Plastic and Reconstructive Surgery • December 2013 not any scientifically valid, objective indicator of “outcome” at a meaningful follow-up interval. Are readers to conclude that outcomes in breast augmentation are definable at 6 months or less? Any significant level of clinical experience clearly indicates that the effects of the device on patients’ tissues and the resultant consequences (and “satisfaction” levels) are often not evident for years. The author states, “Indeed, it has been suggested that plastic surgeons have been paternalistic in telling patients what size is best for them, rather than having their patients inform them.” Is it paternalism, or an informed consent legal requirement, or simply “good medicine” to educate patients about proved and published, quantifiable processes that have produced a 0 percent reoperation rate at 3 years and dramatically reduced morbidity during recovery in an independently monitored study from within a U.S. Food and Drug Administration Premarket Approval study2— results that have been confirmed by similar results from another surgeon?3 If delivering better care for patients is a priority, perhaps a bit of paternalism or maternalism is not a bad thing for patients who do not know that better exists and for surgeons who have no incentive to deliver it or even mention that a dramatically improved alternative exists. It is challenging to validate any outcomes study that loses 86.6 percent of patients to follow-up by 6 months, and virtually ensures, because of that loss of follow-up, that longer term data cannot ever be gathered from the study cohort to validate or refute premature or inaccurate conclusions of the study. Patient satisfaction is important, but patient satisfaction has not historically incentivized surgeons to redefine processes and the patient experience in breast augmentation. The status quo may be tolerable for some patients and surgeons, but average is average. Average patients are often satisfied, especially early, with average results and an unnecessarily prolonged recovery in breast augmentation, often with large implants that are never “large enough.” That may explain the lack of incentive for many surgeons to implement processes published more than a decade ago and confirmed in independently monitored studies2–5 that clearly deliver less morbidity, at less cost, with fewer reoperations, and with fewer uncorrectable tissue deformities longer term compared with legacy methodologies. The data in this article strongly support that perspective. DOI: 10.1097/PRS.0b013e3182a97f62
John B. Tebbetts, M.D.
2801 Lemmon Avenue, Suite 300 Dallas, Texas 75204-2356 [email protected]
DISCLOSURE The author has no financial interest to declare in relation to the content of this communication.
1066e
REFERENCES 1. Hidalgo DA. Discussion: Prospective outcome study of 225 cases of breast augmentation. Plast Reconstr Surg. 2013;131:1167–1168. 2. Tebbetts JB. Achieving a zero percent reoperation rate at 3 years in a 50 consecutive case augmentation mammaplasty PMA study. Plast Reconstr Surg. 2006;118:1453–1457. 3. Adams WP. The process of breast augmentation: Four sequential steps for optimizing outcomes for patients. Plast Reconstr Surg. 2008;122:1892–1900. 4. Tebbetts JB. Achieving a predictable 24-hour return to normal activities after breast augmentation: Part I. Refining practices using motion and time study principles. Plast Reconstr Surg. 2002;109:273–290. 5. 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.
Reply: Prospective Outcome Study of 225 Cases of Breast Augmentation Sir: n his letter suggesting alternative titles to my outcome study,1 Dr. Tebbetts assumes that because the majority of interviews were conducted less than 6 months after surgery, most of the patients were lost to follow-up within 6 months as well. In fact, many patients returned for appointments after their interviews. The mean follow-up time for surveyed patients who were also included in a prospective 10-year clinical study2 was 9 months. Of course, Dr. Tebbetts was unaware of this subsequent clinical publication when he wrote his letter. In response to his question as to whether outcomes are definable at 6 months or less, the answer is yes.3 Unlike liposuction or rhinoplasty, breast augmentation patients do not need to wait long to appreciate the impact of their operation. This time frame is also ideal to assess the patient’s recollection of her recovery experience. It is inadequate for longterm assessment of complications and reoperations, as noted in both articles.1,2 Insistence on longer followup times would reduce the inclusion rate, jeopardizing reliability. This is not to say that follow-up time is not an important consideration. On the contrary, the issue was taken seriously enough to investigate with two statistical analyses. Reassuringly, survey responses were found to be unrelated to follow-up times.1 Preoperative tissue measurements have not been shown to be effective. They tend to underestimate implant volumes. In a study of implants with a mean volume of 289 cc, Adams reports that approximately 20 percent of his patients express concerns to his staff regarding postoperative breast size.4 There are problems with basing volumes on tissue measurements. The base width is considered a critical dimension5 but is overlooked if the breast is too narrow. The inframammary fold serves as a “fixed landmark”5; however, it is known to drop after breast augmentation,6 whether by intention or not. Measuring the soft-tissue thickness
