Articles & Issues Collections CME Supplements Videos Social Journal Info
Skip Navigation LinksHome > Blogs > PRSonally Speaking > PRS Correspondence- Letters to the Editor in Advance: Bra St...
PRSonally Speaking
Friday, January 14, 2011
PRS Correspondence- Letters to the Editor in Advance: Bra Stuffing for Implant Sizing? Satisfaction? Who, When, and Compared to What?

Every month Dr. Rohrich selects interesting and potentially controversial Letters to the Editor and some of their replies to post online ahead of the print edition. While the rest of the official solicited replies will appear in the printed issue, we encourage readers to submit replies as comments on this blog and continue the conversation.

The following letter and reply- and the additional FIVE pieces of correspondence on the topic- will appear in the February issue of PRS. We invite you to read it and let us, and the author, know your thoughts.

Bra Stuffing for Implant Sizing?  Satisfaction?  Who, When, and Compared to What?

 

Sir:

I am writing regarding the paper entitled “Preoperative Sizing in Breast Augmentation" in the June 2010 issue of the Journal.

 

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) in the most stringent, independently monitored FDA PMA studies which are substantially more scientifically robust compared to anecdotal survey series.

 

The authors’ implication that objective, scientifically validated, defined process implant selection methods1,2 preclude or minimize patient involvement in the decision making processes is misguided and incorrect.  The level of patient involvement in the patient education and decision making processes documented in current peer reviewed and published studies in this Journal1-4  is currently unmatched in the world literature with respect to content, comprehensiveness, and scientifically validated efficacy , outcomes, and reoperation rates.  Those methodologies produced the only zero percent reoperation rate ever reported at 3 years from an independently monitored FDA PMA study4.

 

Optimally educated patients rarely opt for bra stuffing size selection when they are aware of alternatives and understand that objective, scientifically validated methods exist and have been shown in peer reviewed and published studies to deliver the most rapid recovery, lowest reoperation rates in independently monitored studies4, and the lowest incidence of uncorrectable tissue deformities.  Armed with that knowledge, most patients rationally temper their wishes with what is best long-term for their tissues.  Absent that knowledge and an opportunity to utilize those methodologies, patients and surgeons historically revert to intuitive, subjective, and outdated methodologies that make them feel temporarily comfortable and “satisfied” , while those same “satisfied” patients report in this study that the methods are only 70% accurate.

 

Other issues with this paper:

·         Statistical analysis does not accord scientific validity to data when survey methodologies and questions were not validated initially.

·         References and discussion conveniently omit FDA PMA data that has shown for more than three decades that the methodologies advocated in this paper generated consistently excessive reoperation rates of 15-25% or more.

·         “Satisfaction” of 142 respondents with bra stuffing at a median 12 months postoperative hardly implies any substantive outcomes information that substantively affects patients’ welfare.

·         Subjective methodologies for implant sizing are non-scientific, not reproducible, not consistently transferable, and are difficult to defend medico legally because the very definitions on which they are based (cup size) are not definable.  Patients cannot be held accountable for decisions using parameters that neither surgeons nor patients can define.

·         Forcing breast tissues to a subjectively defined, desired result instead of allowing objective, scientifically validated measurements and methodologies to drive a much more predictable and reproducible decision process and outcomes guarantees tissue compromises and aesthetic compromises.

·         The surgeon, not the patient, choosing “most often a C cup, although a D cup may be used in some young nulliparous patients and a B cup in dome older and more conservative postpartum patients”;  the former is more likely to force nulliparous tissues to a temporary result that may later result in irreversible stretch, tissue thinning and parenchymal atrophy; and the latter is likely to inadequately fill a parous envelope and produce a “rock-in-a-sock” empty upper breast longer term.

·         Encouraging patients to believe that they can simply choose what they want, regardless of their quantifiable tissue characteristics and the consequences of their wishes on their tissues long-term.

·         Basing implant size decisions on height, weight, hip width, “personality”, and geographic demographics, when none of those parameters have anything to do with the dimensions and tissue characteristics and limitations of the tissues that exist on the breast.

·         Concluding that a methodology is “reasonably accurate”, when 30% of sized respondents said it was not accurate, uses the very data in the paper to disprove the paper’s conclusions.

