Why Do We Need Anatomical Implants? the Science and Rationale for Maintaining Their Availability and Use in Breast Surgery.

The choice between anatomical and round implants is an important decision in breast augmentation surgery; however, both have their place and the decision between them that should be made on a patient-by-patient basis, taking into account the patient's desires, anatomy, and surgical history. In some individuals, there are clear indications for using either anatomical or round devices, and there is good evidence that aesthetic outcomes are better with anatomical implants in some instances. When both types are an option, anatomical devices may offer increased flexibility and, despite a longer learning curve needed to properly manage them, they are associated with positive long-term outcomes and high levels of patient satisfaction. Concerns about implant rotation can be minimized with proper patient selection and surgical technique, and the overall complication rate may favor anatomical over round devices in appropriate patients. Breast implant-associated anaplastic large-cell lymphoma is an important issue, and while rare, it must be considered in the context of the entire patient risk profile. Both anatomical and round implants remain key elements of a complete surgical toolbox in breast augmentation. LEVEL OF EVIDENCE IV: 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.

Prepectoral Revision Breast Reconstruction for Treatment of Implant-Associated Animation Deformity: A Review of 102 Reconstructions.

BACKGROUND: Animation deformity is a direct consequence of subpectoral implant placement for breast reconstruction following mastectomy. Current treatment options ameliorate but do not address the source of the problem. Moving the implant from subpectoral to prepectoral has the potential to eliminate animation deformity. OBJECTIVES: Describe the technique and outcomes of prepectoral revision reconstruction in over 100 cases and discuss patient selection criteria for a successful outcome. METHODS: Patients who presented with animation deformity following two-stage implant reconstruction were included in this retrospective study. Revision surgery involved removal of the existing implant via the previous incision site along the inframammary fold, suturing of the pectoralis major muscle back to the chest wall, creation of a prepectoral pocket for the new implant, use of acellular dermal matrix to reinforce the prepectoral pocket and completely cover the implant, and fat grafting to enhance soft tissue. Patients were evaluated for resolution of animation deformity and occurrence of complications during follow up. RESULTS: Fifty-seven patients (102 breasts) underwent prepectoral revision reconstruction with complete resolution of animation deformity. Complications occurred in 4 breasts (3.9%) and included seroma (2 breasts), skin necrosis (3 breasts), and wound dehiscence (1 breast). All 4 breasts with complications had their implants removed and replaced. There were no incidences of infection or clinically significant capsular contracture in this series. CONCLUSIONS: Revision reconstruction with prepectoral implant placement and complete coverage with acellular dermal matrix resolves animation deformity and results in aesthetically pleasing soft breasts. Patient selection is critical for the success of this technique.

A Comparison of Two Fat Grafting Methods on Operating Room Efficiency and Costs.

BACKGROUND: Centrifugation (Cf) is a common method of fat processing but may be time consuming, especially when processing large volumes. OBJECTIVES: To determine the effects on fat grafting time, volume efficiency, reoperations, and complication rates of Cf vs an autologous fat processing system (Rv) that incorporates fat harvesting and processing in a single unit. METHODS: We performed a retrospective cohort study of consecutive patients who underwent autologous fat grafting during reconstructive breast surgery with Rv or Cf. Endpoints measured were volume of fat harvested (lipoaspirate) and volume injected after processing, time to complete processing, reoperations, and complications. A budget impact model was used to estimate cost of Rv vs Cf. RESULTS: Ninety-eight patients underwent fat grafting with Rv, and 96 patients received Cf. Mean volumes of lipoaspirate (506.0 vs 126.1 mL) and fat injected (177.3 vs 79.2 mL) were significantly higher (P < .0001) in the Rv vs Cf group, respectively. Mean time to complete fat grafting was significantly shorter in the Rv vs Cf group (34.6 vs 90.1 minutes, respectively; P < .0001). Proportions of patients with nodule and cyst formation and/or who received reoperations were significantly less in the Rv vs Cf group. Based on these outcomes and an assumed per minute operating room cost, an average per patient cost savings of $2,870.08 was estimated with Rv vs Cf. CONCLUSIONS: Compared to Cf, the Rv fat processing system allowed for a larger volume of fat to be processed for injection and decreased operative time in these patients, potentially translating to cost savings. LEVEL OF EVIDENCE 3.

