 regardless of risk factors. In 2009, the U.S. Preventive Services Task Force recommended a different schedule which urged the inclusion of an individual’s personal risks:  screening for women ages 40 to 49 should be based on individual risk factors and women ages 50 to 74 should be screened every two years.

Monday, a paper was published in the Annals of Internal Medicine (full reference below) which argues for a more personalized approach to screening mammograms.

The study by Dr. Steven R. Cummings, senior author and senior researcher at the California Pacific Medical Center Research Institute, and colleagues was based on a computer model comparing the lifetime costs and health benefits for women who got mammograms every year, every two years, every three to four years or never.

The researchers concluded that “Annual mammography was not cost-effective for any group, regardless of age or breast density.”

They also note that “Mammography is expensive if the disutility of false-positive mammography results and the costs of detecting nonprogressive and nonlethal invasive cancer are considered.”

I find it interesting that the major limitation of the paper noted by it’s authors is that the results are not applicable to carriers of BRCA1 or BRCA2 mutations.   This is a group of women who has a major risk factor for developing breast cancer, yet “personalization” of screening mammograms might not work for them.  Why not?  Might not personalization for this group involve more frequent rather than fewer mammograms?

I personally like the idea of individualizing the screening schedule, rather than one-size fits all.  It is why I have embraced the U.S. Preventive Services Task Force recommendations. 

Related posts:
New Breast Cancer Screening Guidelines (November 17, 2009)
Screening Mammogram Recommendations (January 7, 2010)
The New Mammogram Guidelines - What You Need to Know (December 27, 2009; TBTAM)
Dr. Marya Zilberberg’s, Healthcare, etc, post:  Why medical testing is never a simple decision (December 15, 2010)

REFERENCES

1.  Personalizing Mammography by Breast Density and Other Risk Factors for Breast Cancer: Analysis of Health Benefits and Cost-Effectiveness; John T. Schousboe, Karla Kerlikowske, Andrew Loh, and Steven R. Cummings; Ann Intern Med July 5, 2011 155:10-20

2.  To Screen or Not to Screen Women in Their 40s for Breast Cancer: Is Personalized Risk-Based Screening the Answer? (Editorial); Jeanne S. Mandelblatt, Natasha Stout, and Amy Trentham-Dietz; Ann Intern Med July 5, 2011 155:58-60

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)

Impact of Obesity on Breast Surgery Complications – article review

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

Obesity is an ever increasing presence in today’s world.  Thirty-four percent of U.S. adults are now estimated to be obese (BMI>30), up from just 15% three decades ago.

Obesity increases the risk of complications in many medical/surgical situations which has pushed some Ob-Gyns in Florida to refuse to care for pregnant women over a certain weight.

Martin A. Makary, MD and colleagues designed a study to measure the impact on complication rates in obese patients presenting for a set of elective breast procedures.

The PRS journal article referenced below has been published online ahead of print and looks at the impact obesity has on breast surgery complication.

The researchers used claims data from seven Blue Cross and Blue Shield Plans covering individuals with employer-provided coverage and residing in Hawaii, Iowa, Michigan, North Carolina, Pennsylvania, Tennessee, and South Dakota to identify a cohort of obese patients and a non-obese control group who underwent elective breast procedures covered by insurance between 2002-2006.

Criteria for the patient  to be included:
Enrolled in the insurance plan for at least one month before and after surgery

Have a paid claim for breast augmentation, breast reduction, breast lift (mastopexy), or breast reconstruction during the period between 2002-2006

Have either 1) a BMI of 30 kg/m2 or greater, 2) a diagnosis of obesity (using ICD 278.x or V85.x code closest to the date of surgery), or 3) at least one comorbidity associated with obesity (diabetes, hypertension, metabolic syndrome, obstructive sleep apnea, hyperlipidemia, or gallbladder disease) within one year of undergoing the breast procedure

There were 2,403 patients (mean age 42.1 yrs)  in the obese group who were compared to a non-obese control group of 5,597 patients (mean age 48.4 yrs).  Breast reduction was the most commonly performed procedure in the obese and control groups (80.7% vs 63.8%), followed by breast reconstruction (10.3% vs 24.2%), augmentation (4.0% vs 8.9%), and mastopexy with or without augmentation (5.0% vs 3.2%).

