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an opportunity to utilize those methodologies, patients and surgeons historically revert to intuitive, subjective, and outdated methodologies that make them feel temporarily comfortable and “satisfied” , while those same “satisfied” patients report in this study that the methods are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.
(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.