Mindful of Two Breast Implant Scandals

This year began with a breast implant scandal.  This one has brought back memories of the one early in my private practice.

The current one involves the PIP-branded breast implants produced by the French company Poly Implant Prothese and rebranded by the Dutch company Rofil as Rofil M-implants breast implants.  The first one involved silicone implants made by American companies including Dow Corning who no longer makes breast implants.

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.

My post Breast Implants -- Some History (March 3, 2008) covers much of the history of implants in the United States.  Kira Cochrane, The Guardian, wrote about the first patient to receive a breast implant:

It was in 1962 that Timmie Jean Lindsey was offered a solution to a non-existent problem. A factory worker from Texas, ….. And the doctors had another proposal. Had she ever thought about breast implants?

Lindsey had not. ….

……...She's 80 today, still living in Texas, working night shifts in a care home, and those first, experimental globes remain in her chest. ……

I would love to know if they are soft or have become hardened by capsular contractures.  The article doesn’t say.

In the current breast implant scandal, I haven’t noticed anyone urging a class action lawsuit against the French company Poly Implant Prothese or the Dutch company Rofil.  The big issues are 1. do the implants need to be removed or just checked and 2. who will pay for the removal, the government or the private clinics.  The issue isn’t just a European one, it affects women in South American, Mexico, and the United States.

The old scandal in the early 1990s was handled by a class action lawsuit.  I had not been in practice long enough for it to truly affect my then current patients, but I saw many who’s doctors were no longer in practice or non-plastic surgeons who has decided due to the scandal to quit doing breast implants.  I did exams for free, but not the surgeries.  I did, however, not raise prices or take advantage of the situation. 

When I was in practice, I encouraged my breast implant patients to return every year or two for a complimentary breast exam.  This keep us in contact so if anything (ie ALCL and implants, or faulty implants) came up I had current addresses.  I made sure each woman had the information on her implants and encouraged her to keep up with it.  I also encouraged the extended warranty on the implants.  This helps settle who pays for what, at least for the first 10 years.

Women and their doctors need to be mindful that implants are foreign bodies we are placing into the human body.   Women and their doctors should be mindful of future costs that might be incurred from breast implant surgery.   In the United States, many things related to implants, especially those placed for cosmetic reasons only, are not covered by insurance or the extended warranty.

Related posts:
Breast Implants -- Some History (March 3, 2008)
FDA Updates Safety Data for Silicone Breast Implants  (June 23, 2011)
ALCL and Breast Implants  (January 31, 2011)

REFERENCES
1.  Breast implant scandal: now women with Rofil M-implants 'are at risk';  The Telegraph, Matthew Holehouse, January 5, 2012
2.  Breast implants – a brief history of the first 50 years; The Guardian, Kira Cochrane, January 11, 2012
3.  Q&A: PIP breast implant s health scare; BBC Health News, James Gallagher, January 11, 2012
4.  Confusion Reigns Abroad Over Faulty Breast Implants; MedPage Today, Cole Petrochko, January 13, 2012
5.  PIP breast implants: European Commission says reform needed;  BBC Health News, James Gallagher, January 14, 2012
6.  Keeping patients safe: The case for a breast implant registry; The Atlantic,  Anna Yukhananov, January 5, 2012

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

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

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)

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

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

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

Can You Tell Me…

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

Office phone rings.

PT1992, “Can you tell me how long Dr. Bates has been at that location?”

“20 years,” I reply.

PT1992, “I think you did my surgery.  One of my saline implants has burst.”

“Let me put you on hold.  I’ll look and see if you were ever our patient.”

I am acutely aware that I don’t recognize the voice or patient name, but feel I am okay with HIPAA to verify to PT1992 that indeed we once had a patient by that name.

I then as politely as I can tell her, “I will need a signed medical records release to give you any more information as I don’t know your voice and have no other way to verify whom I am speaking with.”

She seems to accept this, but then says “Can you just tell me which company made the implants?”

I repeat the above.

PT1992, “Well can you tell me what kind of coverage I might have?”

“You should be able to get free replacement implants, but if it as it has been more than 10 years that will be all the assistance you will be able to receive.”

PT1992, “Thanks.  Since I have moved away, I’ll go to the surgeon here and have them send a release.  Will that work?”

“Yes, that will work.”

 

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)


Mentor Enhanced Advantage Warranty
INAMED (McGhan) ConfidencePlus™ & ConfidencePlus™ Platinum Breast Implant Limited Warranties

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

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

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.