I
Volume 132, Number 6 • Letters does not affect management if one consistently uses the submuscular plane. The skin’s ability to stretch, even in nulliparous women, is well known and is usually not a limiting factor for volumes less than approximately 450 cc. Ptosis is relevant to whether a simultaneous mastopexy is recommended, not implant size. An implant should not be expected to take up the slack.7 Most plastic surgeons, even those performing tissue measurements, ultimately base their volume determinations on their judgment and experience, prioritizing their patients’ objectives. This clinical process is the basis of all cosmetic surgery. It is not “random” and it is certainly less rigid than relying on arbitrary numbers on a measurement form. Dr. Tebbetts suggests that I have a personal preference for “large” (mean volume, 390 cc) implants. In fact, a wide range of sizes is recommended (Fig. 1).1 A similar size distribution and a 385-cc average implant volume were recently reported by other investigators.8 Tebbetts does not offer data to support his repeated warnings that implants larger than 350 cc create excessive long-term tissue-related problems.9 No increased risk of complications in patients with larger implants was found in my 10-year clinical study that included 522 consecutive cases of breast augmentation and 146 consecutive cases of augmentation/ mastopexy.2 On the contrary, a significant positive correlation was detected between larger implant size and a higher result rating.1 Clinical decisions rest on the risk-to-benefit ratio. Even if there were an increased risk, women who desire larger breast sizes may be willing to trade more risk for more benefit. Surgeon size prejudices should not keep them from achieving their goals; it is their choice after all. Complication and reoperation rates are reported separately,2 including the requested reference on the
limitations of reoperation rates.10 Dr. Tebbetts believes that having zero reoperations11 is a marker of surgical prowess. This may be true for a cholecystectomy, where a low reoperation rate may reflect, for example, the surgeon’s care not to injure the common bile duct. In cosmetic surgery, the criterion for success is much more subjective and patient-oriented. Unlike general surgery, patient perception of the cosmetic result is the most important indicator of surgical success.12 Reoperation rates are an unreliable marker of quality in cosmetic surgery.10 A reported rate of zero complications and zero reoperations11 is unique. Other experienced plastic surgeons report reoperation rates between 10.7 and 19.4 percent.2,8,13 Is a 5-year prospective outcomes study just a “snapshot”? By comparison, Dr. Tebbetts’ staff telephoned his patients for 3 days after submuscular breast augmentations and concluded that 96 percent of his patients were fully recovered at 24 hours, to the extent that they were not taking prescription painkillers, were driving, could return to work, and were able to lie prone on their breasts for 15 minutes.14 Such findings stand in stark contrast to patient-reported outcomes data.1 Dr. Tebbetts’ regimented surgical philosophy includes personal preferences (e.g., not touching the perichondrium, cautery dissection only, “400 primary submuscular, inframammary augmentations), greater than 95 percent of patients required no narcotic pain medication after surgery and over 95 percent achieved a 24-hour recovery, thus performing their normal activities of daily living with
DOI: 10.1097/PRS.0b013e3182a97fc6
Swanson Center 11413 Ash Street Leawood, Kans. 66211 [email protected]
DISCLOSURE The author has no conflicts of interest to disclose. There was no outside funding for this study. REFERENCES 1. Swanson E. Prospective outcome study of 225 cases of breast augmentation. Plast Reconstr Surg. 2013;131:1158–1166; discussion 1167–1168. 2. Swanson E. Prospective comparative clinical evaluation of 784 consecutive cases of breast augmentation and vertical mammaplasty, performed individually and in combination. Plast Reconstr Surg. 2013;132:30e–45e. 3. McCarthy CM, Cano SJ, Klassen AF, et al. The magnitude of effect of cosmetic breast augmentation on patient satisfaction and health-related quality of life. Plast Reconstr Surg. 2012;130:218–223. 4. Adams WP Jr. The process of breast augmentation: Four sequential steps for optimizing outcomes for patients. Plast Reconstr Surg. 2008;122:1892–1900. 5. Tebbetts JB, Adams WP. Five critical decisions in breast augmentation using five measurements in 5 minutes: The high five decision support process. Plast Reconstr Surg. 2005;116:2005–2016. 6. Swanson E. Photometric evaluation of inframammary crease level after cosmetic breast surgery. Aesthet Surg J. 2010;30: 832–837. 7. Swanson E. Prospective photographic measurement study of 196 cases of breast augmentation, mastopexy, augmentation/mastopexy, and breast reduction. Plast Reconstr Surg. 2013;131:802e–819e. 8. Lista F, Tutino R, Khan A, Ahmad J. Subglandular breast augmentation with textured, anatomic, cohesive silicone implants: A review of 440 consecutive patients. Plast Reconstr Surg. 2013;132:295–303. 9. Tebbetts JB. The greatest myths in breast augmentation. Plast Reconstr Surg. 2001;107:1895–1903. 10. Pollock H, Pollock T. Is reoperation rate a valid statistic in cosmetic surgery? Plast Reconstr Surg. 2007;120:569. 11. Tebbetts JB. Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval study. Plast Reconstr Surg. 2006;118:1453–1457.
