Management of Asymptomatic Patients With Textured Surface Breast Implants.

With the recent voluntary recall by Allergan of their Biocell textured implants, many plastic surgeons are left with questions of how to best manage asymptomatic patients who have concerns about having these devices. We realized that there is no clear, published recommendations or scientific data to guide surgeons on how to discuss options with their patients and recommendations for surgical management in this uncharted territory. Using available literature and personal experience, we answer the most common questions we are hearing from our plastic surgery colleagues.

Surgical Breast Pocket Irrigation With Hypochlorous Acid (HOCl): An In Vivo Evaluation of Pocket Protein Content and Potential HOCl Antimicrobial Capacity.

Background: Hypochlorous acid (HOCl) demonstrates rapid and broad antimicrobial activity against planktonic and biofilm phenotype bacteria in vitro. Objectives: To identify the protein content present in breast pockets in vivo and calculate the estimated active concentration of HOCl, (PhaseOne, Integrated Healing Technologies, Franklin, TN) following HOCl-protein interactions. Methods: Fluid samples were collected prior to implant insertion in 18 consecutive patients, representing 36 pocket samples, with all cases being bilateral primary breast augmentations. Samples were evaluated by an independent CLIA approved laboratory for albumin and total protein concentration in g/dL. Results were compared to HOCl solution concentration and protein binding potential to determine availability of free HOCl. Results: The mean tissue sample concentration (right and left breast) was 31.6 mg/dL which translates to 0.0001 mmol per 20 cc of interstitial fluid. Mean total protein levels (right and left breast) were 62.3 mg/dL or 0.000187 mmol per 20 cc interstitial fluid. Based upon potential stoichiometric neutralization of HOCl by proteins in either a 1:1 or 3:1 ratio, using 115 cc of HOCl solution (per breast) at a concentration of 250 ppm/mL or 0.025% HOCl or = 0.48 mmol HOCl/dL, there would be 2950 times the amount of active HOCl at a 1:1 reaction ratio, or 983 times more HOCl assuming a 3:1 reaction ratio. Based on the range of identified levels of protein in individual surgical pockets in the study, there is an estimated 242 to 12,500 times more HOCl molecules than protein at a 3:1 molar ratio of binding or reactive protein. Conclusions: n estimated range of 983-2950 times more HOCl molecules are present during irrigation with 230 cc of PhaseOne® (115 cc for each breast) than available protein. This supports the antimicrobial and anti-biofilm activity as described in previous in vitro studies when using PhaseOne® as part of pocket irrigation.

Results of the Postmarket Clinical Study of the Sientra 207 Highly Cohesive Gel Breast Implants in Primary and Revision Augmentation.

BACKGROUND: Board-certified plastic surgeons utilizing the Sientra 207 Highly Cohesive Gel breast implants provided their initial satisfaction with usage and postoperative results on primary and revision augmentation patients, and study participants provided their satisfaction with surgical result. METHODS: Up to 15 participating investigators at institutional review board-approved sites enrolled up to 180 women who received Sientra 207 implants for primary augmentation or revision augmentation procedures. Investigator and participant assessments were performed preoperatively and postoperatively at 3, 6, and 12 months. RESULTS: All participating surgeons found the implants to be easy or very easy to implant, and 92 percentage reported satisfaction with surgical results. Patients receiving these implants reported similarly high rates of satisfaction (94%). CONCLUSION: With this combination of high satisfaction and low complication rates, the Sientra 207 silicone breast implants now provide a welcome addition to plastic surgeons' breast implant options.

Factors Affecting Women's Success in Academic and Private Practice Plastic Surgery.

Because plastic surgery trainees generally spend the majority of their training in academic centers and may have minimal exposure to other practice models, it can be difficult to decide which is the best route to achieve satisfaction and success. Surgeons need to be aware of benefits and challenges associated with different practice models and with workplace factors in general that contribute to happiness at work. This article reviews common practice models and provide specific and practical advice for the female surgeon.

Sientra primary and revision augmentation rupture trending and analysis with magnetic resonance imaging.

BACKGROUND: Rupture of silicone gel breast implants is a rare occurrence but remains one of the key surgical concerns. The objective of this article was to provide visibility and information on trends for the impact that patient and surgical characteristics play in the occurrence of rupture. OBJECTIVES: Examine trends in surgical techniques to better understand the etiology of implant rupture. METHODS: Analysis was based on Sientra's prospective, open-label, U.S.-based clinical study of High-Strength Cohesive silicone breast implants. Patient and surgical characteristics were compared between ruptured and intact implants. RESULTS: The subset of data used for this analysis included 1792 implants in 935 primary and revision augmentation patients implanted by 31 plastic surgeons, with an average follow-up of 6.6 years. The results confirm that rupture remains a rare adverse event. Overall, the rupture prevalence for this study was 2.4%. Rupture prevalence was lower among textured devices (0.8%) compared to smooth devices (3.8%). The prevalence of rupture was 7.8% among devices placed with a transaxillary incision site compared to 1.6% and 3.0% when placed with an inframammary or periareolar incision site, respectively. Rupture was reported in 5.5% of the devices that received steroid pocket irrigation, compared to 1.8% of the devices that did not. CONCLUSIONS: Although ruptures in the Sientra study with the High-Strength Cohesive silicone gel implants were an uncommon occurrence, the authors were able to identify strong trends for the association of certain surgical factors and characteristics. The results show among other factors that an inframammary approach and a textured device were found to be protective against rupture. LEVEL OF EVIDENCE: 2 Therapeutic.

Sientra portfolio of Silimed brand shaped implants with high-strength silicone gel: a 5-year primary augmentation clinical study experience and a postapproval experience-results from a single-surgeon 108-patient series.

BACKGROUND: The Sientra portfolio of silicone gel breast implants was approved by the Food and Drug Administration on March 9, 2012, and included the first approved shaped implants in the United States. The 5-year results from Sientra's Core Gel and Continued Access Study and the results of a single surgeon are presented. METHODS: This analysis used the data of 640 shaped implants in 321 primary augmentation patients implanted by 16 study surgeons through 5 years. The Kaplan-Meier method was used to analyze safety endpoints. In addition, analysis is presented for a single surgeon's results of 213 shaped implants in 108 postapproval patients through up to 16 months of follow-up (9-month mean) using a separate frequency analysis. RESULTS: The overall risk of rupture for primary augmentation patients through 5 years was 0.4%, the risk of infection was 1.4%, and the risk of capsular contracture (Baker grade III/IV) was 3.9%. Reported surgeon satisfaction was 100%, and patient satisfaction remained high. In the separate single-surgeon analysis, after 16 months, 4 of the 108 patients experienced a complication (3.7%) and 3 underwent a reoperation (2.8%). Complications included infection, ptosis (0.9%, each), and capsular contracture (1.9%). CONCLUSIONS: The results of Sientra's large clinical study and the postapproval data from a single surgeon demonstrate the safety and effectiveness of Sientra's shaped implants. The review of the data and author's experience illustrate the ease of incorporating shaped implants into any surgical practice.

Ultrasound-assisted lipoplasty.

The use of ultrasound-assisted lipoplasty (UAL) to assist in the removal of subcutaneous fat has been practiced in Europe for nearly 15 years and over the last 7 years has gained popularity in the United States. Liposuction is now one of the most commonly performed cosmetic procedures by board-certified plastic surgeons. This article will review the UAL procedure, its history, regulatory issues, instrumentation and equipment needed. It will also review changes and recent updates, clinical protocol, complications, and future considerations.