More on Using Singulair Treatment for Capsular Contracture

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

Previously I reviewed the literature on the off-label use of zafirlukast (Accolate) and montelukast (Singulair) for the treatment of capsular contracture.  The recent issue (May/June 2010) of the Aesthetic Surgery Journal has an article (full reference below) on the use of Singulair for capsular contracture (CC).

Huang and Handel’s article reviews the literature, noting some articles I missed.  Their study is a small (17 patients, 4 with bilateral CC for a total of 21breasts treated with Baker’s Grade II or greater CC).  All of their patients were informed of possible risks associated with the off-label application of Singulair before being prescribed 10 mg of Singulair for 90 days and instructed to massage their breasts twice daily.

Unlike Accolate, the adverse event profile of Singulair is comparable to placebo, with the most common side effects being headache (18.4% vs 18.1%), influenza-like symptoms (4.2% vs 3.9%), abdominal pain (2.9% vs 2.5%), cough (2.7% vs 2.4%), and dyspepsia (2.1% vs 1.1%).

Follow-up of patient compliance and treatment results was obtained by a combination of chart review and a standardized telephone questionnaire.  Telephone interviews were used to determine the actual duration and dose of Singulair taken by the patient and whether the patient noted improvement, no change, or worsening of contracture.

The authors note that this is only a preliminary study show without a well-matched population of negative controls.  That said:

Our follow-up data showed that in two (11%) patients, the CC worsened, three (16%) patients had no change, five (26%) improved, and seven (37%) completely resolved.

As for adverse effects from Singulair:

Only one of our patients reported any side effect (fatigue). All other patients tolerated the treatment without any problems.

Their conclusions are (bold highlight is mine):

Our article presents preliminary findings on the off-label use of Singulair for CC. The drug is well tolerated with minimal side effects; therefore, we recommend its application in patients with CC. There was a greater response in breasts with mild CC, so a course of Singulair should be started early. Because it prevented recurrence in two patients with previous severe contracture, we recommend prophylactic prescription in patients with a history of recurrent contracture. In patients who already have moderately advanced CC, Singulair is unlikely to reverse symptoms to the degree that revision can be avoided.

This is a topic I will continue to follow with interest.


REFERENCE

Catherine K. Huang, Neal Handel; Effects of Singulair (Montelukast) Treatment for Capsular Contracture; Aesthetic Surgery Journal May/June 2010 30: 404-408; doi:10.1177/1090820X10374724

Palpable Implant Valve

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

I received a call recently from a patient who is one month postop from an augmentation mammoplasty. She and her family physician had found a “lump” in her left breast on a wellness exam. The patient who loves her new implants was worried she something was wrong and she would have to have the implants removed.

I asked her to come in and allow me to do an exam. She happily agreed.

My first thought was not breast cancer. All her mammograms prior to surgery had been normal. Her breast exam prior to surgery had not revealed any abnormal lumps.

My first thought was a palpable implant valve.

Fortunately, I was right.

This patient is thin, has little breast tissue, submuscular saline implants. She did not want silicone implants. While the valve is flat and non-projecting on the surface of the implant, in women such as this patient the valve can sometimes be felt.

In reassuring the patient, she and her husband were educated. I reminded them of the muscle anatomy. The border of the pectoralis just misses covering the implant valve. I pulled out a saline implant for them to see and feel the valve.

Even though the surface is smooth, the valve is 2-3 mm thick.

She will learn through self-exam her new “normal.” She will be encouraged to come back to my office yearly for a breast exam. She has been educated to continue to get her yearly mammograms.

REFERENCES

Breast Implants and Breast Cancer Screening: Implants and Breast Cancer Screening; Medscape article, 11/14/2003; Stacy M. Smalley, CNM, MSN

Saline-Filled Breast Implant Surgery: Making an Informed Decision, Updated January 2004 (pdf); FDA.gov

Acute Hematoma Seven Years Postop – an Article Review

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

There is a unique case presented in the Canadian Journal of Plastic Surgery of an acute, symptomatic hematoma occurring 7 years postoperatively.  Most unique is the well defined mechanism of injury which caused the hematoma.

For background, the article reminds us that hematoma formation is a complication of augmentation mammoplasty whether for cosmetic or reconstructive purposes.  Most of these will occur in the immediate postoperative period.  The incidence is reported to range from 2-10.3% in this immediate postoperative period.

In their review of the literature, the authors found only 20 cases reported to have occurred in the late postoperative period.  Most of these cases did not have a definitive mechanism of injury or develop symptoms immediately after the triggering event.

In contrast, their patient presented with both a known and traceable cause of her bleed and with symptoms that developed immediately after the initial event.

