Clinical Results of Mentor MemoryGel Xtra Breast Implants From the GLOW Clinical Trial.

BACKGROUND: Mentor MemoryGel Xtra breast implants (Mentor Worldwide LLC, Irvine, CA) were designed to maintain the soft, natural feel of MemoryGel implants while increasing fullness and projection and minimizing wrinkling, rippling, and related complications through optimization of shell gel-fill. OBJECTIVES: To measure 3-year safety and effectiveness of MemoryGel Xtra breast implants in the Mentor MemoryGel and MemoryShape Combined Cohort Clinical Study. METHODS: Participants were implanted with MemoryGel Xtra breast implants in a prospective, multicenter clinical trial. Rates of complications and reoperations were analyzed to assess device safety and BREAST-Q was employed to assess device effectiveness. RESULTS: Two hundred eighty-seven females receiving MemoryGel Xtra breast implants were enrolled. Complication rates in the primary augmentation cohort included rates of 1.5% for implant-related reoperation, 2.3% for explantation, and 1.5% for Baker grade III or IV capsular contracture. For the revisional augmentation cohort, these rates were 2.8% for implant-related reoperation, 4.3% for explantation, and 3.0% for capsular contracture. For the primary reconstruction cohort, these rates were 12.0% for implant-related reoperation, 12.3% for explantation, and 7.3% for capsular contracture. For the revisional reconstruction cohort, these rates were 7.1% for capsular contracture, with zero implant-related reoperations or explantations. There were no reports of infection or implant malposition or displacement in any of these cohorts. Each cohort showed significantly improved satisfaction with breasts and psychosocial and sexual well-being at 1 year following the primary procedure. CONCLUSIONS: These data are consistent with legacy clinical data for MemoryGel and provide the first published safety and effectiveness data regarding the use of MemoryGel Xtra breast implants for breast augmentation and reconstruction.

Evaluation of Vectra® XT 3D Surface Imaging Technology in Measuring Breast Symmetry and Breast Volume.

Level of Evidence V This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The Role of Premastectomy Mastopexy and Breast Reduction in the Reconstruction of the Enlarged or Ptotic Breast.

BACKGROUND: The indications for nipple-sparing mastectomy have broadened over time. Patients undergoing nipple-sparing mastectomy who have enlarged or ptotic breasts are at risk for skin flap and/or nipple-areola complex necrosis. Premastectomy mastopexy or breast reduction may reduce the risk for these complications. METHODS: A retrospective review was undertaken in a series of patients who underwent premastectomy reduction mammaplasty or mastopexy followed by nipple-sparing mastectomy and immediate staged tissue expander/implant-based breast reconstruction. In each case, a subnipple biopsy was performed at the premastectomy procedure to clear it of any potential malignant involvement. In addition, the area under the areola was undermined to maximize the effect of the delay phenomenon on the eventual survival of the nipple-areola complex. Final reconstruction involved tissue expander exchange for a permanent implant with associated fat grafting. Data regarding surgical timing and selected postoperative complications were recorded. RESULTS: In total, 39 implant-based reconstructions were performed in 20 patients. There were no cases of mastectomy flap necrosis, and partial necrosis of the nipple-areola complex with delayed wound healing was seen in two breasts in the same patient. All patients eventually completed the reconstructive process successfully. CONCLUSION: Premastectomy mastopexy or breast reduction may afford a protective effect against mastectomy flap or nipple-areola complex necrosis in patients with large or ptotic breasts who subsequently undergo nipple-sparing mastectomy with immediate breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Defining the Relationship between Pocket and Breast Implant Surface Area as the Basis for a New Classification System for Capsular Contracture.

BACKGROUND: The precise cause of and treatment for capsular contracture remains uncertain, at least partially because there is no reliable quantitative measurement tool. To address this, it is postulated that the surface area of an implant as defined by the surrounding pocket may provide a quantifiable variable that can be measured to evaluate the degree of capsular contracture. METHODS: A bench model for capsular contracture was developed. The surface area of a series of spherical test objects and noncontracted and contracted breast implants was measured using a wax-coating technique and three-dimensional reconstructions created from computed tomographic scan images. RESULTS: Comparison of the mathematically calculated surface areas to the wax and computed tomographic scan results for spheres of known dimension provided nearly identical values, documenting the accuracy of the two experimental methods. Comparison of the surface area measurements between the test groups showed that the average decrease in surface area for all implants was 20 percent, ranging from a high of 30.9 percent for a low-profile implant to a low of 14.1 percent for a high-profile implant. The anatomically shaped devices demonstrated nearly uniform degrees of surface area change over three different heights with volume and projection held relatively constant. CONCLUSIONS: The described bench model provides a useful tool for the study of capsular contracture. Surface area is a descriptive variable that can assess the degree of capsular contracture that is present. A classification system based on surface area is presented. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Use of Three-Dimensional Imaging to Assess the Effectiveness of Volume as a Critical Variable in Breast Implant Selection.

BACKGROUND: In breast augmentation, breast base diameter has been recognized as an important variable in implant selection. However, breast implant volume also has a tremendous impact on the final result. Previous methods of preoperative volume determination have been limited to external devices in a bra. Computer-based three-dimensional simulation technology now allows the physician to effectively communicate with the patient preoperatively regarding volume. METHODS: A cohort of 40 consecutive patients underwent routine breast augmentation with either anatomically shaped or round implants. Five methods of preoperative volume determination including the Crisalix three-dimensional computer imaging system (Crisalix Virtual Aesthetics, Lausanne, Switzerland), along with an associated virtual reality tool, were used to assess the preoperative desires of the patients. A postoperative questionnaire was used to assess patient satisfaction with each volume determination method. RESULTS: Of the 40 patients, 100 percent were satisfied with their result; however, given the opportunity, 12 percent would have chosen a larger implant. The virtual reality tool and external sizers were shown to be the most effective in choosing an implant. The virtual reality tool was judged to be very helpful (62 percent), very accurate (78 percent), and important (88 percent) in helping patients choose their desired implant size. CONCLUSION: Prioritizing volume as an implant selection variable in breast augmentation results in a very high rate of patient satisfaction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Chronic Persisting Hematoma: Report of a Case and Literature Review.

The authors present a unique case of chronic persisting hematoma formation at the site of a remote congenital melanocytic nevus excision with tissue expander reconstruction. Similarities between chronic persisting hematoma and chronic encapsulated seroma are addressed to provide guidance on the appropriate workup and management for the plastic surgeon. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Not All Breast Explants Are Equal: Contemporary Strategies in Breast Explantation Surgery.

SUMMARY: Breast implant removal and replacement has been a common secondary breast procedure in the long-term maintenance of breast augmentation, but more recently growing concerns about silicone-related systemic illness, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and changing perceptions of aesthetic beauty have seen breast implant removal without replacement become increasingly requested by patients. Explantation can be challenging, especially when performed with a total capsulectomy. Currently, there is no evidence regarding whether a partial or total capsulectomy has any effect on BIA-ALCL risk mitigation in patients that have textured implants without disease. Total capsulectomy with incomplete resection of a mass can contribute to hyperprogression of BIA-ALCL and death. There have also been cases of BIA-ALCL diagnosed years after removal of the textured device and "total capsulectomy." Therefore, the common practice of simple prophylactic capsulectomy in a textured implant to mitigate future disease has not been established and at the current time should be discouraged. In addition, aesthetic outcomes can be quite variable, and patients should have appropriate preoperative counseling regarding the indications and contraindications for explantation, associated risks, financial implications, and postoperative appearance. The authors review salient aspects related to the planning and management of breast implant removal.