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

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

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

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

Injectables Roundup

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.

I have come across some interesting articles recently regarding injectables.  Let’s begin the non-controversial one: Behind the Lines by Linda W. Lewis, Nov/Dec 2010 MedEsthetics (pp 32-.  This one notes several filler discontinuations:

Johnson & Johnson (jnj.com) withdrew porcine collagen-based Evolence in November 2009; Allergan (allergan.com) discontinued its human and bovine collagen fillers, CosmoDerm, CosmoPlast, Zyderm and Zyplast, late last year and will stop distribution by the end of 2010.

The article mentions the latest filler introductions:

Juvederm XC from Allergan and Restylane-L and Perlane-L from Medicis (medicis.com).  These products differ from their predecessors only in the addition of lidocaine to the formulations.

Much greater changes are on the horizon, however, as manufacturers seek approval for exciting new products like Novabel (Merz Aesthetic, merzaesthetics.com) and Aquamid (Contura, aquamid.com).

The article also mentions that some physicians are using Restylane SubQ in buttock and breast enlargements.  This leads me to the next article (full reference below):   Macrolane(TM) for breast enhancement: 12-month follow-up.  The Swedish study used a new formulation of a stabilized hyaluronic acid-based gel of non-animal origin (NASHA(TM)-based gel) called Macrolane(TM) VRF30) in their open-label, multicentre, non-comparative study.

The aim of this study was to develop a reproducible technique for injecting NASHA-based gel posterior to the mammary gland (subglandular injection), and to assess treatment safety and efficacy. The feasibility of dual-plane submuscular injection was also explored.

Twenty-four non-pregnant, non-breastfeeding women (mean age 37 years) with small breasts were recruited, 20 of whom underwent subglandular injection.   Patients were treated in groups of four to enable step-wise revision of the injection technique. Safety and efficacy assessments (12-month follow-up) included adverse event (AE) reporting and the Global Esthetic Improvement Scale, respectively.

It’s a small study with the authors reporting 83% satisfaction in the post-procedure breast appearance at 6 months, 69% at 12 months.  I find it interesting that the most commonly reported adverse event was capsular contracture.   Obviously,  larger studies are needed before this can be routinely recommended to patients.

……………………….

Dentist are “pushing” their scope of practice beyond the teeth/dentition to include Botox and fillers.   While dentists may know how to do injections well and should know facial nerve/muscle anatomy well, I personally feel this is beyond the definition of dental practice.  I suppose it will be up to state dental and medical boards to work this out.

 The Evolving Role of Dentist in the Injectables Business by Jeff Frentzen, PSP Blog  leads you to the full article: The next revolution in dentistry: facial injectables by Bruce G. Freund, DDS, Oct 25, 2010.

REFERENCE

Macrolane(TM) for breast enhancement: 12-month follow-up; Per Hedén; Plastic & Reconstructive Surgery: POST ACCEPTANCE, 14 October 2010; doi: 10.1097/PRS.0b013e318200ae57; Original Article: PDF Only

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.

ISAPS Plastic Surgery Survey

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

The International Society of Aesthetic Plastic Surgery (ISAPS) is celebrating it’s 40th anniversary.  To commemorate the event ISAPS commissioned a global survey of plastic surgeon and procedure in the top 25 countries and regions. 

The ISAPS Biennial Global Survey involved survey participants completing a two‐page, English‐based questionnaire that focused on the number of surgical and non‐surgical procedures they performed in 2009.  Approximately 20,000 plastic surgeons were sent the survey and then reminders.  Unsure what percentage responded.

Breast augmentation has been the most popular plastic surgery procedure for the last ten years in the United State.  This study found that liposuction has gained that spot.  The study found that the top five procedures in the U.S are liposuction (18.8%), breast augmentation (17%), eyelid lifts (13.5%),  rhinoplasty (9.4%),  and abdominoplasty  ( 7.3%).

The popularity of surgical procedures varied by country.