Asymmetry of Inframammary Folds in Patients Undergoing Augmentation Mammaplasty.

BACKGROUND: Variation in the anatomical position of the inframammary fold (IMF) in women remains poorly studied. OBJECTIVES: The purpose of this study was to evaluate the incidence of asymmetry between IMF locations on the chest wall of women undergoing breast augmentation and to determine breast measurements associated with IMF asymmetry. METHODS: Three-dimensional imaging analysis of the breasts was performed in 111 women with micromastia, using the Vectra Imaging System(TM). The following measurements were recorded: vertical distance between right and left IMF (inter-fold distance), vertical distance between nipples (inter-nipple distance), and difference between projection of right and left breasts in anterior-posterior direction. RESULTS: Asymmetry between the right and left IMF positions was found in the majority of patients (95.4%), with symmetry only found in 5 patients (4.6%). In the majority of patients (60.3%), the right IMF was located inferior to the left IMF with median inter-fold distance 0.4 cm (range, 0.1, 2.1 cm). In 39 patients (35.1%), the left IMF was located inferior to the right with median inter-fold distance 0.4 cm (range, 0.1, 1.7 cm). There was strong correlation between the degree of asymmetry of IMF and asymmetry of nipple areola complex (NAC) positions (r = 0.687, P < .01). CONCLUSIONS: The majority of women with micromastia demonstrate asymmetry of the IMF, which correlates with asymmetry of NAC location. The authors propose a classification system based on most commonly observed IMF locations as types I (right IMF inferior to left), type II (left IMF inferior to right) and type III (both IMF located on the same level). LEVEL OF EVIDENCE 4: Diagnostic.

The efficacy of botulinum toxin A in post-mastectomy breast reconstruction: a pilot study.

BACKGROUND: Botulinum toxin A has been successfully used in a variety of areas to temporarily obliterate muscle mobility for either functional or aesthetic gain. Tissue expander-based breast reconstruction has been plagued with pain and discomfort. OBJECTIVE: The purpose of this pilot study was to evaluate the role of a neurotoxin (Botulinum toxin A) in expander-based breast reconstruction. METHODS: Thirty patients underwent mastectomies with immediate expander or acellular dermal matrix reconstruction. The neurotoxin group (n = 15) received 40 units of neurotoxin (Botulinum toxin A, Allergan, Inc, Irvine, CA) into each pectoralis major muscle through 4 serial injections and the placebo group (n = 15) received 4 serial injections of 0.9% NaCl. All patients were followed over 1 year, and patient demographics, VAS (visual analog score), laterality, office visits, amount of expansion and number of times to full expansion, and amount of narcotics required were recorded. Statistical significance was considered as p < .05. RESULTS: There were no significant differences between the two groups in terms of age, laterality, expander size, or complications (p = .46-.66). There was a significant difference between the two groups in the VAS score, demonstrating decreased pain in the neurotoxin group (p < .05). In addition, there was a significant increase in the volume of expansion per visit in the neurotoxin group as compared to the placebo group (p < .05). There was no significant difference in narcotic use in the first 3 days after surgery; however, there was a significant decrease in use of narcotics from 7 to 45 days in the neurotoxin group (p < .05). There were no complications associated with the use of the neurotoxin. CONCLUSIONS: The infiltration of the pectoralis major muscle with neurotoxin in immediate, expander-based reconstruction may be beneficial in reducing pain and expediting expansions.

Ten-year results from the Natrelle 410 anatomical form-stable silicone breast implant core study.

