Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation.

BACKGROUND: Despite the increased understanding of surgical best practices, capsular contracture remains the most commonly reported complication and reason for reoperation following breast implant surgery. This study provides a long-term update to a previous investigation of potential contributing risk factors for capsular contracture in primary augmentation patients. METHODS: The data used for this analysis include 5,122 implants in 2,565 primary augmentation patients implanted by 34 surgeons based on long-term results from Sientra's clinical study. Potential risk factors, including patient and implant attributes, surgery characteristics, pocket irrigation, and postsurgery characteristics, were analyzed using frequency and multivariate models. RESULTS: A total of 333 capsular contracture events in 224 patients were reported. The overall Kaplan-Meier rate for capsular contracture was 10.8% by device through 10 years. Results from the multivariate analysis found 8 factors to be independently associated with capsular contracture (implant placement, implant surface, incision site, hematoma or seroma development, device size, surgical bra, steroid, and antibiotic pocket irrigation; all P values < 0.05). Results from correlation analysis found 2 of the 8 factors to be more strongly associated with early onset capsular contracture events, compared with those occurring after 2 and 5 years of implantation (implant surface and steroid pocket irrigation). CONCLUSION: The results of this large-scale, multivariate analysis identified several significant risk factors for capsular contracture, including device features (smooth surface, smaller size), surgical factors (periareolar incision, subglandular placement, antibiotic irrigation), the development of hematoma/seroma, and the use of a surgical bra.

Sientra AlloX2 Short-Term Case Study, Surgical Pearls, and Roundtable Discussion.

BACKGROUND: The AlloX2 Breast Tissue Expander (Sientra, Santa Barbara, Calif.) is a unique device that contains a second port to allow for transdermal communication with the pocket around the implant. The injection dome of this expander contains two ports; one is used for traditional saline injection, and a new second port facilitates fluid drainage from the periprosthetic space through an integral drain. The AlloX2 allows for the treatment of seromas and diagnostic fluid sampling to identify bacteria and hone antibiotic treatment in the setting of periprosthetic infection. This device has a significant advantage over traditional expanders, given that seromas and infections are the most common complications in implant-based breast reconstruction, with or without the use of soft-tissue support matrix. METHODS: This article provides short-term case studies and surgical pearls from 3 surgeons who utilize the AlloX2 in primary breast reconstruction patients. Three surgeons implanted 40 primary reconstruction patients with AlloX2. Follow-up was approximately 6 months, per the standard of care. All patients implanted with AlloX2 underwent immediate reconstruction, with the exception of 1 delayed reconstruction. RESULTS: The most common complications the patients experienced were seromas. In most cases, the surgeons successfully used the second port to drain periprosthetic fluid. CONCLUSIONS: The AlloX2 has been successful in treating seromas and should be considered a tool for noninvasive treatment of common complications of implant-based breast reconstruction. Three surgeons with varied backgrounds and techniques provide their surgical and postoperative management experiences and recommendations.

Cryolipolysis for Nonsurgical Reduction of Fat in the Lateral Chest Wall Post-Mastectomy.

BACKGROUND: Many patients that have undergone mastectomy surgery are left with residual lateral fat under the arm. While the fat may be associated with pain and cause undesirable bulges in clothing and skin irritation, most post-mastectomy patients are not interested in additional surgery. OBJECTIVES: Cryolipolysis is a nonsurgical procedure for fat reduction. The procedure is typically performed for aesthetic improvement in the abdomen, thighs, and flanks, but cryolipolysis was explored in this study for reconstructive purposes. Efficacy was evaluated for nonsurgical reduction of lateral chest wall thickness post-mastectomy. METHODS: A contoured cup vacuum applicator was used to treat 31 post-mastectomy patients under the arms. All subjects had undergone mastectomy but had never received cryolipolysis or any surgical procedures to reduce lateral chest wall fat. Treatments were evaluated by independent photo review and patient surveys. RESULTS: Three blinded, independent physicians correctly identified 84% of the baseline photographs, demonstrating treatment efficacy. The surveys also found that 87% of subjects reported that cryolipolysis met their expectations; 84% noticed reduction in undesirable tissue; 85% reported better bra fit; and 74% noted that clothing fit more comfortably. Patient questionnaires reveal quality of life improvements post-treatment. While 61% of subjects reported pain in the lateral wall prior to the study, when queried post-treatment, only 13% reported pain; the remaining 87% reported no lateral wall pain. CONCLUSIONS: Results from this study indicate that cryolipolysis nonsurgically reduces unwanted fat and may reduce discomfort from residual lateral chest wall fat in post-mastectomy patients.

