evidence based medicine and cosmetic surgery

Evidence based medicine and aesthetic surgery: reality or an

oxymoron

Art vs Science

Or both?

Evidence Based Medicine

• the term itself sounds cold and too detached for plastic surgery

• a specialty that necessarily involves close interpersonal relationships with our patients, each of whom has unique needs and desires that do not seem amenable to a seemingly homogenized statistical review

What is EBM?

“EBM is defined as the conscientious, explicit, and judicious use of current best evidence, combined with individual clinical expertise and patient preferences and values, in making decisions about the care of individual patients”

– Swanson J, Schmitz D, Chung KC. How to practice evidence-based medicine. Plast Reconstr Surg. 2010;126:286–294.

It has five primary components

1. Converting the need for information e.g. about prevention, diagnosis, prognosis, therapy or causation into an answerable question.

It has five primary components

1. Converting the need for information e.g. about prevention, diagnosis, prognosis, therapy or causation into an answerable question.2. Tracking down the best evidence with which to answer that question.

It has five primary components

3. Critically appraising that evidence for its:-validity (closeness to the truth)-impact (size of effect) and -applicability (usefulness in our clinical practice).

It has five primary components

4. Integrating the critical appraisal with our clinical expertise and with our patient's unique biology, values, and circumstances.

5. Evaluating our effectiveness and efficiency in executing steps 1 through 4 and seeking ways to improve for next time

• Currently, most articles in the plastic surgery literature are level 3, 4 or 5

• Articles with these levels of evidence are indeed valuable

• Our intent as a society should not only be to raise the overall level of evidence in the plastic surgery literature BUT also practice it

EBM and massive weight loss surgery

Buchwald, H., Avidor, Y., Braunnald, E., et al. Bariatric surgery: A systematic review and meta-analysis. J.A.M.A. 292: 1724, 2004

• Comprehensive review and meta-analysis analyzed 136 bariatric surgery reports.

• This study reviewed 22,094 patients with a mean age of 39 years (range, 16 to 64 years)

• Average body mass index of 46.9 (range, 32.3 to 68.8).

• The group was 72.6% female and 27.4% male.

Buchwald, H., Avidor, Y., Braunnald, E., et al. Bariatric surgery: A systematic review and meta-analysis. J.A.M.A. 292: 1724, 2004

• The authors concluded that co-morbidities were improved by bariatric surgery– Lipid disorders improved in 70% of patients.– Diabetes improved in 76.8% of patients.– Hypertension improved in 78.5% of

patients.– Obstructive sleep apnea improved in 85.7%

of patients.

• American Society for Bariatric Surgery, its member surgeons performed:– 28,800 weight loss operations in 1999– 63,000 weight-loss operations in 2002, – 140,000 weight-loss operations in 2004• Mayo Foundation for Medical Education and Research.

Gastric bypass: Is this weight-loss surgery for you?

• American Society of Plastic Surgeons, nearly 56,000 body contouring procedures were performed for massive weight loss patients in 2004 (140,000 weight loss operations)

Implications of Weight Loss Method in Body Contouring Outcomes:

Gusenoff, PRS 2009

499 patients (511 cases) were entered into a prospective registry.

Diet and exercise patients were matched to bariatric patients based on identical procedures performed

All patients with a weight loss of greater than 50 lb were included

477 cases (93.3 percent) had bariatric procedures

29 patients representing 34 cases (6.7 percent) lost weight exclusively through diet and exercise

Implications of Weight Loss Method in Body Contouring OutcomesJeffrey A. Gusenoff, M.D. Devin Coon, B.A. J. Peter Rubin, M.D.

Plast. Reconstr. Surg. 123: 373, 2009

• Conclusion, that diet and exercise had:– Higher absolute complication rates, – Significantly higher infection rates (p = 0.03). – When matched to 191 bariatric patients based on

procedures performed, had a higher complication rate that did not reach significance (odds ratio, 1.5; p =0.28)

• Conclusion, that diet and exercise had:– Higher absolute complication rates, – Significantly higher infection rates (p = 0.03). – When matched to 191 bariatric patients based on

procedures performed, had a higher complication rate that did not reach significance (odds ratio, 1.5; p =0.28)

EBM and Breast Augmentation

•?Ab

EBM and Breast Augmentation

– Khan (2009 Aesth Plastic surgery 34:42-47)• 1628 patients (3256 breasts)– Infection lowest in the group that received IV Ab at

induction and no post-op – Nil statistical difference if given IV Ab at induction

and a course of post-op oral Ab

EBM and Breast Augmentation

EBM and Breast Augmentation

• Location of incision?– Weiner (2008 Aesth plastic surgery)• 400 patient group, looking at capsule formation• IMF incision 0.59% compared with 9.5% in periareolar

EBM and Breast Augmentation

• Compression garments post augmentation?

EBM and Breast Augmentation

• Nathan (Aesth plastic surgery 2001)• 130 patients randomised to wearing post-op

compression garments or not• NIL difference to bruising or haematoma• Level 2

EBM and Breast Augmentation

• Drains?

EBM and Breast Augmentation• Drains– Hipps (PRS 1978)• Significantly reduced capsule formation when on low

suction• But now thought outdated data

– Araco (Aesth plastic surgery 2007)• 5 fold increase in infection

– Although level 1 or 2 doesn’t exist large body of clinical data showing low capsular contractures rates when drains not used

EBM and Breast Augmentation Pocket Irrigation?