Overall, 18.3% of obese patients had a complication compared to only 2.2% in the control group (p<0.001). After adjusting for other variables, the researchers found obesity status increased the odds of experiencing a complication by 11.8 times.

Among the obese patients, at least one complication was observed in 50.5% of patients undergoing breast augmentation (vs. 4.4% of controls), 24.1% undergoing mastopexy (vs. 11.4%), 38.9% mastopexy with augmentation (vs. 5.6%), 29.4% of reconstruction (vs. 1.8%), and 14.6% of breast reduction patients (vs. 1.7%).

The differences between the two groups were most pronounced
in complications such as inflammation (OR=22.2), infection (OR=13.4), pain (OR=11.7), the development of seroma (OR=11.4) and hematoma (OR=10.9).

Obesity status  increased the odds of experiencing a complication (OR = 10.1, adjusted 11.8).  Diabetes (OR = 1.37, adjusted 1.16) and a history of prior chest wall irradiation (adjusted OR = 1.4) were associated with a higher odds of complication.

Hypertension, COPD, a history of neoadjuvant chemotherapy and undergoing a bilateral procedure were not significantly associated with the development of complications.

Makary and colleagues write in their discussion (bold emphasis is mine):

Our data demonstrate that obesity is a major risk factor for complications following elective breast procedures. In light of current trends towards pay-for-performance-based reimbursement, although obesity is currently not accounted for in quality metrics, based on our study, it increases the odds of experiencing any complication within a 30-day postoperative period by 11.8 times. This is in marked contrast to previous studies, which showed either no significant difference in complications between
obese and non-obese patients undergoing elective breast surgery, or just a slight increase.

Although pay-for-performance strives to reward healthcare providers for meeting certain performance measures for quality and efficiency, there is no guarantee that the measures being used accurately reflect the quality of surgical care being provided. For example, the current assumption behind pay-for-performance is that high-quality care reduces surgical
complications.  Our results suggest that variations seen in the rate of complications may be, in part, related to the characteristics of the population--in this case, body habitus. These complications could even occur despite adherence to process measures such as administering appropriate antibiotic prophylaxis. Thus, any measure of quality should consider the effect of obesity on these measures.

REFERENCES
The Impact of Obesity on Breast Surgery Complications; Chen, Catherine L.; Shore, Andrew D.; Johns, Roger; Clark, Jeanne M.; Manahan, Michele; Makary, Martin A.; Plastic & Reconstructive Surgery., POST ACCEPTANCE, 9 June 2011; doi: 10.1097/PRS.0b013e3182284c05

Transaxillary Breast Augmentation and Sentinel Lymph Node Integrity

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

I’m not a huge fan of transaxillary breast augmentation (TABA).  One of the major selling points for the transaxillary approach is the lack of scars on the breasts.  As a woman living in the south, my arm pits are much more likely to be seen in public than my breasts. 

As a surgeon, I also know that when revisions need to be done (capsule issues, etc) most recommend using an inframammary approach so why not just start there.  In my opinion, all women with implants will have a repeat surgery at some point in the future – implant failure (deflation, rupture) being a given.

I admit I had not thought about how the incision might interfere with future sentinel lymph node assessment prior to this article (full reference below).

Dr. Ana Claudia Weck Roxo, Rio de Janeiro State University, Brazil and colleagues conducted a small study to evaluate changes in axillary lymphatic drainage in patients who underwent TABA.