1068e
Nothing Dubious or Unpredictable about 24-Hour Recovery in Breast Augmentation
I
John B. Tebbetts, M.D.
2801 Lemmon Avenue, Suite 300 Dallas, Texas 75204-2356 [email protected]
DISCLOSURE The author has no financial interest to declare in relation to the content of this communication.
1066e
REFERENCES 1. Hidalgo DA. Discussion: Prospective outcome study of 225 cases of breast augmentation. Plast Reconstr Surg. 2013;131:1167–1168. 2. Tebbetts JB. Achieving a zero percent reoperation rate at 3 years in a 50 consecutive case augmentation mammaplasty PMA study. Plast Reconstr Surg. 2006;118:1453–1457. 3. Adams WP. The process of breast augmentation: Four sequential steps for optimizing outcomes for patients. Plast Reconstr Surg. 2008;122:1892–1900. 4. Tebbetts JB. Achieving a predictable 24-hour return to normal activities after breast augmentation: Part I. Refining practices using motion and time study principles. Plast Reconstr Surg. 2002;109:273–290. 5. 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.
Reply: Prospective Outcome Study of 225 Cases of Breast Augmentation Sir: n his letter suggesting alternative titles to my outcome study,1 Dr. Tebbetts assumes that because the majority of interviews were conducted less than 6 months after surgery, most of the patients were lost to follow-up within 6 months as well. In fact, many patients returned for appointments after their interviews. The mean follow-up time for surveyed patients who were also included in a prospective 10-year clinical study2 was 9 months. Of course, Dr. Tebbetts was unaware of this subsequent clinical publication when he wrote his letter. In response to his question as to whether outcomes are definable at 6 months or less, the answer is yes.3 Unlike liposuction or rhinoplasty, breast augmentation patients do not need to wait long to appreciate the impact of their operation. This time frame is also ideal to assess the patient’s recollection of her recovery experience. It is inadequate for longterm assessment of complications and reoperations, as noted in both articles.1,2 Insistence on longer followup times would reduce the inclusion rate, jeopardizing reliability. This is not to say that follow-up time is not an important consideration. On the contrary, the issue was taken seriously enough to investigate with two statistical analyses. Reassuringly, survey responses were found to be unrelated to follow-up times.1 Preoperative tissue measurements have not been shown to be effective. They tend to underestimate implant volumes. In a study of implants with a mean volume of 289 cc, Adams reports that approximately 20 percent of his patients express concerns to his staff regarding postoperative breast size.4 There are problems with basing volumes on tissue measurements. The base width is considered a critical dimension5 but is overlooked if the breast is too narrow. The inframammary fold serves as a “fixed landmark”5; however, it is known to drop after breast augmentation,6 whether by intention or not. Measuring the soft-tissue thickness
I
Volume 132, Number 6 • Letters does not affect management if one consistently uses the submuscular plane. The skin’s ability to stretch, even in nulliparous women, is well known and is usually not a limiting factor for volumes less than approximately 450 cc. Ptosis is relevant to whether a simultaneous mastopexy is recommended, not implant size. An implant should not be expected to take up the slack.7 Most plastic surgeons, even those performing tissue measurements, ultimately base their volume determinations on their judgment and experience, prioritizing their patients’ objectives. This clinical process is the basis of all cosmetic surgery. It is not “random” and it is certainly less rigid than relying on arbitrary numbers on a measurement form. Dr. Tebbetts suggests that I have a personal preference for “large” (mean volume, 390 cc) implants. In fact, a wide range of sizes is recommended (Fig. 1).1 A similar size distribution and a 385-cc average implant volume were recently reported by other investigators.8 Tebbetts does not offer data to support his repeated warnings that implants larger than 350 cc create excessive long-term tissue-related problems.9 No increased risk of complications in patients with larger implants was found in my 10-year clinical study that included 522 consecutive cases of breast augmentation and 146 consecutive cases of augmentation/ mastopexy.2 On the contrary, a significant positive correlation was detected between larger implant size and a higher result rating.1 Clinical decisions rest on the risk-to-benefit ratio. Even if there were an increased risk, women who desire larger breast sizes may be willing to trade more risk for more benefit. Surgeon size prejudices should not keep them from achieving their goals; it is their choice after all. Complication and reoperation rates are reported separately,2 including the requested reference on the