BACKGROUND: Silicone breast implants have long been used for breast augmentation and reconstruction. During this time, these medical devices have gone through a number of modifications to improve their safety, quality, and clinical outcome performance. OBJECTIVES: The authors conducted a 10-year study to determine the safety and effectiveness of Natrelle 410 silicone breast implants. METHODS: This prospective, multicenter study enrolled 941 subjects who were undergoing either augmentation, augmentation revision, reconstruction, or reconstruction revision. Data on complications, reoperations, explantations, and subject satisfaction were collected at annual clinic visits, and one-third of subjects underwent biennial magnetic resonance imaging (MRI) to screen for implant rupture. The authors used the Kaplan-Meier estimator to calculate risk rates for local complications, reoperations, and explantations. RESULTS: Capsular contracture rates increased approximately 1% per year from the previously reported 6-year rates. The rates were significantly lower than those from the Natrelle round gel core study. The overall rate of confirmed ruptured implants in subjects who underwent MRI was 5.7%. Eleven late seromas were reported. The most common reason for explantation was a subject requesting a size or style change. Satisfaction rates remained high through 10 years, with most subjects saying they were somewhat or definitely satisfied with their implants. CONCLUSIONS: This 10-year prospective trial demonstrated the long-term safety and effectiveness of Natrelle 410 anatomical form-stable implants. The complication rates were low and the satisfaction rates were high. LEVEL OF EVIDENCE 1: Therapeutic.

Non-cross-linked porcine acellular dermal matrix in revision breast surgery: long-term outcomes and safety with neopectoral pockets.

BACKGROUND: Revision breast surgery represents a significant problem among patients who have undergone augmentation mammaplasty. Current techniques do not adequately prevent recurrence, thus requiring novel approaches, including placement of Strattice (LifeCell, Branchburg, New Jersey), a non-cross-linked porcine acellular dermal matrix, to minimize recurrence. OBJECTIVE: The authors review their experience and long-term outcomes with placement of Strattice in revision breast surgery patients who underwent previous augmentation mammaplasty. METHODS: All patients in the authors' practice with a previous history of augmentation mammaplasty who underwent revision breast surgery with placement of Strattice between January 2007 and December 2011, and who had a minimum of 12 months of follow-up, were included in this retrospective study. A total of 106 patients met the study's inclusion criteria. RESULTS: Average patient age was 42.3 years and average follow-up time was 3.1 years. Indications for revision surgery included capsular contracture (51.9%), implant malposition (38.7%), and ptosis (8.5%); approximately 40% had ≥1 previous attempts to correct the presenting complaint. Revision surgery included creation of neosubpectoral pockets with retention of previous noncalcified capsules in 81% of patients with subpectoral implants. Presenting complaints were successfully resolved in all patients. The overall complication rate was 0.9%. CONCLUSIONS: Adding Strattice to traditional revision surgery procedures results in reliable, durable repair of the presenting complaint with minimal associated complications. Treatment with Strattice in conjunction with noncalcified capsules retained during site change also appears to be safe. The data support a role for Strattice in revision breast surgery for patients who have undergone previous augmentation mammaplasty.

Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness.

Implant texture is an important factor influencing implant selection for breast augmentation. Natrelle Biocell implants are characterized by macrotextured shell surfaces containing irregularly arranged concavities with large open-pore diameters and depths. These properties facilitate adhesion of the implant to the surrounding tissue, thereby promoting implant immobilization. Relative to implants with other surfaces, macrotextured implants offer low rates of capsular contracture; low rates of malposition, rotation, and rippling; and high rates of patient satisfaction. However, macrotextured implants are associated with a slightly higher risk of double capsule and late seroma. The surgeon can minimize these risks with straightforward techniques that encourage tissue adhesion. This report presents experience-based recommendations to optimize the effectiveness of Biocell anatomic implants. The authors discuss the application of best practices to all aspects of the breast implantation process, from implant selection and surgical planning to operative technique and postoperative management. LEVEL OF EVIDENCE 3.