Sientra high-strength cohesive shaped technique: roundtable discussion.

UNLABELLED: A panel of board-certified plastic surgeons chaired by Dr Michael Schwartz convened to discuss their respective experiences with the Sientra High-Strength Cohesive (HSC+) shaped silicone gel breast implants (Sientra, Inc., Santa Barbara, CA). The authors have implanted a combined total of over 700 patients. Preoperative planning, surgical techniques, and practice integration tips are among the topics reviewed. The surgeons also present breakthrough cases and describe how the HSC+ textured implants helped them achieve a successful outcome. LEVEL OF EVIDENCE: 5Therapeutic.

The biology and evolution of cohesive gel and shaped implants.

The introduction of the silicone gel implant in 1962 began the modern era of breast augmentation, and over the past 50 years, breast implants have evolved to encompass a wide array of commercially available implants today. In April 1992, the moratorium on silicone gel breast implants began, and much of the experience and development of the cohesive shaped implants occurred outside the United States. During this time, saline implants were used almost exclusively in North America, whereas silicone implants continued to be used throughout the rest of the world. In 2001, cohesive gel implants became available in the United States under an Investigational Device Exemption Study. Three companies have US Food and Drug Administration approval of fifth-generation implants: Sientra, Allergan, and Mentor. These implants are unique due to the texture of the shell, implant dimensions, gel-shell interaction, gel fill ratio, degree of cross-linking, and form stability. Although form stability is a relative term, it may best be reserved to describe the increased ability of the implant to maintain its basic, intended shape. The cross-linking, form stability, and cohesiveness of these fifth-generation implants provide surgeons with an innovative tool to more closely create a natural breast in both shape and softness.

Risk factor analysis for capsular contracture: a 5-year Sientra study analysis using round, smooth, and textured implants for breast augmentation.

BACKGROUND: Although there are a few broadly agreed on contributory factors, the multifaceted causes of capsular contracture have remained unresolved for decades. This study investigates a variety of potential risk factors that contribute to capsular contracture in primary augmentation patients. METHODS: The data used for this analysis include 5109 implants in 2560 primary augmentation patients implanted by 34 surgeons based on 5-year results from Sientra's clinical study. Patients were evaluated at annual visits where the capsular contracture Baker grade was recorded. Potential risk factors, including patient attributes, implant attributes, surgery characteristics, pocket irrigation, and postsurgery characteristics, were analyzed using frequency and multivariate models. RESULTS: A total of 265 capsular contracture events in 179 patients were reported through 5 years. The overall Kaplan-Meier rate for capsular contracture was 7.6 percent by device. The unadjusted analysis showed increased odds of capsular contracture in smooth devices, periareolar incision, subglandular placement, antibiotic and steroid pocket irrigation, recommended massage, and surgical bra (p<0.05 for all). Results from the multivariate analysis, adjusting for all variables in the model, found six factors to be independently associated with capsular contracture (i.e., implant placement, implant surface, incision site, hematoma or seroma development, device size, and surgical bra; p<0.05 for all). CONCLUSION: This analysis has provided evidence that submuscular placement and textured implants, in addition to other factors, are significant in reducing the incidence of capsular contracture.

Reverse sural artery flap: caveats for success.

Complex open wounds of the distal third of the leg and ankle remain a reconstructive challenge for the plastic surgeon. In many cases, these wounds are best addressed with a free tissue transfer. Although this group has performed more than 400 free flaps to the leg during the past 6 years, free tissue transfer can be an arduous operation that requires a team approach and substantial donor site morbidity for the patient. In recent years, the authors have favored the reverse sural artery fasciocutaneous flap in 11 patients for its ease of dissection, limited morbidity, and preservation of major vessels to the limb. Caveats for successful performance of the reverse sural artery flap include Doppler evidence of patent peroneal perforators, placement of a lazy T-shape skin paddle over the distal gastrocnemius muscle bellies, inclusion of the lesser saphenous vein to augment venous drainage, and, lastly, careful dissection to provide a wide adipofascial pedicle.