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Updated 3/2017-- all links removed (except to my own posts) removed as many no longer active.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

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)

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

Breast Augmentation: A Geographical Comparison

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.

This article (full reference below, free access) came to my attention via MDLinx.  It was interesting to read.  The conclusion verified my expectations rather than surprised me.

The authors conducted a retrospective review of patient demographics and implant information from three university settings:  Kelowna (British Columbia, Canada), Loma Linda (California, USA), and Temple (Texas, USA).  Each cohort included 100 consecutive breast augmentation cases.

Characteristic analyzed included age, height, weight, BME, parity, and average implant volume. 

When considering the 300 as one cohort, the average age was 34 years with a height of 163 cm (5’4”), weight of 58.1 (127.8 lb) and parity of 1.7 .  The average implant size was 370 ml.

When considered separately, the three group medians were significantly different for weight, BMI and implant volume, but not for age.

Kelowna’s average patient was 33 years of age, had a BMI of 20.8 kg/m² and an implant volume of 389 mL.

Loma Linda’s average patient was 32 years of age, had a BMI of 21.6 kg/m² and an implant volume of 385 mL.

Temple’s average patient was 36 years of age, had a BMI of 22.6 kg/m² and an implant volume of 335 mL.

 

Without going back through all my cases, I can say it the average size of implants used has increased over the years.  It was rare to use more than 300 cc when I was in training (1987-89), now it is rare to use one smaller than 300 cc.

REFERENCE

Breast augmentation: A geographical comparison;   JL Maher, DC Bennett, P Grothaus, RC Mahabir; Canadian Journal of Plastic Surgery, 12/07/2010 (pdf file)

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.

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

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

Elated

Crying she says, “Dr. Bates, my right implant has deflated. Help!”

“Don’t panic. It’ll be okay.”

We review the options and risks. Fortunately, her 9 year old implants are covered by the 10 year plan.

“Dr. Bates, can I go bigger this time?”

“Yes, that’s an option.”

Smiling, “Then let’s do it.”

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)

Breast Implants and Lymphoma Risk

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

Yes, I’m behind in my journal reading. This article was published in the March issue of the Plastic and Reconstructive Surgery Journal. The article is the summary of a literature review using PubMed to review the evidence from all epidemiologic cohort studies of cancer incidence among women with cosmetic breast implants that include results on the incidence of non-Hodgkin's lymphoma, with specific attention to lymphomas arising in the breast.

The review was prompted by the article from The Netherlands (second reference below) which suggested an association of breast implants with anaplastic large T-cell lymphoma.

Primary breast lymphoma is a rare malignancy. Most of them are of B-cell origin. It is important for anecdotal reports not to alarm providers or patients. This review article found only five long-term cohort studies which had evaluated the incidence of non-Hodgkin's lymphoma following cosmetic breast augmentation surgery.

The authors looked at each study and came to the following conclusion:

The association between cosmetic silicone breast implants and non-Hodgkin's lymphoma has been examined in a number of long-term cohort and surveillance studies, based on large numbers of women with virtually complete follow-up substantially longer than the 17-year study period presented in the Dutch case-control study.

In the only cancer incidence study to include women followed for at least 25 years after implantation, including 3336 women followed for 15 years or more and 827 followed for at least 25 years, no significant excess of non-Hodgkin's lymphoma was observed overall and not one primary lymphoma of the breast was observed.

Moreover, the largest study to date, with cancer surveillance up to 24 years, actually reported a reduced incidence of total non-Hodgkin's lymphoma among almost 25,000 Canadian women with cosmetic breast implants.

Based on the epidemiologic studies published to date, there is no evidence of an excess of non-Hodgkin's lymphoma incidence overall among women with cosmetic silicone-filled breast implants.

REFERENCES

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. (subscription required)

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

Breast Implant Deflation

Recently I had a patient call to tell me to report that her right breast implant had deflated.  She is a patient from the early years of my practice.  This is her second deflation, but this one is complicated by pregnancy.  She has listened to my “lectures” over the years and was not panicked.  She wanted to check in with me.

I reminded her

• 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.