The top 25 countries and their top two surgical procedures:
1. United States (1st -- liposuction, 2nd -- breast augmentation)
2. Brazil (liposuction, breast augmentation)
3. China (breast augmentation, liposuction)
4. India (liposuction, breast augmentation)
5. Mexico (breast augmentation, blepharoplasty)
6. Japan (liposuction, breast augmentation)
7. South Korea (breast augmentation, liposuction)
8. Germany (liposuction, blepharoplasty)
9. Italy (liposuction, breast augmentation)
10. Russia (liposuction, breast augmentation)
11. Turkey (breast augmentation, liposuction)
12. Spain (liposuction, breast augmentation)
13. Argentina (breast augmentation, liposuction)
14. France (liposuction, breast augmentation)
15. Hungary (liposuction, blepharoplasty)
16. Canada (breast augmentation, liposuction)
17.  Colombia  (liposuction, breast augmentation)
18. United Kingdom (liposuction, breast augmentation)
19. Taiwan  (breast augmentation, liposuction)
20. Venezuela (liposuction, blepharoplasty)
21. Thailand (breast augmentation, liposuction)
22. Australia (blepharoplasty, rhinoplasty)
23.  Portugal (liposuction, breast augmentation)
24.  Belgium  (liposuction, breast augmentation)
25.  Saudi Arabia (breast augmentation, liposuction)

The study found the number of non-surgical procedures topped the surgical procedures.  The top five non surgical procedures were found to be Botox injections (32.7%), hyaluronic acid injections (20.1%), laser hair removal (13.1%), autologous fat injections (taking a patient's fat from one location and transferring it in the same patient in another location) (5.9%) and IP Laser treatment (4.4%).

Capsular Contracture

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

Capsular contracture is a complication of breast implants of all types:  saline, silicone, smooth, textured, etc. 

When the implant is placed, the body forms a capsule of fibrous material around it as it would for any foreign body (ie pace maker, breast implant, etc).  The capsule is initially thin and soft, with little or no effect on the appearance of the breast.  If it remains that way, then it is not called a contracture.

Capsular contracture occurs when the scar tissue or capsule that normally forms around the implant tightens and squeezes the implant. It can happen to one or both of the implants. There are four grades of capsular contracture known as Baker grades.

The Baker grading is as follows
Grade I
breast is normally soft and looks natural
Grade II
breast is a little firm but looks normal
Grade III
breast is firm and looks abnormal
Grade IV
breast is hard, painful, and looks abnormal
Capsular contracture may require reoperation, usually for Grades III and IV, and it may occur again.

The first article listed below looks at the current literature relating to this complication of breast implant surgery, focusing particularly on occurrence rates, risk factors, cause, and treatment modalities to provide the plastic surgeon with an up-to-date review of the current available evidence.

The authors did a literature search of the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases using three groups of key words --the first relating to the organ involved (breast), the second relating to the surgical procedure performed and related technical issues, and the third relating to the surgical complications. Potentially relevant articles were identified by means of the title and the abstract, and full articles were obtained and assessed in detail.

The authors note:  “Only a few studies have included large enough sample sizes, were conducted in a prospective manner, were adequately randomized, and achieved adequate follow-up periods to obtain a true measure of rates of capsular contraction occurrence.”

Reported rates of capsular contractures vary widely, ranging from 1.3 to 30 percent of patients who receive implants.

The longer the implants were in place, the greater the cumulative risk of developing contracture, which would suggest a direct correlation between when the implant is placed and the time to developing contractures.

Approximately 92 percent of contractures occur within the first 12 months following surgery.

A number of parameters seem to influence the occurrence of contractures, including the indications for surgery (breast reconstructions versus cosmetic augmentations), type of prosthesis used (smooth versus textured and saline versus silicone), and positioning of the implant (subglandular versus submuscular).

Currently, Mentor lists the rate of capsular contracture in their patient information brochures (cosmetic not reconstructive) as 9% (Grade III – IV), but note the literature has a wide range of 1.3% to 30%.

Women having reconstructive rather than aesthetic (or cosmetic) augmentation have a higher risk of developing capsular contracture.

Radiotherapy increases the incidence of capsular contractures. Unfortunately, most studies are retrospective in nature and analyze groups of patients who received radiotherapy at variable time points (before, during, or after reconstruction), concomitant chemotherapy, implant positioning or type, and type of contractures reported (only Baker grade 3 or 4 versus all contractures).  All of these factors may partly explain the wide range of reported contractures in the irradiated groups (32- 73%) versus non-irradiated groups (0- 40%).