The authors share this information as to why this is important (bold emphasis is mine):

The sentinel lymph node is the first node in the lymphatic chain and the first to receive tumor cells via lymphatic drainage. Therefore, sentinel lymph node analysis allows physicians to predict the status of the lymphatic chain. The recent validation of the capacity of the sentinel lymph node to stage breast cancer patients and to help identify those who require axillary dissection has dramatically improved surgical treatment and reduced morbidity. Thus, sentinel lymph node biopsy has become an alternative to axillary dissection in patients with T1 and T2 breast cancer and is a gold standard for axillary staging because of its high sensitivity (84%-98%) and low false-negative rates (2%-8.8%).  Nevertheless, it is contraindicated in patients with palpable axillary metastatic lesions, multicentric breast disease, previous mammary or axillary radiotherapy, and/or previous axillary or mammary procedures.

The prospective study enrolled 27 patients who underwent preoperative mammary lymphoscintigraphy, a subsequent TABA (using a subglandular placement of round, textured, high-profile silicone implants through a 4-cm incision at the anterior axillary fold), and postoperative lymphoscintigraphy at 21 days and six months after the procedure.  

The postoperative imaging results examining the axillary lymphatic chain and the first axillary lymph node were analyzed and compared to the preoperative images.

None of the patients showed any changes between the preoperative and postoperative images at six months.  Only one of the 27 patients (4.5%) demonstrated a lower rate of lymphatic drainage at 21 days postoperatively compared to preoperative values.

The sentinel lymph node remained visible in all patients at all time points, and all breasts showed drainage primarily to the axillary lymphatic chain.

Their data showed preservation of lymphatic drainage and visible sentinel lymph nodes even after transaxillary breast augmentation.  I would love a larger study to confirm, but am pleased they looked at this.

REFERENCE

Evaluation of the Effects of Transaxillary Breast Augmentation on Sentinel Lymph Node Integrity; Ana C Weck Roxo, Jose H Aboudib, Claudio C De Castro, Maria L De Abreu, and Margarida M Camões Orlando; Aesthetic Surgery Journal May 2011 31: 392-400, doi:10.1177/1090820X11404399

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

More on Link Between Breast Implants and ALCL

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

I have written about this previously. 
ALCL and Breast Implants – an article review (March 9, 2011)
ALCL and Breast Implants (January 31, 2011)
Breast Implants and Lymphoma Risk (June 29, 2009)

A quick review:  In January, the Food and Drug Administration (FDA) released a safety alert warning of the possible association of acute large cell lymphoma (ALCL) with breast implants.

After the Plastic Surgery Societies got through being defensive (http://www.theplasticsurgerychannel.com/fda-issues-safety-signal-on-alcl-breast-implants/), they did the right thing  reviewed the literature (4th reference below) and the Plastic Surgery Foundation and the Aesthetic Surgery Education and Research Foundation commissioned RAND to conduct an exhaustive review of the medical literature and organize a panel of medical experts to evaluate the evidence for a potential link and its implications.

The results of this RAND review confirmed breast implants do indeed appear to be associated with the rare form of lymphoma ALCL.  The report notes there is not yet evidence to show that the cancer is caused by implants or to suggest an underlying mechanism for how the disease might develop.

The study, published online (3rd reference below) by the journal Plastic and Reconstructive Surgery, also finds that the disease takes a slow course and can be controlled by surgical removal of the implant and surrounding capsule.

The conclusions are based on an exhaustive review of the medical literature regarding breast implants and anaplastic large cell lymphoma or ALCL, a type of immune system cancer that was first linked to breast implants more than a decade ago, and input from a multidisciplinary expert panel.

"Much more research is still needed to explore the link between breast implants and ALCL and the clinical significance of this rare disease, but our findings provide useful information for both patients and physicians in the near term," said Dr. Soeren Mattke, the study's senior author and a senior scientist at RAND, a nonprofit research organization.

The panel concluded that the evidence suggests an association between breast implants and anaplastic large cell lymphoma, but cannot definitely prove that implants cause the disease nor explain how the implants might trigger ALCL.

The experts recommended that the appearance of a fluid-filled sac near a breast implant six or more months after surgery should lead to a thorough diagnostic evaluation for anaplastic large cell lymphoma. They also concluded that the diagnosis of anaplastic large cell lymphoma should result in a complete evaluation to rule out spread of the disease outside of the breast capsule (the lining that forms around the implant), followed by removal of the implant and capsule.