·         Seeking to resurrect and validate an obsolete, subjective methodology based on indefinable cup size parameters using a 52.5% response rate of 142 respondents, 30% of whom, despite their supposed “satisfaction”, reported that the sizing methodology is inaccurate.

 

The sad story for patients is that surgeons continue to promote four decade old subjective methodologies and try to tell the old story with a different (“patient satisfaction” oriented) twist; when existing peer reviewed and published studies prove the inadequacies of those outdated methodologies, and especially when other peer reviewed and published studies, independently monitored, offer methodologies with proved superior processes and outcomes1-4.

 

Satisfaction?  Who is satisfied, when, and compared to what? 70% accuracy may “satisfy” some patients, but it should not satisfy any surgeon. I trust that informed patients and surgeons will not be satisfied with reverting to four decade old methodologies based on a small series of survey respondents at a median 6 month response time when 30% of sized respondents stated that the methods did not accurately predict their size.

 

The authors concluded that “It is expected that future improvements in methodology and equipment will improve the precision of the technique.” I couldn’t agree more, but the “future” was four years ago,  the required equipment is a measuring tape, and the methodologies and processes are peer reviewed and published in this Journal1-4.

 

John Tebbetts, M.D.

Dallas, Texas

 

References

(1)           Tebbetts, J.B.: A system for breast implant selection based on patient tissue characteristics and implant-soft tissue dynamics.  Plast. Reconstr. Surg.109 (4): 1396-1409, April, 2002

(2)           Tebbetts JB and Adams WP.  Five critical decisions in breast augmentation using 5 measurements in 5 minutes:  The high five system. Plast. Reconstr. Surg.116(7), 2005-16, Dec 2005.

(3)           Tebbetts, J.B.: An approach that integrates patient education and informed consent in breast augmentation.  Plast. Reconstr. Surg. 110 (3): 971-78, September, 2002.

(4)           Tebbetts, J.B. Achieving a zero percent reoperation rate at 3 years in a 50 consecutive case augmentation mammaplasty PMA study.  Plast. Reconstr. Surg.  118 (6), 1453-57, Dec 2006.

 

 

 

REPLY

Sir:

 

            Criticism is always welcome as an opportunity for discussion and further clarification of the role of preoperative sizing in breast augmentation.  To begin with, the writer implies that progress in medicine over time is strictly linear and that by that measure “four decade old subjective methodologies” must be obsolete.  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.  Consistent with that breast augmentation should be viewed more as couture procedure that intimately involves the patient rather than a purely scientific process focused largely on efficiency.

 

            We disagree with the notion that “up to three visits to the surgeon’s office…” is a waste of time.  If one’s core beliefs include that a breast augmentation lasting more than 24 minutes is inefficient, that each minute step of a surgical procedure should be precisely choreographed without variation, and that implant size selection should not take more than five minutes, then the value placed on efficiency is disproportionate.1-3  In our experience seeing patients more than once is mandatory.  Patients are often nervous and uncertain at the first visit.  They are also usually on their best behavior.  Several visits allows the staff, patient, and surgeon to become comfortable with one another (or not) and establish a definitive operative plan.

 

            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.  Operations for size change soon after the initial procedure are infrequent but patient anxiety regarding size immediately after surgery is not.  Preoperative sizing has virtually eliminated early postoperative calls in our practice that question size because the patient has actively participated in the size selection process beforehand.  She has experienced a simulation of the final result that includes both appearance in clothes and feeling the weight of the implants, not something achievable by tissue analysis and lecturing to the patient alone.  Although an imperfect method it is a far more collaborative tool compared to the practice of having the patient sign multiple consent forms that bind her to taking full responsibility for size prior to even seeing the surgeon for the first time.4 

 

            Preoperative sizing does not ignore an analysis of tissue characteristics and breast dimensions.  It is an adjunct, albeit an important one, in allowing the surgeon and the patient to collaborate on selecting an implant size that satisfies her wishes while respectful of the limitations imposed by anatomy.  When the sizing process is complete there is a narrow size range that will be considered during surgery, perhaps two options, compared to presumably only one determined by the “high five” system.  This gives the surgeon some latitude during surgery to make the best judgment based on operative conditions, something the patient willingly accepts and is often grateful for.  Our critic has misunderstood the process when he says it allows the patient to “simply choose what they want”.