Numerous studies have looked at shell characteristics (smooth vs textured surface) in regards to contracture rate and tend to find textured surfaces produced a lower incidence of contractures when compared with smooth ones.  

In the first meta-analysis, Barnsley et al. proved the protective effect of textured implants over smooth surfaces (relative risk, 0.19; 95 percent confidence interval, 0.07 to 0.52), with smooth implants showing a five-times greater risk of contracture formation. 

In the second meta-analysis, 235 patients were analyzed, and textured implants were shown to produce fewer capsular contractures when compared with smooth implants at 1 year (relative risk, 4.2; 95 percent confidence interval, 1.6 to 11.0), 3 years (relative risk, 7.3; 95 percent confidence interval, 2.4 to 21.7), and 7 years of follow-up (relative risk, 3.0; 95 percent confidence interval, 0.9 to 10.4).

Only one study showed no significant differences between smooth versus textured implants for the occurrence of capsular contractures.  However, this trial had a Jadad score of 2, indicating a poor methodologic quality with a high degree of variance in the results.

Partial or complete submuscular placement and subfascial positioning are  association with lower rates of capsular contractures.  Many of the articles mentioned are either small or retrospective.

Seckel and Costas retrospectively studied 76 patients (146 breasts) who had undergone partial or total submuscular breast cosmetic augmentation.  No difference was observed between the total and the partial musculofascial coverage for the occurrence of capsular contractures [zero of 35 (0 percent) versus one of 41 (0.02 percent); Fisher's exact test, p = not significant].

Hendricks reviewed 650 patients who had received textured silicone gel implants beneath the pectoralis major muscle, the external oblique muscle, the rectus sheath, and the serratus anterior muscle fascia.  In this study, no cases of Baker grade 3 or 4 capsular contractures were reported.

Ventura and Marcello retrospectively analyzed 100 patients who had received primary breast enlargement with textured implants positioned in the subfascial compartment and found that only two patients (2 percent) experienced Baker grade 2 capsular contractures.

Finally, in a retrospective multicenter study of more than 500 patients, Gutowski et al. found that the use of subglandular positioning of the prosthesis increased the risk of capsular contractures by almost eight times.

It is a nice review of the literature which points out the short comings of our knowledge.

Although it is apparent from the articles studied in this review that a great deal of progress has been made over the past few decades toward elucidating the etiopathogenesis of capsular contractures, the exact nature and contribution of molecular, immunologic, and microbiological factors remain unclear.

Only a few studies have included large enough sample sizes, were conducted in a prospective manner, were adequately randomized, and achieved adequate follow-up periods to obtain a true measure of the rates of capsular contracture occurrence.

Therefore, there is a scant and often inconclusive body of evidence relating to this complication. For example, the contribution of chemotherapy to the occurrence of capsular contractures warrants more thorough investigation.

Likewise, the possibility of preventing this complication by use of experimental drugs needs to be looked at more closely.

Revision surgery remains the only effective treatment option available to us at this time but is limited by its high associated risk of recurrences and complications (hematoma or pneumothorax) when the implant is originally placed in the submuscular position. It is hoped that future studies will focus on attempting to resolve some of the issues highlighted in this review.

REFERENCE

Capsular Contractures: A Systematic Review; Plastic and Reconstructive Surgery. 124(6):1808-1819, December 2009; Araco, Antonino; Caruso, Riccardo; Araco, Francesco; Overton, John; Gravante, Gianpiero

FDA Breast Implant Info, May 2009

Double-Bubble Breast Deformity

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

Recently a Staten Island woman was awarded $3.5 million after developing a double-bubble breast deformity after a breast augmentation/mastopexy surgery.

I don’t know if the award was warranted, but I do know that the deformity is a known risk of breast augmentation surgery. I try very hard to tell patients about possible risks of surgery, but none of us go into surgery thinking we will be the half or one or two percent.

As the surgeon, I take pride in my work and give the best I can. It is never my intention for a patient to have a poor result. It is not good for them or for me.

So let’s talk a minute about double-bubble deformities. What is it? In a double bubble deformity the implants are usually positioned too superiorly under the muscle (first bubble) with an overhang of skin/breast tissue drooping lower (second bubble). (photo credit)

Patients with significant postpartum atrophy, glandular ptosis, and significant native tissue volume are at a higher risk for developing a double-bubble deformity.