Experts did not believe that disease confined to the implant capsule warrants radiation treatment or chemotherapy after surgery and expressed the belief that the risk of recurrence or development of systemic disease following surgical removal was low, but that close clinical follow-up was necessary.

The U.S. Food and Drug Administration and the American Society of Plastic Surgeons recently announced an effort to create a registry that will collect information on women with breast implants who have been diagnosed with anaplastic large cell lymphoma in order to gather information that will help increase understanding of the disease.

Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online at http://www.fda.gov/Safety/MedWatch/default.htm or
by calling 800-332-1088.


REFERENCES
1.  RAND Corporation;  Press Release April 19, 2011
2.  FDA safety alert; January 2011

3.  Anaplastic Large Cell Lymphoma and Breast Implants: Results From a Structured Expert Consultation Process; Kim, Benjamin; Roth, Carol; Young, V. Leroy; Chung, Kevin C.; van Busum, Kristin; Schnyer, Christopher; Mattke, Soeren; Plastic & Reconstructive Surgery., POST ACCEPTANCE, 15 April 2011; doi: 10.1097/PRS.0b013e31821f9f23

4.  Anaplastic Large Cell Lymphoma and Breast Implants: A Systematic Review; Kim, Benjamin; Roth, Carol; Chung, Kevin C.; Young, V. Leroy; van Busum, Kristin; Schnyer, Christopher; Mattke, Soeren; Plastic & Reconstr Surgery., POST ACCEPTANCE, 25 February 2011; doi: 10.1097/PRS.0b013e3182172418

Breast Self Exam Poster

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

HT to Street Anatomy for the link to this great poster (photo credit)  by iHeartGuts!

Related posts:
Breast Self-Exam (October 8, 2009)
October – Breast Cancer Awareness Month (October 2, 2008)
Mammograms (October 13, 2008)
Breast Cancer Screen in Childhood Cancer Survivors – An Article Review (February 2009)
Indications for Breast MRI – an Article Review (March 2009)

Fat Grafting to the Breast and Oncologic Risks

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

Fat grafting to the breast has become an acceptable practice.  It is being used to repair small defects as well as to augment.  As I noted in my post (November 22, 2010), the two articles (2nd and 3rd 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.

This new article (first reference below) discusses potential risks of current and novel approaches to autologous fat grafting to the breast within the context of both the underlying science and clinical practice.  They conclude (bold emphasis is mine):

There are theoretical reasons why fat grafting might influence breast cancer growth or metastasis. Certain laboratory studies can be interpreted as supporting their negative impact on tumor development, metastasis, or recurrence. However, careful review of these concerns suggests that they arise from factors and situations that are not present to a significant extent in the clinical setting.

A study that approximates more closely the clinical situation of fat grafting into the breast has been presented in poster form.   This study investigated an orthotopic model of breast cancer in which human breast cancer cells were implanted into the mammary fat pad of immunodeficient animals, followed by placement of a human fat graft (with or without noncultured supplemental cells) immediately adjacent to the mammary fat pad containing the nascent tumor. The study found no increase in tumor growth with either an estrogen receptor-positive or an estrogen receptor-negative human breast cancer line. This is consistent with the absence of evidence for increased cancer risk in the many reports of fat grafting for breast reconstruction and augmentation. However, at this time, the number of patients with prolonged follow-up is only approximately 1000 and appropriate caution in proceeding is indicated.

……….In the clinical setting, several studies note the importance of good communication between the surgeon and an experienced radiologist to ensure accurate interpretation of breast imaging findings. Incorporation of these steps into good clinical practice and timely reporting of outcome data, including long-term follow-up—preferably in the form of multi-center clinical studies or a robust international patient registry—will ensure that the field develops in a safe and appropriate manner.

