The Best Breast

By John B. Tebbetts, M.D.

On September 15, 2009, an article in the British tabloid The Sun advised the public that “breast enlargement using natural fat from other parts of their bodies are to be offered to women” by the Harley Medical Group of London “early next year.”  The article contains several statements that may be misleading for patient and patients should carefully consider more information before signing up for the procedure.

What a concept (especially for revenue seeking surgeons)– remove unwanted fat from areas like the buttocks, thighs, abdomen, and arms, and transfer it to the breast to enlarge and improve breast shape.  Imagine the market for such a procedure.  How many women would instantly sign up to relocate unwanted fat to their breasts?

Sound too good to be true?  It’s true that the procedure being done, but it’s also true that the entire concept may turn out to be a major disaster with uncorrectable and even potentially deadly consequences for patients.  The observations that follow are directed specifically at fat that is harvested from one are of a woman’s body and then transferred to her breasts. 

What are the most critical questions that must be answered by independently monitored scientific studies before fat should be injected into women’s breasts?  Here is a short list of the critical questions and the status of the answers:

1)      How much fat survives?  Surgoens who promote the procedure claim high survival rates of the fat, but this is not proved by independently monitored studies.

2)      How much inflammation does fat injection create?  No definitive studies answer the question

3)      What is released from injected fat and subsequent inflammation?  No definitive studies answer the question.

4)      Could any substances released from injected or dead fat possibly be carcinogenic (cause cancer) or potentially increase risks of breast cancer?  This is a critically important question for patients, and it remains unanswered in independently monitored, long-term studies.

5)      Could any chemical released from injected fat stimulate or promote tumor growth? This question remains unanswered

6)      We know that fat injected into the breast causes calcifications (calcium deposits) that are visible on mammograms and MRI imaging of the breast.  To what extent might the calcifications caused by injected fat interfere with the detection of smaller calcifications that enable early diagnosis and treatment of breast cancer?  This critical question has not been answered in long-term, independently monitored studies.

7)      How many procedures, how much time, and how much money are required to inject enough fat to provide an average volume breast augmentation?  We know that most women who have breast augmentation have at least a 250cc volume augmentation.  Based on presentations by surgeons who advocate fat injection for breast augmentation, we know that multiple procedures, much longer anesthetic times, and much greater costs are common compared to conventional breast augmentation.

8)      What does the FDA or any other regulatory agency  think about fat injection to the breast for breast augmentation?  No regulatory agency currently has any jurisdiction over fat injection into the breast in the United States.  Surgeons can inject fat into the breast in any quantity or in any manner they choose, with no independent monitoring or oversight.  The two largest and most respected professional organizations for board certified plastic surgeons have both expressed substantial negative concerns and lack of science based evidence of safety of fat injection into the breast.

I have personally taken a very strong position against fat injection into the breast for breast augmentation in plastic surgeon professional  education forums and other communications to colleagues for the following reasons:

1)      Currently, there is insufficient scientific evidence from independently monitored studies, for anyone to claim that fat injection into the female breast for breast augmentation is safe for patients.

2)      Fat injection into the breast should be at least as thoroughly studied as breast implants—possibly even more.  While breast implants have their own set of risks and tradeoffs, they have been more thoroughly studied than any other aesthetic device or procedure.  As a result, patients considering breast augmentation have solid, independently monitored scientific data on which to base their decisions.  Equally valid scientific evidence does not currently exist for fat injection into the breast.

3)      The best current scientific studies indicate that breast implants neither cause cancer nor promote tumor growth if it occurs.  No studies prove that injected fat poses no increased risks of breast cancer.

4)      Until surgeons can provide patients with conclusive, valid, long-term scientific evidence that fat injection is safe and poses no increased risks compared to other alternatives,  surgeons are not providing patients the best information to enable patients to make the best decisions.

5)      Transferring fat from unwanted areas to the breast for augmentation is a pie in the sky marketing package that may potentially deceive and harm patients.  The concept  sounds so good that unless patients receive optimal education about potential risks, costs, and tradeoffs, many patients may elect to have the procedure based on emotion and marketing appeal instead of optimal scientific facts and information.  The potential for misinformation or lack of information for patients, combined with the potential revenue generation for surgeons is a dangerous combination for optimal patient safety.

6)      Until equivalent, independently monitored scientific studies with criteria and follow up equal to FDA PMA studies for breast implants are available for fat injection for augmentation, fat injection should not be performed except in carefully controlled and monitored studies.

Injection of small amounts of fat as a supplement to post mastectomy breast reconstruction is very different compared to injections of large amounts of fat for first time breast augmentation.  Surgeons should not be trying to sell patients on the safety of fat injection for breast augmentation based on a very limited experience with injecting small amounts of fat in breast reconstruction procedures.  Advising patients that small volume fat injection verifies the safety of larger volume fat injection is scientifically and ethically questionable, and not in the best interests of patients.  Injecting large volumes of fat for breast augmentation exposes potentially large numbers of women with normal breasts to risks they would otherwise not incur.  Mastectomy patients have already lost their breast, and risks of small amounts of fat injection in those patients as a supplement to major breast reconstructive procedure is potentially much safer compared to large volume fat injections for breast augmentation.

I have challenged some of the most prominent advocates of fat injection for breast augmentation in national and international surgeon education venues, specifically asking if they would commit to performing independently monitored studies to confirm the long-term safety of fat injection.  On public record in these forums, prominent advocates of fat injection have made the verbal commitment to perform independently monitored studies.  To date, not a single surgeon advocate of the procedure has performed an independently monitored study.  If surgeons who purport to be world experts on fat injection fail to assure patient safety by performing independently monitored studies, patients should be very wary of the procedure and question the veracity and priorities of surgeons who try to sell fat injection for breast augmentation.

If surgeons who stand to profit most from a procedure are not willing to fund and carry out independently monitored research to assure patient safety of the procedure before subjecting patients to a potentially unsafe course of treatment, I openly question the priorities of those surgeons, especially when they have made public verbal commitments to perform independently monitored studies.  There is simply no excuse for not assuring patient safety for any procedure, much less a medically unnecessary, totally elective procedure that is unmonitored and uncontrolled.

Until we can provide patients the best quality, long-term, independently monitored studies, I strongly advise patients to prioritize their safety above their emotions to move fat from an unwanted area to the breasts.  Patients should insist on information from independently monitored studies, and not be duped by marketing for fat injection for breast augmentation.   I further suggest that surgeons who perform the procedure be very careful to assure that patients receive only the best, honest, valid scientific information on which to base their decisions.

Surgeons who market   fat injection to the breast for augmentation or perform the procedure on patients are responsible for untoward or dangerous consequences that happen to patients because the surgeons did not assure adequate scientific study to assure optimal patient safety and optimal patient outcomes.