I told her I would report the deflation to the implant company and get a file number for her case.  When she has delivered a healthy baby and finished breast feeding, then she should call me back.  At that time we will arrange a visit and decide what she wants to do (remove or replace; same size or smaller/larger; etc).

We didn’t discuss costs at this point in time.  We will later.  She unfortunately was augmented prior to the “extended warranty” offers that both Mentor and McGhan (INAMED) have now.  The programs didn’t exist prior to October 2, 2000.  The company will offer free implants for replacement.

Locally, the surgery center I use charges $840, anesthesia’s charge is $525, and my fee is $***(depends on time passed since surgery and whether I was the initial surgeon).  I began paying for the “extended warranty” for each patient out of my fee back in 2002 when I realized too many of them were failing to spend the extra $100.

I truly appreciate the patient who remembers the preoperative discussion and who read the information brochure. 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.

Other Posts of Interest:
It Happened Again (June 5, 2007)
Breast Implants – Some History (March 3, 2008)
Silicone vs Saline Breasts Implants (March 4, 2008)
Silicone Implants and Health Issues (March 5, 2008)

Silicone Implants and Health Issues

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

There are many questions and concerns about silicone gel implants and the effects on the health of the woman or her child. The Supplement to the Journal of Plastic and Reconstructive Surgery covers several of these. I will try to hit the high points and conclusions. If you want more, then these articles have very nice reference lists themselves.

Silicone Implants and Connective Tissue Disease

Dr Hölmich and colleagues did a comprehensive search of PubMed, EMBASE, and The Cochrane Library. They added manual searches using the related link facility to extend the number of references identified. They identified additional references by cross-checking the reference lists of the identified publications. Here are their conclusions:

• There appears to be little scientific basis for any association between implant rupture and well-defined connective tissue disease or undefined or atypical connective tissue diseases.
• The concept of silicone-related disease was developed by rheumatologists based on highly selected groups of symptomatic breast implant patients seen in their practices.
• It is likely that nonspecific complications or symptoms related perhaps to capsular contracture or implant rupture may be misinterpreted as representing a systemic disease.

Anecdotal reports and case series have suggested that silicone implants may cause various diseases, in particular, connective tissue diseases, or a new silicone adjuvant syndrome. However, large-scale epidemiologic studies have consistently failed to demonstrate increased risks of these diseases among women with breast implants.

Silicone Implants and Breast Cancer

Soon after breast implants were commercially introduced questions about potential carcinogenicity were raised. Case reports of breast cancer following augmentation mammaplasty appeared. Two early surveys intended to address the question somewhat implausibly reported zero breast cancers among 16,000 women and one breast cancer among 10,941, respectively. In addition to the question of breast cancer incidence, the possibility of delayed breast cancer detection in the augmented breast and the risk of poorer survival have raised concern.

However, over the past 20 years, a robust body of literature examining breast cancer-related risks among breast implant patients has been published. This was reviewed by Dr Deapen. Here are the conclusions:

Risk of Breast Cancer

• The majority of studies report somewhat lower breast cancer incidence and mortality among implant patients. A comprehensive literature search and meta-analysis published in 2001 summarized results from 10 studies available at that time and estimated the relative risk for breast cancer as 0.72 (95 percent confidence interval, 0.61 to 0.85).

Delayed Detection of Breast Cancer

• There are clear reasons for concern that implant patients may experience delayed detection of breast cancer and poorer prognosis. Nevertheless, using stage at diagnosis and tumor size as indicators of detection delay, no consistent evidence of delay or decreased survival has been found.
• It is well-established that the silicone devices are radiopaque and obscure some portions of breast tissue from mammographic visualization, which may increase the risk of late detection. [One of the reasons for the FDA recommendation that these patients have periodic MRI's.]

Breast Cancer Length of Survival and Recurrence

• The risk of a local and distant recurrence of breast cancer was 50 percent of expected, a non-significant difference, and the risk of secondary breast cancer was no different from expected.

Breast Cancer and Mortality

• No difference in the breast cancer mortality experience has been found.