REFERENCES

1.  Oncologic Risks of Autologous Fat Grafting to the Breast; Fraser JK,  Hedrick MH, Cohen SR;  Aesthetic Surgery Journal January 2011 31: 68-75, doi:10.1177/1090820X10390922

2.  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.

3.  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.

ALCL and Breast Implants – an article review

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

In light of the recent new regarding the FDA safety alert on the possible association of acute large cell lymphoma (ALCL) with breast implants, the authors of the recently Plastic and Reconstructive Surgery Journal article (full reference below, published online ahead of print) conducted a systematic literature search on the topic.

The search included the literature of PubMed, Embase, and Web of Science (Science Journals & Proceedings) databases.  Dates searched included references from 1966 for PubMed and Embase ; from 1980 for Web of Science; and from 1990 for Web of Science Proceedings, through July 2010 for all of them.

Research (categorized as epidemiologic studies or scientific papers) and non-research (case reports or case series) articles from peer-reviewed journals, conference abstracts, and unpublished manuscripts were retrieved from the literature search.

Only human-based topics and articles written in English were considered. Of the initial 884 titles, 83 articles discussed ALCL and breast implants. Fourteen additional articles were provided by 2 expert plastic surgeons (V.L.Y. and K.C.C.).

Their conclusions:

A form of ALCL, which clinically behaves more like the less-aggressive cutaneous form of ALK-negative ALCL rather than the more-aggressive systemic form, may be associated with breast implants. Future research on the epidemiology and biology of this rare disease is clearly needed to better understand its nature.

What is conclusive:

• ALCL is a rare disease, comprising 2% of all newly-diagnosed non-Hodgkin’s lymphomas (NHLs) worldwide2 and 0.9% of the estimated 65,540 cases of NHL diagnosed in the U.S. in 2010.
• Lymphomas of the breast are extremely rare, comprising 0.04-
  0.5% of all breast cancers and approximately 1-2% of all extranodal lymphomas.
• Despite the rarity of both ALCL and primary breast lymphomas, multiple cases of ALCL developing adjacent to breast implants have been reported, including by Brody et al., who have recently presented but not yet published a series of 34 cases.
• In 2009 alone, a reported 289,328 breast augmentation, 86,424 reconstruction, and 87,386 lift procedures were performed in the U.S.; unfortunately, the exact number of women who received implants is not known because only some breast reconstructions and lift procedures utilized implants.

The literature review noted the case presentation characteristics (bold emphasis is mine):

Fourteen (48%) of 29 ALCL cases were noted to have presented with a seroma, 1 (3%) ALCL case did not present as a seroma and data was not reported in the remaining 14 (48%) ALCL cases.

Seven (24%) of the 29 ALCL cases reported data indicating that the patient had a palpable breast mass on presentation, 5 (17%) reported absence of a mass and information was missing for the remaining 17 (59%) ALCL cases.

Less frequently cited symptoms among ALCL cases were pain [6/29 (21%], redness [4/29 (14%)], and capsule contracture [2/29
(7%)].

Other symptoms (e.g., skin lesions, fever) were reported in only 2 (7%) of 29 ALCL cases but in 5 (71%) of 7 patients with other NHLs [not reported in 27/29 (93%) ALCL and 2/7 (29%) non-
ALCL cases].

Duration of symptoms was rarely noted. In the 7 cases where it was, mean duration in years for ALCL cases was 0.8 (range 0.2-1.7). Mean symptom duration among 5 non-ALCL cases for which it was reported was 5.4 years (range 0.5-17).

…..
Remember the FDA report noted (bold emphasis is mine):

ALCL is a very rare condition; when it occurs, it has been most often identified in patients undergoing implant revision operations for late onset, persistent seroma. Because it is so rare and most often identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, it is unlikely that increased screening of asymptomatic patients would change their clinical outcomes. The FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormality.