limitations of reoperation rates.10 Dr. Tebbetts believes that having zero reoperations11 is a marker of surgical prowess. This may be true for a cholecystectomy, where a low reoperation rate may reflect, for example, the surgeon’s care not to injure the common bile duct. In cosmetic surgery, the criterion for success is much more subjective and patient-oriented. Unlike general surgery, patient perception of the cosmetic result is the most important indicator of surgical success.12 Reoperation rates are an unreliable marker of quality in cosmetic surgery.10 A reported rate of zero complications and zero reoperations11 is unique. Other experienced plastic surgeons report reoperation rates between 10.7 and 19.4 percent.2,8,13 Is a 5-year prospective outcomes study just a “snapshot”? By comparison, Dr. Tebbetts’ staff telephoned his patients for 3 days after submuscular breast augmentations and concluded that 96 percent of his patients were fully recovered at 24 hours, to the extent that they were not taking prescription painkillers, were driving, could return to work, and were able to lie prone on their breasts for 15 minutes.14 Such findings stand in stark contrast to patient-reported outcomes data.1 Dr. Tebbetts’ regimented surgical philosophy includes personal preferences (e.g., not touching the perichondrium, cautery dissection only, “400 primary submuscular, inframammary augmentations), greater than 95 percent of patients required no narcotic pain medication after surgery and over 95 percent achieved a 24-hour recovery, thus performing their normal activities of daily living with
DOI: 10.1097/PRS.0b013e3182a97fc6
Swanson Center 11413 Ash Street Leawood, Kans. 66211 [email protected]
DISCLOSURE The author has no conflicts of interest to disclose. There was no outside funding for this study. REFERENCES 1. Swanson E. Prospective outcome study of 225 cases of breast augmentation. Plast Reconstr Surg. 2013;131:1158–1166; discussion 1167–1168. 2. Swanson E. Prospective comparative clinical evaluation of 784 consecutive cases of breast augmentation and vertical mammaplasty, performed individually and in combination. Plast Reconstr Surg. 2013;132:30e–45e. 3. McCarthy CM, Cano SJ, Klassen AF, et al. The magnitude of effect of cosmetic breast augmentation on patient satisfaction and health-related quality of life. Plast Reconstr Surg. 2012;130:218–223. 4. Adams WP Jr. The process of breast augmentation: Four sequential steps for optimizing outcomes for patients. Plast Reconstr Surg. 2008;122:1892–1900. 5. Tebbetts JB, Adams WP. Five critical decisions in breast augmentation using five measurements in 5 minutes: The high five decision support process. Plast Reconstr Surg. 2005;116:2005–2016. 6. Swanson E. Photometric evaluation of inframammary crease level after cosmetic breast surgery. Aesthet Surg J. 2010;30: 832–837. 7. Swanson E. Prospective photographic measurement study of 196 cases of breast augmentation, mastopexy, augmentation/mastopexy, and breast reduction. Plast Reconstr Surg. 2013;131:802e–819e. 8. Lista F, Tutino R, Khan A, Ahmad J. Subglandular breast augmentation with textured, anatomic, cohesive silicone implants: A review of 440 consecutive patients. Plast Reconstr Surg. 2013;132:295–303. 9. Tebbetts JB. The greatest myths in breast augmentation. Plast Reconstr Surg. 2001;107:1895–1903. 10. Pollock H, Pollock T. Is reoperation rate a valid statistic in cosmetic surgery? Plast Reconstr Surg. 2007;120:569. 11. Tebbetts JB. Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval study. Plast Reconstr Surg. 2006;118:1453–1457.
1068e
Nothing Dubious or Unpredictable about 24-Hour Recovery in Breast Augmentation
I