Efficacy of acellular dermal matrices in revisionary aesthetic breast surgery: a 6-year experience.

BACKGROUND: Augmentation mammaplasty and augmentation mastopexy are associated with a substantial primary and secondary revision rate. Capsular contracture (CC), implant malposition, ptosis, asymmetry, and rippling are the main reasons for revisionary surgery in these patients. Traditional corrective techniques have not been completely reliable in preventing or treating these complications. Recently, acellular dermal matrices (ADM) have been used to assist with revisionary surgery with promising results. OBJECTIVE: The authors review their 6-year experience using ADM for revisionary surgery in aesthetic patients and evaluate long-term outcomes with this approach. METHODS: Patients who underwent revisionary breast augmentation or augmentation mastopexy with ADM in conjunction with standard techniques over a 6-year period between October 2005 and December 2011 were retrospectively reviewed. Only patients with at least 1 year of follow-up were included in the analysis. RESULTS: A total of 197 revisions were performed (197 patients). Reasons for revision included CC (61.8%), implant malposition (31.2%), rippling (4.8%), ptosis (4.8%), implant exposure (1.6%), and breast wound (0.5%). The mean ± SD follow-up period was 3.1 ± 1.1 years (range, 0.1-6.1 years). The complication rate was 4.8%, including Baker grade III/IV CC (1.6%), infection (1.6%), implant malposition (0.5%), hematoma (0.5%), and seroma (0.5%). Most (98%) revisions were successful, with no recurrence of the presenting complaint. CONCLUSIONS: The use of ADM in conjunction with standard techniques for the reinforcement of weak tissue in revision augmentation and augmentation mastopexy patients appears to be effective.

The use of Targeted MicroCurrent Therapy in postoperative pain management.

Effective postoperative analgesia is a prerequisite to enhance the recovery process and reduce morbidity. The use of local anesthetic techniques is well documented to be effective, but single-dose techniques (infiltration, peripheral blocks, neuraxial blocks) have been of limited value in major operations because of their short duration of analgesia. Recent advances in technology have led to the development of a noninvasive device, targeted MicroCurrent Therapy, which enhances postsurgical recovery by stimulating the body's natural healing process. This therapy transmits gentle, short bursts of electrical current targeted to the tissue cells at the surgical site. This article reviews recent clinical experience and evidence of this device in plastic and reconstructive surgery.

Bleeding risks of herbal, homeopathic, and dietary supplements: a hidden nightmare for plastic surgeons?

The utilization of complementary and alternative medicine has increased tremendously in the last two decades. Herbal products, homeopathic medicines, and dietary supplements are extremely popular and are available without a prescription (which likely contributes to their popularity). Despite their "natural" characteristics, these remedies have the potential to cause bleeding in patients who undergo surgery. The high use of these supplements among cosmetic surgery patients, coupled with increasing reports of hematomas associated with herbal and homeopathic medicines, prompted the authors to conduct a comprehensive review focused on bleeding risks of such products in an effort to raise awareness among plastic surgeons. This review focuses on 19 herbs, three herbal formulas, two herbal teas, and several other supplements that can cause bleeding perioperatively and postoperatively. In addition to being aware of such adverse effects, plastic surgeons must adequately screen all patients and educate them on the possible dangers associated with these treatments.

Natrelle style 410 form-stable silicone breast implants: core study results at 6 years.