…..
Of interest is this post from Maggie Mahr:  The FDA “Has a Chat” With Plastic Surgeons

………….It is probably not a coincidence that ASPSS and ASAPS repeated the cancer-denial line first promulgated by Allergan: Both organizations have received funding from the company. ASPSS has also received funding from Allergan’s main competitor, J&J, which makes the Mentor implant line. (Mentor’s reaction to the FDA warning was more muted than Allergan’s but its statement also avoided mentioning the C-word.)

Both Allergan and J&J fund provide funds for ASPSS, as noted on its web site.

At ASAPS, Allergan’s funding is more indirect. It has supplied research grants through ASAPS’ research arm, the Aesthetic Surgery Education and Research Foundation. You can see those grant award announcements by searching for “Allergan” here.

The two groups ought to be ashamed of themselves. It is one thing to take funding from drug and device companies . .  . . But the groups ought to represent the medical expertise of the healthcare providers who are their members, not the PR agendas of two companies who are afraid they may lose money from too much blunt but accurate talk about breast cancer.

Previous related posts:
ALCL and Breast Implants (January 31, 2011)
Breast Implants and Lymphoma Risk (June 29, 2009)


REFERENCE

Anaplastic Large Cell Lymphoma and Breast Implants: A Systematic Review; Kim, Benjamin; Roth, Carol; Chung, Kevin C.; Young, V. Leroy; van Busum, Kristin; Schnyer, Christopher; Mattke, Soeren; Plastic & Reconstr Surgery., POST ACCEPTANCE, 25 February 2011; doi: 10.1097/PRS.0b013e3182172418

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

ALCL and Breast Implants

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

Last week, the U.S. Food and Drug Administration requested health care professionals to report confirmed cases of anaplastic large cell lymphoma (ALCL) in women with breast implants.

The FDA made this request as they continue to investigate a possible association between breast implants, both saline and silicone gel-filled, and ALCL.

The definition given of ALCL by the National Cancer Institute calls ALCL an aggressive type of non-Hodgkin lymphoma, but oncologist Elaine Schattner, M.D. concludes after studying the FDA’s assessment (bold emphasis is mine)

Most of the ALCL tumors were limited to the area of the implant cap­sules, and could – as best I can tell from the few reports – be treated by removal of the implants and affected, adjacent breast tissue. These don’t appear to be aggressive lym­phomas, as are some ALCL’s. I would go as far as to spec­ulate that these might indeed be antigen-driven tumors; in this light, it would make sense in prin­ciple and in practice to treat these by removal of the implants, at least as a first-line approach.

 

The FDA cites the Surveillance, Epidemiology, and End Results (SEER) Program of the NCI when noting ALCL is diagnosed in the United States in  approximately 1 in 500,000 women each year. ALCL in the breast is even more rare; approximately 3 in 100 million women per year in the United States are diagnosed with ALCL in the breast (Altekruse et al., 2010).

The FDA press release mentions an awareness of about 60 cases of ALCL in women with breast implants worldwide.   The same press release later notes “a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.”

There are an estimated 5 million to 10 million women worldwide who have breast implants.

Among the 34 unique cases, the median age was 51 (28-87, with no age given in 8 cases); implant type (24 silicone, 7 saline, 3 unknown); implant texture (4 textured, 0 smooth, 30 unknown); median time from implant to diagnosis was 8 years (1-23, but not known in 11 cases); reason for implantation (11 reconstructive, 19 augmentation, 4 unknown).

The FDA notes (bold emphasis is mine):

ALCL is a very rare condition; when it occurs, it has been most often identified in patients undergoing implant revision operations for late onset, persistent seroma. Because it is so rare and most often identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, it is unlikely that increased screening of asymptomatic patients would change their clinical outcomes. The FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormality.

……..

The FDA is requesting health care professionals report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

……..….