In patients with the above, it is best to consider placing the implant in the subglandular position rather than the submuscular. It is also important to consider doing the mastopexy first and the implantation procedure at a different surgery in the future.

Another important consideration is doing the proper lift procedure so that enough skin is removed. This may mean the patient has to accept more scars (ie an anchor scar rather than inferior vertical scar, or an inferior vertical scar rather than a periareolar scar).

Once the deformity has developed, then correction may require capsule work, repositioning the implant, revising the mastopexy (or adding one).

REFERENCES

Breast Augmentation; Plastic and Reconstructive Surgery. 114(5):73e-81e, October 2004; Spear, Scott L.; Bulan, Erwin J.; Venturi, Mark L.

Breast Augmentation: Choosing the Optimal Incision, Implant, and Pocket Plane; Plastic and Reconstructive Surgery. 105(6):2202-2216, May 2000; Hidalgo, David A.

Shaping the Breast in Aesthetic and Reconstructive Breast Surgery: An Easy Three-Step Principle. Part IV-Aesthetic Breast Surgery; Plastic and Reconstructive Surgery. 124(2):372-382, August 2009; Blondeel, Phillip N.; Hijjawi, John; Depypere, Herman; Roche, Nathalie; Van Landuyt, Koenraad

Breast Asymmetry; Aesthetic Surgery Journal, Nov 2003 (Vol. 23, Issue 6, Pages 472-479); Daniel C Morello, Marie Christensen, David A Hidalgo, Scott L Spear

Treatment of Breast Ptosis; Aesthetic Surgery Journal, July 2003 (Vol. 23, Issue 4, Pages 279-285); Stephen R Colen, Sharon Y Giese, Ruth Graf, Dennis C Hammond

Possible Implant Rupture: Is MRI Useful? – an Article Review

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

Currently, magnetic resonance imaging (MRI)  is considered the accepted standard to evaluate silicone breast implant integrity.  This article (full reference below) reports a retrospective review study devised to “evaluate its utility in diagnosing ruptured silicone implants in the setting of capsular contracture and to correlate the preoperative assessment of implant integrity with or without magnetic resonance imaging with operative findings.”

The study involved 171 patients with capsular contractures with a total of 319 capsulectomies.  Preoperative MRIs was done on 160 implants, whereas the remaining 159 were evaluated using only physical examination and/or mammography. The authors then analyzed postoperative results  to determine the sensitivity, specificity, and accuracy of preoperative MRI in comparison with clinical and/or mammography evaluation alone.

They found that while the MRI was occasionally valuable, overall it was no more accurate than clinical evaluation in predicting implant status (intact or ruptured):   magnetic resonance imaging 124 of 160 (78 percent) and clinical 121 of 159 (76 percent; p = 0.77).
Their conclusions:

In the setting of capsular contracture, physical examination with or without mammogram is as accurate as magnetic resonance imaging in determining implant integrity. Although magnetic resonance imaging is a sensitive diagnostic tool, in symptomatic patients with capsular contracture, it cannot be viewed as infallible

It is nice to know that I am not slighting my patient by not always getting that MRI.  If she has a hard capsule, if my clinical exam suggests a rupture, then I strongly encourage her to have a capsulectomy with implant removal or exchange.  The MRI will not change that plan, so I don’t tend to order one.

REFERENCES

Capsular Contracture and Possible Implant Rupture: Is Magnetic Resonance Imaging Useful?; Plast Reconstr Surg 125(3):830-835, March 2010; Paetau, Alyssa A.; McLaughlin, Sarah A.; McNeil, Rebecca B.; Sternberg, Erez; TerKonda, Sarvam P.; Waldorf, James C.; Perdikis, Galen [doi: 10.1097/PRS.0b013e3181cb6066]

Autoaugmentation Mastopexy After Breast Implant Removal – an Article Review

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

This is a nice article, but I take exception to the  term “autoaugmentation”  as it is simply a repositioning of the breast tissue as part of the mastopexy.  I would say the term “autoaugmentation” is simply marketing as no augmentation has taken place.   The mastopexy helps reshape the breast, making it look better – higher, firmer, more tissue behind the nipple.