 

            The writer says that “optimally educated patients rarely opt for bra stuffing size selection”.  How would he know?  Has he tried it?  Does he offer it as an option?  Better yet, after scientifically applying the “high five” technique and determining the exact implant size for the patient, why not let the patient try it on beforehand as an additional adjunct in managing the patient’s expectations, not to mention individually verifying a purely numbers driven size determination? 

 

            We are baffled by the assertion that a patient’s height, weight, hip width, personality and even geographic demographics have nothing to do with implant size selection.  Even the most doctrinaire methodology must reveal many instances where more than one size will be compatible with a patient’s tissue characteristics.  These other factors are important determinants in final size selection within the range that the patient’s anatomy will permit.  Not to consider factors other than breast anatomy ignores the patient as a whole.  Furthermore, these factors speak to the artistry involved in breast augmentation, an element that is not served by a purely numbers driven technique that does not focus outside of the breast base diameter.

 

            It is well understood that too large an implant can result in late tissue stretch and its sequellae.  Most of the implants that we use are between 250 to 350 ccs and the postpartum patients typically less than that.  We rarely use sizes that begin with a “4”, a practice that minimizes late stretch problems.  It is also axiomatic that sufficient upper pole fill is a key goal in the postpartum patient.  We disagree however, that a postpartum patient must always be larger than a “B” cup in order to achieve this. 

 

            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. 

 

            Finally, what can we say to the individual who makes vociferous arguments supported only by his own publications?  It logically follows that the ideas of others will not be considered without strong prejudice.  We have not witnessed the cognoscenti in plastic surgery today taking up the charge of perfecting choreographed surgery, utilizing the “high five” system, permitting their patients to go out for dinner, shopping, and dancing on the day of surgery1, or replicating the perfect record of 50 consecutive breast augmentations without a single instance of reoperation (itself a gift to the plaintiff’s bar).  Our system operates on a different value system that fosters a collaborative bond between the patient and surgeon, embraces the role of artistry beyond scientific analysis alone, and pursues a unique solution for each patient. 

 

David A. Hidalgo, M.D.

Jason A. Spector, M.D.

Weill-Cornell Medical College

 

 

REFERENCES

 

1.      Tebbetts, JB. Achieving a predictable 24 hour return to normal activities after breast augmentation: Part I. Refining practices by using motion and time study priniciples. Plast Reconstr Surg. 2002;109:273-290.

 

2.      Tebbetts, JB. Achieving a predictable 24 hour return to normal activities after breast augmentation: Part II. Patient preparation, refined surgical techniques, and instrumentation.  Plast Reconstr Surg. 2002;109:293-305.

 

3.      Tebbetts, JB. Five critical decisions in breast augmentation using five measurements in 5 minutes: The high five decision support process. Plast Reconstr Surg. 2006;118:35S-45S.

 

4.      Tebbetts, JB. An approach that integrates patient education and informed consent in breast augmentation. Plast Reconstr Surg. 2002;110:971-978. 

This is only the beginning of a very interesting discussion. Read the Februrary issue for the complete set of letters and replies, and be sure to add your thoughts below. As always, Letters and Replies are offered for free online at PRSJournal.com. There may be discrepancies between the blogged and printed versions of this letter.

1/27/2011
Craig N. Creasman MD said:
Sir:

We have read with great interest and some amusement the raging discourse regarding sizing of breast implants that followed the recent publication of Hidalgo and Spector1. As active developers and investigators in a novel 4D imaging system (Precision Light, Incorporated), we have had nose to grindstone for several years with efforts to end this question and move the specialty beyond systematic, but highly examiner-dependent schemes for surgical planning as described by Tebbetts, et.al.2,3, as well as the somewhat more subjective albeit more interactive process described by Hidalgo and Spector1. Our initial work was presented at the Hot Topics session of the Aesthetic Meeting in 20104 and will not be reviewed here, but suffice it to say that with sophisticated software, precise and detailed anatomical measurements are obtainable that far exceed anything done with a caliper and measuring tape, and they can be put into an interactive three dimensional construct in under one minute. The patient and her surgeon can analyze her anatomy together with automated measurement functions, asymmetry analysis, and simulation of implant placement across all implant platforms. Fold repositioning and minor degrees of ptosis correction can also be simulated. Portrayals of results reflect six month data on hundreds of patients, thus accounting for “settling”, which is to say skin stretch, areolar enlargement, muscle stretch, glandular atrophy and lower pole elongation.