The patient was a 53 year old female who had undergone a right mastectomy with reconstruction using a saline implant seven years previous to this injury. 

The patient reported having right breast soreness after performing vigorous stretching exercises.  The following morning, she noted increased pain and bruising over the medial aspect of the breast.  She underwent right breast ultrasound in the clinic that demonstrated a small fluid collection between the anterior surface of the implant and the overlying tissue, which was of unclear consistency…..A magnetic resonance imaging scan confirmed both intracapsular and extracapsular hemorrhage.

The patient was taken to the operating room; on entering the capsule, a pool of dark red blood was visualized and 200 ml of clot was removed…..

Interesting case review.


REFERENCE
Acute symptomatic hematoma with defined etiology seven years after breast reconstruction: A case report and literature review;
Canadian Journal of Plastic Surgery, Summer 2010, Volume 18 Issue 2: e 27-e 29; AK Seth, JY Kim

Late Hematoma after Augmentation Mammaplasty Apparently Due to Myoelectrostimulation; Cagli, Barbara; Vulcano, Ettore; Marangi, Giovanni Francesco; Cogliandro, Annalisa; Persichetti, Paolo; Plastic and Reconstructive Surgery. 119(1):439-440, January 2007; doi: 10.1097/01.prs.0000233618.94269.d4

Local Complications after Cosmetic Breast Augmentation: Results from the Danish Registry for Plastic Surgery of the Breast; Hvilsom, Gitte B.; Hölmich, Lisbet R.; Henriksen, Trine F.; Lipworth, Loren; McLaughlin, Joseph K.; Friis, Søren; Plastic and Reconstructive Surgery. 124(3):919-925, September 2009; doi: 10.1097/PRS.0b013e3181b0389e

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

It's Happened Again

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

A patient calls–My right implant has ruptured. I woke up this morning and now my right breast is smaller than the other. I gently correct her–Your implant has deflated. Saline implants deflate, they don’t rupture.

Patient–Is it going to harm me?/I have a trip planned for this coming week. Me--Your body will simply absorb the IV saline that was used to fill the implant. It isn’t a medical emergency though it can be embarrassing. We can take our time and fit it into your life/work schedule (If patient is pregnant, it can safely wait until the delivery of her baby.) Put a shoulder pad or some other padding in your bra to even it out for now. When would you like to be seen?

Patient–Well what do we have to do? I didn’t realize they would do this. Me–Yes, I reviewed this with you before surgery. All implants fail at some point. Just like anything else man-made.

Patient–So what do we do now. Me--I will need to see you and then call the implant company to arrange the free implant replacement(s). Do you know if you have the "extended warranty"?

Patient–No, I don’t think so. I think my surgery was yyyy. Me–Okay, the extended warranty program didn’t exist prior to October 1, 2000, so you won’t get any other financial help. Just the free implants.

Patient–So what will this cost me? Me–The surgery center will charge you $800, anesthesia’s charge is $500, and my fee is $***(depends on time passed since surgery and whether I was the initial surgeon). This time we will make sure you get the extended warranty (I began paying for it for each patient out of my fee back in 2002 when I realized too many of them were failing to spend the extra $100.)

Patient–I will have to talk to my husband and see if we can afford that. Me–Okay, just let me know when you want to go forward. I will need a minimum of 2-3 days between the office visit and the surgery date (shipping time for the implants and the paper work to facilitate payment, if warranty is in effect). Would you like to schedule an appointment or call back after talking to your husband?

I truly appreciate the patient who remembers the preoperative discussion and who read the information brochure (pdf file). I try very hard to make sure the woman knows that the saline implant is not permanent. Approximately 1% deflate within 1 year, 3% within 3 years, and 10% within 5 years. Because of the warranty set at 10 years, I caution all of them that the mean deflation is 10-12 years (or half at that point). I tell them that it is rare to have a deflation at 1 year, but it can happen. And yes, the implant may last for 20 years, but don’t count on it. I tell them to begin saving money, if they get to 8-9 years without a deflation because they will likely end up out of the extended warranty period.

And all this is said on top of reminding them that this is surgery, the risks of surgery are infection, bleeding, anesthesia/drug reactions, scar, loss of/or decrease nipple sensation. The risks due to the implant include capsular contracture, asymmetry, visible wrinkling of the implant, deflation, repeat surgery to correct any of the before mentioned problems. You will need to be more careful with your mammograms. Four views will need to be done rather than just two. Make sure you go to a facility that is comfortable with implants and do mammograms often on women who have implants.