Women with implants should remember ALCL is extremely rare.  There is no need to change your routine medical care and follow-up.  For more information from the FDA:
Breast Implant Consumer Information
ALCL and Breast Implants Consumer Article



Other blog posts on topic:
An Oncologist Considers Rare Lymphomas in Women With Breast Implants; Medical Lessons Blog (January 28, 2011)
Breast implants and anaplastic large cell lymphoma (ALCL): Is there a link?; Science-Based Medicine Blog (January 31, 2011)

REFERENCES

FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer; January 26, 2011

Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses; FDA

Breast Implants and Lymphoma Risk: A Review of the Epidemiologic Evidence through 2008; Plastic & Reconstructive Surgery. 123(3):790-793, March 2009; Lipworth, Loren Sc.D.; Tarone, Robert E. Ph.D.; McLaughlin, Joseph K. Ph.D.

Anaplastic large-cell lymphoma in women with breast implants; JAMA. 2008;300:2030-2035; De Jong D, Vasmel WLE, de Boer JP, et al.

Determining Implant Size Preop

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

There is an interesting debate going on regarding bra stuffing for implant size at PRSonally Speaking.  In the interest of full disclosure, I use normal saline implant sizers which I place inside a thin sleep bra.  I then inflate with sizer (usually use two different sizes for comparison) with air.  I then have the woman place her shirt on and stand in front of the full length mirror.  It has worked well for me over the years.  And, yes, I know it is not perfect, but it allows the two (or three if a friend or spouse has come with her) to assess how she looks AND presents herself. (photo credit)

It has amazed me over the years how some women will decide on larger implants when I show them what a “C” cup for their body really is [the volume for a 34C is not the same as for a 38C] but also how some will decide they can’t go as large as they intended.  It has worked both ways.  Most of the time the decision is made in one office visit, occasionally two.  Rarely, do they come back wishing we’d made a different choice on size.

Back to the discussion at the PRSonally Speaking:  Letters to the Editor in Advance: Bra Stuffing for Implant Sizing? Satisfaction? Who, When, and Compared to What?

The discussion is in regards to an article in the PRS Journal’s June 2010 edition (full reference below)
A portion of Dr. John Tebbett’s comment

The authors characterize their bra stuffing implant sizing methodologies as “simple” and “accurate”. Simple? Up to three visits to the surgeon’s office to ruminate over shades of gray using a totally subjectively derived decision processes based on indefinable cup size parameters and patient’s visual perceptions? Accurate? 30% of sized respondents reported that the sizing methods were inaccurate.

Choosing breast implant size by bra stuffing has a repetitive, three decade track record of 15-25% reoperation rates (and a major percentage of reoperations for size change) …...

The authors’ implication that objective, scientifically validated, defined process implant selection methods preclude or minimize patient involvement in the decision making processes is misguided and incorrect…

A portion of Dr. David Hidalgo replies

……..What is truly outdated is the model of the surgeon as an autocratic figure that dictates what is best while ignoring patient input beyond presenting anatomy. The trend today instead is towards personalized medicine. ……….

While FDA PMA studies may show a 15-25% reoperation rate preoperative sizing techniques are not specifically implicated as the source of the problem, as implied. In fact the vast majority of reoperations today are for capsular contracture, implant malposition, and saline implant deflations. ……

To be clear, preoperative sizing is not a precise method and is of course subjective. Improvements in the technique would be helpful and hopefully forthcoming. We do not believe that the ongoing advances in three dimensional patient photography with implant size simulation is the answer. There is no substitute for the patient trying on different sizes and visualizing the effect in clothing as well as experiencing the implant weight. The method is very instructive in revealing the patient’s aesthetic vision in a way that dictating a size based on tissue characteristics alone can never do. …….

Thoughts?  Add them here or over at PRSonally Speaking


REFERENCE

Preoperative Sizing in Breast Augmentation; Hidalgo, David A.; Spector, Jason A.; Plastic & Reconstructive Surgery. 125(6):1781-1787, June 2010; doi: 10.1097/PRS.0b013e3181cb6530

Five Critical Decisions in Breast Augmentation Using Five Measurements in 5 Minutes: The High Five Decision Support Process; Tebbetts, John B.; Adams, William P.; Plastic & Reconstructive Surgery. 118(7S):35S-45S, December 2006; doi: 10.1097/01.prs.0000191163.19379.63