By having the patient view herself in the third person, the paradigm has changed for how we conduct our consultations, making them more interactive and more productive. But interactive should not be misconstrued as pandering to whatever the patient requests. This is a straw man argument. In actuality, the ability to project in the third person details of anatomy even the most rigorously self-aware patient cannot have appreciated lends greater validity to the surgeon’s insight and recommendations and makes the educational aspect of the consultation richer and less authoritarian. By having reliable simulation algorithms that have been validated through hundreds of consultations and many software reiterations, we can now show patients with a high degree of reliability how they will look with breast augmentation, with the specific Implant selected (specific with regard to dimensions, volume, and shape, i.e. the exact manufacturer’s cataloged implant).

When patients see how they will appear after surgery, they feel a stronger connection to the surgeon because the impression is left that their goals are understood. When patients feel this connection and can be shown characteristics of their anatomy, they are more easily counseled regarding size, incision site, implant type, and other issues. In essence, this tool makes the educational process far simpler and yet more powerful. Despite our affection for our high tech imaging system, it must be admitted that having the patient hold the implant up to her breast to emphasize the concepts of base width, projection, and feel of the device remains very important in our practices. Our experience with bra stuffing methods is that it overestimates size because size changes in the first three months as the impact of the implant results in soft tissue atrophy, and this is not taken into account by any other planning method than ours.

Patient satisfaction with the accuracy of Precision Light 4D simulation of outcome vs. actual outcome at 6 months is 95% and there have been no reoperations for size change in the nearly two year period of clinical use, involving approximately 350 augmentations.

Craig N. Creasman, M.D.
G. Patrick Maxwell, M.D.

1. Hidalgo, DA, Spector, JA. Preoperative sizing in breast augmentation. Plast Reconstr Surg. 2010;125:1781-1787.
2. Tebbetts, JB. A system for breast implant selection based on patient tissue characteristics and implant-soft tissue dynamics. Plast Reconstr Surg. 2002;109:1396-1409.
3. Tebbetts JB, Adams, WP. Five critical decisions in breast augmentation using five measurements in 5 minutes: The high five decision support system. Plast Reonstr Surg. 2005;116:2005-2016.
4. Creasman, CN, Mordaunt D, Liolios, T, Chiu, C, and Maxwell, GP. 4D Breast Imaging: The introduction of an evidence-based approach to breast augmentation planning. Presented at ASAPS International Hot Topics in Plastic Surgery, April 2010, Washington, D.C.

Disclosures:
Dr. Maxwell is the founder of and a shareholder in Precision Light, Inc., a consultant for Allergan Medical and LifeCell.

Dr Creasman is a principle investigator for and a shareholder in Precision Light, Inc.
1/19/2011
Dr. Maurice Y. Nahabedian said:
The importance of preoperative assessment prior to breast augmentation is well recognized. Preoperative assessment may include but is not limited to breast dimensions, tissue compliance, parenchymal volume, and patient expectation. The relative importance of each is debatable and subject to diversity. These two respected and talented surgeons have devised their own strategy for preoperative breast assessment that has demonstrated success in their respective practices. I am confident that if I were to review each of their last 100 consecutive breast augmentations, it would be evident that their preoperative assessment was accurate and that their postoperative outcomes were optimal.

In an attempt to balance the apposing perspectives, it is important to appreciate that once a surgeon becomes comfortable with a particular method of analysis or a particular technique, there becomes very little need to change their approach, especially when it delivers excellent outcomes that are predictable and reproducible. That said, our specialty prides itself on innovation and advancement. As plastic surgeons, we continuously evaluate our outcomes and think of ways to improve. We combine our personal experience with that of the masters. We learn from the masters by reading their papers and listening to their presentations. We evaluate the objective and subjective information and then formulate our own strategic plan. Our methods are often a compilation of what we have learned and what we decide to incorporate into our practices.

Diversity is good. It is this diversity that defines our specialty. It is often said that what differentiates plastic surgery from other specialties is that with other specialties differential diagnoses are numerous but the remedy is solitary. With plastic surgery the differential diagnosis is solitary, but the remedies are numerous. The bottom line is that as long as we utilize good judgment and apply proper principles and concepts, more than one remedy may be possible for a given problem.