Silicone Implants and Breast Feeding

Despite the overwhelming advantages of breast-feeding, there is a persistent concern that maternal exposure to chemical contaminants may result in contamination of breast milk and have an effect on the child's growth and development. A parallel concern regarding lactation in women with silicone implants over the past years has led to confusion and anxiety relating to the potential risks to the child. Dr Semple reviewed the facts and issues as he knows them, including biomaterials, lactation toxicology, and a previous study where no difference was found in silicon (a proxy measurement of silicone) in women breast-feeding with silicone implants and those without. Here are his conclusions:

• A recent study revealed that there was no significant difference in the levels of silicone in breast milk and blood between two groups of women. One group of women was breast-feeding with silicone implants, whereas the group breast-feeding without silicone implants acted as a control group.
• Mothers with silicone implants may decide not to breast-feed because of the suspected risk of breast milk contamination. The alternative source of nutrition for these infants is a variety of commercially available formulas.
• It is well known that there are sources of silicone in the everyday diet, including its use as an antifoaming agent in fruit juices and other types of food. Infants have been given silicone drops for colic for many years, with no identifiable problems [Mylicon drops (Merck Consumer Pharmaceutical, Ft. Washington, Pa.), used in the United States, have 67 mg of polydimethylsiloxane per milliliter and Miniform, as used in Europe, has 94 mg of polydimethylsiloxane per milliliter].

Adverse Health Outcomes in Offspring of Mothers with Silicone Implants

Dr. Kjøller and colleagues attempted to assess the question of "whether maternal cosmetic breast implants are associated with adverse health outcomes among offspring". They examined published findings of epidemiologic studies (all of Scandinavian origin) that addressed this hypothesis. Here are their conclusions:

• Rates of esophageal and rheumatic disorders, congenital malformations, and perinatal mortality and hospitalization were comparable between children born to mothers with breast implants and children born to mothers who had undergone other cosmetic surgery.
• Based on this review, the epidemiologic evidence to date does not support an increased risk to offspring of women with breast implants for health problems such as esophageal and rheumatic disorders, congenital malformations, or perinatal mortality.

REFERENCES
Silicone Breast Implants: Outcomes and Safety; Supplement to Plastic and Reconstructive Surgery, Vol 120, No 7, Suppl 1, December 2007

• Breast Implant Rupture and Connective Tissue Disease: A Review of the Literature; Lisbet Rosenkrantz Hölmich, M.D.; Loren Lipworth, Sc.D.; Joseph K. McLaughlin, Ph.D.; Søren Friis, M.D
• Breast Implants and Breast Cancer: A Review of Incidence, Detection, Mortality, and Survival; Dennis Deapen, Dr.P.H.
• The Relationship of Silicone Breast Implants and Cancer at Other Sites; Louise A. Brinton, Ph.D.
• Breast-Feeding and Silicone Implants; John L. Semple, M.D., M.Sc.
• Adverse Health Outcomes in Offspring of Mothers with Cosmetic Breast Implants: A Review; Kim Kjøller, M.D.; Søren Friis, M.D.; Loren Lipworth, Sc.D.; Joseph K. McLaughlin, Ph.D.; Jørgen H. Olsen, M.D., Dm.Sc.

FDA Breast Implant Home Page

Silicone vs Saline Breast Implants

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

With the reintroduction of silicone implants into more general use and not simply in controlled studies, comparisons between silicone and saline are inevitable. Any comparison seems to be potentially biased, but I will try to give a fair one. To try to keep it simpler, I will stick to a comparison in augmentation use not reconstructive.

In general, normal saline implants are not thought of as first or second generation implants. Silicone gel implants are. Depending on who you read, silicone gel implants are either in their third or fifth generation. I'll give you the information from the first reference below (Supplement, page 45S):

Implant	Description
1st generation, 1962-1970	Thick, two-piece shell Smooth surface with Dacron fixation patches Anatomically shaped (teardrop) Viscous silicone gel
2nd generation, 1970-1982	Thin, slightly permeable shell Smooth surface, no Dacron patches Round shape Less viscous silicone gel
3rd generation, 1982-1992	Thick, strong, low-bleed shell Smooth and textured surface Round shape More viscous silicone gel
4th generation, 1993-present	Thick, strong, low-bleed shell Smooth and textured surfaces Round shape More viscous (cohesive) silicone gel Refined manufacturing processes
5th generation, 1993-present	Thick, strong, low-bleed shell Smooth and textured surfaces Round and diverse anatomical shapes Enhanced cohesive & form-stable silicone gel

So when comparing implants, saline to silicone or 1st generation to 4th generation silicone, there may be a distinct difference in years of follow-up. There is no long-term data yet available for the 4th and 5th generation silicone gel implants. The data from these latest generation of silicone implants are approximately 3 to 4 years old. The data collection period on saline implants (during the moratorium on silicone gel implants) spanned more than 15 years in the United States, and the information gathered has shown that saline implants are safe and effective.