BACKGROUND: The Natrelle Style 410 shaped, form-stable silicone gel implant (Allergan, Inc; Irvine, California) has been the subject of a pivotal study that supports potential US Food and Drug Administration approval of the device. The 3-year results of this study were reported previously. OBJECTIVES: The authors update the safety and effectiveness findings for the Natrelle Style 410 implants through 6 years of study. METHODS: This prospective, nonrandomized, multicenter study included 941 patients (492 primary augmentations, 156 revision-augmentations, 225 primary reconstructions, and 68 revision-reconstructions). Since the original 3-year report, follow-up visits have been conducted annually. Kaplan-Meier risk rates were calculated for local complications, reoperations, and explantations. One-third of the subjects were enrolled in the magnetic resonance imaging (MRI) cohort and underwent biannual MRI rupture screening. Effectiveness was measured by subject satisfaction on a 5-point scale. RESULTS: As expected after breast implantation, capsular contracture (CC) was one of the most common complications, with 6-year risk rates of 4.6% for augmentation, 6.9% for revision-augmentation, 10.7% for reconstruction, and 18.3% for revision-reconstruction. The rates for CC among augmentations and revision-augmentations were significantly lower with the Natrelle 410 implants than with other standard gel implants. The rupture rate (confirmed plus suspected) across all cohorts was 6.4% by subject and 3.8% by implant. The most common reasons for reoperation were style or size change (augmentation), implant malposition (revision-augmentation), scarring (reconstruction), and CC (revision-reconstruction). The satisfaction rate exceeded 80% in all cohorts. CONCLUSIONS: These fifth-generation, form-stable implants represent another option to achieve desired aesthetic outcomes with minimal complications.

Clinical Evaluation of Safety and Efficacy of Radiofrequency-Assisted Lipolysis on Breast Envelope and Nipple-Areola Complex Position.

BACKGROUND: Breast ptosis as a result of pregnancy and/or breastfeeding, age, genetics, and weight loss is a common complaint among women visiting a plastic surgeon. This study sought to evaluate the utility, efficacy, and safety of radiofrequency-assisted lipolysis on the breast and nipple-areola complex position in women with breast ptosis. METHODS: This was a single-center (i.e., Maxwell Aesthetics) study of women desiring tightening of the breast envelope and elevation of the nipple-areola complex. Each patient underwent one treatment with radiofrequency-assisted lipolysis in the operating room. Radiofrequency-assisted lipolysis was applied to each breast with a BodyTite Pro handpiece. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3 months, 6 months, and 12 months by means of manual and three-dimensional computer-generated measurements (i.e., Vectra). RESULTS: Ten female patients were enrolled. Ages ranged from 23 to 54 years. Follow-up was 12 months. Data were captured for seven measurements from the nipple longitudinally at five time points. The sternal notch-to-nipple distance, the nipple-to-inframammary fold distance, and the nipple-to-nipple distance improved statistically at 6-week follow-up, which persisted through the 12-month follow-up ( p < 0.05). Patient questionnaires revealed moderate to excellent satisfaction. CONCLUSIONS: Radiofrequency-assisted lipolysis with a bipolar device to deliver radiofrequency energy to the breast is an effective modality to moderately improve breast ptosis. This study demonstrates that this treatment improves breast measurements across time, regardless of measurement type (manual versus Vectra). This modality affords a minimally invasive, effective method to improve mild to moderate breast ptosis with minimal scarring and high patient satisfaction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Evaluation of the Safety of a GalaFLEX-AlloDerm Construct in Prepectoral Breast Reconstruction.

