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.