There is still a lot of data on silicone implants, but not any 10 year follow-up on the new cohesive gel implants. So we are giving patients the information we have now, not what time may prove out. The following table compares complication rates between the two types of implants (information from 3rd reference mainly).

	Saline	Silicone
Rupture rate 1-2 yrs 3 yr 5 yr 9-10 yr	1-4% 3-5% 16% 7%	8% 0.5% 1% 8-10%
Contracture rates 1-3 yr 7 yr 10 yr	4-9% 11-16% 16.6%	8.1% 5.6% No comparison, 38.5-90% with earlier generation
Patient satisfaction	97% at 6 yrs	95% at 5 yrs, 87% at 7 yrs
Implant removal (1-4 years)	8% at 2 years 12% at 4 years	5.1 % at 3 years 7.5% at 4 years
Detection of deflation/rupture	Physician/patient able to detect	MRI at 3 yrs then every 2 yrs recommended by the FDA
Deflation rate	0.34/1000 implants
Implant cost range	1X	2X
Incision size	3-4 cm	6-8 cm
Integrity at 10 yrs	96.9-98%	not collected yet, projected to be 83-85%
Implant removal	Simple	Complicated

Consideration of incision size between the two types of implants is significant. Saline implants can be placed unfilled and so a small 3- to 4-cm incision can be used. Silicone implants must be placed through an incision almost twice that length, depending on the size of the implant used. The incision must be large enough that the silicone implant can be placed with ease, so that the gel is not fractured on placement. Brown et al found this to be at least 5 cm.

Cost is also a factor. The cost of saline implants is approximately 50 percent less than that for silicone implants. Satisfaction rates are high for both silicone and saline.

Hard to know what to make of the implant removal rates. Often the reasons for removal are to change size rather than to simply remove and leave out. That data is not often broken down further and it would be helpful if it were.

For me it is tough to justify going back to silicone gel implants in light of the satisfaction of the patient with saline, the difference in cost (both initial and long term as the MRI recommended by the FDA may not be covered by the patient's insurance), the size of the incision, the lack of clear advantage of silicone over saline.

Silicone implants do simulate the feel of breast tissue much better than saline implants ever will. They are therefore perceived as more natural to some patients. There may also be less palpable rippling and less potential for visible rippling with silicone implants. However, women with minimal subcutaneous tissue and/or poor skin turgor are difficult (if not impossible) to hide all rippling. The subpectoral placement can help this with either implant.

The Food and Drug Administration recommends a magnetic resonance imaging scan at 3 years after surgery using silicone gel implants, and then every 2 years thereafter. MRI is an excellent imaging modality in localizing free silicone and evaluating an implant for rupture. It has a sensitivity and specificity of greater than 90%. I don't order one if it won't change my plan of care. If the patient and I have already decided that (for whatever reason--age of implant, etc) that she needs to go to surgery, then why add the cost? The FDA's recommendations are to pick up "silent" ruptures.

Regardless of which type of implant is used for augmentation mammoplasty there are risks that are inherent to the surgery and are non-implant related. These include bleeding, infection, malposition of the implant, changes in nipple and breast sensation, and scar formation.

Breast implants interfere with mammography detection of breast cancer and require additional views and skilled technologists to compensate. So make sure you have your mammogram done at a facility that does a lot (more than a few a week) of women with implants.

With either implant, there WILL be future surgery. I posted about this with saline implants here.