BACKGROUND: Prepectoral implant-based breast reconstruction is gaining in popularity. Acellular dermal matrices are an integral part of prepectoral reconstruction. However, large quantities of acellular dermal matrix are required for total implant coverage, and the cost of acellular dermal matrices could be a deterrent to reconstruction. To minimize the cost, the authors have resorted to the use of a bioabsorbable mesh, GalaFLEX, as a partial replacement to acellular dermal matrices. This study evaluates the comparative safety of using a GalaFLEX-AlloDerm construct versus AlloDerm alone in prepectoral reconstruction. METHODS: Consecutive patients who underwent immediate, expander-implant, prepectoral breast reconstruction were included in this retrospective study. Patients were stratified into two groups: those who received the GalaFLEX-AlloDerm combination versus AlloDerm alone. In GalaFLEX-AlloDerm reconstructions, the lower third of the expander was covered by the AlloDerm, whereas the rest of the expander was covered by GalaFLEX. Complications following reconstruction were compared between the groups. RESULTS: AlloDerm alone was used in 128 patients (249 breasts) and GalaFLEX-AlloDerm was used in 135 patients (250 breasts). The rate of any complication was 7.6 percent in the AlloDerm-alone group and 6.4 percent in the GalaFLEX-AlloDerm group. The rate of infection, major skin necrosis, seroma, capsular contracture, prosthesis exposure/extrusion, and prosthesis loss were less than or equal to 3.0 percent in the GalaFLEX-AlloDerm group and did not differ significantly from those in the AlloDerm-only group. CONCLUSIONS: GalaFLEX bioabsorbable matrix is a less costly alternative to acellular dermal matrices in two-stage, prepectoral reconstruction with comparable safety outcomes. Further long-term data and clinical experience are needed to better understand the safety of this matrix for use in breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Prepectoral Breast Reconstruction in Morbidly Obese Patients.

Prosthetic breast reconstruction via the subpectoral approach in morbidly obese patients (body mass index: ≥40 kg/m2) has been reported to be associated with an increased risk of perioperative complications and poor outcomes. Further, immediate reconstruction appears to carry a higher risk of poor outcomes than delayed reconstruction in this population. The impact of morbid obesity on outcomes after prepectoral breast reconstruction has not yet been evaluated, and such was the purpose of this study. Methods: This retrospective study included all consecutive patients with morbid obesity who underwent prepectoral expander/implant reconstruction between July 2009 and April 2020 in the first author's practice. Patient records were reviewed, and data on demographics, comorbidities, radiotherapy use, type of mastectomy, mastectomy specimen weight, and postoperative complications following reconstruction were retrieved. Complications were stratified and compared by timing of reconstruction (immediate versus delayed). Results: Eighty-five breasts in 45 morbidly obese patients were reconstructed. Postoperative complications occurred in 11 breasts (12.9%) and included major skin necrosis (3.5%), seroma (4.7%), wound dehiscence (5.9%), and reconstructive failure (1.2%). Timing of reconstruction had little impact on postoperative complications other than major skin necrosis, which was significantly higher in the delayed group (11.1% versus 1.5%). Conclusions: Prosthetic breast reconstruction via the prepectoral approach can be successfully performed in morbidly obese patients, with outcomes approaching those seen in nonobese patients when performed by experienced surgeons. Patients with morbid obesity should not be denied this reconstructive approach because of their body mass index.

Revisionary breast surgery with acellular dermal matrices.

Revisionary breast surgeries are challenging, and advanced techniques must often be utilized in the correction of the underlying anatomical deformities. In this Featured Operative Technique, the authors describe their method, which includes a combination of revisionary surgery techniques with site change and acellular dermal matrices. This use of acellular dermal matrices has four indications based on the underlying clinical presentation: (1) as a lower pole implant interface (usually for revision mastopexy), (2) as a capsular contracture treatment (technically similar to lower pole interface), (3) as a tissue thickener (superomedial or inferolateral implant interface), or (4) as an implant stabilizer (malposition correction).

Acellular dermal matrix in aesthetic revisionary breast surgery.

Breast augmentation is one of the most commonly-performed cosmetic procedures worldwide. Unfortunately, many women require revisionary surgery related to unsatisfactory results or complications such as capsular contracture, implant malposition, and ptosis. While, historically, surgeons have relied on often-imperfect native tissue to correct these deformities, acellular dermal matrix (ADM) offers a new option for solving these difficult aesthetic problems. In this article, the authors provide background information about the role of ADM in providing excellent and lasting results to cosmetic breast augmentation patients, and they describe their method of subpectoral revisionary augmentation with ADM.