In conclusion, it should be remembered that plastic surgery is both a science and an art form. The science is common to all but it is that artistry that separates us as surgeons. In an environment where artistry is desirable, we should be appreciative of the various tools and methods that allow us to perform a particular operation and deliver high quality outcomes.

Maurice Nahabedian
1/18/2011
Charles H. Thorne MD said:
I would like to thank Drs. Hidalgo and Spector for writing such an articulate, helpful and educational response to Dr. Tebbetts' entertaining but dogmatic comments. I am concerned that a plastic surgeon would ever consider time spent with a patient as "wasted." C. Thorne
1/15/2011
Dr. John Tebbetts MD said:
Advocating soft, fuzzy, artistic subjectivity in lieu of quantifiable science is what it is. With respect to the authors and the " cognoscenti in plastic surgery today” and what they have not adopted, that fact attests to the differences in what is possible for the patient that, in our case, are documented in the only independently monitored study of its type in the literature. Perhaps it’s the same reason some chefs don’t match the cooking of others. When the ingredients are the recipes are published and available, it isn’t because they couldn’t--it’s because they chose not to follow the recipe. Alternatives for breast implant sizing certainly exist. But until equally rigorous, independently monitored data by a CRO prove otherwise, there are one set of processes that, compared to the authors and the “cognoscenti” of plastic surgeons, whoever they are, deliver another level of recovery and reoperation rates for patients. John Tebbetts
About the Blog

Plastic and Reconstructive Surgery

PRSonally Speaking is the official blog of Plastic and Reconstructive Surgery, the journal of the American Society of Plastic Surgeons. Visit our blog for exclusive previews of and discussions on hot topics in plastic surgery as well as insider-tips on open access content. PRSonally Speaking is now powered by frequent contributions from the American Society of Plastic Surgeons’ Young Plastic Surgeons Forum (YPS); these practicing plastic surgeons provide the personal side of the plastic surgery story, from daily challenges to unique insights. PRSonally Speaking is home to lively, civil debate on hot topics and great discussions pertaining to our field. So, bookmark us, subscribe to the RSS feed and join in the on-going conversation with Plastic and Reconstructive Surgery. This is your Journal; have fun, be respectful, get engaged and interact with the PRS community.

The views and recommendations of guest contributors do not necessarily indicate official endorsements or opinions of the Journal, PRS, or the ASPS. All views are those of the authors and the authors alone.

Contributors

Anureet K. Bajaj, MD is a practicing plastic surgeon in Oklahoma City. She completed residency and fellowship in 2004, had a brief stint in academia at the University of Cincinnati, and then chose to join her father (Paramjit Bajaj MD, also a practicing plastic surgeon) in private practice in OKC, where she focuses on breast reconstruction and general cosmetic surgeries.

Devra B. Becker, MD, FACS, is an Assistant Professor of Plastic Surgery in the Department of Plastic Surgery at University Hospitals/Case Western Reserve University School of Medicine in Cleveland, Ohio. She completed Plastic Surgery residency at Washington University School of Medicine in St. Louis, and completed fellowships with Daniel Marchac and with Bahman Guyuron. She currently has a primarily reconstructive practice.

Henry C. Hsia, MD, FACS is at Robert Wood Johnson Medical School of Rutgers University in New Brunswick, New Jersey and also holds an appointment at Princeton University.  When he’s not working hard trying to be a good father and husband, he runs a practice focused on reconstructive surgery and wound care as well as a research lab focused on wound biology and regenerative medicine.

Stephanie K. Rowen, MD is a senior physician at The Permanente Medical Group in San Jose, California.  She joined TPMG upon finishing residency and a hand surgery fellowship in 2005.  She has a primarily reconstructive practice, about 50% hand surgery.  Outside of work she enjoys participating in triathlons and spending time with her family.

Jon Ver Halen, MD is currently an Assistant Professor in the Department of Plastic Surgeryat the University of Tennessee Health Science Center, in Memphis. He also acts as Program Director for the plastic surgery residency. His practice focuses on oncologic reconstruction.

Tech Talk Bloggers

Adrian Murphy is a plastic surgery trainee in London, England. He studied medicine in Dublin, Ireland and has trained in Ireland, Boston, MA and the United Kingdom. He is a self-confessed geek and gadget aficionado.

Ash Patel, MD is Assistant Professor of Plastic Surgery and Associate Program Director at Albany Medical College, in Albany NY. His practice is primarily reconstructive.