REFERENCES
Silicone Breast Implants: Outcomes and Safety; Supplement to Plastic and Reconstructive Surgery, Vol 120, No 7, Suppl 1, December 2007
The FDA approves saline-filled breast implants: What does this mean for our patients?; Plast. Reconstr. Surg. 106: 903, 2000; Rohrich, R. J.
Breast Augmentation Today: Saline versus Silicone--What Are the Facts?; Plastic & Reconstructive Surgery. 121(2):669-672, February 2008; Rohrich, Rod J. M.D.; Reece, Edward M. M.D., M.S.
Cohesive Silicone Gel Breast Implants in Aesthetic and Reconstructive Breast Surgery; Plast. Reconstr. Surg, 116, 768, soo5; Brown MH, Shenker R, and Silver SA
Rupture and aging of silicone gel breast implants. Plast. Reconstr.
Surg. 91: 828; discussion 835, 1993; de Camara, D. L., Sheridan, J. M., and Kammer, B. A.
Mentor Corporation. Saline-Filled Breast Implant Surgery: Making
an Informed Decision. Product Insert; Mentor Corporation,
Santa Barbara, California: 2005.
FDA Breast Implant Home Page

Breast Implants -- Some History

One of AOL News stories this morning is "Making a Comeback: 20 Trends to Watch in 2008". The number one listed is Silicone Implants. So I am going to try to look at "just the facts". I will try to cover some of the history of implants and the controversy.

Here is a time line of breast implants in the United States:

1962 -- Silicone gel-filled implants first available as a result of Tom Cronin, MD and Frank Gerow, MD's work with Dow Corning

1976 -- US Food & Drug Administration (FDA) given Congressional authority to regulate medical devices. Silicone gel-filled breast implants were "grandfathered in" pending further review.

1988 -- FDA classified breast implants as Class III medical devices. This set in motion a process requiring manufacturers to demonstrate safety and effectiveness in a pre-market approval application.

1962-1988 -- A number of different implant designs and modifications were developed. These included double-lumen, reverse double-lumen, triple-lumen, smooth surface, textured surface, polyurethane-covered, thick shell, thin shell, barrier shell, and implants of varying gel cohesivity. Also, during this time other manufactures joined Dow Corning in the marketplace. Some of these companies included Bioplasty, McGhan (became Inamed in 2001, then Allergan Corp in 2006), Mentor (absorbed American Heyer-Schulte in April 1984), and Surgitek .

1991 -- FDA held an advisory panel meeting on silicone gel-filled breast implants. In September, sent letter to manufacturers accepting Pre-market Approval Applications (PMAAs) for review with a listing of major and minor deficiencies.

Sept 1991 -- Bristol-Meyers Squibb Company announced its decision to withdraw from the breast implant market and closed the plastic surgery unit of its Surgitek subsidiary.

January 1992 -- FDA called for a 45 day moratorium on the sale and use of silicone gel-filled breast implants. Later moratorium extended until recently. Saline implant use allowed.

February 1992 -- FDA reconvened General and Plastic Surgery Devices Panel to review "new material". The Panel recommended limited availability of implants under carefully controlled clinical protocols for augmentation mammoplasty. The Panel recommended broader access for reconstruction patients.

March 1992 -- Bioplasty announced withdrawal of its PMAAs for its single and double-lumen gel-filled breast implants.

April 1992 -- Dow Corning Corporation announced it's withdraw for PMAAs for silicone gel-filled breast implants.

April 1992 -- FDA announced 1) extension of the PMAAs for silicone gel-filled breast implants for reconstruction under the public health extension while studies are conducted and 2) denial of PMAAs for silicone gel-filled breast implants for cosmetic purposes while studies are conducted (limited availability under investigational device study).

1992 -- Mentor began its Core and Adjunct Studies
1998 -- McGhan received approval to initiate its Core and Adjunct Studies.
2005 -- FDA approved Mentor's application to market its Memory Gel Implants.
In 2006 -- the FDA approved silicone implants for general clinical use in breast augmentation.
November 2007 -- FDA approved Allergan's application to market its Inamed silicone-filled breast implants.
REFERENCES
Silicone Breast Implants: Outcomes and Safety; Supplement to Plastic and Reconstructive Surgery, Vol 120, No 7, Suppl 1, December 2007
ASPRS Breast Implant Resource Guide; May 1992