EBM and Breast Augmentation • Pocket Irrigation– Weiner ( PRS 2007)• 50% betadine irrigation of pockets significantly lowered

capsule formation compared with saline• No deflation of the implant device

– Adams (PRS 2001)• In-vivo study using triple Ab solution (50000 unit

bacitracin, 1gm cefazolin, 80mg gent and 500mls saline)– 3-4 decrease in capsule formation

EBM and Breast Augmentation • Adams (PRS 2006)

• Prospective 6 year clinical study using above solution compared with saline• 1.8% vs 9.0% in augmentation group• 9.5% vs 27.5% in reconstructive group

– Adams (Clinic Plastic Surgery 2009)• Final solution with most broad spectrum cover is: • 50mls betadine, 1gm cefazolin, 80mg gentamicin and

500mls saline

EBM and Breast Augmentation

Texturing?

EBM and Breast Augmentation Barnsley (PRS 2006) and Wong (PRS 2006)

Performed meta-analyses on effects of texturing on capsule formation

Although many conflicting studies there is evidence that when placed in subglandular position textured implants produce less capsule formation than smooth

HOWEVER, this benefit is lost in the submuscular position Level 1

Studies on types of implants, saline vs silicone, highly cohesive vs less cohesive all have good results BUT majority funded by manufacturer or the surgeons were paid by them

EBM and Breast Augmentation and Cancer

EBM and Breast Augmentation and Cancer

Silverstein (Cancer 1991) presented a series of 20 women with breast ca who

had implants. 13 of these women had involved nodes. Suggested

implants had delayed diagnosis because silicone obscured the breast tissue on mammography

Level 2 Xie (Int Journal of Cancer 2010)

Implants delayed the diagnosis of breast cancer but there was no survival difference

Level 2

EBM and Breast Augmentation and Cancer

Deapen: LA County (PRS 1997; 99:1346) 3182 women with implants (1953-1990) f/u for 18.7 yrs –

No evidence of delayed diagnosis or more advanced staging. Augmentation in fact had 31 ca detected compared with expected

49 in general population Level 2

Bryant & Brasher: Alberta, Canada (NEJM 1995; 332:1535) 10,835 women with implants (1973-1990) no evidence for an increased risk of breast ca Level 2

McLaughlin (J of National Cancer Inst 2006) 3486 patients followed up 9-37 years Cancer rate was lower in the augmentation group but not statistically

significant Level 2

EBM and Breast Augmentation and Cancer

Jakub (PRS Dec 2004; 114(7), pp1737-1753) 4186 breast ca patients in Florida. 78 had prior augmentation. If had augment:

More likely to present with a palpable mass - ?due to a smaller volume of breast tissue which is pushed to the surface making examination easier.

Tumour size, nodal positivity, stage or prognosis was no different to the non-augmented group.

Level 2 Hoshaw (PRS 2001; 107:1393)

Meta analysis of current literature. Concluded that women with implants have no increased risk of breast cancer

nor is there a delay in diagnosis, an increased risk of of recurrence or decreased survival.

Level 1

EBM Breast Reduction and breast feeding

EBM Breast Reduction• Cruz and Korchin (PRS 2004)

– Retrospective case series– Control group of 149 women with a mean age of 27

who had children and were evaluated for breast reduction

– Study group of 58 with mean age of 29 who had children after breast reduction

– 61% control group vs 65% of study group were successful at breast feeding (nil significant difference)

– 36% of control vs 28% of study group needed to supplement breast feeding with formula

– Level 4

EBM Abdominoplasty

EBM Abdominoplasty

• Smoking:– Manassa (2003 PRS)• 1st to look at smoking and abdominoplasty• 132 patients• 49.7% vs 14.8% (p<0.01)• Also related to number of cigarettes smoked over a

lifetime….with cut-off value of smoking and infection being 8.5 pack years• Relative risk 12-14 times• Level 2

EBM Abdominoplasty Antibiotics

Sevin (2007 JPRAS) Prospective study of 200 patients

Nil Ab Pre-op Ab only Pre-op and post-op Ab

Significant increase in infection in no Ab group Nil difference between the either Ab group Level 2

Casear (2009 PRS) 300 patients with nil Ab with only 8% post-op infection rate requiring Ab

therefore advocated nil pre-op Ab Level 4

EBM Facelift

• Drains?

EBM Facelift• Jones (2007 PRS)

– Prospective randomised clinical trial on 50 consecutive patients

– Demonstrated a statistically significant decrease in bruising as assessed by the patient and the surgeon

– Level 2• Tissue sealants?– ????

“For surgeons who may accept average as adequate, evidence-based medicine can be a haven”

John Tebbetts PRS vol 128 (2) 596-597. 2011

“Surgical innovations have never in history derived from level I or II evidence studies… Benchmarking to average (even from an evidence level I or II study) and excluding references to what is possible, regardless of evidence level, guarantees mediocrity and suboptimal outcomes for patients”

“Since when is best evidence (by evidence-based medicine) better than evidence of what is best for patients?”– John Tebbetts PRS vol 128 (2) 596-597. 2011