Autoaugmentation of the breast can be achieved following implant removal when mastopexy is planned without insertion of a new implant. This procedure corrects ptosis and increases the projection and apparent volume of the breast. The advantages of the technique are that it both minimizes the skin scar and optimizes the shape following upper-pole fullness and suture fixation of the pillars of the breast parenchyma. In addition, autoaugmentation mammaplasty is a good technique for patients desiring only an uplift following breast implant removal.

The article describes the procedure well.  There are nice photos of before, during, and after.  The journal (and its publishing company) has made the full article available via open access for which I say, thank you.

REFERENCE

Inferior Pedicle Autoaugmentation Mastopexy After Breast Implant Removal;  Aesth Plast Surg [Received: 20 May 2008 / Accepted: 26 May 2009] DOI 10.1007/s00266-010-9471-4;
Johannes Franz Ho¨nig, Hans Peter Frey, Frank Michael Hasse, Jens Hasselberg (full article, pdf)

Symmastia After Augmentation Mammoplasty

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

Symmastia (also known as synmastia) is a condition that occurs when breast implants sit too close to the middle of the patient’s chest.  Extreme cases can even lead to the “uniboob” look. Fortunately, it is a rare complication of augmentation mammoplasty surgery. 

Developmental symmastia can occur without prior surgery in patients who have breast hypertrophy and an aberrant soft-tissue connection across the midline.

Dr Spear (4th reference article below) noted (bold highlight is mine):

Based on our experience with postaugmentation synmastia, a number of facts have emerged. All of the implants were subpectoral. The majority of these women had undergone more than one operation. Many of them had undergone successive operations to enlarge the size of their implants and breasts. Many of them had large implants, arbitrarily defined by us as greater than 400 cc or with a diameter of 14 cm or more. Several of the patients had associated chest wall skeletal deformities, and some had undergone simultaneous mastopexy at the time of their breast enlargement.

Prevention of symmastia is much better than having to try to fix it.   Care must be taken in dissection of the pocket, especially medially.  It is preferable to use implants that “fit the body.”  By this I mean, implants should not be wider than the available hemithorax of the individual patient.  Try to get the patient to use a smaller implant or perhaps a high profile with a smaller base width.  Avoid excessive detachment of the pectoralis muscle’s medial sternal attachments. 

Correction of symmastia requires restoration of the presternal subcutaneous integrity and medial closure of the pocket.   Techniques to achieve this include capsulorrhaphy, capsular flaps, AlloDerm or other materials, adjustable implants, explantation with delayed reimplantation, and change to a subglandular pocket.  All have drawbacks in terms of reliability, technical difficulty, and convenience.

 

REFERENCES

1.  Symmastia: The Problem of Medial Confluence of the Breasts;  Plast & Reconstr Surg 73(2):261-266, February 1984; Spence, Robert J.; Feldman, Joel J.; Ryan, James J.

2.  Surgical Reconstruction of Iatrogenic Symmastia; Plas & Recontr Surg 121(3):143e-144e, March 2008; Foustanos, Andreas; Zavrides, Harris

3.   The "Neosubpectoral" Pocket for the Correction of Symmastia; Plast & Reconstr Surg 124(3):695-703, September 2009; Spear, Scott L.; Dayan, Joseph H.; Bogue, David; Clemens, Mark W.; Newman, Michael; Teitelbaum, Steven; Maxwell, G Patrick

4.   Synmastia after Breast Augmentation; Plas & Reconstr Surg 118(7S):168S-171S, December 2006; Spear, Scott L.; Bogue, David P.; Thomassen, John M.

5.   Correcting Symmastia; Steven Teitelbaum, MD, FACS Website (nice photos)

6.   Correction of Symmastia After Augmentation; Thomas M. DeWire, Sr., MD, FACS Website  (nice photos)
7.   YouTube Video of Symmastia Repair
8.    My Breast Augmentation & Chin Revision (YouTube Video)

Stem Cells in Breast Augmentation?

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


There is a short article, Using Stem Cells in Breast Augmentation, in the January 2010 issue of the PSP Newsletter.  It is more an interview of Todd Malan, MD by Connie Jennings than a scientific article (and that’s okay). 

It is an interesting read which includes some of the history of fat grafting for breast augmentation, particularly in the United States but also world wide.  It will be interesting to watch as this procedure/method evolves.  I hope it will be done with scientific protocol that really looks at how it works, if it works, the risks, etc.

Dr. Malan quotes the costs:

Cost wise, liposuction with fat transfer to the breasts is only about $5,000 over the cost of just liposuction.  It is comparable in cost to a breast augmentation with implants and liposuction.

However, adding stem cells to the mix adds an additional $5,000 to the procedure.  This is because the procedure for processing and extraction of the stem cells is very time consuming and expensive.  The disposables that are required for the 3-hour procedure cost around $2,800.

The automated processing is faster and cheaper than the manual extractions, which are popular in Japan and Korea.  Using the latest automated devices saves time and money, but is still more costly than implants.  However, if you look at the lifetime cost of implants based on published statistics on complications and reoperation, then fat transfer is actually less expensive.

From the UK Times article last March:

A STEM cell therapy offering “natural” breast enlargement is to be made available to British women for the first time.

The treatment could boost cup size while reducing stomach fat. It involves extracting stem cells from spare fat on the stomach or thighs and growing them in a woman’s breasts. An increase of one cup size is likely, with the potential for larger gains as the technique improves.

A trial has already started in Britain to use stem cells to repair the breasts of women who have had cancerous lumps removed. A separate project is understood to be the first in Britain to use the new technique on healthy women seeking breast enlargement.

Professor Kefah Mokbel, a consultant breast surgeon at the London Breast Institute at the Princess Grace hospital, who is in charge of the project, will treat 10 patients from May. He predicts private patients will be able to pay for the procedure within six months at a cost of about £6,500.

Other related articles:

Breast Augmentation Via Fat Grafting:  The History and the Controversy  by Sydney R. Coleman, MD; PSP January 2008

Stem Cells May Fix Breast Defects; PSP December 2007

Stem Cells to Grow Bigger Breasts by Jeffrey Frenzen; PSP April 2009

Stem cells to grow bigger breasts; (UK) Times Online article, March 2009

Previous related blog posts:

Update on Breast Augmentation Using Fat Injections (November 2, 2009)

ASPS Task Force Updates Position on Fat Grafting (August 13, 2009)

Recent NPR Stories on Plastic Surgery (June 3, 2009)
Complications After Autologous Fat Injections to the Breast – an Article Review (April 2, 2009)

Fat Injections for Breast Augmentation (November 6, 2008)

Exercises for Breast Implant Capsule Prevention

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

Implant movement or massage is often recommended to help prevent capsular contracture after breast augmentation surgery.   I try to show patients how to do this, but often it is simply easier to hand them a copy of this photo from the first referenced article below.  If they seemed to have difficultly with the exercises, I have told them to lay on a hard floor using their body weight to “flatten” the implants as an alternative method.  To view a video of implant massage go here.

As this quote from the second article below points out, it is important for the implant to be moved or massaged rather than simply the breast tissue:

Implant Movement (as Opposed to Breast Massage)

Early implant movement (within 2 days of surgery) is recommended, and aggressive movement is instituted if firmness is noticed. It is important that the patient be instructed in the proper technique of moving the implants (with full excursion throughout the pocket and pressure techniques to increase the diameter of the implant, performed three times daily), as opposed to just massage of the breast tissue, to insure maximal results.  A velcroelastic strap (Breast strap, Cosmetic Solutions, Boca Raton, Fla.) is applied to facilitate early postoperative implant positioning when needed.

From the third article below (bold emphasis is mine):

Our current approach to breast implant capsules reflects the assumption that the best nonsurgical approach to prevent capsular contracture is early postsurgical external massage. Once a capsule is established, it will most likely persist even if the implant is removed.

From the forth article:

Hipps et al reported that breast massage was not helpful; however, the exercises were begun 2 weeks postoperatively and it has been shown that the capsule begins to form by postoperative day 3…

Without doing a complete literature search, it would appear from my brief review that the issue of breast implant massage is not scientifically settled and would fall more into the “accepted practice, can’t do any harm, may help” category.  The theory is if the pocket the implant sits in is slightly larger than the implant, then the scar pocket cannot contract or squeeze the implant and cause hardness.

As pointed out at the beginning, this is a practice that I tell my patients to do.

REFERENCES
Giving Patients a Chart Displaying Massage Techniques May Help to Reduce Capsular Contracture Rates (letter to the editor); Aesthetic Surgery Journal, Vol 22, No 5, pp 458-459, Sept 2002; Botti, Giovanni; Cella, Anonio
Prevention of Capsular Contracture; Plastic and Reconstructive Surgery, Vol 103(6):1766-1768, May 1999; Becker, Hilton; Springer, Rachelle

Treatment of Capsule Surrounding Breast Implants; Plastic and Reconstructive Surgery, Vol 115(5):1416-1417, April 15, 2005; Rockwell, W Bradford; Regenass, Heidi; Fryer, Richard

Quantitative Assessment of Breast Massage;  Plastic and  Reconstructive  Surgery, Vol  86: 355, 1990; Becker, I. I., and Prysi, M. F.

Guidelines and Indications for Breast Implant Capsulectomy; Plastic and  Reconstructive  Surgery,  Vol 102: 884, 1998; Young, V. L.

Update on Breast Augmentation Using Fat Injections

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

A new study on fat grafting for breast augmentation was presented at last week’s American Society of Plastic Surgeons (ASPS) Plastic Surgery 2009 conference which I wasn’t able to attend.  The ASPS News Brief section gave an update on the presentation with a pdf of the abstract.

The main study author, Roger Khouri, MD, FACS, is featured in a video explaining the study and technique.  He feels that his study of 50 women is enough to settle the question of safety and effectiveness of fat injections for cosmetic breast augmentation.  Even though his results are good, I remain a skeptic. 

The study involved 50 women, ages 17-63.  Initially the length of surgery was 5 hours.  This decreased as their learning curve and technique improved to 1.5 hours.  Each woman received 250 cc of fat injected into each breast.  Five women had a second procedure (unclear if this was due to fat graft loss or desire further increased size).  All patients are reported to have returned to their normal activities within 3-4 days.

The procedure involved using atraumatic low pressure harvesting of the fat with fine cannulas, minimal fat manipulation, and diffuse periglandular graft placement as microdroplets through multiple injection ports in a pre-expanded, hypervascular bed.  This “pre-expanded, hypervascular” bed was obtained by having the patients wear a bra-like (external) tissue expander device several weeks before and after surgery.  This device is called the Brava.

[Keep the use of the Brava in mind as you continue reading.  If the Brava truly gains the 100 cc of breast growth on it’s own (as reported on its website), then the volumes and fat survival obtained by the fat grafting should possibly be refigured with this taken into account.]

MRI’s were done to access volume.

Breast volume was unchanged between the 3 and 6 months MRI measurements (p>0.2).  Thus the 3month MRI was discontinued for the remainder of the study. Average augmentation volume at 6-12 months MRI was 210 ml/breast (90ml - 360ml).

On long-term follow up, breast volume changes were commensurate with BMI fluctuations. Graft survival averaged 85% (70% - 120%). There was a direct correlation between maximal pre-grafting expansion and the resultant final breast volume augmentation.

The study authors report no suspicious breast masses or nodules.   There was an 18% incidence of fat necrosis noted on the MRI’s, all of which were identified on the one-year mammogram identified.  The authors state “More importantly, the radiologist had no difficulty interpreting any of the studies.”  There is one reported infection.

The researchers report good patient satisfaction with an average increase in breast volume at 6-12 months was 210 ml (in my experience slightly less than one bra cup size).  The fat graft survival achieved averaged 85% of the actual fat injected volume. 

The main drawbacks reported by the researchers  include changes in breast volume are proportionate with BMI fluctuations. 

ASPS reports that breast augmentation was the most popular cosmetic surgical procedure in 2008, with more than 307,000 procedures performed.  It's also the most commonly requested procedure among women.

REFERENCES

Study:  "Autologous Breast Augmentation with Liposuctioned Fat: A Fifty Patient Prospective Study Over Five Years" is being presented Sat., Oct. 24, 1:00 - 1:05PM PDT, at the Washington State Convention and Trade Center.  (abstract—pdf file)

American Society of Plastic Surgeons News Brief (October 24, 2009)

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.